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"html": "<h2><strong>I. Summary</strong></h2><p>On February 21, 2025, President Trump issued a national security policy memorandum entitled <a href=\"https://www.whitehouse.gov/presidential-actions/2025/02/america-first-investment-policy/#:~:text=The%20United%20States%20will%20establish,those%20investments%20that%20serve%20American\" target=\"_blank\" rel=\"noopener noreferrer\">America First Investment Policy</a> (Policy Directive). The Policy Directive reiterates an open investment policy with respect to investors from allied and partner countries while outlining further restrictions on inbound and outbound investment to and from China and other so-defined foreign adversaries. </p><p>The Policy Directive is consistent with the Trump Administration’s approach of promoting U.S. technological competitiveness and manufacturing independence through deregulation and encouraging investment in U.S. industry. At the same time, it projects a tough-on-adversaries approach—defined to include China (including Hong Kong), Cuba, Iran, North Korea, Russia, and the Maduro regime in Venezuela—by describing additional measures to restrict investment from these countries, which in most cases is already non-existent or very limited, and to incentivize investors from other countries to reduce their ties to China.</p><p>The Policy Directive sets forth Administration policy, but implementation will fall to regulations and other policy actions to be implemented primarily by the Department of the Treasury (Treasury), in consultation with certain other agencies of the U.S. government. A significant portion of the Policy Directive involves measures to be implemented by the Committee on Foreign Investment in the United States (CFIUS), which is chaired by Treasury. </p><p>In Section II below, we outline some of the elements of the Policy Directive that are likely to have the most significant impact on investors. In Section III, we provide a more detailed breakdown of the policy statements in the Policy Directive.</p><h2><strong>II. Key Takeaways</strong></h2><p>As we had <a href=\"https://blog.freshfields.us/post/102jnpo/instant-reaction-cfius-under-trump-ii-back-to-the-future\" target=\"_blank\" rel=\"noopener noreferrer\">predicted</a>, the Policy Directive indicates that (1) investors from allied and partner countries will likely benefit from more predictable and efficient CFIUS reviews, and (2) Chinese investments, which already were generally unable to make it through the process, will likely face a presumption of prohibition. While some portion of the Policy Directive is simply a restatement or formalization of past practice, it also hints towards some changes that could have a material impact—for the better for allied country investors and for the worse for Chinese investors.</p><p>The Policy Directive signals the potential for increased complexity in outbound investment to China by U.S. persons, expanding the scope of, and limiting the exceptions to, the recently-effective outbound investment restrictions administered by the Department of the Treasury (Treasury).</p><p>Key takeaways for investors include the following:</p><ul><li><strong>Foreign investment is welcome again (with an asterisk*)</strong>. After a Biden Administration that was, at best, lukewarm on welcoming foreign investment, with a CFIUS process that often left investors from allied and partner countries feeling battered and bruised, the unambiguous statement recognizing the value of foreign inbound investment, including in emerging technologies and including from sovereign wealth funds, is a notable shift. </li></ul><p style=\"margin-left: 40px\">This welcoming stance could manifest in concrete ways, such as the creation of a fast-track procedure (or further clarification of the criteria for clearance through the existing declarations process) to favor investors from allied or partner countries in specific sectors.</p><p style=\"margin-left: 40px\">*However, given this White House’s willingness already to weigh in on specific transactions, the politicization of the process under the Biden Administration could persist, with risk that the outcome of some transactions could be affected by their alignment with the Administration’s political agenda. Further, the Policy Directive refers to partners and allies, but without reference to formal definitions, leaving unclear which countries (beyond treaty allies) are included.</p><ul><li><strong>The technologies that could trigger CFIUS jurisdiction over non-controlling investments (including for non-Chinese investors) could materially expand.</strong> The Policy Directive contemplates the expansion of technologies defined to be “emerging and foundational,” which could sweep non-controlling investments into a broad range of technologies into the purview of CFIUS. This could foreseeably include a wider range of technology companies, with significant impact on investments in companies engaged in biotechnology and advanced work using artificial intelligence, which today are subject to very limited controls under export regulations.<br /> </li><li><strong>Chinese investment in the United States (including greenfield investment) will find ever fewer open doors.</strong> Chinese investments into the United States, already facing significant hurdles, will be possible only into the most benign companies and industries. With a likely presumption against relying on mitigation agreements to resolve any national security concerns with Chinese investment and a presumption of prohibition for any non-passive Chinese investments into certain critical sectors, any transaction involving a U.S. business with any national security sensitivity will stand a very low chance of approval.</li></ul><p style=\"margin-left: 40px\">The more significant change for Chinse companies would be an expansion of rules (or introduction of new legislation) to allow CFIUS review of greenfield investment even in urbanized areas. This expansion, likely to be limited to investors from foreign adversaries, could mean, for example, that Chinese-owned companies could not open offices or start businesses in strategic sectors, which could have a significant impact on their ability to grow organically in the United States. Such authority has been proposed before, but with Administration support, it may be more likely than before to come to pass.</p><p style=\"margin-left: 40px\">The strongly negative messaging on investment from China reflects the views of key officials in the White House and is consistent with the expressed views of many other nominees or appointees in the Administration. We would not rule out the possibility, however, that the approach towards China, or at least particular Chinese investments, could shift as part of a deal on a trade issue that is a competing priority for the President.</p><ul><li><strong>Non-Chinese investors will still feel the burden of their ties to China.</strong> For a number of years now, CFIUS has scrutinized non-Chinese investors to understand their ties to China (including R&D, JVs, and manufacturing in China, and overall revenue dependence on China). In some cases this has led CFIUS to impose hugely burdensome mitigation and, occasionally, to recommend prohibition. The Policy Directive does not necessarily suggest that such scrutiny will be relaxed. However, it does have some constructive language that suggests that CFIUS may be more willing to work with companies that show that they understand the risk that CFIUS perceives and are taking steps to distance themselves from this risk. <br /> </li><li><strong>U.S. investors into China may face increasing burdens.</strong> The recently effective outbound investment regulations target the semiconductor industry, high performance and quantum computing, and artificial intelligence and provide for a number of meaningful exceptions. These restrictions may be expanded to include additional sectors, such as aerospace, advanced manufacturing, and biotechnology. Further, some of the existing exceptions, such as those for limited partner investments and investments in publicly traded securities, may be narrowed or eliminated. These changes could significantly narrow the scope for U.S. persons to invest in China and lead many investors to derisk by avoiding Chinese investment altogether or passing or conditioning their investment in non-US funds on those funds not making a broad range of investments in China.</li></ul><h2><strong>III. Elements of the Policy Directive</strong></h2><p style=\"margin-left: 20px\"><strong>A. CFIUS</strong></p><ul><li><strong>The Policy Directive contemplates specific measures to incentivize investment from allies and partners.</strong><br /><br />The Policy Directive matches rhetoric with specific policy prescriptions that could have a meaningful positive impact on investors from allied and partner countries.<br /><br /><ul><li>The Policy Directive states that the policy is to <strong>preserve an open investment environment</strong>, specifically noting its value in ensuring growth of artificial intelligence and other emerging technologies.<br /> </li><li>It specifically calls out <strong>sovereign wealth funds (SWFs)</strong> from allies and partners. This is notable both because it clearly signals that these countries are not lumped in with China in the context of the Policy Directive and because it pushes back against skepticism that some in the security community have had due to the engagements some of these countries and SWFs have had tied to China (but see the note further below about the continuing relevance of China ties).<br /> </li><li>It calls for the creation of an “expedited <strong>‘fast-track’” process</strong>, based on objective standards” from specified allied and partner sources. This could include, for example, CFIUS issuing guidance describing transactions that would likely receive approval if filed as a declaration such as transactions involving investors from specified countries that have already been cleared by CFIUS within a certain time period or have a history of cooperation with CFIUS. CFIUS may also use its authority to waive the mandatory filing requirements for certain sovereign wealth funds that operate independently from their respective governments and have a history of cooperation with CFIUS.<br /> </li><li><strong>Passive investment </strong>will continue to be welcomed and remain outside the scope of CFIUS review. While the Policy Directive’s statement that passive investment is welcomed from “all foreign persons” nominally would cover Chinese investment, the threshold for Chinese investment being considered non-passive is probably exceedingly low, such that investments other than in publicly traded securities will often not qualify.<br /> </li></ul></li><li><strong>While encouraging investment from partners and allies, investor ties to China will still be an important factor in CFIUS reviews of non-Chinese investors.</strong><br /><br />Non-Chinese investors may nonetheless have an elevated threat profile if they have any number of types of ties to China. These could include Chinese ownership, commercial ties to China (R&D, JVs, revenue dependency), geopolitical ties of the investor’s home country to China, and other ties that the investor has unknowingly to China.<br /><br />The Policy Directive indicates that such factors will continue to be a meaningful part of CFIUS’s risk assessment of investment by non-Chinese companies. It further notes that restrictions on investment in sensitive areas (critical technology, critical infrastructure, personal data, etc.), the likelihood or stringency of mitigation will be “proportional to their verifiable distance and independence” from Chinese government points of leverage.<br /> </li><li><strong>No Chinese investment in “strategic” sectors.</strong><br /><br />Transactions involving investors from China and other “foreign adversaries” into certain critical sectors (technology, critical infrastructure, healthcare, agriculture, energy, raw materials, “or other strategic sectors”) are expected to be fully restricted.<br /><br />This will likely have a limited impact as very few such transactions have been approved in the past eight years.<br /> </li><li><strong>Chinese investment in other sectors would require either a completely benign target or risk that can be eliminated within a defined time. No behavioral mitigation.</strong><br /><br />For investments in other sectors, CFIUS will only consider three options: (1) approve without mitigation, (2) carveout the source of the risk by a time certain, or (3) recommend prohibition. The Policy Directive suggests CFIUS will approve a transaction only if the target is completely benign or if any risk posed by the transaction can be mitigated through “concrete actions that companies can complete within a specific time,” which implies structural mitigation, such as carving out and divesting a part of the U.S. business. Otherwise, if a transaction poses a national security risk that is inherent to the U.S. business, it will not be permitted to go forward.<br /><br />This too is largely a reflection of how CFIUS has been treating such investments since 2018, in so far as CFIUS has generally been unwilling to clear Chinese investment based on a complex mitigation agreement.<br /> </li><li><strong>CFIUS authorities could be expanded to include “greenfield” investments, though likely only for foreign adversary investments.</strong><br /><br />Pursuant to the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA), CFIUS already has greenfield jurisdiction (i.e., where there is no existing business) based on proximity of real estate to sensitive locations. FIRRMA, however, carves out real estate in urbanized areas, which is likely what the Administration is seeking to cover with respect to Chinese investments in strategic sectors. To remedy this, the Administration could seek new legislation that may have a broader impact by subjecting substantially more foreign investments to CFIUS jurisdiction. Alternatively, and more likely, CFIUS can take advantage of language in FIRRMA that allows CFIUS real estate jurisdiction even in an urbanized area if prescribed by CFIUS in regulations in consultation with the Secretary of Defense.<br /> </li><li><strong>Technologies defined to be “emerging and foundational” technologies will likely expand, expanding CFIUS jurisdiction for all investors.</strong><br /><br />“Emerging and foundational technologies” are a form of “critical technologies” for CFIUS purposes. Expanding what technologies are emerging and foundational technologies will expand the types of transactions subject to CFIUS “covered investment” jurisdiction (i.e., over non-controlling investments) and potentially those subject to a mandatory filing requirement.<br /><br />The Department of Commerce (Commerce), which has been charged to date with defining such technologies, has been criticized as being too slow to designate technologies as emerging or foundational. Personnel changes and appointments at Commerce suggest the potential for a significant shift in how it approaches the definition of emerging and foundational technologies, likely much more willing to sweep in technologies regardless of the willingness of allies and partners to do so.</li></ul><p style=\"margin-left: 20px\"><strong>B. Outbound Investment</strong></p><ul><li><strong>Outbound restrictions may be materially expanded to include new sectors, including, e.g., biotechnology, aerospace, and advanced manufacturing.</strong><br /><br />Companies contemplating investment into China should review pending and future investments, in particular those that related to any technology enumerated on the White House Office of Science & Technology (OSTP) Critical and Emerging technologies <a href=\"https://www.govinfo.gov/content/pkg/CMR-PREX23-00185928/pdf/CMR-PREX23-00185928.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">list</a> or the <a href=\"https://crsreports.congress.gov/product/pdf/IF/IF10964\" target=\"_blank\" rel=\"noopener noreferrer\">Made in China 2025 list</a>.<br /> </li><li><strong>Significant exceptions in the recently-effective rules (e.g. for investment in publicly traded securities) may be limited or eliminated.</strong><br /><br />The current outbound investment regulations contain exceptions for limited partner investments in private equity and venture capital funds in certain circumstances, greenfield investments and corporate expansions where they do not involve expansion to new covered activities, and investments in publicly traded securities. The Policy Directive suggests that these exceptions may be drawn back and that the Administration will pressure large-scale financial investors (such as pension funds, university endowments, and other institutional investors) from allowing their largess to support foreign adversary advances in strategic areas. </li></ul><p> </p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k1as\" />",
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"text": "‘fast-track’” process",
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"text": ", based on objective standards” from specified allied and partner sources. This could include, for example, CFIUS issuing guidance describing transactions that would likely receive approval if filed as a declaration such as transactions involving investors from specified countries that have already been cleared by CFIUS within a certain time period or have a history of cooperation with CFIUS. CFIUS may also use its authority to waive the mandatory filing requirements for certain sovereign wealth funds that operate independently from their respective governments and have a history of cooperation with CFIUS."
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"text": "will continue to be welcomed and remain outside the scope of CFIUS review. While the Policy Directive’s statement that passive investment is welcomed from “all foreign persons” nominally would cover Chinese investment, the threshold for Chinese investment being considered non-passive is probably exceedingly low, such that investments other than in publicly traded securities will often not qualify."
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"text": "Non-Chinese investors may nonetheless have an elevated threat profile if they have any number of types of ties to China. These could include Chinese ownership, commercial ties to China (R&D, JVs, revenue dependency), geopolitical ties of the investor’s home country to China, and other ties that the investor has unknowingly to China."
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"text": "The Policy Directive indicates that such factors will continue to be a meaningful part of CFIUS’s risk assessment of investment by non-Chinese companies. It further notes that restrictions on investment in sensitive areas (critical technology, critical infrastructure, personal data, etc.), the likelihood or stringency of mitigation will be “proportional to their verifiable distance and independence” from Chinese government points of leverage."
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"text": "Pursuant to the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA), CFIUS already has greenfield jurisdiction (i.e., where there is no existing business) based on proximity of real estate to sensitive locations. FIRRMA, however, carves out real estate in urbanized areas, which is likely what the Administration is seeking to cover with respect to Chinese investments in strategic sectors. To remedy this, the Administration could seek new legislation that may have a broader impact by subjecting substantially more foreign investments to CFIUS jurisdiction. Alternatively, and more likely, CFIUS can take advantage of language in FIRRMA that allows CFIUS real estate jurisdiction even in an urbanized area if prescribed by CFIUS in regulations in consultation with the Secretary of Defense."
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"html": "<p><i>Within the first week of taking office, President Trump issued Executive Orders regarding diversity, equity, and inclusion (<strong>DEI</strong>) policies, affecting federal government agencies as well as private companies. Multinational companies with business in the United States and the EU now face shifting DEI dynamics in the United States while also being subject to EU sustainability regulations and the DEI requirements. Understanding this new risk environment is crucial for managing divergent compliance obligations. This blog post examines the implications of potentially contradictory regulatory regimes and offers guidance on how to navigate adherence with both. </i></p><h2>I. New Executive Orders signal scrutiny of private sector DEI programs and potential for liability</h2><p>On January 21, 2025, President Trump issued three Executive Orders regarding federal DEI policies, including terminating DEI-related programs in the federal government (“<a href=\"https://www.whitehouse.gov/presidential-actions/2025/01/ending-radical-and-wasteful-government-dei-programs-and-preferencing/\">Ending Radical and Wasteful Government DEI Programs and Preferencing</a>”); prohibiting the influence of race, gender, and other factors in federal employment decisions (“<a href=\"https://www.whitehouse.gov/presidential-actions/2025/01/reforming-the-federal-hiring-process-and-restoring-merit-to-government-service/\">Reforming the Federal Hiring Process and Restoring Merit to Government Service</a>”); and directing every federal agency to develop strategies to deter unlawful DEI practices in the private sector (“<a href=\"https://www.whitehouse.gov/presidential-actions/2025/01/ending-illegal-discrimination-and-restoring-merit-based-opportunity/\">Ending Illegal Discrimination and Restoring Merit-Based Opportunity</a>”).</p><p>In particular, one Executive Order mandates several steps that will affect companies with exposure to the United States. </p><ul style=\"list-style-type: disc\"><li>First, the Order directs every federal agency to identify “up to” nine private entities for investigation for operating “illegal” DEI programs. <ul style=\"list-style-type: circle\"><li>It also requires every federal agency to name the most “egregious and discriminatory DEI practitioners in each sector of concern and a plan of specific steps or measures to deter DEI programs or principles”. </li><li>In an order implementing the Executive Order, the new Attorney General directed the Department of Justice to consider criminal charges among the potential actions to take.</li></ul></li><li>Second, it requires U.S. departments and agencies to ensure that the employment, procurement, and contracting practices of their contractors and subcontractors do not unlawfully consider race, color, sex, sexual preference, religion, or national origin for procurement decisions. <ul style=\"list-style-type: circle\"><li>When entering into a contract with a U.S. government agency, companies will need to formally certify that they do not operate any programs “promoting DEI that violate any applicable Federal anti-discrimination laws”. </li><li>The Executive Order directs that these contract terms are “material,” which could become a basis for False Claims Act (FCA) actions in the United States. The FCA—which can be enforced by the federal government or private whistleblowers—imposes treble damages and civil monetary penalties on individuals and companies that knowingly submit false claims for payment to the government, which can include misrepresentations regarding compliance with statutory or regulatory rules (so-called “false certification” cases).</li></ul></li></ul><p>Although the Executive Orders do not change U.S. federal anti-discrimination statutes, they reflect the new Administration’s desire to pressure companies to change their practices and identify potential legal actions to change the law through litigation. Moreover, the directive to name “egregious” practitioners of DEI suggests companies will elicit parallel actions and even coordination among federal agencies, the U.S. Congress, U.S. state attorneys general, and private plaintiffs. The anti-ESG efforts of recent years present a clear model.</p><p>Given this increased level of scrutiny, companies doing business in the United States, particularly those seeking federal contracts, should consider taking steps to coordinate legal and policy experts across divisions and jurisdictions to assess their DEI policies, and how they are communicated. Each company will need to make these assessments based on their own circumstances and their specific risks. In the United States, some companies have announced significant changes to their workforce policies, while others have asserted they intend to maintain their lawful initiatives.</p><h2>II. Conflicting requirements under EU law </h2><p>One significant factor for any company considering changes to its workforce policies will be its regulatory requirements under EU law and the law of EU Member States.</p><p>Several EU Member States have adopted laws requiring DEI measures. German corporate law, for example, expressly mandates gender diversity quotas for supervisory boards and requires establishing gender diversity targets for executive boards and management levels below the executive board (sec. 96, 76 Stock Corporations Act/Aktiengesetz). Moreover, companies may be required to take measures to eliminate existing gender pay gaps under the EU Pay Transparency Directive (as transposed into national law). In addition, remuneration reports on board compensation, which are mandatory under EU law, have to present the degree to which sustainability targets, which can include diversity, impact variable compensation plans.</p><p>Specifics will matter, but it is possible that programs designed to comply with EU laws will be in tension with U.S. laws or guidance, especially as the latter evolve. Thus, companies subject to EU law with U.S operations or subsidiaries should consider the impact of these regulatory obligations on their risk and compliance in the United States. For example, a company applying for government-contracting in the United States should carefully analyze whether the contracting entity can certify that they do not operate any programs promoting DEI “that violate any applicable Federal anti-discrimination laws,” as required by President Trump’s Executive Order. Companies should consider whether their websites or other public reporting include contradictory statements, or statements that could be misconstrued as contradictory. In addition, companies should make clear when disclosing this information that they are doing so in compliance with specific laws and regulations. </p><p>It is not yet clear how broadly U.S. federal agencies will apply the Executive Order vis-à-vis different corporate structures, including group members outside of the United States. They may interpret it to require certifications beyond contracting entities, to mandate companies certify that none of their subsidiaries/group companies operate unlawful DEI programs. This scenario, in which a U.S. company could be required to certify that its EU affiliates do not operate DEI programs that would be unlawful in the U.S., would certainly lead to challenges regarding global, group-wide compliance/sustainability programs. In the extreme, companies might be required to take sides between conflicting laws.</p><p>Upcoming reporting obligations may highlight potential conflicts. Companies that fall under the scope of the EU Corporate Sustainability Reporting Directive (<i><strong>CSRD</strong></i>) (as transposed into national law) are, for example, required to report (if considered material):</p><ul style=\"list-style-type: disc\"><li>whether they have specific policies aimed at the elimination of discrimination, including harassment, promoting equal opportunities and other ways to advance diversity and inclusion (i.e. DEI policies), </li><li>whether these grounds for discrimination are specifically covered in the policy: racial and ethnic origin, color, sex, sexual orientation, gender identity, disability, age, religion, political opinion, national extraction or social origin, or other forms of discrimination covered by Union regulation and national law,</li><li>whether the undertaking has specific policy commitments related to inclusion or positive action for people from groups at particular risk of vulnerability,<i> and</i></li><li>whether and how these policies are implemented.</li></ul><p>Complying with these requirements may invite unintended attention from U.S. government agencies or Congress. Notably, the reporting boundaries under the CSRD are not limited to EU companies; it usually also includes reporting on U.S. subsidiaries or U.S. parent companies. Companies should consider inviting their U.S. colleagues to review their CSRD or other disclosures and retaining counsel to navigate any risks or tensions. </p><h2>III. Strategies for navigating the new regulatory landscape</h2><p>There is no single solution for a company to navigate the changing circumstances in the United States while respecting global regulatory regimes. Each company will need to assess its risk exposure and, once understood, determine whether changes are required to achieve compliance or mitigate unwanted risks. The new Executive Orders in the United States mandate federal agencies to take steps by May 21, 2025. Accordingly, companies should undertake risk assessments and stakeholder coordination now. Specifically, companies may want to adopt the following strategies to minimize legal risks: </p><ul style=\"list-style-type: disc\"><li>Bringing together stakeholders and experts in the United States and in Europe to properly analyze DEI requirements to avoid operating in silos;</li><li>Stocktaking of any jurisdictional links to the United States and (potential) legal enforcement risks;</li><li>Assessing reporting obligations under CSRD and other EU reporting regulations (e.g. the EU Pay Transparency Directive), as well as other global reporting obligations the company may face;</li><li>Reviewing drafts of sustainability reports, security prospectuses, investor presentations, websites, and published materials for potential conflicts with the new presidential DEI actions; and</li><li>Exploring whether it is possible and advisable to adjust global, group-wide policies in favor of regional governance structures specifically tailored to locally applicable regulatory requirements (i.e. careful governance carve-outs, while keeping best efficiency of group-wide compliance to the largest extent).</li></ul><p>Freshfields has a cross-disciplinary, global team that is available to advise on solutions to assess exposure to shifting U.S. dynamics to ensure our clients’ commitments—and how they are communicated—match their global business and legal needs.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102jzy0\" />",
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"html": "<p>Today, the UK government issued its draft strategic steer to the Competition & Markets Authority (CMA) for consultation. </p><p>Our separate blog (<a href=\"https://riskandcompliance.freshfields.com/post/102k013/the-uk-governments-strategic-steer-to-the-cma-resetting-the-priorities-part-1\">The UK Government’s Strategic Steer to the CMA: resetting the priorities (Part 1)</a>) summarises the government’s key directions to the CMA in the steer, and the impact that we think the steer is likely to have on the CMA’s overall approach. Here we specifically consider what the strategic steer tells us about the future direction of UK merger control and what impact we believe the steer – and the CMA’s reaction to it – are likely to have on M&A activity in the UK. </p><p><strong>What does the strategic steer say in relation to M&A?</strong></p><p>While the government’s previous strategic steer had encouraged the CMA to make “<i>full use of its tools for merger control</i>”, the position this year is markedly different. The new steer sends a clear message to the CMA: in discharging its statutory functions, the government expects the CMA to harness its tools to support and contribute to the<i> </i>“<i>overriding national priority</i>” of economic growth. It reiterates the government’s expectation that the CMA’s approach must clearly, and unambiguously, reflect the need to enhance the attractiveness of the UK as a destination for international investment. </p><p>More specifically, in considering which cases to pursue (while the CMA’s merger control functions are, technically, mandatory the voluntary nature of the regime gives it some flexibility to shape its caseload), and/or which remedies to accept, the CMA is directed to: (i) prioritise pro-growth and pro-investment interventions; (ii) focus on markets and harms that impact UK-based consumers and businesses; and (iii) support growth and international competitiveness in the Industrial Strategy’s eight key sectors (advanced manufacturing, clean energy industries, creative industries, defence, digital and technologies, financial services, life sciences and professional and business services).</p><p>Moreover, while the previous steer encouraged the CMA to be an international “<i>thought leader</i>”, the government now urges the CMA to consider the actions being taken by competition agencies in other jurisdictions internationally, and to ensure that any parallel regulatory action it undertakes is “<i>timely, coherent and avoids duplication</i>”.</p><p><strong>How has the CMA (already) responded?</strong></p><p>The CMA (having presumably seen the draft steer) <a href=\"https://competitionandmarkets.blog.gov.uk/2025/02/13/new-cma-proposals-to-drive-growth-investment-and-business-confidence/\">has already set out its intention to make a number of changes</a>, including to:</p><ul style=\"list-style-type: square\"><li>Complete the “pre-notification” process before a formal investigation begins within 40 working days (as compared to the current average of 65 and in some cases, longer);</li><li>Approve “straightforward” Phase 1 cases within 25 working days (as compared to the current target of 35); and</li><li>Clarify the approach that it will take to the application of two of the more flexible (and, in recent years, more controversial) aspects of the regime which the CMA recognises create particular uncertainty: the jurisdictional “material influence” and “share of supply” tests.</li></ul><p>The CMA also flags other changes in the pipeline, most notably the previously announced review of its approach to merger remedies and an assessment of a “proportionate” approach to looking at global deals (under which it would “wait and see” whether actions taken by other authorities might address concerns in the UK). A new “Mergers Charter” (to be published in March) will set out the CMA’s commitment to this new approach but will (it is hoped) make clear what will be required from businesses and advisers to give positive and practical effect to these changes.</p><p><strong>What are we likely to see from the CMA, both immediately and in the longer-term?</strong></p><ul style=\"list-style-type: disc\"><li><strong>Quicker and more efficient reviews: </strong>the new Chair of the CMA, Doug Gurr, had already highlighted the need to make investigations and processes “<i>as simple and rapid as possible</i>”. In recent years, deals have been spending increasingly longer periods of time in “pre-notification” – the duration of which has increased to the current average of 65 working days from an average period that was around half that just five years earlier. The CMA therefore now faces the task of living up to its commitment to get deals “onto the clock” faster (while also trying to ensure that an obstructionist approach to engagement in pre-notification is not “rewarded” – with the CMA already making clear that this change will require the “<i>cooperation of merging parties</i>”). Once the statutory clock does start, the CMA is eager to reach decisions as soon as possible. So, in addition to issuing clearance decisions more quickly, the CMA is also likely to be open to solutions (e.g. early engagement on possible remedies) that allow cases with substantive concerns to reach a binding outcome more quickly.</li><li><strong>Engagement, engagement, engagement:</strong> Doug Gurr has committed to engaging “<i>directly and meaningfully</i>” with the business community, with “<i>an open door, open ears and open minds</i>”. The CMA continues put great weight on its revised Phase 2 process, which provides increased opportunities for engagement with businesses on both competition issues and remedies. Some of these innovations – such as more senior-level engagement early in the review process, an earlier prioritisation of potential concerns, and the introduction of early “triggers” for remedies discussions – could find a place in the Phase 1 process, which has been criticised for compressing key interactions into the relatively narrow window (of a handful of days) provided by the “issues meeting” process.</li><li><strong>A reduced role on (at least some) global transactions: </strong>there is clearly some dampening in the CMA’s appetite to be seen to be playing a prominent role in multi-jurisdictional mergers. The suggestion that the CMA could “wait and see” how proceedings in other jurisdictions play out before deciding whether a formal investigation in the UK is necessary was originally highlighted in the refresh of the CMA’s procedural guidance prepared for Brexit (at the end of 2020) but has rarely been used. The degree of certainty that the CMA is able to provide to merging parties in “wait and see” cases (given the impact that the opening of a CMA investigation at a later stage could have on overall transaction timing) is likely to be key to establishing whether this is a workable approach. On cases where the CMA does choose to open an investigation (or merging parties choose to notify the deal to mitigate these timing risks), we could see the CMA seeking to make use of its new power to “pause” Phase 2 investigations, subject to the agreement of the merging parties, while the direction of travel in other key jurisdictions (particularly the US and the EU) becomes clearer.</li><li><strong>A “back to basics” approach: </strong>given the focus on encouraging investment, removing regulatory burdens, and improving predictability and certainty for business, the CMA is expected to be less inclined to pursue the more “marginal” cases that have been a high-profile part of its portfolio in recent years. So, deals that would involve a novel approach to the application of jurisdictional boundaries or pursue “fringe” theories of harm are less likely to be called in for review (or, if they are, referred for in-depth Phase 2 investigations), absent clear and obvious harm to UK businesses and consumers.</li></ul><p><strong>More radical changes on the horizon?</strong> </p><p>On top of the shorter-term changes announced today, the CMA’s forthcoming review of remedies, now confirmed to be kicking off in March, offers the potential to bring about more significant changes to the “end game” for many transactions. This review will include looking at an increased openness to behavioural remedies (of the type commonly accepted by the European Commission in recent years), the scope for remedies to play a role in “locking-in” pro-competitive efficiencies (which have been given limited weight in recent years – with the notable exception of <i>Vodafone/Three</i>), and the role of “relevant customer benefits” (which have barely been accepted outside of the very specific context of NHS hospital mergers) to offset any anti-competitive effects.</p><p>The CMA’s response also recognises, in several places, that its hands are tied to some extent by the existing law – and notes that it would be for the government to go further through legislative change. So, while aspects of the UK regime will change, the key statutory tests (on jurisdiction and substance) remain the same. </p><p>There is still no sense that wholescale legislative change is on the agenda, with the government likely to first assess the impact of these initial changes announced by the CMA. In particular, notwithstanding the rumblings of government dissatisfaction, there is no indication that the government intends to pursue a more active role in individual merger decisions.</p><p><strong>So, where does this leave us? </strong></p><p>In recent years, the CMA has established a reputation as a tough and forceful presence on the global merger control scene. For deals that sit squarely within its centre of gravity (i.e. UK-centric deals with evidence of potentially significant direct harm for UK businesses/consumers), its approach to merger enforcement seems unlikely to soften, although there will be some differences in how those investigations are carried out. For other deals, there is an opportunity for the CMA to pursue a more “pragmatic” approach (within the limits provided by law) –although not one in which it will wave through every deal with ill-substantiated claims to promote “growth”. The enforcement environment is likely to remain complex, so thoughtful deal planning and execution will continue to be essential.</p><p>If you would like to discuss these issues in more detail or respond to (or stay updated on) the consultations on the draft strategic steer, please <a href=\"https://www.freshfields.com/en-gb/contacts/find-a-lawyer/?Name=&t=&Service=2&Role=partner&Location=&Office=&Industry=&Page=1\">speak to your usual Freshfields contact</a>. To read more about our thoughts on the key global merger control trends to be aware of in the coming year, <a href=\"https://cloud.mailings.freshfields.com/Antitrust10KT2025\">request access to our Navigating antitrust in 2025: 10 key themes publication</a>.</p><p> </p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k01v\" />",
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"html": "<p>On April 9, 2025, the CDU, CSU, and SPD parties <a href=\"https://www.spd.de/fileadmin/Dokumente/Koalitionsvertrag2025_bf.pdf\">unveiled</a> their coalition agreement, setting out the plans of the new government for the next four years. In this blog post, we take a closer look at the impact of the coalition agreement on the financial services industry in Germany and highlight our top 8 takeaways. For a comprehensive look at the 2025 German election, please visit our dedicated <a href=\"https://www.freshfields.com/en/our-thinking/campaigns/trump-2.0-a-us-and-global-perspective/german-federal-election/\">election hub</a>. </p><details class=\"accordion\"><summary class=\"accordion__title\"><strong>Banking Union / EDIS</strong></summary><div class=\"accordion__content\"><p>Unsurprisingly, and in line with current developments at the European level, the new government advocates further strengthening the European Capital Markets Union (or, according to the new terminology, the Savings and Investment Union).</p><p>The statements on deposit protection are, however, more interesting. In this context, the coalition agreement emphasizes that the interests of smaller banks and savings banks should consistently be taken into account when discussing changes to regulation. A common European deposit guarantee scheme is generally rejected. </p><p>This was not necessarily to be expected after various representatives from the savings bank sector had recently spoken out in favor of opening up the discussion, indicating a shift of sentiment in Germany. In the past, concerns had been expressed that a European Deposit Insurance Scheme (<i><strong>EDIS</strong></i>), among others, could incentivize Member States with fragile banking sectors to take on more risks to the detriment of German depositors.</p><p>As a recap: The EDIS <a href=\"https://finance.ec.europa.eu/publications/commission-proposal-european-deposit-insurance-scheme-edis_en\">proposal</a> of the EU Commission, published in 2015, was meant to create the ‘third pillar’ of the Banking Union. It envisaged a pan-European deposit protection scheme to be introduced in three stages. However, negotiations in the EU Council on EDIS have been suspended for a long time.</p><p>In June 2022, after intense and controversial debates which did not lead to a joint position, it was agreed to initially focus on strengthening the framework for bank crisis management framework and deposit insurance (<i><strong>CMDI</strong></i>). The CMDI package, which was proposed by the EU Commission on 18 April 2023 and is currently being negotiated in <a href=\"https://data.consilium.europa.eu/doc/document/ST-5407-2025-INIT/en/pdf\">trilogues</a>, does not make a new push for a pan-EU deposit protection scheme, but instead proposes new rules regarding depositor protection to harmonize and clarify the existing framework (see for further details regarding the proposal our <a href=\"https://riskandcompliance.freshfields.com/post/102idkk/eu-commission-hits-a-snag-with-its-proposal-for-a-revised-bank-crisis-management\">blogpost</a>). EDIS and other elements should only be discussed subsequently and by consensus among the Member States. Considering the statements in the new coalition agreement, Germany’s position in this respect seems to be clear!</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Increasing competitiveness of the EU financial market</summary><div class=\"accordion__content\"><p>The competitiveness of the German economy has been a key concern for the <a href=\"https://www.cdu.de/wahlprogramm-von-cdu-und-csu/\">CDU/CSU</a> during their election campaign. It therefore does not come as a surprise that the competitiveness of the German and EU financial markets is specifically addressed in the coalition agreement. This is also in line with frequent demands from the financial industry criticizing German <a href=\"https://www.bruegel.org/blog-post/banking-regulation-euro-area-germany-different?utm_source=chatgpt.com\">goldplating</a> of EU law requirements, a lack of digitalization of German ministries and supervisory authorities, as well as bureaucratic complexity and red tape.</p><p>The new government is “<i>committed to a unified European financial regulation and, in this context, will also refrain from goldplating</i>”. It thus appears to explicitly support some of the core statements of the von der Leyen II Commission in the context of financial services. Ursula von der Leyen herself noted that “<i>we have a very clear signal from the European business sector that there is too much complexity, the duration of permitting is too long and administrative procedures are too cumbersome. We have to cut red tape. We will deliver an unprecedented simplification effort</i>” (see our separate <a href=\"https://riskandcompliance.freshfields.com/post/102jzye/treading-a-fine-line-simplification-or-deregulation-a-view-on-financial-service\">blogpost</a> for an overview on the impact of the von der Leyen II Commission on financial services).</p><p>Yet, the coalition agreement remains vague on what the new government’s plans in this context are and how it aims to achieve these plans. The express reference to goldplating raises the question whether the new government will not only refrain from goldplating going forward but will also review where Germany has goldplated EU law in the past. An obvious example of this practice is the implementation of MiFID 2 in Germany.</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Anti-Money Laundering</summary><div class=\"accordion__content\"><p>Germany has often been hailed to be a haven for money laundering activities. The former German finance minister <a href=\"https://www.dw.com/en/germany-announces-crackdown-on-money-laundering/a-62941625\">Christian Lindner</a> referred to it as a “money laundering paradise”. Accordingly, the FATF <a href=\"https://www.fatf-gafi.org/en/publications/Mutualevaluations/Mer-germany-2022.html\">found in its 2022</a> assessment of the German anti-money laundering (<i><strong>AML</strong></i>) regime that, among others,</p><ul style=\"list-style-type: disc\"><li>the domestic coordination across Germany’s 16 states is a challenge and coordination and consistency between the different supervisory and law enforcement authorities should be enhanced;</li><li>priority should also be given to mitigating the risks associated with the high use of cash in the country and the use of informal money or value transfer services;</li><li>Germany needs to continue to prioritize its reforms of the financial intelligence unit (FIU) at the operational level and continue to enhance the collection, analysis, dissemination and use of financial intelligence; and</li><li>Germany needs to adequately resource its over 300 AML supervisors and the transparency register.</li></ul><p>The coalition agreement directly addresses the FATF report and announces “decisive improvements” ahead of the next FATF assessment, which – for the most part – appear to be a direct response to the above issues. The new government envisages, among others, </p><ul style=\"list-style-type: disc\"><li>improving the coordination and exchange between federal and state level authorities, national and international organizations as well as the new European AML authority AMLA (see our separate <a href=\"https://riskandcompliance.freshfields.com/post/102k383/will-you-be-directly-supervised-by-amla-draft-rts-on-the-selection-of-obliged\">blogpost</a> for an overview on AMLA);</li><li>closing gaps in the transparency register. Where one or more ultimate beneficial owners cannot be determined, obliged entities must not carry out transactions of legal entities in excess of 10,000 euros; and</li><li>introducing a suspicious wealth order tool which shall allow authorities to confiscate assets of significant value, where there are doubts about the legality of their acquisition. </li></ul><p>Unsurprisingly, the use of cash is also mentioned in the coalition agreement. The new government aims to ensure that “<i>everyone can continue to decide for themselves how they pay for everyday transactions. We will maintain cash as a common form of payment.</i>” It remains to be seen whether and how these statements will be taken up by the FATF, which could at least take comfort from Germany’s <a href=\"https://riskandcompliance.freshfields.com/post/102i66u/new-german-ban-on-cash-and-crypto-payments-for-real-estate-acquisitions\">existing ban on cash payments for the acquisition of real estate</a> assets and the upcoming <a href=\"https://riskandcompliance.freshfields.com/post/102jh6s/the-new-european-aml-package-a-comprehensive-overview\">general ban on cash payments</a> over 10,000 euros under the AMLR.</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Digital Euro and digital payments</summary><div class=\"accordion__content\"><p>The new government’s statements on the future availability of cash payments are undoubtedly driven by public demand. Cash is still the most common form of payment used for over-the-counter purchases (in 2023, a <a href=\"https://www.bundesbank.de/en/press/press-releases/payment-behaviour-in-germany-in-2023-934894\">Bundesbank study</a> found that 51% of these payments were settled in cash). The same study revealed that a majority of respondents would like to carry on being able to use cash in the future. However, the coalition agreement also envisages that “<i>at least one digital payment option</i>” shall gradually be offered in addition to cash. If Germany were to introduce a mandatory digital payment option to be offered by merchants, this could trigger a boost for the payment industry in Germany. For the time being, however, it remains unclear how, when and if such mandatory payment offer will be introduced, and whether such an obligation will also apply to novel payment options, such as payments by QR code or with crypto-assets, in addition to debit/credit card payment products. </p><p>The coalition has also agreed to support the introduction of a digital Euro for consumers in both wholesale and retail markets, that complements cash, protects consumer privacy, is free for consumers to use, and does not impair financial stability. The decision for the introduction of a digital euro would, of course, be taken in Brussels (and Frankfurt), and not in Berlin. For an overview on the digital Euro proposal, see our separate <a href=\"https://technologyquotient.freshfields.com/post/102iiku/the-next-milestone-reached-are-we-on-the-way-to-a-digital-euro\">blogpost</a>.</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Investments in infrastructure, renewable energies and venture capital</summary><div class=\"accordion__content\"><p>Investments in infrastructure, renewable energies and venture capital are one of the key themes of the coalition agreement, not only with respect to public investments by the “Deutschlandfonds” but also with a view to private capital deployment through fund investments. </p><p>To this end, the agreement announces to “<i>establish a framework for fund investments in infrastructure and renewable energies that is reliable and competitive in the EU, including by targeted amendments to applicable tax laws</i>”. This statement likely alludes to the <a href=\"https://www.bundesfinanzministerium.de/Content/DE/Standardartikel/Themen/Steuern/Steuerarten/Investmentsteuer/2024-05-21-DISKGE-investitionen-fonds.html\">discussion draft</a> published by the Ministry of Finance on 21 May 2024 for a new law promoting fund investments in renewable energies and infrastructure (see our <a href=\"https://www.freshfields.de/our-thinking/knowledge/briefing/2024/06/ueberblick-zum-diskussionsentwurf-fuer-ein-gesetz-zur-foerderung-von-investitionen-von-fonds-in-erneuerbare-energien-und-infrastruktur/\">Client Briefing</a>), which provided for clarifications in the German Capital Investment Code (<i>Kapitalanlagegesetzbuch, KAGB</i>) and the German Investment Tax Act (<i>Investmentsteuergesetz, InvStG</i>) on investments in infrastructure, as well as the proposed amendments to the InvStG with regard to investments in renewable energies and infrastructure in the <a href=\"https://www.bundesfinanzministerium.de/Content/DE/Gesetzestexte/Gesetze_Gesetzesvorhaben/Abteilungen/Abteilung_VII/20_Legislaturperiode/2024-08-27-ZuFinG-II/2-Regierungsentwurf.pdf?__blob=publicationFile&v=3\">government draft bill</a> of a 2nd Future Financing Act (<i>Zukunftsfinanzierungsgesetz, ZuFinG</i>) of 27 November 2024. These draft laws were intended to create an attractive and reliable investment framework for indirect investments in renewable energies and infrastructure via investment funds and may be taken up again, in this or an amended form, in the new legislative period. </p><p>The statement also ties up with the recent changes to the Investment Ordinance (<i>Anlagenverordnung, AnlV</i>) which established additional investment capacities of pension schemes and small insurance companies (i.e. those not subject to the Solvency II framework) for infrastructure and venture capital investments (see our <a href=\"https://riskandcompliance.freshfields.com/post/102jzdg/amendments-to-the-investment-ordinance-anlv-more-infrastructure-risk-capital\">Client Briefing</a>). The coalition intends to create more incentives to invest in infrastructure and venture capital also for Solvency II companies as they announce to “<i>activate several billions of Euros</i>” by lowering the solvency capital requirements for these purposes in the context of the current Solvency II revision. They add that they intend to “<i>abolish, where possible, additional national capital buffers</i>”, a statement that will draw attention not only from insurance companies. Moreover, institutional investors’ capabilities to provide venture capital shall be improved in order to make Germany more attractive for start-ups.</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Fee caps for payment accounts and overdrafts</summary><div class=\"accordion__content\"><p>Consumer protection plays an important role throughout the coalition agreement. An interesting example of this is the section on fees on payment accounts with basic features and overdraft facilities, in relation to which the new government wants to assess whether fee caps should be introduced in order to enforce adequate and market-standard fee caps. </p><p>German/EU law already provides that banks may only charge <a href=\"https://www.gesetze-im-internet.de/zkg/__41.html\">reasonable fees</a> for payment accounts with basic features. The reasonableness is determined taking into account the usual and user behavior. To this end, BaFin published a <a href=\"https://kontenvergleich.bafin.de/de\">website</a> in January 2025 that allows consumers to compare fees and other conditions for payment accounts. On average, the fees amount to approx. 27 euros - the highest in the EU, according to a recent <a href=\"https://www.vzbv.de/pressemitteilungen/europaweiter-vergleich-basiskonto-deutschland-am-teuersten#:~:text=Bis%20zu%2027%2C83%20Euro,ein%20Konto%20mit%20grundlegenden%20Funktionen&text=In%20Deutschland%20werden%20in%20der,des%20Verbraucherzentrale%20Bundesverbands%20(vzbv).\">report</a>.</p><p>Similarly, fees for overdrafts are also often in the news for being too excessive. A 2024 <a href=\"https://www.tagesschau.de/wirtschaft/verbraucher/dispozinsen-anstieg-fortsetzung-warentest-100.html\">Finanztest report</a> found that some banks charge up to 17.2 % overdraft interest rates, noting that “<i>anything above 15% is inacceptable</i>”. According to the news outlet <a href=\"https://finanz-szene.de/banking/was-bedeutet-der-koalitionsvertrag-konkret-fuer-banken-fintechs-und-payment/\">Finanzszene</a>, the effective interest rate in February 2025 was, however, significantly lower (10.3%).</p><p>Nonetheless, the new government only wants to assess whether fee caps should be introduced. A decision on this issue will therefore be formally postponed until another day. In practice, the introduction of a fee cap on overdrafts seems rather unlikely under the new government, as both CDU/CSU and SPD rejected a proposal for a fee cap quite strongly only in <a href=\"https://rsw.beck.de/aktuell/daily/meldung/detail/finanzausschuss-lehnt-deckelung-von-dispozinsen-ab\">2023</a>.</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Legacy funds</summary><div class=\"accordion__content\"><p>The coalition agreement also presents an approach in respect of the so-called ‘legacy funds’ (‘<i>Altmittel’</i>), i.e., the portion of the German Restructuring Fund’s assets, which can be traced back to the national bank levies from 2011 to 2014. During the build-up of the Single Resolution Fund, these national funds were retained in the Restructuring Fund to serve as an additional buffer. With the end of the Single Resolution Fund’s build-up period <a href=\"https://www.srb.europa.eu/en/content/single-resolution-fund-no-expected-contribution-2024-target-level-reached#:~:text=In%20accordance%20with%20Article%2069,ending%20on%2031%20December%202023.\">on 31 December 2023</a>, a discussion on the future use of the retained funds arose.</p><p>The coalition agreement now states that the funds in the amount of 2 billion euros shall be utilized to support the digital and climate-neutral transformation of German ‘<i>Mittelstand’ </i>businesses<i> </i>in cooperation with the German financial institutions. They shall be used to co-finance a promotional fund which shall be capable of providing up to 10 billion euros of equity and debt capital.</p></div></details><details class=\"accordion\"><summary class=\"accordion__title\">Reform of the German law on general terms and conditions</summary><div class=\"accordion__content\"><p>The German law on General Terms and Conditions (<i><strong>GTCs</strong></i>) is particularly burdensome. Judicial review of GTCs is a significant source of uncertainty. Courts may strike down clauses that are widely used and well established based on a substantive review and applying broad principles. Even careful drafting and legal review cannot fully address legal risks because courts may develop an interpretation of unfairness or transparency that has not been considered or that, while having been considered, was not deemed likely against the body of available case law. Unlike in other EU jurisdictions, in Germany this uncertainty is not limited to contracts with consumers but also applies to contracts between professional parties – a further example of excessive German goldplating. In the past, this often constituted a significant risk factor for the financial industry, which often switched to English law governed contracts as a consequence (where possible).</p><p>In 2023, the German legislator already sought to address this uncertainty with an express carve-out for the financial services industry (section 310(1a) BGB). While the intention was welcomed, the implementation appeared to be overly complex, which led <a href=\"https://beck-online.beck.de/Dokument?vpath=bibdata%2Fzeits%2Fbkr%2F2024%2Fcont%2Fbkr.2024.281.1.htm&pos=3&hlwords=on\">representatives of the financial industry</a> to attest that significant changes to standardized agreements used in the financial industry appear to be unlikely. </p><p>Against this backdrop, the coalition agreement now appears to provide for an (unconditional) GTC review carve-out for all agreements between large undertakings (as defined in accounting law). The coalition agreement leaves open, however, how the new government envisages implementing such carve-out. Among others, it will need to be ensured that the exclusions for financial services that the German civil code already provides for, will not be rolled back.</p></div></details><p> </p><p><strong>Next steps</strong></p><p>The publication of the coalition agreement was only the first step on the way to a new government. The CSU party has already agreed to the coalition agreement. The planned further steps on the way to forming a government are outlined below:</p><ul style=\"list-style-type: disc\"><li>28 April: CDU federal committee (<i>Bundesausschuss</i>) vote on the coalition agreement (a confirmation by the <i>Bundesausschuss</i> is said to be certain)</li><li>Approx. 29 April: Vote of all SPD members on the coalition agreement (the outcome of the vote is less clear; yet, a majority of SPD members is expected to support the coalition agreement) </li><li>Approx. 30 April: Signing of the coalition agreement</li><li>Approx. 6 May: Election and swearing-in of Friedrich Merz as new chancellor</li><li>Approx. 8 May: Swearing-in of new federal ministers</li></ul><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k8f7\" />",
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"url": "https://riskandcompliance.freshfields.com/post/102jzye/treading-a-fine-line-simplification-or-deregulation-a-view-on-financial-service",
"children": [
{
"text": "blogpost"
}
]
},
{
"text": " for an overview on the impact of the von der Leyen II Commission on financial services)."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Yet, the coalition agreement remains vague on what the new government’s plans in this context are and how it aims to achieve these plans. The express reference to goldplating raises the question whether the new government will not only refrain from goldplating going forward but will also review where Germany has goldplated EU law in the past. An obvious example of this practice is the implementation of MiFID 2 in Germany."
}
]
}
]
}
]
},
{
"type": "details",
"class": "accordion",
"children": [
{
"type": "summary",
"class": "accordion__title",
"children": [
{
"text": "Anti-Money Laundering"
}
]
},
{
"type": "div",
"class": "accordion__content",
"children": [
{
"type": "paragraph",
"children": [
{
"text": "Germany has often been hailed to be a haven for money laundering activities. The former German finance minister "
},
{
"type": "link",
"url": "https://www.dw.com/en/germany-announces-crackdown-on-money-laundering/a-62941625",
"children": [
{
"text": "Christian Lindner"
}
]
},
{
"text": " referred to it as a “money laundering paradise”. Accordingly, the FATF "
},
{
"type": "link",
"url": "https://www.fatf-gafi.org/en/publications/Mutualevaluations/Mer-germany-2022.html",
"children": [
{
"text": "found in its 2022"
}
]
},
{
"text": " assessment of the German anti-money laundering ("
},
{
"text": "AML",
"italic": true,
"bold": true
},
{
"text": ") regime that, among others,"
}
]
},
{
"type": "bulleted-list",
"list-style-type": "disc",
"children": [
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"type": "list-item",
"children": [
{
"text": "the domestic coordination across Germany’s 16 states is a challenge and coordination and consistency between the different supervisory and law enforcement authorities should be enhanced;"
}
]
},
{
"type": "list-item",
"children": [
{
"text": "priority should also be given to mitigating the risks associated with the high use of cash in the country and the use of informal money or value transfer services;"
}
]
},
{
"type": "list-item",
"children": [
{
"text": "Germany needs to continue to prioritize its reforms of the financial intelligence unit (FIU) at the operational level and continue to enhance the collection, analysis, dissemination and use of financial intelligence; and"
}
]
},
{
"type": "list-item",
"children": [
{
"text": "Germany needs to adequately resource its over 300 AML supervisors and the transparency register."
}
]
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "The coalition agreement directly addresses the FATF report and announces “decisive improvements” ahead of the next FATF assessment, which – for the most part – appear to be a direct response to the above issues. The new government envisages, among others, "
}
]
},
{
"type": "bulleted-list",
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"children": [
{
"type": "list-item",
"children": [
{
"text": "improving the coordination and exchange between federal and state level authorities, national and international organizations as well as the new European AML authority AMLA (see our separate "
},
{
"type": "link",
"url": "https://riskandcompliance.freshfields.com/post/102k383/will-you-be-directly-supervised-by-amla-draft-rts-on-the-selection-of-obliged",
"children": [
{
"text": "blogpost"
}
]
},
{
"text": " for an overview on AMLA);"
}
]
},
{
"type": "list-item",
"children": [
{
"text": "closing gaps in the transparency register. Where one or more ultimate beneficial owners cannot be determined, obliged entities must not carry out transactions of legal entities in excess of 10,000 euros; and"
}
]
},
{
"type": "list-item",
"children": [
{
"text": "introducing a suspicious wealth order tool which shall allow authorities to confiscate assets of significant value, where there are doubts about the legality of their acquisition. "
}
]
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Unsurprisingly, the use of cash is also mentioned in the coalition agreement. The new government aims to ensure that “"
},
{
"text": "everyone can continue to decide for themselves how they pay for everyday transactions. We will maintain cash as a common form of payment.",
"italic": true
},
{
"text": "” It remains to be seen whether and how these statements will be taken up by the FATF, which could at least take comfort from Germany’s "
},
{
"type": "link",
"url": "https://riskandcompliance.freshfields.com/post/102i66u/new-german-ban-on-cash-and-crypto-payments-for-real-estate-acquisitions",
"children": [
{
"text": "existing ban on cash payments for the acquisition of real estate"
}
]
},
{
"text": " assets and the upcoming "
},
{
"type": "link",
"url": "https://riskandcompliance.freshfields.com/post/102jh6s/the-new-european-aml-package-a-comprehensive-overview",
"children": [
{
"text": "general ban on cash payments"
}
]
},
{
"text": " over 10,000 euros under the AMLR."
}
]
}
]
}
]
},
{
"type": "details",
"class": "accordion",
"children": [
{
"type": "summary",
"class": "accordion__title",
"children": [
{
"text": "Digital Euro and digital payments"
}
]
},
{
"type": "div",
"class": "accordion__content",
"children": [
{
"type": "paragraph",
"children": [
{
"text": "The new government’s statements on the future availability of cash payments are undoubtedly driven by public demand. Cash is still the most common form of payment used for over-the-counter purchases (in 2023, a "
},
{
"type": "link",
"url": "https://www.bundesbank.de/en/press/press-releases/payment-behaviour-in-germany-in-2023-934894",
"children": [
{
"text": "Bundesbank study"
}
]
},
{
"text": " found that 51% of these payments were settled in cash). The same study revealed that a majority of respondents would like to carry on being able to use cash in the future. However, the coalition agreement also envisages that “"
},
{
"text": "at least one digital payment option",
"italic": true
},
{
"text": "” shall gradually be offered in addition to cash. If Germany were to introduce a mandatory digital payment option to be offered by merchants, this could trigger a boost for the payment industry in Germany. For the time being, however, it remains unclear how, when and if such mandatory payment offer will be introduced, and whether such an obligation will also apply to novel payment options, such as payments by QR code or with crypto-assets, in addition to debit/credit card payment products. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "The coalition has also agreed to support the introduction of a digital Euro for consumers in both wholesale and retail markets, that complements cash, protects consumer privacy, is free for consumers to use, and does not impair financial stability. The decision for the introduction of a digital euro would, of course, be taken in Brussels (and Frankfurt), and not in Berlin. For an overview on the digital Euro proposal, see our separate "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102iiku/the-next-milestone-reached-are-we-on-the-way-to-a-digital-euro",
"children": [
{
"text": "blogpost"
}
]
},
{
"text": "."
}
]
}
]
}
]
},
{
"type": "details",
"class": "accordion",
"children": [
{
"type": "summary",
"class": "accordion__title",
"children": [
{
"text": "Investments in infrastructure, renewable energies and venture capital"
}
]
},
{
"type": "div",
"class": "accordion__content",
"children": [
{
"type": "paragraph",
"children": [
{
"text": "Investments in infrastructure, renewable energies and venture capital are one of the key themes of the coalition agreement, not only with respect to public investments by the “Deutschlandfonds” but also with a view to private capital deployment through fund investments. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "To this end, the agreement announces to “"
},
{
"text": "establish a framework for fund investments in infrastructure and renewable energies that is reliable and competitive in the EU, including by targeted amendments to applicable tax laws",
"italic": true
},
{
"text": "”. This statement likely alludes to the "
},
{
"type": "link",
"url": "https://www.bundesfinanzministerium.de/Content/DE/Standardartikel/Themen/Steuern/Steuerarten/Investmentsteuer/2024-05-21-DISKGE-investitionen-fonds.html",
"children": [
{
"text": "discussion draft"
}
]
},
{
"text": " published by the Ministry of Finance on 21 May 2024 for a new law promoting fund investments in renewable energies and infrastructure (see our "
},
{
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"url": "https://www.freshfields.de/our-thinking/knowledge/briefing/2024/06/ueberblick-zum-diskussionsentwurf-fuer-ein-gesetz-zur-foerderung-von-investitionen-von-fonds-in-erneuerbare-energien-und-infrastruktur/",
"children": [
{
"text": "Client Briefing"
}
]
},
{
"text": "), which provided for clarifications in the German Capital Investment Code ("
},
{
"text": "Kapitalanlagegesetzbuch, KAGB",
"italic": true
},
{
"text": ") and the German Investment Tax Act ("
},
{
"text": "Investmentsteuergesetz, InvStG",
"italic": true
},
{
"text": ") on investments in infrastructure, as well as the proposed amendments to the InvStG with regard to investments in renewable energies and infrastructure in the "
},
{
"type": "link",
"url": "https://www.bundesfinanzministerium.de/Content/DE/Gesetzestexte/Gesetze_Gesetzesvorhaben/Abteilungen/Abteilung_VII/20_Legislaturperiode/2024-08-27-ZuFinG-II/2-Regierungsentwurf.pdf?__blob=publicationFile&v=3",
"children": [
{
"text": "government draft bill"
}
]
},
{
"text": " of a 2nd Future Financing Act ("
},
{
"text": "Zukunftsfinanzierungsgesetz, ZuFinG",
"italic": true
},
{
"text": ") of 27 November 2024. These draft laws were intended to create an attractive and reliable investment framework for indirect investments in renewable energies and infrastructure via investment funds and may be taken up again, in this or an amended form, in the new legislative period. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "The statement also ties up with the recent changes to the Investment Ordinance ("
},
{
"text": "Anlagenverordnung, AnlV",
"italic": true
},
{
"text": ") which established additional investment capacities of pension schemes and small insurance companies (i.e. those not subject to the Solvency II framework) for infrastructure and venture capital investments (see our "
},
{
"type": "link",
"url": "https://riskandcompliance.freshfields.com/post/102jzdg/amendments-to-the-investment-ordinance-anlv-more-infrastructure-risk-capital",
"children": [
{
"text": "Client Briefing"
}
]
},
{
"text": "). The coalition intends to create more incentives to invest in infrastructure and venture capital also for Solvency II companies as they announce to “"
},
{
"text": "activate several billions of Euros",
"italic": true
},
{
"text": "” by lowering the solvency capital requirements for these purposes in the context of the current Solvency II revision. They add that they intend to “"
},
{
"text": "abolish, where possible, additional national capital buffers",
"italic": true
},
{
"text": "”, a statement that will draw attention not only from insurance companies. Moreover, institutional investors’ capabilities to provide venture capital shall be improved in order to make Germany more attractive for start-ups."
}
]
}
]
}
]
},
{
"type": "details",
"class": "accordion",
"children": [
{
"type": "summary",
"class": "accordion__title",
"children": [
{
"text": "Fee caps for payment accounts and overdrafts"
}
]
},
{
"type": "div",
"class": "accordion__content",
"children": [
{
"type": "paragraph",
"children": [
{
"text": "Consumer protection plays an important role throughout the coalition agreement. An interesting example of this is the section on fees on payment accounts with basic features and overdraft facilities, in relation to which the new government wants to assess whether fee caps should be introduced in order to enforce adequate and market-standard fee caps. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "German/EU law already provides that banks may only charge "
},
{
"type": "link",
"url": "https://www.gesetze-im-internet.de/zkg/__41.html",
"children": [
{
"text": "reasonable fees"
}
]
},
{
"text": " for payment accounts with basic features. The reasonableness is determined taking into account the usual and user behavior. To this end, BaFin published a "
},
{
"type": "link",
"url": "https://kontenvergleich.bafin.de/de",
"children": [
{
"text": "website"
}
]
},
{
"text": " in January 2025 that allows consumers to compare fees and other conditions for payment accounts. On average, the fees amount to approx. 27 euros - the highest in the EU, according to a recent "
},
{
"type": "link",
"url": "https://www.vzbv.de/pressemitteilungen/europaweiter-vergleich-basiskonto-deutschland-am-teuersten#:~:text=Bis%20zu%2027%2C83%20Euro,ein%20Konto%20mit%20grundlegenden%20Funktionen&text=In%20Deutschland%20werden%20in%20der,des%20Verbraucherzentrale%20Bundesverbands%20(vzbv).",
"children": [
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"text": "report"
}
]
},
{
"text": "."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Similarly, fees for overdrafts are also often in the news for being too excessive. A 2024 "
},
{
"type": "link",
"url": "https://www.tagesschau.de/wirtschaft/verbraucher/dispozinsen-anstieg-fortsetzung-warentest-100.html",
"children": [
{
"text": "Finanztest report"
}
]
},
{
"text": " found that some banks charge up to 17.2 % overdraft interest rates, noting that “"
},
{
"text": "anything above 15% is inacceptable",
"italic": true
},
{
"text": "”. According to the news outlet "
},
{
"type": "link",
"url": "https://finanz-szene.de/banking/was-bedeutet-der-koalitionsvertrag-konkret-fuer-banken-fintechs-und-payment/",
"children": [
{
"text": "Finanzszene"
}
]
},
{
"text": ", the effective interest rate in February 2025 was, however, significantly lower (10.3%)."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Nonetheless, the new government only wants to assess whether fee caps should be introduced. A decision on this issue will therefore be formally postponed until another day. In practice, the introduction of a fee cap on overdrafts seems rather unlikely under the new government, as both CDU/CSU and SPD rejected a proposal for a fee cap quite strongly only in "
},
{
"type": "link",
"url": "https://rsw.beck.de/aktuell/daily/meldung/detail/finanzausschuss-lehnt-deckelung-von-dispozinsen-ab",
"children": [
{
"text": "2023"
}
]
},
{
"text": "."
}
]
}
]
}
]
},
{
"type": "details",
"class": "accordion",
"children": [
{
"type": "summary",
"class": "accordion__title",
"children": [
{
"text": "Legacy funds"
}
]
},
{
"type": "div",
"class": "accordion__content",
"children": [
{
"type": "paragraph",
"children": [
{
"text": "The coalition agreement also presents an approach in respect of the so-called ‘legacy funds’ (‘"
},
{
"text": "Altmittel’",
"italic": true
},
{
"text": "), i.e., the portion of the German Restructuring Fund’s assets, which can be traced back to the national bank levies from 2011 to 2014. During the build-up of the Single Resolution Fund, these national funds were retained in the Restructuring Fund to serve as an additional buffer. With the end of the Single Resolution Fund’s build-up period "
},
{
"type": "link",
"url": "https://www.srb.europa.eu/en/content/single-resolution-fund-no-expected-contribution-2024-target-level-reached#:~:text=In%20accordance%20with%20Article%2069,ending%20on%2031%20December%202023.",
"children": [
{
"text": "on 31 December 2023"
}
]
},
{
"text": ", a discussion on the future use of the retained funds arose."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "The coalition agreement now states that the funds in the amount of 2 billion euros shall be utilized to support the digital and climate-neutral transformation of German ‘"
},
{
"text": "Mittelstand’ ",
"italic": true
},
{
"text": "businesses"
},
{
"text": " ",
"italic": true
},
{
"text": "in cooperation with the German financial institutions. They shall be used to co-finance a promotional fund which shall be capable of providing up to 10 billion euros of equity and debt capital."
}
]
}
]
}
]
},
{
"type": "details",
"class": "accordion",
"children": [
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"type": "summary",
"class": "accordion__title",
"children": [
{
"text": "Reform of the German law on general terms and conditions"
}
]
},
{
"type": "div",
"class": "accordion__content",
"children": [
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"type": "paragraph",
"children": [
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"text": "The German law on General Terms and Conditions ("
},
{
"text": "GTCs",
"italic": true,
"bold": true
},
{
"text": ") is particularly burdensome. Judicial review of GTCs is a significant source of uncertainty. Courts may strike down clauses that are widely used and well established based on a substantive review and applying broad principles. Even careful drafting and legal review cannot fully address legal risks because courts may develop an interpretation of unfairness or transparency that has not been considered or that, while having been considered, was not deemed likely against the body of available case law. Unlike in other EU jurisdictions, in Germany this uncertainty is not limited to contracts with consumers but also applies to contracts between professional parties – a further example of excessive German goldplating. In the past, this often constituted a significant risk factor for the financial industry, which often switched to English law governed contracts as a consequence (where possible)."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "In 2023, the German legislator already sought to address this uncertainty with an express carve-out for the financial services industry (section 310(1a) BGB). While the intention was welcomed, the implementation appeared to be overly complex, which led "
},
{
"type": "link",
"url": "https://beck-online.beck.de/Dokument?vpath=bibdata%2Fzeits%2Fbkr%2F2024%2Fcont%2Fbkr.2024.281.1.htm&pos=3&hlwords=on",
"children": [
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"text": "representatives of the financial industry"
}
]
},
{
"text": " to attest that significant changes to standardized agreements used in the financial industry appear to be unlikely. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Against this backdrop, the coalition agreement now appears to provide for an (unconditional) GTC review carve-out for all agreements between large undertakings (as defined in accounting law). The coalition agreement leaves open, however, how the new government envisages implementing such carve-out. Among others, it will need to be ensured that the exclusions for financial services that the German civil code already provides for, will not be rolled back."
}
]
}
]
}
]
},
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"type": "paragraph",
"children": [
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"text": " "
}
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},
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"type": "paragraph",
"children": [
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"text": "Next steps",
"bold": true
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]
},
{
"type": "paragraph",
"children": [
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"text": "The publication of the coalition agreement was only the first step on the way to a new government. The CSU party has already agreed to the coalition agreement. The planned further steps on the way to forming a government are outlined below:"
}
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"text": "28 April: CDU federal committee ("
},
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"text": "Bundesausschuss",
"italic": true
},
{
"text": ") vote on the coalition agreement (a confirmation by the "
},
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"text": "Bundesausschuss",
"italic": true
},
{
"text": " is said to be certain)"
}
]
},
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"text": "Approx. 29 April: Vote of all SPD members on the coalition agreement (the outcome of the vote is less clear; yet, a majority of SPD members is expected to support the coalition agreement) "
}
]
},
{
"type": "list-item",
"children": [
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"text": "Approx. 30 April: Signing of the coalition agreement"
}
]
},
{
"type": "list-item",
"children": [
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"text": "Approx. 6 May: Election and swearing-in of Friedrich Merz as new chancellor"
}
]
},
{
"type": "list-item",
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"text": "Approx. 8 May: Swearing-in of new federal ministers"
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"html": "<p>On 23 February 2025, almost 60 million German voters will elect a new federal parliament in snap elections after the collapse of the governing coalition of Chancellor Olaf Scholz's Social Democrats (SPD) with the Greens (B90/Die Grünen) and the Liberals (FDP) in November 2024. A change of government with the participation of the Conservatives (CDU/CSU) and their lead candidate for Chancellor, Friedrich Merz, seems likely. In addition, a spin-off of the Left Party (BSW) will be a new party on the ballot, which has already entered government coalitions in two federal states. Polls show that the AfD will likely emerge from the elections as the strongest opposition party. All other parties have indicated not to enter a coalition with the right-wing party. Irrespective of who wins, a change in the political majorities in Germany is to be expected, which will also have an impact on European and international politics. Freshfields has the latest developments and positioning in view. </p><h3><strong>Key Takeaways</strong></h3><ol><li>Germany's ambitious target of achieving climate neutrality by 2045 has lost unanimous support and is being contested. The EU goal of reaching climate neutrality by 2050 remains largely accepted by most parties.</li><li>Energy production strategies vary, from a full renewable transition by 2035 to a more diversified approach including natural gas and possibly even the reactivation of decommissioned nuclear power plants.</li><li>All parties agree on the need to mitigate the costs of the energy transition for end consumers. Disagreement exists over the methods and extent of this intervention.</li></ol><h3><strong>The current energy policy landscape in Germany</strong></h3><p>Germany’s next government faces significant hurdles in shaping its energy policy. The loss of cheap gas from Russia led to soaring energy costs, which are said to be one of the main drivers of the current economic downturn. While renewable energy continues to make progress and accounted for over 50% of Germany’s electricity consumption in 2024, high installation costs and bureaucratic obstacles remain a concern in their expansion. Much like at EU level, the European Green Deal and the accompanying bureaucratic are facing increasing opposition within the German political landscape. All major parties acknowledge the need for climate action, but opinions differ on the speed and economic implications of decarbonization. </p><h3><strong>Climate targets: A shifting consensus</strong></h3><p>Germany’s ambitious goal of achieving climate neutrality by 2045 — earlier than the EU’s 2050 target — has become a major point of contention. While the SPD and Greens remain committed to ambitious decarbonization timelines, the CDU/CSU state they have the 2045 target \"firmly in sight\", which might leave a loophole for a potential policy change. The FDP takes it one step further and argues for totally abandoning the national target. </p><p>The CDU/CSU and FDP want to see climate goals aligned with maintaining economic competitiveness. The CDU/CSU advocates for a pragmatic evolution of EU climate legislation, while the FDP directly calls for the abolition of reporting requirements under the Green Deal, including the CSRD, CSDDD, and EU Taxonomy. The SPD remains more reserved on this front, whereas the Greens push for the consistent implementation of the Green Deal, arguing that without it, planning security for businesses could be at risk—a crucial factor for economic stability. As a common ground, all parties support in principle the possibility of achieving climate goals not only by reducing emissions but also by addressing hard-to-abate sectors through carbon capture, with subsequent storage in the seabed or reuse (Carbon Capture and Storage/Utilization).</p><h3><strong>Energy production: balancing security, affordability, and sustainability</strong></h3><p>The debate over energy production highlights the parties’ ideological differences. Particularly the Greens emphasize a stronger expansion of wind and solar energy, pushing for a goal of 100% renewable energy production in 2035 supported by subsidies and regulatory incentives. The CDU/CSU and FDP argue for “technological openness” allowing energy providers to decide for themselves which energy source is worthwhile investing, including renewables but also natural gas and potentially even a reactivation of decommissioned nuclear power.</p><p>On coal, the Green party pushes for a complete phase-out by 2030, whereas the CDU/CSU supports adhering to the existing coal compromise, which sets the end of coal-fired power generation for 2038. Decentralized energy production through communal energy-sharing initiatives and energy cooperatives is promoted by the SPD, BSW, and the Left Party. A significant amount of electricity will also be needed to scale up the hydrogen economy, a goal shared by all parties. The CDU/CSU, SPD, and Greens even advocate for establishing pioneering markets where mandatory quotas for green steel would be introduced, for example by leveraging the state's bargaining power in public procurement contracts.</p><h3><strong>Subsidies and incentives: Who pays for the green transition?</strong></h3><p>The costs of the energy transition remain a key challenge and passing them directly onto consumers has proven politically sensitive, as the controversy surrounding the so-called “Heating Law” to reform the <i>Buildings Energy Act</i> (GEG) demonstrated. CDU/CSU, FDP, and BSW are now calling for it to be repealed, while only the Greens actively support keeping the law in place.</p><p>Despite their differences, all parties agree that consumers should not bear the costs of the energy transition alone, though they diverge on how to structure financial relief. Regarding rising CO2 prices, CDU/CSU wants price relief for both consumers and businesses, while the Greens prioritize lower- and middle-income households. The SPD advocates a “climate compensation” scheme specifically for heating and fuel price increased by higher CO2 prices from 2027 onwards, while the FDP favours redistributing emissions trading revenues as direct transfers to everyone. In terms of subsidies under the <i>Renewable Energy Sources Act</i> (EEG), the FDP calls for phasing them out earlier than foreseen and transitioning renewable energy fully to the free market. Meanwhile, all parties support lowering grid fees while CDU/CSU, SPD and the Greens also advocate for reductions in electricity taxes. </p><h3><strong>Outlook</strong></h3><p>Whether the next government will succeed in balancing climate action with economic development seems pivotal not only for the energy transition but also for Germany's broader economic future. As ambitious national climate goals face increasing scrutiny, the decisive continuation of the energy transition will also depend on whether its costs for consumers can be effectively mitigated by the state. The scope for government action in this regard will heavily depend on a potential reform of the debt brake. Despite significant differences in energy policy, all parties acknowledge the need for decisive action. </p><p>You can find more in our overview of the election manifestos on energy and climate (<a href=\"https://ssl.freshfields.com/noindex/documents/elections/Freshfields-German-Federal-Election-Overview-Energy-and-climate.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">English version</a>/<a href=\"https://ssl.freshfields.com/noindex/documents/elections/Freshfields-Ubersicht-Bundestagswahl-Energie-und-Klima.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">German version</a>). This blog post is part of our <a href=\"https://www.freshfields.com/en-gb/our-thinking/campaigns/trump-2-0-a-us-and-global-perspective/german-federal-election/\">German Election Supercycle</a> series.</p><p style=\"margin-left: 0\"><i>Co-Author: Niklas Hauser, Public Affairs Germany research assistant</i></p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102jzxf\" />",
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"html": "<p style=\"text-align: justify\"><strong>What specific impacts of geopolitical tensions are companies facing today? How should governments balance free trade with the protection of national interests? And what might investment policies look like in the future? These and other questions were the focus of a high-profile panel discussion at this year’s Munich Security Conference, hosted by Freshfields in cooperation with the American Chamber of Commerce to the European Union.</strong></p><p>Together with our distinguished speakers and panelists – Ambassador<strong> </strong>(ret.)<strong> Wolfgang Ischinger</strong>, President of the Munich Security Conference Foundation; <strong>Udo Philipp</strong>, State Secretary at the German Federal Ministry for Economic Affairs and Climate Protection; <strong>Mara Karlin</strong>, Professor, Johns Hopkins University, and former U.S. Assistant Secretary of Defense for Strategy, Plans, and Capabilities; <strong>John Harrison</strong>, General Counsel & Head of Public Affairs at Airbus; and <strong>Koos Lodewijkx</strong>, Chief Information Security Officer at IBM – we discussed the growing geopolitical uncertainties and what they mean for investments and businesses around the world. Our partner <strong>Beth George</strong>, who leads our Strategic Risk Management Group, moderated this official side event at this year’s Munich Security Conference. </p><p><i>“We live in a world with growing geopolitical challenges</i>.<i>”<strong> – Udo Philipp</strong></i></p><p>Regional wars and conflicts, tensions between powerful nations, rising nationalism and fierce technological competition are currently reshaping – and will continue to reshape – the global business environment. Globalisation and the era of unrestricted trade as we have known it over the last decades may slow down and a new era of rising protectionism seems to be on the horizon. Also, new technologies are not immune from this development and may be used to the detriment of others. </p><p>“<i>With the proliferation of cybercrime and acceleration of new technologies, cybersecurity can no longer be addressed in silos. Integrated, robust and resilient cybersecurity strategies and trusted partnerships are the best way to protect critical services, economies and people</i>.<i>“ <strong>– Koos Lodewijkx</strong> </i></p><p>To meet these global challenges, states and unions like the European Union must develop a coherent policy balancing free trade with national interests. In safeguarding their national priorities, countries frequently regulate the investment in and trade of critical and influential technologies. This balance allows them to engage in global markets without jeopardising their essential resources and security.</p><p>“<i>Today’s threats are complex and interconnected. The plasticity of this period, wherein major regions and conflicts are being fundamentally reshaped, contains challenges and opportunities for national security interests.</i>” <i><strong>– Mara Karlin</strong></i></p><p>“<i>In this world where economic policy and security policy are more and more intertwined, together with our European partners, we need to strengthen the EU’s resilience and sovereignty. We need to secure our supply chains, counter hybrid attacks effectively, secure a green and steady energy supply and strengthen our technological leadership in innovative sectors“</i>, explains <strong>Udo Philipp</strong>, showing his perspective on opportunities and objectives of furthering European harmonisation in terms of FDI regulation.</p><p>Just recently, the U.S., still under the Biden administration, added the instrument of outbound investment control to its regulatory toolbox, requiring investors to report or restrict certain investments in companies engaged in sensitive technologies, such as semiconductors and microelectronics, quantum computing and AI systems, in China (learn more about this issue in <a href=\"https://www.freshfields.com/en-gb/our-thinking/our-podcasts/transactions/essential-antitrust-40-americas-impending-outbound-investment-controls-what-investors-need-to-know/\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>this podcast</strong></a>). Similarly, the European Commission has just issued a recommendation for Member States to review outbound investments, relating to sensitive technologies and data (more on this <a href=\"https://riskandcompliance.freshfields.com/post/102jv31/eu-to-follow-suit-outbound-investment-control-at-the-gates-recommendation-eu\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>here</strong></a>). While such regimes may be justified to protect important interests, they pose additional burdens on businesses and may lead to undesired outcomes. </p><p>“<i>A global company like Airbus needs a rules-based economic world order. But rules-based must not mean overregulation. In Europe, regulation is an important impediment to competitiveness of our companies</i>.<i>“ <strong>– John Harrison</strong></i>.<i> </i></p><p>“<i>Geopolitical events, from armed conflicts to sanctions to tariffs, can have existential impacts on businesses. Executives need to be laser focused not only on these events, but they need to understand their potential downstream impacts on the markets. Deciphering these risks is crucial for our clients and their business and legal strategies,</i>”<i> </i>says Freshfields Partner <strong>Beth George</strong>. </p><p style=\"text-align: justify\">Our Strategic Risk Management Group will continue to publish a series of blog posts providing valuable insights on how to protect companies from those risks and implement a geopolitical strategy. </p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k04c\" />",
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"text": ", Chief Information Security Officer at IBM – we discussed the growing geopolitical uncertainties and what they mean for investments and businesses around the world. Our partner "
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"text": "Beth George",
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"text": ", who leads our Strategic Risk Management Group, moderated this official side event at this year’s Munich Security Conference. "
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"text": "Regional wars and conflicts, tensions between powerful nations, rising nationalism and fierce technological competition are currently reshaping – and will continue to reshape – the global business environment. Globalisation and the era of unrestricted trade as we have known it over the last decades may slow down and a new era of rising protectionism seems to be on the horizon. Also, new technologies are not immune from this development and may be used to the detriment of others. "
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"text": "With the proliferation of cybercrime and acceleration of new technologies, cybersecurity can no longer be addressed in silos. Integrated, robust and resilient cybersecurity strategies and trusted partnerships are the best way to protect critical services, economies and people",
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"text": "Just recently, the U.S., still under the Biden administration, added the instrument of outbound investment control to its regulatory toolbox, requiring investors to report or restrict certain investments in companies engaged in sensitive technologies, such as semiconductors and microelectronics, quantum computing and AI systems, in China (learn more about this issue in "
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"text": "). Similarly, the European Commission has just issued a recommendation for Member States to review outbound investments, relating to sensitive technologies and data (more on this "
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"text": "). While such regimes may be justified to protect important interests, they pose additional burdens on businesses and may lead to undesired outcomes. "
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"text": "Geopolitical events, from armed conflicts to sanctions to tariffs, can have existential impacts on businesses. Executives need to be laser focused not only on these events, but they need to understand their potential downstream impacts on the markets. Deciphering these risks is crucial for our clients and their business and legal strategies,",
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"html": "<p style=\"margin-left: 0; text-align: justify\">On 11 February 2025, the European Commission published its 2025 work programme, accompanied by a Communication on implementation and simplification and relevant Annexes – link <a href=\"https://commission.europa.eu/strategy-and-policy/strategy-documents/commission-work-programme/commission-work-programme-2025_en\"><u>here</u></a>. The Communication outlines the Commission’s strategy to create faster, simpler, and more effective rules, while the programme lays out what the Commission will work on in terms of new initiatives, withdrawn proposals, ongoing proposals making their way through the legislative process, and repeals. While the Communication shows the new ways of working of the Commission, this blogpost focuses on the 2025 work programme for financial services, which provides a good overview of what to expect in the year ahead. However, given the fast-changing political landscape, we might see other initiatives gaining traction or momentum in 2025. </p><p style=\"margin-left: 0; text-align: justify\"><strong>Background</strong> </p><p style=\"margin-left: 0; text-align: justify\">The 2025 work programme is framed against the backdrop of the new Commission´s plans on simplification in order to boost the bloc’s competitiveness (see here our outlook on the <a href=\"https://riskandcompliance.freshfields.com/post/102jqo7/the-von-der-leyen-ii-commission-navigating-a-fragmented-eu\"><u>von der Leyen II Commission</u></a>). While some familiar challenges remain, such as support for Ukraine or the energy crisis (see <a href=\"https://riskandcompliance.freshfields.com/post/102hzku/a-new-and-changing-geopolitical-backdrop-the-european-commissions-2023-work-pr\"><u>2023 work programme</u></a>) there are new mantras that are here to stay: the Commission’s push for effective implementation and enforcement of existing pieces of legislation, but potentially more significantly, simplification of existing laws. The message from the Commission in the new mandate is clear: reducing reporting obligations by at least 25%, and by at least 35% for small- and medium-sized enterprises (SMEs). </p><p style=\"margin-left: 0; text-align: justify\">This vision was reinforced by the publication of the <a href=\"https://ec.europa.eu/commission/presscorner/detail/en/ip_25_339\"><u>Competitiveness Compass</u></a> on 29 January 2025 and the announcement of the publication of a first Omnibus to simplify the sustainable finance architecture (Taxonomy, CSRD and CSDDD), expected by the end of February or early March 2025, and followed by additional omnibus simplification packages in the course of the year </p><p style=\"margin-left: 0; text-align: justify\">While the Omnibus announcement was radical and took all of industry by surprise, what we see now is a clear will from the Commission to push this simplification agenda much further, which is rapidly gaining momentum and moving far beyond sustainability or corporate reporting and into other sectors such as financial services and digital. This is further confirmed by the Commission’s 2025 work programme outlined <a href=\"https://commission.europa.eu/document/download/f80922dd-932d-4c4a-a18c-d800837fbb23_en?filename=COM_2025_45_1_EN.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">here</a> in more detail. Commissioner Dombrovskis, who spoke about the work programme at its unveiling to the press, underlined that the EU is “emerging from a period of intense regulatory activity” and as such, “the accumulation of rules over time limits the EU’s economic potential and prosperity”. When challenged on this new approach that the Commission is pursuing, Commissioner Dombrovskis recalled that the idea of reviewing legislative frameworks is not new nor unprecedented, and that a similar exercise was carried out after the global economic crisis when a large numbers of new legislation were put into place and the Commission later undertook a call for evidence and streamlined its rulebook. While one could argue that a similar approach is being pursued by the Commission now, the level of ambition is far higher and the results far more unpredictable. </p><p style=\"margin-left: 0; text-align: justify\"><strong>Last minute revival of the open finance proposal </strong> </p><p style=\"margin-left: 0; text-align: justify\">On 03 July 2023, the Commission published the proposal on a framework for Financial Data Access or so-called FIDA (see here our <a href=\"https://technologyquotient.freshfields.com/post/102iihd/from-open-banking-to-open-finance-european-commission-unveils-rules-on-financia\"><u>blogpost</u></a>). The Commission published this proposal, demonstrating its commitment to bringing the wider financial sector into the digital age by securing and opening access to customer data across a broader range of financial services. Following the approval of the ECON Committee <a href=\"https://urldefense.com/v3/__https:/www.europarl.europa.eu/news/en/press-room/20240408IPR20274/committee-meps-want-to-enhance-customers-control-over-their-financial-data__;!!MfzFaTml5A!i_6cjES--ujeWcbjpTpWHUvxuMCdkKpgaqMD60q7Sasqr4Pne6wXZAzFvhAEMlMfL-tTpj76gqKNyoHMAVYmNyCYYJGfdDU5IuwI$\"><u>position</u></a>, the Parliament <a href=\"https://urldefense.com/v3/__https:/www.europarl.europa.eu/cmsdata/291678/Point*206*20-*20FiDA.pdf__;JSUl!!MfzFaTml5A!jGCXAFVPqh8j-vrrld-XLnx40Jzp_o40cktWGQw1bqC7rku3Pu0_hDyRx29xKMXbPHRXHYOJwk2A7fwJRDafj85DYdAqomKqcP3-$\"><u>decided</u></a> to enter into interinstitutional negotiations in December 2024. On 04 December 2024, the Council <a href=\"https://urldefense.com/v3/__https:/data.consilium.europa.eu/doc/document/ST-16312-2024-INIT/en/pdf__;!!MfzFaTml5A!jGCXAFVPqh8j-vrrld-XLnx40Jzp_o40cktWGQw1bqC7rku3Pu0_hDyRx29xKMXbPHRXHYOJwk2A7fwJRDafj85DYdAqorb_KGtb$\"><u>adopted</u></a> their FIDA General Approach to enter trilogues. While trilogues were set to begin in March 2025, leaked versions of the Commission’s 2025 work programme took an unexpected approach by including FIDA in the list of proposals to be withdrawn – a fate usually reserved for initiatives that have been stuck in negotiations for months on end, often years, and that stand little to no chance of ever being approved. </p><p style=\"margin-left: 0; text-align: justify\">Finally, however, the official 2025 Commission work programme listed FIDA under the heading of pending proposals, meaning negotiations will continue, preventing the file from being abandoned. Why is this seemingly small change significant? The last minute changes affecting the status of FIDA shows that this new Commission is ready to scrap initiatives it thinks are too burdensome on industry even when negotiations are in full force, and that despite the decision to have FIDA removed by the very highest ranks in the Commission, individual services such as DG FISMA and the new financial services Commissioner were able to push back. In the specific case of FIDA, it should be noted that if political disagreements persist or discussions stall, withdrawal could still be an option. A withdrawal would likely spark mixed reactions from industry stakeholders and consumer protection groups. Meanwhile, with the US and UK leading in Open Banking and Open Finance, the EU’s next steps in financial data sharing—and its potential for monetization—will be crucial to watch. (See our <a href=\"https://technologyquotient.freshfields.com/post/102juwt/freshfields-fintech-our-predictions-for-2025\"><u>2025 Fintech Predictions for more insights</u></a>). </p><p style=\"margin-left: 0; text-align: justify\"> </p><p style=\"margin-left: 0; text-align: justify\"><strong>Revamping the Savings and Investments Union</strong> </p><p style=\"margin-left: 0; text-align: justify\">The Commission's work programme includes a forthcoming Communication on the Savings and Investments Union, planned for Q2 of 2025. This non-legislative initiative will be shaped by feedback from the call for evidence that opened on 03 February 2025 and will be closed on 03 March 2025 (see link to the <a href=\"https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14488-Savings-and-Investments-Union_en\"><u>call for evidence</u></a>). </p><p style=\"margin-left: 0; text-align: justify\">As suggested in the Letta and Draghi reports (see here our takeaways from the <a href=\"https://riskandcompliance.freshfields.com/post/102j6g2/enrico-letta-on-eu-competitiveness-an-analysis-of-his-key-recommendations-for-a\"><u>Letta</u></a> and <a href=\"https://riskandcompliance.freshfields.com/post/102jk1d/will-the-draghi-report-boost-european-competitiveness\"><u>Draghi</u></a> reports), the Capital Markets Union has been rebranded as the Savings and Investments Union, but its core objective remains the same: unlocking funding to drive Europe’s growth and competitiveness. The Savings and Investments Union aims to help households grow their wealth by improving returns on savings while also expanding financing opportunities for businesses. The Commission aims to address a key issue: EU capital markets lack sufficient opportunities, scale and depth, with cross-border business still facing many barriers. To fix this, the Commission is gathering feedback specifically on the progress made so far and the remaining challenges for making progress on the Savings and Investments Union. </p><p style=\"margin-left: 0; text-align: justify\"><strong>Other key new initiatives</strong> </p><p style=\"margin-left: 0; text-align: justify\">When it comes to other novelties and following the line of focusing on investment, simplification and cutting red tape, the Commission is also planning a third Omnibus package on investment simplification as well as a review of the existing Securitisation Framework, both slated to come in Q2 of 2025. What is clear is that the Omnibus on sustainable finance will set a precedent on the Commission’s approach to legislation and will lead the way for the other Omnibus initiatives that will follow. </p><p style=\"margin-left: 0; text-align: justify\">Regarding other key topics, the Commission launched on 18 June 2024 a <a href=\"https://finance.ec.europa.eu/regulation-and-supervision/consultations-0/targeted-consultation-artificial-intelligence-financial-sector_en\"><u>targeted consultation</u></a> on artificial intelligence in the financial sector and it is currently analysing the feedback received. With the targeted consultation having closed on 13 September 2024, the Commission is likely to follow up with a non-legislative initiative in the future. While this workstream has not been included in the work programme, this might come in 2026. For now, in parallel to the work of the Commission to ensure the proper implementation of the AI Act (see here our <a href=\"https://www.freshfields.com/en-gb/our-thinking/campaigns/technology-quotient/tech-and-platform-regulation/artificial-intelligence-regulation/\"><u>AI Insights</u></a>), the Parliament has kicked off work on an own-initiative report on AI in financial services. While the timeline for this non-binding report is still under discussion, it is likely to feed into future discussions and influence the Commission’s work. </p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102jzye\" />",
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"html": "<p><i>Note: this article originally ran in </i><a href=\"https://medcitynews.com/2025/01/10-key-medtech-themes-for-2025/\" target=\"_blank\" rel=\"noopener noreferrer\"><i>MedCity News</i></a></p><h2><strong>The MedTech industry is accelerating at an unprecedented pace.</strong> As AI reshapes the landscape, global collaborations are expanding, and the regulatory frameworks are evolving to meet new challenges. Here are 10 global MedTech trends for 2025: </h2><h3><strong>1. Renewed focus on expanding existing product lines in M&A</strong></h3><p>The MedTech sector rebounded strongly in 2024, with M&A poised for even greater momentum in 2025. Potential reductions in interest rates and sector deregulation set the stage for heightened deal activity. Opportunities abound for larger companies, especially in areas like telemedicine, where low valuations present a chance for strategic expansion. Both the size and number of acquisitions are expected to grow, with larger players seeking operational efficiencies and focusing on deals that complement their existing product lines and business models. Cutting-edge innovations like AI-based diagnostics will take centerstage, with niche technologies in emerging markets offering acquirers a competitive edge in this dynamic and unpredictable landscape. </p><h3><strong>2. Economic uncertainty affects investor activity in early 2025</strong></h3><p>Despite some economic uncertainty, MedTech investors are optimistic about growth in 2025. Early in the year, investors may adopt a “wait and see” approach as the economic impacts of President Donald Trump’s re-election become clearer. However, some experts speculate that the prospect of lower interest rates could stimulate investor interest in MedTech assets sooner rather than later. Additional uncertainty stems from Robert F. Kennedy Jr.’s potential confirmation to head the Department of Health and Human Services, the possible downstream regulatory changes to the U.S. Food and Drug Administration (FDA) and other agencies, and the unknown impacts of the pending BIOSECURE Act—all of which could influence investor confidence in early 2025. Nonetheless, strong MedTech funding trends in late 2024—marked by increased venture capital and M&A activity—bolster confidence in the industry’s outlook for 2025.</p><h3><strong>3. AI-MedTech collaborations continue to take centerstage</strong></h3><p>AI and machine learning technologies remain at the forefront of MedTech innovation, as industry players continue to integrate AI into existing product and service offerings. AI’s MedTech applications span patient-focused care, personnel management, administrative tasks, high-volume data analysis and virtual healthcare assistants, underscoring its transformative potential. The continued shift towards telemedicine and remote hyper-personalized care elevates the role of digital and communications technologies as key components of a modern MedTech enterprise. Digital solution providers remain key targets for strategic partnerships within MedTech, enabling rapid innovation in promising fields. </p><h3><strong>4. Shifting targets for heightened antitrust scrutiny</strong></h3><p>In 2025, US antitrust scrutiny for MedTech companies is generally expected to revert to more historical norms. Most experts anticipate that the Trump administration’s focus on fact-based analysis of M&A activity will ultimately have a larger impact than its anticipated position toward technology companies. Nonetheless, antitrust scrutiny is expected to remain high generally though the extent to which the Federal Trade Commission (FTC) and Department of Justice will continue to prioritize innovation protection, pricing practices, and merger control in the MedTech industry remains uncertain. However, AI-related mergers, partnerships and investments are expected to remain under enhanced scrutiny, alongside any transactions that may increase drug prices. </p><p>In the UK, new regulatory thresholds introduced by the Digital Markets, Competition and Consumers Act, coupled with growing interest from global competition authorities, are likely to intensify antitrust scrutiny in MedTech. Digital health platforms are likely targets for antitrust authorities, reflecting evolving concerns about data sharing and whether access to critical health data could potentially confer anti-competitive advantages.</p><h3><strong>5. Cyber threats drive stricter data privacy regulations</strong></h3><p>As the volume of individuals’ healthcare data collected and processed within the MedTech industry continues to grow, data privacy and security remain key focal points of regulators. The February 2024 ransomware attack on Change Healthcare, the United States’ largest medical claims processor, threatened the security of sensitive personal information for over 100 million people, and reignited concerns over companies’ obligations to ensure HIPAA compliance in the digital age. </p><p>Regulatory actions in 2024 signal a clear trend toward stronger protections for personal health data and are expected to continue in 2025. The FTC’s revisions to the Health Breach Notification Rule, protecting health information held by non-HIPAA-accountable entities, and the European Commission’s agreements on the European Health Data Space, strengthening personal health data protections provided under the EU’s General Data Protection Regulation, illustrate policy makers’ commitment to safeguarding citizens’ sensitive information as the MedTech industry collects and processes increasing amounts of data. MedTech will likely remain a prime target for increasingly sophisticated cyberattacks. Enhanced regulations will require proactive cybersecurity measures from MedTech companies, a topic explored in our podcast: <a href=\"https://www.freshfields.us/insights/our-podcasts/navigating-cybersecurity-risks-in-the-healthcare-sector/\" target=\"_blank\" rel=\"noopener noreferrer\">Navigating Cybersecurity Risks in the Healthcare Sector | Freshfields</a></p><h3><strong>6. Further AI-focused overhauls of medical device regulation </strong></h3><p>AI and other advanced technologies are driving intensified regulatory oversight, with increased dialogue between regulators and MedTech companies anticipated in 2025. The FDA’s Innovative Science and Technology Approaches for New Drugs Pilot Program signals continued support for AI-driven drug development, paving the way for more AI life sciences and healthcare innovations. Recent acceptance of Deliberate AI’s Clinical Outcome Assessment (AI-COA™)—an innovative AI-driven tool designed to assess anxiety and depression severity reflects this trend. </p><p>In 2025, the UK Department for Health and Social Care plans to expand its MedTech Innovation Classification Framework, and the Innovative Devices Access Pathway pilot, streamlining market entry for new AI-powered medical technologies. The Medicines and Healthcare Products Regulatory Agency (MHRA) is set to roll out its AI Strategy, adapting regulatory frameworks to better support evolving AI applications in healthcare and leveraging internal AI tools to enhance efficiency. </p><p>The EU’s European Medicines Agency will advance its 5-year AI workplan in 2025, focusing on implementing the EU AI Act, developing AI-driven regulatory tools, and fostering collaboration and training to enhance the safe and effective integration of AI technologies in medicine regulation. As global regulations expand, we expect MedTech companies to actively engage with regulators to ensure compliance, shape regulatory frameworks, and seize opportunities for innovation while managing risks. </p><h3><strong>7. Mitigating the risk of disputes involving “commercially reasonable efforts” clauses</strong></h3><p>Commercially reasonable efforts (CRE) clauses are ubiquitous in MedTech M&A, collaboration, licensing, and manufacture and supply agreements and were frequently litigated in 2024. We anticipate these disputes will persist in 2025. Such litigation arises, in part, from contractual ambiguities and occasionally opportunism—where one party compels another to undergo the often-burdensome process to demonstrate compliance with CRE obligations. Companies can mitigate the risk of such litigation by carefully drafting CRE terms, and documenting compliance with CRE obligations. When drafting, parties should decide between a subjective (company-specific) or objective (industry-wide) standard and specify the factors a party can consider when calibrating its efforts, including potential economic costs and benefits. When performing subject to a CRE clause, careful and consistent documentation of compliance with a CRE obligation can pay dividends by enabling the performing party to quickly and confidently respond to a threat of litigation by a counterparty. </p><h3><strong>8. Embrace of virtual care and direct-to-consumer models</strong></h3><p>Virtual care and direct-to-consumer (DTC) models are expected to grow in 2025, driven by rapid technological advancements and evolving consumer expectations. Pharmaceutical companies are leading the way with online platforms that allow patients to access medications directly bypassing traditional distribution channels and offering services like home delivery for treatments for COVID-19 and migraines. This shift reflects a broader trend of pharmaceutical and healthcare companies embracing digital health solutions to improve medication access and patient engagement. </p><p>Meanwhile, the virtual care market is transitioning to a \"new normal\" as major players such as Walmart, Optum, and Teladoc adjust their strategies. These changes indicate that, beyond behavioral health, consumers may no longer view telehealth as a complete substitute for in-person care. As the market matures, telehealth is becoming a vital complement to traditional care, and digital health companies must adapt to evolving consumer demand.</p><h3><strong>9. Harnessing the potential of generative AI</strong></h3><p>Generative AI is reshaping MedTech, driving breakthroughs in drug discovery, clinical trials and personalized patient care. Generative AI is increasingly enhancing the design of innovative therapies and is demonstrating its value to the drug discovery process. In clinical trials, generative AI is streamlining digital outcome assessments, significantly reducing the time and burden on sponsors and equipping life sciences professionals with actionable insights and enhance decision-making. Generative AI is also revolutionizing gene editing – such technology is capable of vastly improving gene editing precision and therapeutic antibody binding, taking a major step toward controlled, intentional protein design. </p><h3><strong>10. Global focus on AI safety and accountability</strong></h3><p>The regulatory landscape for AI in medical devices is evolving rapidly, with safety, transparency, and accountability at the forefront of global priorities. In the United States, the FDA is intensifying its oversight of AI and machine learning-driven medical devices, particularly through updates to its 510(k) clearance process and increased post-market surveillance. These developments are part of a broader effort to ensure that adaptive AI systems meet rigorous safety and performance standards. </p><p>In the EU, the AI Act (Regulation 2024/1689), which will be fully enforceable by August 2, 2026, will introduce stringent requirements for high-risk AI systems, including medical devices. </p><p>In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is working to adapt its medical device regulations to address AI-driven technologies, ensuring that AI as a Medical Device is regulated proportionately to its associated risks while maintaining global standards for safety, performance, and transparency. </p><p>In China, draft AI regulations that include mandatory labeling and metadata standards for AI-generated content are advancing, further pushing for greater transparency and accountability. As these global frameworks take shape, MedTech companies will need to navigate an increasingly complex regulatory environment.</p><p>***</p><p>The MedTech industry has demonstrated remarkable resilience in navigating uncertainty, and 2025 promises to be a pivotal year as the election supercycle concludes and AI regulatory frameworks become clearer. The evolving legal and regulatory landscape will remain central to MedTech innovation and strategy. Adopting a global, forward-thinking approach will enable MedTech companies to stay competitive and ultimately, deliver better outcomes for patients.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102jx2p\" />",
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"html": "<p>The UK Government recently <a href=\"https://www.gov.uk/government/publications/cyber-security-and-resilience-bill-policy-statement/cyber-security-and-resilience-bill-policy-statement\">published</a> a policy statement outlining the scope of its proposed Cyber Security and Resilience Bill. This is the latest in a series of actions by the Government regarding cyber security, following the <a href=\"https://www.gov.uk/government/news/data-centres-to-be-given-massive-boost-and-protections-from-cyber-criminals-and-it-blackouts\">designation of data centres as critical national infrastructure</a> in September last year, and its <a href=\"https://technologyquotient.freshfields.com/post/102k1em/ransomware-beware-government-launch-consultation-on-new-regime\">recent consultation on a new regime for ransomware</a>. The Bill’s aim will be to create a regulatory framework that can ’<i>keep pace and provide flexibility</i>’ and ensure regulators ’<i>have the right tools and the clarity of purpose</i>’ within the ever-evolving cyber threat landscape. </p><p>Below we outline the top seven changes the Bill is likely to bring, some of the key implications for businesses, related reforms the Government is considering, and likely next steps.</p><p><strong>What will it change?</strong></p><p>Currently, the only cross-sector cyber security legislation in the UK is the Network and Information Systems Regulations 2018 (the NIS Regs). The NIS Regs impose security duties on:</p><ul style=\"list-style-type: disc\"><li>those involved in delivering essential services covering five sectors (transport, energy, drinking water, health, and digital infrastructure) (so-called OES); and </li><li>certain digital services (online marketplaces, online search engines and cloud computing services) (so-called RDSPs).</li></ul><p>The Bill would update the NIS Regs, bringing more businesses into scope and aligning the UK regime more closely with the approach in the EU’s new NIS 2 Directive (NIS2) (see this <a href=\"https://technologyquotient.freshfields.com/post/102i9kb/the-eus-nis2-directive-key-aspects-for-businesses-to-consider\">previous blog</a>). It also proposes to strengthen the tools available to regulators in this area.</p><p>Key proposals include:</p><p><strong>1. Bringing managed services into scope</strong></p><p>The Bill will bring so called ‘Managed Service Providers’ (MSPs)<strong> </strong>that offer core IT services to businesses into the scope of the NIS Regs. Some examples of MSP services covered may include (among others): managed IT services, IT infrastructure and applications management, IT remote support and systems integration and management, managed security services, various other security, threat and incident response services and certain business process outsourcing. Although the precise definition of an MSP is yet to be confirmed, the policy sets out a working definition and estimates that the new obligations will impact around 900–1100 businesses. </p><p>Covered MSPs would be subject to the same duties as those currently providing digital services, and would be regulated by the Information Commissioner’s Office (ICO).</p><p><strong>2. Increasing duties for OES, RDSPs and their suppliers</strong></p><p>Secondary legislation will impose new duties on OES and RDSPs to manage cyber risks in their supply chains, such as new contractual requirements, security checks, and/or continuity plans. </p><p>Regulators would be able to designate specific suppliers to OES/RDSPs as ’designated critical suppliers’, bringing them under comparable obligations to OES and RDSPs. The Government anticipates this would be a ’<i>very small’ </i>number and percentage of suppliers to OES/RDSP, where failure or disruption to their services could have a <i>‘significant disruptive effect’ </i>on the provision of the OES or RDSP<i> </i>that it supports.</p><p>Regulators could also designate smaller RDSPs as critical suppliers (currently small and micro RDSPs are exempt from the NIS Regs).</p><p><strong>3. Updating the UK NIS Regs</strong> <strong>to more closely align with the EU’s NIS2, but keeping significant divergence</strong> </p><p>For example, to align more closely with the EU’s NIS2 regime, the Bill may:</p><ul style=\"list-style-type: disc\"><li>bring MSPs into scope (as explained above);</li><li>grant the Government new powers to set various technical and methodological security requirements (alongside a supporting code of practice); and</li><li>introduce closer alignment on incident reporting timelines (see below).</li></ul><p>However, it is clear the UK does not intend to simply copy the EU’s NIS2. Key aspects of the UK regime (including its scope, enforcement and terminology) will continue to diverge from the EU’s regime, which will complicate compliance for international businesses. </p><p><strong>4. Enhancing incident reporting</strong></p><p>Working in tandem with any reforms to the regime for ransomware (as discussed above), the Bill would:</p><ul><li>expanding the circumstances in which an incident is reportable to include those that are capable of having a significant impact on the provision of the OES or RDSP and incidents that significantly affect the confidentiality, availability and integrity of a system; and</li><li>introduce a two-stage reporting structure, which will require regulated entities to notify their regulator and the NCSC no later than 24 hours after becoming aware of an incident, followed by an incident report within 72 hours. Businesses providing digital services and data centres that experience a significant incident will also have to alert customers who may have been affected by the incident.</li></ul><p><strong>5. Extending the ICO’s information gathering powers</strong></p><p>This includes expanding the duty on RDSPs to share information with the ICO on registration, expanding the ICO’s scope to serve information notices on RDSPs, establishing information gateways for other entities outside the NIS Regs regime to share information with the ICO, and introducing enforcement powers where businesses fail to register with the ICO.</p><p><strong>6. Enhancing regulators’ cost recovery mechanisms</strong></p><p>The Bill will allow regulators to set up new fee regimes, allowing for fees to be levied as well as recovering costs via invoices. This reform may not only increase costs for impacted businesses, but also give regulators stronger resources - and hence capacity - to enforce. </p><p><strong>7. New powers to reform the regime without primary legislation</strong></p><p>The Bill will provide the Secretary of State with various powers to update the regulatory framework without requiring an Act of Parliament, subject to certain safeguards. The intent is to ensure requirements can be updated in line with technological changes, emerging threats, and lessons learned. Businesses should prepare to deal with a more rapidly evolving regulatory regime after the Bill becomes law.</p><p><strong>Other cyber reforms being considered by the Government </strong></p><p>The policy statement also mentions a number of additional areas where the Government is considering legislating, which may ultimately be addressed in the Bill. Among these are proposals to: </p><ul style=\"list-style-type: disc\"><li>bring data centres within the regulatory framework;</li><li>publish a statement of strategic priorities for regulators, on which regulators would provide annual updates; and</li><li>empower the Secretary of State to issue directions that require specific actions by regulated entities or regulators where threats affect national security.</li></ul><p><strong>Next steps</strong></p><p>There is currently no clear timeline for the Bill’s publication or introduction to Parliament. </p><p>However, the publication of this policy statement shows that significant development and preparatory work have been completed. Action in this sphere is a clear priority for the Government, and we anticipate a draft of the Bill will be published this year and potentially before Parliament’s summer recess.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k92l\" />",
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"html": "<p style=\"text-align: justify\"><i>Read Part 1 of this mini series </i><a href=\"https://technologyquotient.freshfields.com/post/102k8mi/legal-implications-of-agentic-ai-in-healthcare-regulatory-compliance-part-1-of\" target=\"_blank\" rel=\"noopener noreferrer\"><i>here</i></a><i>.</i></p><p style=\"text-align: justify\">***</p><p style=\"text-align: justify\"><strong>Potential for inaccurate or biased data</strong></p><p style=\"text-align: justify\">Inaccuracy and bias in datasets used to build agentic AI applications present both legal and ethical challenges. Agentic AI applications, including those used for clinical decision-making, rely heavily on datasets to train models. If these datasets are incomplete or unrepresentative or contain inherent biases, and reasonable steps aren’t taken to cure these problems, the underlying AI models can perpetuate or even exacerbate existing healthcare disparities. For example, biased data may lead to inaccurate predictions for certain demographic groups, particularly those underrepresented in clinical research, resulting in unequal healthcare outcomes. The issue is compounded by the “black box” nature of some AI models, as even developers may struggle to explain how certain decisions are made. Such challenges raise concerns about the reliability of agentic AI in making critical healthcare decisions, as well as the potential harm that could arise from inaccurate or biased inputs, emphasizing the need for robust AI governance to ensure fairness, transparency, and accuracy. </p><p style=\"text-align: justify\"><strong>Practical tips: </strong></p><p style=\"text-align: justify\">AI developers working on agentic AI applications, particularly in healthcare, may consider prioritizing building models that are not only technically robust but also free from bias. Below are some practical ways that developers can mitigate the risks of inaccuracy and bias:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\">Regularly review and update their AI models to reduce the risk of algorithmic bias.</li><li style=\"text-align: justify\">Employ data governance techniques to ensure that the datasets used for training are representative of the broader population.</li><li style=\"text-align: justify\">Collaborate with healthcare professionals to ensure that the AI system aligns with clinical standards and real-world practices.</li><li style=\"text-align: justify\">Conduct thorough risk assessments to evaluate the potential harms that could arise from biased or inaccurate AI predictions and implement strategies to minimize such harm, such as establishing fallback protocols if the AI system fails to perform as expected.</li></ul><p style=\"text-align: justify\">Healthcare organizations and other companies contracting with AI developers can potentially mitigate contractual liability stemming from inaccurate or biased data by:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\">Requiring such developers to ensure the accuracy and fairness of their datasets and implement mechanisms for regular audits and updates.</li><li style=\"text-align: justify\">Establishing accountability for any adverse outcomes caused by faulty AI recommendations, including stipulations for corrective actions or credits if the AI system fails to meet agreed-upon standards for performance.</li></ul><p style=\"text-align: justify\">For companies covered by the AI Act, the lack of statutory rules on contractual liability requires the development of customized liability frameworks in contracts concerning AI systems. While the AI Act imposes obligations on providers and developers, including with respect to the ethical, transparent, and accountable creation of AI systems, contracting parties can redistribute liability (e.g., seeking indemnities to account for non-compliance) or further designate liability for specific tasks. Such agreements, however, cannot override the statutory obligations under the AI Act. Additionally, such agreements should delineate the parties’ ownership and usage rights for AI outputs, responsibility for IP infringement of such outputs, and other risk considerations, in order to account for the full universe of key risks stemming from contracting with AI systems.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k8zs\" />",
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"html": "<p style=\"text-align: justify\"><strong>Introduction</strong></p><p style=\"text-align: justify\">The agentic capabilities of large language models (LLMs) offer considerable promise for the healthcare sector. Agentic AI refers to AI systems that can make autonomous decisions and perform tasks with a degree of independence, often with minimal human oversight. </p><p style=\"text-align: justify\">While some proponents argue that agentic AI will obviate the need for primary care doctors altogether, it would be difficult to envision a healthcare system fully managed by AI-powered agents without any human personalized interaction. Nonetheless, the transformative effects of agentic AI in healthcare cannot be overstated, particularly in light of the challenges surrounding electronic health records administration and the prevalence of physician burnout, which are driven in large part by inefficient hospital information systems. </p><p style=\"text-align: justify\">However, as these technologies advance, they present significant legal risks, including concerns around regulatory compliance, the potential for biased or inaccurate data, and safeguarding patient privacy, all of which must be carefully addressed to ensure that the benefits of agentic AI are realized without compromising patient safety or violating legal standards.</p><p style=\"text-align: justify\">Over the next three weeks, we will outline the legal implications of agentic AI in healthcare. This first blog covers regulatory compliance and provides practical tips.</p><p style=\"text-align: justify\"><strong>Regulatory compliance</strong></p><p style=\"text-align: justify\">Regulatory compliance remains a critical issue for the integration of agentic AI in healthcare as regulators and policymakers around the world grapple with balancing innovation in agentic AI with safeguarding public health. </p><p style=\"text-align: justify\">In the EU, the AI Act aims to provide a clear framework for AI applications, with a focus on transparency, accountability, and patient safety. The AI Act classifies AI systems based on their risk levels, with higher-risk applications like healthcare AI facing stricter requirements, including data governance and human oversight. The Act also includes specific rules for underlying AI models. </p><p style=\"text-align: justify\">Further, the European Health Data Space (EHDS) seeks to create a unified health data space, ensuring interoperability and addressing privacy and security concerns while also enabling health data to be exchanged and used for research and innovation purposes, including for the development of agentic AI in healthcare. After being formally adopted by the Council of the European Union in January, the new EHDS rules will become applicable in all EU member states between 2027 and 2031.</p><p style=\"text-align: justify\">Meanwhile, in the US, the regulatory landscape remains fragmented, with oversight split between federal agencies such as the Food and Drug Administration (FDA) and Federal Trade Commission and state laws that vary in scope and application. In his first week back in office, President Trump rescinded President Biden’s executive order on safe, secure, and trustworthy AI and issued his own AI order aimed at reinforcing American leadership in AI by eliminating regulatory barriers and revoking prior policies. </p><p style=\"text-align: justify\">While the federal government seeks to scale back its supervision of AI developers, companies must continue to contend with state regulation. The inconsistency between federal and state-level regulations in the US, in addition to emerging foreign regulations, poses challenges for healthcare providers and AI developers, who must navigate a complex patchwork of laws and regulations to ensure compliance while fostering innovation in the global health technology industry.</p><p style=\"text-align: justify\">An emerging regulatory focus in the US is the FDA’s classification of AI as “software as a medical device.” The FDA recently issued draft guidance for AI-enabled medical devices, providing developers with key product design, development, and documentation recommendations for initial submissions to help ensure the safety and effectiveness of such devices. </p><p style=\"text-align: justify\">The draft guidance also includes the FDA’s current thinking on strategies to address transparency and mitigate bias throughout the life cycle of a device. This guidance follows the FDA’s recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how developers can proactively plan for device updates once the product is on the market. The FDA’s evolving framework on AI-enabled medical devices demonstrates the agency’s efforts to ensure that agentic AI applications in healthcare meet stringent standards of safety, efficacy, and performance. </p><p style=\"text-align: justify\"><strong>Practical tips:</strong></p><p style=\"text-align: justify\">For developers working with agentic AI applications in healthcare, being mindful of the fragmented and evolving regulatory landscape is important. A best practice for developers to consider would be to build a compliance program around the key common elements among the various international, federal, and state laws, regulations, and guidance, which include:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\">Design for transparency and explainability: Develop AI systems that are accurate and explainable, using techniques that allow clinicians to understand how the AI arrived at its decisions.</li><li style=\"text-align: justify\">Continuous validation and testing: Regularly validate the AI model with real-world data, including by conducting clinical trials. Keep track of how the system performs over time to address any changes or emerging medical trends.</li><li style=\"text-align: justify\">Clear documentation: Provide thorough and clear documentation that explains the AI model’s design, development process, data sources, testing procedures, and validation results.</li><li style=\"text-align: justify\">Focus on patient safety and ethical use: Ensure that the AI system is designed with patient safety as a top priority. Review ethical considerations to align with evolving regulations and ethical norms in healthcare.</li></ul><p style=\"text-align: justify\">These practices can aid developers in navigating the complexities of regulatory compliance while advancing AI innovation in the healthcare sector.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k8mi\" />",
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"html": "<p style=\"text-align: justify\">In this week’s edition of our ‘DSA decoded’ blog series, we look at the “safe harbour” provisions of the DSA dealing with liability of online services providers for content available via their services. We explain the concept of liability exemption, evolving from its initial implementation in the <a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000L0031\" target=\"_blank\" rel=\"noopener noreferrer\">e-Commerce Directive</a><a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000L0031\">,</a> we highlight an important nuance applicable to online marketplaces, and discuss potential overlaps with other EU laws, making life more difficult for platforms in practice.</p><p style=\"text-align: justify\"><i>[You can find all episodes of our DSA decoded blog series </i><a href=\"https://technologyquotient.freshfields.com/tag/eu%20dsa%20decoded%20series\" target=\"_blank\" rel=\"noopener noreferrer\"><i>here</i></a><i>.]</i></p><p><strong>Liability rules: from the e-Commerce Directive to the DSA </strong></p><p style=\"text-align: justify\">Prior to the DSA, the liability of online service providers was regulated in the EU by the e-Commerce Directive (<a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02000L0031-20240217\" target=\"_blank\" rel=\"noopener noreferrer\">200/31/EC</a>) which exempted intermediaries from liability for content made available by third parties on their service. For hosting services, the condition for such exemption to be invoked was that the hosting service provider does not have any knowledge of the illegal content and removes such content expeditiously once knowledge of its prevalence is obtained. This is still true under the DSA.</p><p style=\"text-align: justify\">A key principle underlying the liability exemption is that the intermediary should <strong>not be obliged to generally monitor or proactively moderate third-party content</strong>. The DSA clarifies this further by stating that general awareness of the fact that a service might be used to store illegal content does not give rise to knowledge of that fact and therefore potential liability. The DSA draws the line where the third party providing the content acts under the provider’s authority or control. In such a case, the provider is deemed to have sufficient knowledge and control over the content to be held liable. To encourage pre-emptive diligence by providers, the DSA introduces the so-called ‘<strong>good Samaritan clause</strong>’, which enables service providers to undertake voluntary investigations and implement other measures aimed at identifying and removing illegal content without risking losing their liability privilege.</p><p style=\"text-align: justify\">In contrast to the e-Commerce Directive, the DSA establishes a specific set of rules for a ‘notice and takedown’ mechanism for users to report illegal content: Once the hosting service provider has received a notice, providing the exact electronic location of the content and sufficiently substantiated reasons for the illegality of the content, it will give rise to the hosting service provider gaining actual knowledge or awareness of the unlawful content flagged in the notice. In other words, the provider must effectively remove such content for the liability exemption to apply – but at the same time ensure that the rights of the user who uploaded or owns the content in question – including potentially affected fundamental rights and freedoms – are duly considered. This difficult assessment as to whether the content in question should, or should not, be considered illegal, ultimately lies with the provider. </p><p style=\"text-align: justify\"><strong>Carve-out for online marketplaces </strong></p><p style=\"text-align: justify\">To address issues arising from online marketplaces under consumer protection law, the DSA includes a new carve out that limits the ability of online marketplaces to benefit from the liability exemption in certain circumstances. The carveout extends only to breaches of consumer law and is engaged where a marketplace holds itself out as the seller of goods or services. It is intended as a consumer protection measure, seemingly grounded in a concern that the line between a platform as an intermediary and traders can be blurred in the modern digital economy, making it difficult for consumers to identify their contractual counterpart.</p><p style=\"text-align: justify\">The carve out is triggered where consumers are led to believe that ‘<i>the information, or the product or service that is the object of the transaction, is provided either by the online platform itself or by a recipient of the service who is acting under its authority or control’</i> (Art. 6 (2) DSA). Based on their active role, providers usually wouldn’t be privileged in such circumstances under the previous rules already but the new carve out clarifies that it will suffice if an <i>average consumer</i> gets this impression. This may include circumstances where providers of online marketplaces fail to clearly display the identity of the third party trader, where an online platform withholds the identity or contact details of the trader until after the conclusion of the contract concluded between the trader and the consumer, or where an online platform markets the product or service in its own name rather than in the name of the trader who will supply that product or service.</p><p style=\"text-align: justify\"><strong>Overlaps with other laws </strong></p><p style=\"text-align: justify\">The implementation of a liability exemption applicable to such a broad scope of digital services in a densely regulated space, inevitably results in considerable overlaps with other regulations. Especially the requirement for service providers to remove illegal content expeditiously once on notice of its existence, intersects with various provisions of other laws that contain liability mechanisms relating to such content. These include the Digital Single Markets Directive (DSM-Directive) (<a href=\"https://eur-lex.europa.eu/eli/dir/2019/790/oj/eng\" target=\"_blank\" rel=\"noopener noreferrer\">Directive (EU) 2019/790</a>), the Terrorist Content Online Regulation (TCOR) (<a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R0784\" target=\"_blank\" rel=\"noopener noreferrer\">Regulation (EU) 2021/784</a>), the General Product Safety Regulation <a href=\"\" target=\"_blank\" rel=\"noopener noreferrer\">(Regulation (EU) 2023/988</a>) as well as the proposed Regulation to prevent and combat child sexual abuse (which can be accessed <a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52022PC0209\" target=\"_blank\" rel=\"noopener noreferrer\">here</a>). For companies in this space, it is important to be aware of these other existing and upcoming laws to include additional requirements on dealing with potentially illegal content effectively into their governance. </p><p style=\"text-align: justify\">In practice, dealing with overlapping regulations often requires delving into the intricacies of the respective scope of the regulations. Let’s take <strong>copyrighted content for example</strong>: Here, the interplay of the DSA with the DSM-Directive illustrates the complexities in reconciling different EU laws which typically all aim for full harmonization within their respective scope:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\">The DSM-Directive aims to introduce new regulations on copyright in a digitalized market and has introduced its own liability regime for online content in Art. 17, requiring so-called Online Content Sharing Service Providers (OCSSPs) to obtain authorization for user generated copyrighted content or prove that they made “<i>best efforts</i>” to obtain such authorization as well as having implemented sufficient notice and takedown/staydown systems.</li><li style=\"text-align: justify\">The overlap of this regime with DSA’s provisions on illegal content is meant to be addressed by the DSA’s application <strong>without prejudice</strong> to provisions of other Union law regulating <strong>other aspects of intermediary services</strong> or further <strong>specifying </strong>and <strong>supplementing</strong> the DSA. </li><li style=\"text-align: justify\">Applying these application principles renders the liability regime of Art. 17 DSM-Directive <i>lex specialis</i> since it specifically addresses liability of specific types of providers for specific types of content. As a result, intermediaries falling into the scope of Art. 17 DSM-Directive will not be able to rely on the liability exemption provided under the DSA, if they do not adhere to the (more specific) exemption requirements pursuant to Art. 17 DSM-Directive. </li><li style=\"text-align: justify\">However, the <strong>devil is in the details</strong> and this exercise becomes trickier when looking e.g., at the obligations to implement notice-and-takedown systems. The DSA requires such systems to not only enable users of the service, but also third parties not using the service, to report illegal content. It does not provide further specification on who is to be enabled to report which content. Regarding copyrighted content on Art. 17 in-scope platforms, , this gap is closed by the DSM-Directive, which foresees a removal obligation only where the <u>rightsholder</u> has reported copyright infringing content. In addition, Art. 17 DSM-Directive also mandates Member States to make sure copyrighted works covered by exceptions or limitations must not be taken down, and certain copyright exemptions such as for purposes of caricature, parody or pastiche can be relied upon by users.</li><li style=\"text-align: justify\">In other words, the more specific regime of the DSM-Directive is not automatically ‘stricter’ than the mechanism provided in the DSA but may also result in more ‘liberal’ rules regarding the availability of certain content. The interplay of both legal acts results in a situation in which intermediaries falling into the scope of Art. 17 DSM-Directive must implement notice-and-takedown systems according to the DSA but only remove copyright infringing content upon receipt of a notification by rightsholders, and duly considering applicable copyright exemptions.</li></ul><p style=\"text-align: justify\">On balance, the DSA is meant to present the baseline regulation for digital services offering a go-to set of rules applying in the digital space, including a clear-cut liability exemption for hosting service providers. However, the multitude of legal acts aiming to regulate specific liability aspects of digital services considerably complicates the issue of the Host-Provider-Liability, creating the need for a holistic moderation approach depending on the type of platform and content in question.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k793\" />",
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"html": "<p>The Belgian Data Protection Authority (DPA) has recently updated its <a href=\"https://www.autoriteprotectiondonnees.be/publications/recommandation-01-2025-relative-aux-traitements-de-donnees-a-caractere-personnel-dans-le-cadre-du-marketing-direct.pdf\">Guidelines on Direct Marketing</a> (the Guidelines) - originally published in 2020 - to account for evolving legal interpretations, case law, and industry practices. </p><p>Accompanied by a practical <a href=\"https://www.autoriteprotectiondonnees.be/publications/checklist-marketing-direct.pdf\">checklist</a>, the Guidelines are open for consultation until <strong>10 May 2025</strong>, providing businesses with an opportunity to comment on the DPA's notably stricter interpretations.</p><p><strong>Key points</strong></p><p><strong>Expanded definition of direct marketing</strong></p><p>The updated Guidelines consider regulatory and industry developments to broaden their definition of direct marketing. It now explicitly intends to include: </p><ul style=\"list-style-type: disc\"><li><strong>Preparatory data-processing activities</strong>, such as audience profiling, segmentation, and automated decision-making (such as dynamic pricing algorithms). For example, an e-commerce platform analysing user behaviour to adjust prices in real-time would now be considered as direct marketing, even if no final promotional communication is sent.</li><li><strong>Mixed-content communications</strong>: any communication combining informational and promotional content - such as a customer service email subtly promoting a premium subscription or a newsletter highlighting paid features – would be considered as direct marketing.</li></ul><p><strong>Retention periods </strong></p><p>The DPA notes that organisations still struggle to apply the principle of proportionality when setting personal data retention periods. It emphasises that retention periods must be evaluated individually and based on concrete, context-specific factors.</p><p>The DPA shares two overlooked factors that should in its view influence an appropriate retention period: the nature of the relationship between the data controller and the data subject and the life cycle of the product or service originally purchased by the data subject.</p><ul style=\"list-style-type: disc\"><li><strong>Nature of the relationship</strong>: if a data subject is a long-term client who regularly interacts with the business of the data controller, a longer retention period may be justifiable, as commercial communications from the data controller are more likely to present an interest to the data subject. However, if they are a one-time purchaser or merely a prospect, retention should generally be shorter. The DPA explicitly states that prospect data should not be retained as long as customer data, reinforcing the principle that weaker relationships warrant shorter retention periods.</li><li>The <strong>life cycle of a product or service</strong> also plays a role in defining retention limits. For example, marketing communications regarding cars and related services may remain relevant for a longer period compared to those concerning short-lifespan consumer goods. Data controllers must factor in product longevity when determining data retention policies.</li></ul><p><strong>Legitimate interest </strong></p><p>The updated Guidelines reaffirm that legitimate interest remains a potentially valid legal basis for direct marketing, as recently <a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:62022CJ0621\">recognised by the CJEU</a>. </p><ul style=\"list-style-type: disc\"><li><strong>Reasonable expectations:</strong> the DPA states that data subjects’ reasonable expectations of the processing are a key factor to determine whether the conditions for legitimate interest are met. It then notes that individuals generally do not expect marketing from organisations with which they have had no prior relationship. Consequently, pure ‘cold outreach’ is generally not justifiable under legitimate interest – and may therefore be prohibited in practice, as other legal bases are also unlikely to apply.</li><li><strong>Contextual exceptions:</strong> data subjects’ expectations can vary depending on previous interactions. For example, if a prospect contacts a business for information or a quote, they may reasonably anticipate subsequent marketing communications, depending on the information provided at the moment of data collection.</li><li><strong>Documentation via LIA:</strong> data controllers must conduct rigorous legitimate interest assessments (LIAs) to demonstrate that their interests outweigh the data subjects’ rights and freedoms. This is particularly true in cases involving minimal prior engagement.</li></ul><p><strong>Emphasis on transparency </strong></p><p>Throughout the Guidelines, the DPA insists on transparency obligations, specifically:</p><ul style=\"list-style-type: disc\"><li><strong>Purpose specification:</strong> the DPA considers that simply indicating that the processing purpose is \"direct marketing\" is insufficient - organisations must specify the nature and extent of their marketing activities with sufficient detail to allow a <i>prima facie</i> assessment of proportionality of the processing. The DPA provides examples of purpose descriptions that meet this demanding standard.</li><li><strong>Data sources: </strong>the DPA also places renewed emphasis on transparency regarding personal data sources when personal data are not obtained directly from the data subject. Referencing its own case law, the DPA maintains that the obligation to inform data subjects under Article 14 GDPR extends beyond merely naming the data source. According to it, controllers must provide all available information concerning the source, including the legal basis relied upon for the initial data collection, how the data was collected, and the contact details of the source, ensuring data subjects can exercise their rights directly with the original source.</li></ul><p><strong>Due diligence on data brokers</strong></p><p>The DPA requires that data controllers relying on data brokers conduct thorough due diligence to ensure they are GDPR compliant. They must verify:</p><ul style=\"list-style-type: disc\"><li>the origin of the data;</li><li>how it was obtained;</li><li>the legal basis for collection;</li><li>by whom and for what purposes it was collected;</li><li>the retention periods that apply.</li></ul><p>The DPA makes it clear that data controllers cannot simply rely on contractual assurances obtained from data brokers. Instead, they must take active steps to verify compliance, ensuring that personal data they obtain from brokers was lawfully obtained and processed under an appropriate legal basis. The inclusion of contractual clauses alone does not absolve controllers of liability in case of GDPR breaches.</p><p><strong>Responding to data subject requests regardless of format</strong></p><p>The DPA emphasises that data controllers must respond to Data Subject Access Requests (DSAR) even when they are incomplete or imprecisely formulated - reflecting a strict interpretation of this obligation.</p><p>The DPA's litigation chamber has enforced this principle in a <a href=\"https://www.autoriteprotectiondonnees.be/publications/decision-quant-au-fond-n0-43-2025.pdf\">recent decision</a> (not explicitly referenced in the Guidelines). In this case, the DPA found a GDPR violation when a controller failed to respond to a DSAR that appeared as a single sentence within a multi-page email. The request was neither explicitly labelled as a DSAR nor submitted through designated channels. This suggests that businesses should adopt a broad approach to recognising and processing data subject requests.</p><p><strong>Conclusion </strong></p><p>With the consultation period open until <strong>10 May 2025</strong>, data controllers should review their current practices, identify areas requiring clarification, and consider <a href=\"https://www.autoriteprotectiondonnees.be/citoyen/actualites/2025/03/10/consultation-publique-relative-au-marketing-direct\">providing feedback</a>.</p><p>Affected data controllers might wish to highlight practical concerns if they believe some aspects of the Guidelines exceed typical compliance expectations. Organisations seeking advice in adapting to or understanding these Guidelines are welcome to contact us.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k746\" />",
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"html": "<p style=\"text-align: justify\">As part of our <a href=\"https://technologyquotient.freshfields.com/tag/eu%20digital%20fairness%20series\">blog series on the EU Commission’s (EC) Digital Fairness Fitness Check</a> and a potential new EU legislative proposal, the Digital Fairness Act, we recently took a closer look at ‘<a href=\"https://technologyquotient.freshfields.com/post/102juif/digital-fairness-fitness-check-and-digital-fairness-actpart-4-social-media-comm\">Social Media Commerce and Influencer Marketing’</a>.</p><p style=\"text-align: justify\">Another focus area that may be the subject of future EU legislation are ‘Unfair Contract Terms’. In this blogpost, we analyse the main findings of the Digital Fitness Check and summarise the key takeaways for you.</p><h3>Existing framework and what is an ‘Unfair Contract Term’?</h3><p style=\"text-align: justify\">The EU's Unfair Contract Terms Directive (Directive 93/13/EEC, as amended by Directive (EU) 2019/2161, UCTD) applies to B2C contracts for the purchase of goods and services and aims to protect consumers from unfair standard terms imposed by traders, including in digital environments. </p><p style=\"text-align: justify\">The UCTD establishes a minimum level of consumer protection in the EU, but allows EU Member States to implement stricter rules in their national law. The UCTD prohibits certain unfair terms, in particular if they (i) are not in plain, intelligible language (transparency test) or (ii) are non-negotiable and designed to restrict the consumer's rights or impose unreasonable obligations on the consumer (unfairness test) – thus taking into account the typical (perceived) lack of bargaining power of consumers in relation to standard terms. In addition, the Annex to the UCTD contains a non-exhaustive list of terms which may be regarded as unfair. Examples of unfair terms include unilateral changes to the contract by the trader without proper justification or general exemptions from the trader's liability. </p><h3>What are the main results of the Digital Fitness Check?</h3><p style=\"text-align: justify\">Survey data cited in the Fitness Check report shows that over 62% of consumers who buy digital services say they have come across terms they consider unfair. Unsurprisingly, the survey results also suggest that many consumers do not read terms and conditions carefully: Only 36% of respondents said they regularly read them, while a further 23% indicated they sometimes read terms and conditions. Based on these results, about two-thirds of consumers would often accept terms they haven’t read while around 40% do not even read terms and conditions ‘sometimes’. Young adults, particularly those aged 18-25, reported the lowest levels of engagement with terms and conditions, with only 26% saying they always read them. Across all age groups, factors such as complex language, long texts and difficult presentation of the text contributed to low levels of understanding and awareness of terms and conditions.</p><p style=\"text-align: justify\">In addition to these qualitative datasets, the EU Commission referred to an automated assessment (using an experimental natural language processing tool) of the terms of service and privacy policies of 35 websites commonly used by EU consumers (15 e-commerce sites covering sectors such as telecoms, energy and travel, 15 online platforms, 5 micro-contract operators such as influencers/content creators) from a UCTD and GDPR perspective. The study identified several types of terms that were perceived as problematic, including unilateral terminations and amendments, jurisdiction and choice of law clauses, and limitation of liability clauses. It was also noted that website terms can change dynamically and rapidly, without direct communication to consumers.</p><p style=\"text-align: justify\">The Fitness Check correctly notes that the UCTD and existing case law can be used to ‘… successfully … tackle the most prevalent issues related to transparency and fairness of contract terms in the digital environment.’ It further found, however, that enforcement actions have ‘… not rooted out all non-transparent and unfair terms in the digital markets …’ (p. 189). Clearly no legislation will ever ‘root out <strong>all</strong> non-transparent and unfair terms’ and hence further legislation also will need to consider whether possibly only incremental gains in consumer protection justify additional burden and risks on businesses. </p><p style=\"text-align: justify\">Regarding more specific terms, the report notes that while the UCTD is principles-based and therefore generally applicable to the digital environment, some clarification of its applicability in digital contexts may improve its effectiveness. It was also highlighted that the ‘average consumer’ benchmark for assessing transparency may set the bar too high in online contexts. Stakeholders also noted that the national nature of the enforcement system of the UCTD (through national authorities or courts) may be a limitation given the cross-border nature of B2C transactions in the digital environment. In this context, stakeholders, including several ministries and enforcement authorities, also noted that the UCTD may only have a limited deterrent effect, especially for global digital players, despite the new provision on sanctions introduced by the EU Modernisation Directive ((EU) 2019/2161), providing for fines in cases of widespread or cross-border infringements up to at least 4% of the trader's annual turnover in the member state(s) concerned. </p><p style=\"text-align: justify\">With respect to the new EU legislation under the EU Digital Agenda (including the Digital Services Act and the Data Act), the Fitness Check concludes that the UCTD is generally coherent with these new regulatory pieces of legislation but potential consistency issues may arise since the enforcement competence is fragmented between different authorities.</p><h3>Taking action: Potential countermeasures</h3><p style=\"text-align: justify\">The Digital Fitness Check identified possible approaches to address the perceived shortcomings :</p><ul style=\"list-style-type: disc\"><li>First, stakeholders suggested updating the existing Commission guidance on the UCTD to better reflect the specific challenges of digital markets. </li><li>Second, updates to the UCTD are being discussed in order to create a ‘blacklist’ of presumed unfair terms in the digital environment (going beyond the existing minimum annex). Such changes could also provide authorities with further enforcement options and facilitate consistent cross-border enforcement. However, the Digital Fitness Check correctly recognises that the current minimum harmonisation nature of the UCTD may even allow for more effective consumer protection: Contract law falls within the national competence of Member States and contract terms may be specific to a given Member State.</li><li>Third, some stakeholders suggested to define additional obligations (such as the provision of a summary of key contract terms, the presentation of terms in clear language and the avoidance of excessively long documents). The Digital Fitness Check recognises certain disadvantages concerning these proposals, such as additional administrative burden for traders and the challenge of identifying key terms in a general terms and conditions document. Moreover, a potential oversimplification may lead to less legal certainty for consumers. It also does not seem entirely convincing to fight a perceived abundance of text with an obligation to produce more (shorter) text – even more so when the current legal standard provides for consumer protection irrespective of whether they read the terms or not.</li><li>Fourth, a modification of the 'average consumer' standard (reasonably observant, attentive and circumspect) relevant for the transparency test has been discussed by certain stakeholders to take into account the vulnerability of digital consumers. This seems questionable, since the standard of a <strong>reasonably</strong> observant, attentive and circumspect consumer leaves room for a flexible application and it would seem surprising to use unreasonable behaviour as a yardstick for the assessment of unfair contract clauses.</li><li>Fifth, in order to facilitate the enforcement of the UCTD and its deterrent effect, some stakeholders suggested higher revenue-based penalties, website blocking and voiding of contracts with unfair terms. This would follow a general tendency to include high revenue-based penalties in many pieces of new legislation (cf. DSA, DMA, AI Act, Data Act) which are often overlapping in scope. In light of the existing significant fine risk (as implemented by the Modernisation Directive) it remains, however, at least questionable whether such an approach would balance the interests between consumers and traders appropriately. It was also recommended to support ‘preventive’ enforcement, such as negotiations and dialogue with traders to address consumer and enforcement concerns. </li></ul><p style=\"text-align: justify\">In conclusion, there was broad consensus among stakeholders that the key principles introduced by the UCTD remain useful in a digital environment. However, there are also vocal demands for additional regulatory guidance on the specific challenges of digital B2C environments. While it remains to be seen which proposals will ultimately be considered for a potential Digital Fairness Act, businesses are well-advised to monitor both existing and potential future requirements in this area. This will equip them to stay ahead of legal developments and reduce the legal and reputational risk associated with unfair terms.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k640\" />",
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"text": "Another focus area that may be the subject of future EU legislation are ‘Unfair Contract Terms’. In this blogpost, we analyse the main findings of the Digital Fitness Check and summarise the key takeaways for you."
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"text": "The EU's Unfair Contract Terms Directive (Directive 93/13/EEC, as amended by Directive (EU) 2019/2161, UCTD) applies to B2C contracts for the purchase of goods and services and aims to protect consumers from unfair standard terms imposed by traders, including in digital environments. "
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"text": "The UCTD establishes a minimum level of consumer protection in the EU, but allows EU Member States to implement stricter rules in their national law. The UCTD prohibits certain unfair terms, in particular if they (i) are not in plain, intelligible language (transparency test) or (ii) are non-negotiable and designed to restrict the consumer's rights or impose unreasonable obligations on the consumer (unfairness test) – thus taking into account the typical (perceived) lack of bargaining power of consumers in relation to standard terms. In addition, the Annex to the UCTD contains a non-exhaustive list of terms which may be regarded as unfair. Examples of unfair terms include unilateral changes to the contract by the trader without proper justification or general exemptions from the trader's liability. "
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"text": "Survey data cited in the Fitness Check report shows that over 62% of consumers who buy digital services say they have come across terms they consider unfair. Unsurprisingly, the survey results also suggest that many consumers do not read terms and conditions carefully: Only 36% of respondents said they regularly read them, while a further 23% indicated they sometimes read terms and conditions. Based on these results, about two-thirds of consumers would often accept terms they haven’t read while around 40% do not even read terms and conditions ‘sometimes’. Young adults, particularly those aged 18-25, reported the lowest levels of engagement with terms and conditions, with only 26% saying they always read them. Across all age groups, factors such as complex language, long texts and difficult presentation of the text contributed to low levels of understanding and awareness of terms and conditions."
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"text": "In addition to these qualitative datasets, the EU Commission referred to an automated assessment (using an experimental natural language processing tool) of the terms of service and privacy policies of 35 websites commonly used by EU consumers (15 e-commerce sites covering sectors such as telecoms, energy and travel, 15 online platforms, 5 micro-contract operators such as influencers/content creators) from a UCTD and GDPR perspective. The study identified several types of terms that were perceived as problematic, including unilateral terminations and amendments, jurisdiction and choice of law clauses, and limitation of liability clauses. It was also noted that website terms can change dynamically and rapidly, without direct communication to consumers."
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"html": "<p style=\"text-align: justify\">The EU is committed to bringing the wider financial sector into the digital age. To this end, it has proposed a new framework for secure and open access to customer data across a broader range of financial services. As trilogue negotiations between the European Commission, the Council, and the European Parliament on the framework for financial data access (FIDA) are set to begin, it’s an opportune moment to reflect on where we stand. </p><p style=\"text-align: justify\">FIDA’s path to trilogues, however, has not been without disruption. In early 2025, a leaked draft of the Commission’s 2025 work programme suggested that FIDA could be withdrawn—an unexpected move typically reserved for long-stalled initiatives with little prospect of agreement. This raised questions across the financial sector, as withdrawal would have signalled a major shift in the EU’s approach to Open Finance. Yet, in a last-minute reversal and following pushback within the Commission from the responsible department, the final version of <a href=\"https://riskandcompliance.freshfields.com/post/102jzye/treading-a-fine-line-simplification-or-deregulation-a-view-on-financial-service\" target=\"_blank\" rel=\"noopener noreferrer\">the work programme</a> listed FIDA under pending proposals, ensuring that negotiations would proceed as planned.</p><p style=\"text-align: justify\">While the Commission’s proposal has already set the stage, notable differences remain between the Parliament and the Council on key issues such as Customer control over their data, the treatment of so called ‘gatekeepers’, the obligations of Account Information Service Providers (AISPs), market access for third-country financial information service providers (FISPs) and the timeline for implementing the framework.</p><p style=\"text-align: justify\">This blog first highlights the key measures of the FIDA (I.), then discusses the current state of the debate surrounding the identified key issues (II.) and concludes with an outlook on the next steps (III.).</p><p style=\"text-align: justify\"><strong>I. Key measures</strong></p><p style=\"text-align: justify\">The proposal builds on the (mixed) success of ‘open banking’ under the revised Payment Services Directive (PSD2) and extends its principles to a wider ‘open finance’ framework. This should empower consumers and businesses with effective tools to control their financial data, ensure compliance with GDPR, and standardise data-sharing processes to foster competition and innovation. <a href=\"https://technologyquotient.freshfields.com/post/102iihd/from-open-banking-to-open-finance-european-commission-unveils-rules-on-financia\" target=\"_blank\" rel=\"noopener noreferrer\">This framework</a> prioritises consumers’ interests, competition and security aspects, aiming to create a more efficient and innovative financial ecosystem.</p><p style=\"text-align: justify\">Key measures include:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\">Clear rights and obligations for managing customer data sharing beyond payment accounts.</li><li style=\"text-align: justify\">Standardised technical interfaces to streamline data access.</li><li style=\"text-align: justify\">Enhanced consumer control over data-sharing decisions.</li></ul><p style=\"text-align: justify\">These efforts are set to transform the financial sector, unlocking opportunities for new providers and fostering innovative financial products for consumers.</p><p style=\"text-align: justify\"><strong>II. Key issues and institutional positions</strong></p><p style=\"text-align: justify\"><strong>1. Data and permissions</strong></p><p style=\"text-align: justify\">While the expressed aim of the proposal is to mobilise customer data and increase data-sharing, the ubiquitous availability of sensitive consumer data may increase the risk of financial exclusion. Accordingly, FIDA needs to strike the right balance between both considerations. To limit the risk of financial exclusion, the <strong>Commission </strong>(and in the same vein, the<strong> Parliament</strong>) excluded data collected as part of a creditworthiness assessment of a consumer as well as cover data related to the sickness and health insurance (or insurance-based investment products) of a consumer from the scope of FIDA. To the extent that other data permits related conclusions, in particular on the creditworthiness of consumers, the EBA will be tasked, according to the Commission's proposal, with drawing up technical rules describing to what extent other customer data may be used for these purposes. The <strong>Council </strong>largely followed that approach but granted member states the discretion whether to also include customer data on pension rights in occupational pension schemes. The Council also clarified that customer data should be limited to raw data received by the data holder and that it excludes any enriched data or other data that could reveal trade secrets or confidential business data of the data holder.</p><p style=\"text-align: justify\"><strong>2. Financial data sharing schemes and phase-in</strong></p><p style=\"text-align: justify\">The implementation timelines differ between the various proposals, particularly regarding the Financial Data Sharing Schemes. The Commission has proposed this quite novel regime under which data holders and data users would be required to establish and become members of those schemes, which would regulate most aspects of data sharing, such as technical details, liability and compensation for transferred data.</p><p style=\"text-align: justify\">The <strong>Commission</strong> proposed 18 months for the establishment of those schemes. The <strong>Parliament</strong> proposal introduces a staggered approach, with the general rules for the schemes agreed upon within 12 months, the technical and compensation rules within 26 months, the schemes becoming operational within 30 months and the rules becoming applicable 36 months after FIDA entered into force. The <strong>Council</strong> Position distinguishes between different categories of customer data and introduces a staggered approach for the implementation of FIDA in general. For data on, for example, savings, accounts, and general consumer credit agreements, FIDA would apply 24 months after entry into force, whereby schemes would have to be established within 18 months. For other categories of customer data, such as residential mortgage credit agreements and data on investments and suitability assessments, FIDA would apply after 36 months (and rules on schemes after 30 months). For more specific data, such as insurance-based investment products and data on creditworthiness assessments, the regulation would apply 48 months after the entry into force (and rules on schemes after 42 months). The Council bases the need for a phased approach on the availability and standardization of different categories of customer data.</p><p style=\"text-align: justify\"><strong>3. Gatekeepers </strong></p><p style=\"text-align: justify\">The (generally welcomed) sharing of data has triggered considerations whether the objective of FIDA would conflict with the regulatory objective of other regulations. More specifically, the EU has introduced specific regulations under the Regulation on Contestable and Fair Markets in the Digital Sector (also known as the Digital Markets Act, DMA) that address large tech companies that already have the advantage of extensive access to customer data. </p><p style=\"text-align: justify\">The <strong>Commission</strong> proposal refers to gatekeepers only in their general consideration, confirming that the proposal fits into the broader European strategy for data, to which also the DMA belongs. It emphasizes enabling data sharing and market contestability, particularly within the financial sector, but does not establish specific rules for gatekeepers. The <strong>Parliament</strong> introduces limitations for gatekeepers to use customer data. They are not only barred from transferring data from an eligible data user into other group companies, but the eligible data user must also not combine received customer data with other customer data obtained elsewhere. A gatekeeper may not become or establish a FISP. Furthermore, any eligible data user that is a gatekeeper or controlled by a gatekeeper would need to undergo a specific additional assessment by its financial regulator that assesses the network effects and data-driven advantages as well as organisational compliance with the FIDA requirements. The <strong>Council</strong> Position clarifies some ambiguities under the Parliament’s approach but still requires a similar assessment of gatekeepers. </p><p style=\"text-align: justify\"><strong>4. Obligations on AISPs </strong></p><p style=\"text-align: justify\">AISPs play a key role in open banking by offering value-added services through user-authorized access to payment account data held by banks and other financial institutions. AISPs have been regulated since the introduction of PSD2, which established a framework for open banking by mandating banks to provide secure access to payment account data upon user request. Now, with the proposed FIDA, AISPs are set to fall under an expanded regulatory framework, covering access to financial data beyond payment accounts, and it is not certain which role AISPs will play in such an extended regulatory framework.</p><p style=\"text-align: justify\">The key differences between the Commission, Parliament, and Council regarding AISPs and their access to customer data revolve around authorisation requirements and the timing of evaluations. The <strong>Commission</strong> generally includes payment institutions and AISPs in the scope of the regulation but excludes AISPs from the definition of a ‘data holder’. The lack of specific treatment indicates that AISPs may access all customer data without further steps. The <strong>Parliament,</strong> however, requires AISPs to obtain an additional license as FISP to access customer data. The <strong>Council</strong> Position introduces additional steps for AISPs seeking authorisation, allowing competent authorities to use previously submitted registration information if still valid, streamlining the process. </p><p style=\"text-align: justify\"><strong>5. No market access for third-country FISPs </strong></p><p style=\"text-align: justify\">The <strong>Commission</strong> envisaged an authorisation and market access regime for FISPs established in third countries if they appoint a legal presentative in the Union. However, both the <strong>Parliament</strong> and the <strong>Council</strong> removed these provisions, effectively eliminating the possibility for third-country providers to access the market under the current regulation. </p><p style=\"text-align: justify\"><strong>III. Next steps</strong></p><p style=\"text-align: justify\">Following the approval of the Economic and Monetary Affairs Committee <a href=\"https://urldefense.com/v3/__https:/www.europarl.europa.eu/news/en/press-room/20240408IPR20274/committee-meps-want-to-enhance-customers-control-over-their-financial-data__;!!MfzFaTml5A!i_6cjES--ujeWcbjpTpWHUvxuMCdkKpgaqMD60q7Sasqr4Pne6wXZAzFvhAEMlMfL-tTpj76gqKNyoHMAVYmNyCYYJGfdDU5IuwI$\">position</a>, the Parliament <a href=\"https://urldefense.com/v3/__https:/www.europarl.europa.eu/cmsdata/291678/Point*206*20-*20FiDA.pdf__;JSUl!!MfzFaTml5A!jGCXAFVPqh8j-vrrld-XLnx40Jzp_o40cktWGQw1bqC7rku3Pu0_hDyRx29xKMXbPHRXHYOJwk2A7fwJRDafj85DYdAqomKqcP3-$\">decided</a> to enter into interinstitutional negotiations in December 2024. On the Council’s side, on 04 December 2024, the Council <a href=\"https://urldefense.com/v3/__https:/data.consilium.europa.eu/doc/document/ST-16312-2024-INIT/en/pdf__;!!MfzFaTml5A!jGCXAFVPqh8j-vrrld-XLnx40Jzp_o40cktWGQw1bqC7rku3Pu0_hDyRx29xKMXbPHRXHYOJwk2A7fwJRDafj85DYdAqorb_KGtb$\">adopted</a> their position on FIDA to enter trilogues. Co-legislators were expected to kick off trilogues in February 2025 under the leadership of the Polish Presidency.</p><p style=\"text-align: justify\">While the last-minute reversal of FIDA’s potential withdrawal has ensured that discussions can continue, its long-term fate remains uncertain. If negotiations stall, the possibility of withdrawal could resurface. A failure to advance FIDA would leave the EU at a crossroads in financial data policy, especially as the UK moves ahead with Open Finance initiatives. </p><p style=\"text-align: justify\">We are now expecting trilogues to kick off in March 2025 although the general expectation is that this final stage of negotiations would last longer than is usual and would likely be finalized under the Danish Presidency between July and December 2025. These will be critical in determining whether the EU can establish a competitive framework for financial data access or risks falling behind global peers.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k3at\" />",
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"text": "The EU is committed to bringing the wider financial sector into the digital age. To this end, it has proposed a new framework for secure and open access to customer data across a broader range of financial services. As trilogue negotiations between the European Commission, the Council, and the European Parliament on the framework for financial data access (FIDA) are set to begin, it’s an opportune moment to reflect on where we stand. "
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"text": "FIDA’s path to trilogues, however, has not been without disruption. In early 2025, a leaked draft of the Commission’s 2025 work programme suggested that FIDA could be withdrawn—an unexpected move typically reserved for long-stalled initiatives with little prospect of agreement. This raised questions across the financial sector, as withdrawal would have signalled a major shift in the EU’s approach to Open Finance. Yet, in a last-minute reversal and following pushback within the Commission from the responsible department, the final version of "
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"text": "While the Commission’s proposal has already set the stage, notable differences remain between the Parliament and the Council on key issues such as Customer control over their data, the treatment of so called ‘gatekeepers’, the obligations of Account Information Service Providers (AISPs), market access for third-country financial information service providers (FISPs) and the timeline for implementing the framework."
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"text": "This blog first highlights the key measures of the FIDA (I.), then discusses the current state of the debate surrounding the identified key issues (II.) and concludes with an outlook on the next steps (III.)."
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"text": "The proposal builds on the (mixed) success of ‘open banking’ under the revised Payment Services Directive (PSD2) and extends its principles to a wider ‘open finance’ framework. This should empower consumers and businesses with effective tools to control their financial data, ensure compliance with GDPR, and standardise data-sharing processes to foster competition and innovation. "
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"text": "Clear rights and obligations for managing customer data sharing beyond payment accounts."
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"text": "Standardised technical interfaces to streamline data access."
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"text": "These efforts are set to transform the financial sector, unlocking opportunities for new providers and fostering innovative financial products for consumers."
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"text": "II. Key issues and institutional positions",
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"text": "1. Data and permissions",
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"text": "While the expressed aim of the proposal is to mobilise customer data and increase data-sharing, the ubiquitous availability of sensitive consumer data may increase the risk of financial exclusion. Accordingly, FIDA needs to strike the right balance between both considerations. To limit the risk of financial exclusion, the "
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"text": "(and in the same vein, the"
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"text": ") excluded data collected as part of a creditworthiness assessment of a consumer as well as cover data related to the sickness and health insurance (or insurance-based investment products) of a consumer from the scope of FIDA. To the extent that other data permits related conclusions, in particular on the creditworthiness of consumers, the EBA will be tasked, according to the Commission's proposal, with drawing up technical rules describing to what extent other customer data may be used for these purposes. The "
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"text": "Council ",
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"text": "largely followed that approach but granted member states the discretion whether to also include customer data on pension rights in occupational pension schemes. The Council also clarified that customer data should be limited to raw data received by the data holder and that it excludes any enriched data or other data that could reveal trade secrets or confidential business data of the data holder."
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"text": "2. Financial data sharing schemes and phase-in",
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"text": "The implementation timelines differ between the various proposals, particularly regarding the Financial Data Sharing Schemes. The Commission has proposed this quite novel regime under which data holders and data users would be required to establish and become members of those schemes, which would regulate most aspects of data sharing, such as technical details, liability and compensation for transferred data."
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"text": " proposed 18 months for the establishment of those schemes. The "
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{
"text": " proposal introduces a staggered approach, with the general rules for the schemes agreed upon within 12 months, the technical and compensation rules within 26 months, the schemes becoming operational within 30 months and the rules becoming applicable 36 months after FIDA entered into force. The "
},
{
"text": "Council",
"bold": true
},
{
"text": " Position distinguishes between different categories of customer data and introduces a staggered approach for the implementation of FIDA in general. For data on, for example, savings, accounts, and general consumer credit agreements, FIDA would apply 24 months after entry into force, whereby schemes would have to be established within 18 months. For other categories of customer data, such as residential mortgage credit agreements and data on investments and suitability assessments, FIDA would apply after 36 months (and rules on schemes after 30 months). For more specific data, such as insurance-based investment products and data on creditworthiness assessments, the regulation would apply 48 months after the entry into force (and rules on schemes after 42 months). The Council bases the need for a phased approach on the availability and standardization of different categories of customer data."
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"text": "3. Gatekeepers ",
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"text": "The (generally welcomed) sharing of data has triggered considerations whether the objective of FIDA would conflict with the regulatory objective of other regulations. More specifically, the EU has introduced specific regulations under the Regulation on Contestable and Fair Markets in the Digital Sector (also known as the Digital Markets Act, DMA) that address large tech companies that already have the advantage of extensive access to customer data. "
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"text": "The "
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{
"text": " proposal refers to gatekeepers only in their general consideration, confirming that the proposal fits into the broader European strategy for data, to which also the DMA belongs. It emphasizes enabling data sharing and market contestability, particularly within the financial sector, but does not establish specific rules for gatekeepers. The "
},
{
"text": "Parliament",
"bold": true
},
{
"text": " introduces limitations for gatekeepers to use customer data. They are not only barred from transferring data from an eligible data user into other group companies, but the eligible data user must also not combine received customer data with other customer data obtained elsewhere. A gatekeeper may not become or establish a FISP. Furthermore, any eligible data user that is a gatekeeper or controlled by a gatekeeper would need to undergo a specific additional assessment by its financial regulator that assesses the network effects and data-driven advantages as well as organisational compliance with the FIDA requirements. The "
},
{
"text": "Council",
"bold": true
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"text": " Position clarifies some ambiguities under the Parliament’s approach but still requires a similar assessment of gatekeepers. "
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"text": "AISPs play a key role in open banking by offering value-added services through user-authorized access to payment account data held by banks and other financial institutions. AISPs have been regulated since the introduction of PSD2, which established a framework for open banking by mandating banks to provide secure access to payment account data upon user request. Now, with the proposed FIDA, AISPs are set to fall under an expanded regulatory framework, covering access to financial data beyond payment accounts, and it is not certain which role AISPs will play in such an extended regulatory framework."
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"text": "The key differences between the Commission, Parliament, and Council regarding AISPs and their access to customer data revolve around authorisation requirements and the timing of evaluations. The "
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{
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"bold": true
},
{
"text": " generally includes payment institutions and AISPs in the scope of the regulation but excludes AISPs from the definition of a ‘data holder’. The lack of specific treatment indicates that AISPs may access all customer data without further steps. The "
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"text": "Parliament,",
"bold": true
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{
"text": " however, requires AISPs to obtain an additional license as FISP to access customer data. The "
},
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"text": "Council",
"bold": true
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"text": " Position introduces additional steps for AISPs seeking authorisation, allowing competent authorities to use previously submitted registration information if still valid, streamlining the process. "
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"html": "<p style=\"text-align: justify\">On 4 February 2025, the European Commission published guidelines on prohibited practices under the EU’s AI Act (the Guidelines). These <a href=\"https://click.mailings.freshfields.com/?qs=e08b34a3af7649fc1b5953354d66c632039953fd442c8b70a4f8296fc21331dfa07449c263a6b56f087cdc0ffdf65020ae45a89743d95af6\">Guidelines</a> provide the Commission’s interpretation of the prohibitions under Article 5 AI Act, including legal explanations and various practical examples to help companies understand and comply with the requirements outlined in the AI Act. </p><p style=\"text-align: justify\">While the Guidelines are non-binding, with ultimate authoritative interpretations reserved for the Court of Justice of the EU, they reflect how the Commission – through the AI Office – will coordinate EU-level enforcement. They are designed to help both businesses and national regulators understand compliance requirements. </p><p style=\"text-align: justify\">The Commission is making clear that the application of Article 5 requires a case-by-case assessment. As a result, companies developing or using AI system should be vigilant to verify they are not caught by a prohibition.</p><p style=\"text-align: justify\">In this blogpost, we focus on few key clarifications provided by the Commission in relation to the ‘general concepts’ applicable to prohibited practices, and on the key takeaways from the Guidelines on the first three prohibitions under Article 5: (1) AI-enabled harmful subliminal techniques, manipulation and deception, (2) exploitation of vulnerabilities, and (3) social scoring.</p><p><strong>General concepts applicable to Prohibited AI Practices</strong></p><p>The Guidelines shed some light on several important general concepts that apply across prohibited AI practices: </p><p style=\"margin-left: 20px\"><strong>Material scope and key definitions</strong>. The Commission clarifies the concepts of ‘placing on the market,’ ‘putting into service’ or ‘using’ an AI system':</p><ul style=\"list-style-type: disc\"><li>The ‘placing on the market’ of an AI system covers any supply for distribution or use in commercial activity within the Union. Any means of supply are covered, including providing access online through APIs or other user interfaces, via cloud services, direct downloads, as physical copies, or embedded in physical products.</li><li>The ‘putting into service’ of an AI system covers both supply for first use to third parties and in-house development and deployment in the Union.</li><li>The ‘use’ of an AI system covers deployment at any moment of its lifecycle after being placed on the market or put into service.</li></ul><p style=\"margin-left: 20px\"><strong>Liability considerations for AI providers</strong>.<strong> </strong>The Commission emphasises that the prohibitions apply to any AI systems, whether with an ‘intended purpose’ or ‘general-purpose.’ Deployers are expected not to use any AI system in a manner prohibited under Article 5 AI Act, including not bypassing any safety guardrails implemented by the providers. With regard to providers, the Commission expects them: </p><ul style=\"list-style-type: disc\"><li>to build in safeguards and prevent and mitigate harmful behaviour and misuse.</li><li>to include provisions in their contractual relationships with deployers (eg in the terms of use) that: (1) exclude use of their AI system for prohibited practices; (2) provide ‘appropriate information’ to deployers; and (3) establish necessary human oversight.</li></ul><p style=\"margin-left: 40px\">While this may be particularly challenging for ‘general-purpose’ AI system providers who may not have sufficient visibility of how deployers use their systems, operators are only required to take the measures ‘appropriate,’ ‘feasible,’ and ‘proportionate’ to their AI systems and to the circumstances of the case.</p><p><strong>Prohibitions of AI-enabled harmful subliminal techniques, manipulation and deception, and exploitation of vulnerabilities</strong></p><p>The first two prohibitions in Article 5(1)(a) and (b) aim to protect individuals and vulnerable persons from significantly harmful effects of AI-enabled manipulation and deception, and exploitation.</p><p>The Commission provides detailed definitions and examples of these prohibited techniques:</p><ul style=\"list-style-type: disc\"><li><strong>Subliminal Techniques</strong>. These are techniques capable of influencing behaviour in ways where the person remains unaware of the influence, how it works, or its effects. For example, this could include hidden images within visual content that aren’t consciously perceived but may still be processed by the brain and influence behaviour.</li><li><strong>Purposefully Manipulative Techniques</strong>. These techniques are designed or objectively aim to influence, alter, or control an individual’s behaviour. The Commission notes that merely incidental manipulative behaviour may not be covered under certain conditions. A key example would be an AI system that deploys background audio or images leading to mood alterations (such as increasing anxiety) that influence users’ behaviour.</li><li><strong>Deceptive Techniques</strong>. These involve presenting false or misleading information with the objective or effect of deceiving individuals and influencing their behaviour. A notable example is an AI chatbot that impersonates a friend or relative using synthetic voice technology to pretend it is that person.</li><li><strong>Exploitation of Vulnerabilities</strong>. This refers to objectively making use of age, disability, or specific socioeconomic situations in a manner that is harmful for the exploited persons or others. For instance, certain AI-enabled differential pricing practices in insurance services that exploit specific socio-economic situations to provide higher prices to lower-income consumers would fall under this category.</li></ul><p>The Commission emphasises two crucial conditions that must be met for these prohibitions to apply:</p><ul style=\"list-style-type: disc\"><li>The practices may have either the objective or the ‘effect’ of causing material distortion of natural persons’ behaviours. These effects can be simply ‘likely’ or ‘capable’ of materialising, requiring an objective assessment of circumstances, knowledge, and available information.</li><li>The practices must cause or be reasonably likely to cause ‘significant harm,’ which is broadly defined to include physical, psychological, financial, and economic harm.</li></ul><p>The underlying rational is to protect individual autonomy and well-being from manipulative, deceptive, and exploitative AI practices that can subvert and impair an individual’s autonomy, decision-making, and free choices. </p><p><strong>Prohibition of AI-enabled social scoring </strong></p><p>The AI Act prohibits AI practices that (i) <strong>evaluate or classify people</strong> over time, (ii) <strong>based on their social behaviour</strong> <strong>or personal or personality characteristics</strong> when they (iii) <strong>lead to detrimental or unfavourable treatment</strong> in social contexts unrelated to the contexts in which the data comes from, and/<strong>or</strong> when they <strong>lead to unjustified or disproportionate treatment</strong> to the gravity of the social behaviour (Article 5(1)(c)). The objective of this prohibition is to target scoring practices that treat or harm people unfairly and cause social control.</p><p>The Commission provides detailed guidance on how to read the different elements of the provision. Here are the key points:</p><p style=\"margin-left: 20px\"><strong>Evaluation or classification system</strong></p><ul style=\"list-style-type: disc\"><li>‘Evaluation or classification’ should give rise to a score that can take various forms such as a number, a ranking, label etc. With respect to the term ‘evaluation,’ the Commission refers to the concept of ‘profiling’ under the GDPR as being a specific form of evaluation.</li></ul><ul><li>‘Social behaviour’ is seen as a broad term that can generally include actions, behaviour, habits, and interactions within society, and usually covers behaviour-related data points from multiple sources. This includes social behaviours in business contexts, for example the payment of debts or behaviour when using certain services.</li></ul><ul style=\"list-style-type: disc\"><li>‘Personal or personality characteristics’ covers a broad category of objective or subjective characteristics related to a natural person, including gender, race, ethnicity, address, income, health, personal preferences and interests, behaviour, financial liquidity, level of debt, type of car, performance at work etc.</li></ul><p style=\"margin-left: 20px\"><strong>Detrimental treatment and its links to scoring</strong></p><p style=\"margin-left: 20px\">The causal link between the social score and the treatment is crucial: the detrimental or unfavourable treatment must be the consequence of the score. The Commission clarifies several important points:</p><ul><li>If the AI-generated score is combined with a human assessment, the prohibition applies if the AI-generated score plays a ‘sufficiently important’ role in the final decision.</li><li>The prohibition applies even if the social score is produced by an organisation different from the one that uses the score. For example, a public authority may obtain a score for a natural person's creditworthiness assessment produced by another company.</li><li>A treatment in ‘unrelated social context’ would in most cases happen against the reasonable expectations of the persons and in violation of GDPR.</li><li>To determine if the treatment is ‘disproportionate to the gravity of the social behaviour,’ the Commission calls for a case-by-case assessment.</li></ul><p style=\"margin-left: 40px\">The Commission emphasizes that the prohibition has a broad scope of application in both public and private contexts. For example, an unacceptable social scoring practice would be a private credit agency using an AI system to determine the creditworthiness of people and deciding whether an individual should obtain a loan based on <strong>unrelated personal characteristics</strong>.</p><p style=\"margin-left: 20px\"><strong>What falls outside the prohibition of social scoring</strong><i>:</i></p><p style=\"margin-left: 20px\">The Commission lists situations which are out of scope of the prohibition:</p><ul><li>Scoring of a legal entities (unless based on the evaluation of natural persons’ social behaviour).</li><li>Individual ratings by users (unless combined with other information and analysed by AI).</li><li>More generally, the Commission points out that social scoring is only prohibited in the limited cases where <strong>all the conditions</strong> listed in the prohibitions are fulfilled. For instance, practices in credit-scoring, targeted commercial advertising and profiling, anti-money laundering and other financial fraud surveillance, would typically fall outside the scope when they are:</li><li>Based on relevant data;</li><li>Complying with sectoral Union legislation (for example, consumer protection, data protection and digital services); and </li><li>Involving treatment justified and proportionate to the social behaviour.</li></ul><p style=\"margin-left: 20px\">These practices remain subject to case-by-case assessment to ensure compliance. </p><p style=\"text-align: justify\">Understanding these nuances is crucial for companies developing or deploying AI systems to ensure compliance with the new regulatory framework. </p><p style=\"text-align: justify\">In our next blogpost ‘European Commission releases critical AI Act implementation Guidelines - Prohibited AI Practices (Part 3)’ we will delve deeper into the remaining prohibitions covered in the Guidelines (ie facial recognition databases, emotional recognition at the workplace or in education institutions, predictive crime, biometric categorization, real-time remote biometric identification).</p><p style=\"text-align: justify\"> </p><p style=\"text-align: justify\"><i>You can find all episodes of our EU AI Act unpacked blog series </i><a href=\"https://technologyquotient.freshfields.com/tag/eu%20ai%20act%20series\"><i><strong>by clicking here</strong></i></a><i>.</i></p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k2zl\" />",
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"html": "<p style=\"text-align: justify\">The European Commission has taken a significant step forward in clarifying the EU AI Act by releasing new implementation guidelines in early February 2025. These guidelines specifically address two fundamental aspects of the Act: the definition of AI systems (Art. 3 (1)) and prohibited AI practices (Art. 5). While technically still in draft form, the guidelines have received Commission approval and are expected to remain substantially unchanged before their Official Journal publication.</p><p style=\"text-align: justify\">For businesses developing or deploying AI systems, these guidelines serve as a crucial roadmap for compliance, reflecting how the Commission’s AI Office will coordinate enforcement across the EU. Though non-binding, they provide essential interpretation that both companies and national regulators will rely upon.</p><p style=\"text-align: justify\">In this blogpost we give an overview on the guidelines on the definition of AI systems (Part 1). Our following blogposts will cover the guidelines on prohibited practices (Part 2 and Part 3). </p><p style=\"text-align: justify\"><i>You can find all episodes of our EU AI Act unpacked blog series </i><a href=\"https://technologyquotient.freshfields.com/tag/eu%20ai%20act%20series\"><i><strong>by clicking here</strong></i></a><i>.</i></p><p style=\"text-align: justify\"><strong>Understanding the AI system definition</strong></p><p style=\"text-align: justify\">The Commission emphasises that determining whether a system qualifies as AI requires a nuanced analysis of its specific architecture and functionality, rather than a mechanical checklist approach. This answers concern of some companies, that was expressed during the preparation of the EU AI Act, that traditional automated systems, that have been running for a long time, might be caught by accident in the new AI regulation. The following elements define an AI system under the guidelines, each requiring careful consideration in your compliance strategy. </p><p style=\"text-align: justify\">While those elements are cumulative, the Commission specifies that they should not necessarily be present continuously throughout both the pre-deployment phase and the post-deployment (or ‘use’) phase of the AI system. Some elements may appear at one phase only.</p><p style=\"text-align: justify\"><strong>1. Machine-based system – a technology-neutral approach</strong></p><p>The Commission adopts a deliberately broad, technology-neutral interpretation that encompasses both hardware and software components enabling AI functionality. This approach extends from traditional computing architectures to advanced systems like quantum computing, ensuring the guidelines remain relevant as technology evolves.</p><p><strong>2. Autonomous operation – degrees of independence</strong></p><p>Systems must demonstrate some independence from human involvement, though this doesn’t mean complete automation. The Commission clarifies that systems requiring manual inputs may still qualify if they generate outputs autonomously. ‘Autonomy’ in this context refers to having some degree of independence in actions.</p><p>Systems capable of operating with limited human intervention may trigger particular risks and human oversight measures. The Commission places responsibility on providers to evaluate the need for enhanced human oversight on a case-by-case basis, considering the specific risks and capabilities of each system.</p><p><strong>3. Adaptive capabilities – optionality over necessity</strong></p><p>The Commission takes a flexible approach to adaptiveness, considering that systems don't need to possess adaptive or self-learning capabilities (i.e. allowing the behaviour of the system to change during use). While not a decisive condition, adaptiveness seems to be used as an illustration of the type of tools that may qualify as an AI system. Therefore, the fact that a tool shows adaptiveness or is capable of adaptiveness (even if not activated or employed) should, if all other criteria are met, corroborate the qualification of an AI system.</p><p><strong>4. System objectives – both explicit and implicit</strong></p><p>The guidelines distinguish between explicit and implicit objectives. Explicit objectives are clearly stated goals directly encoded by developers, such as the optimization of cost functions, probabilities, or cumulative rewards. Implicit objectives, on the other hand, are goals deduced from system behaviour or underlying assumptions. For specific examples of implicit objectives, reference can be made to the OECD’s <a href=\"https://www.oecd.org/content/dam/oecd/en/publications/reports/2024/03/explanatory-memorandum-on-the-updated-oecd-definition-of-an-ai-system_3c815e51/623da898-en.pdf\">Explanatory Memorandum on the Updated OECD Definition of an AI System</a>.</p><p><strong>5. Inference capabilities – understanding the boundaries</strong></p><p>The Commission provides detailed guidance on what constitutes ‘inference’, encompassing three main approaches. </p><p>First, machine learning approaches include supervised, unsupervised, and self-supervised learning, as well as deep learning and reinforcement learning. Systems must demonstrate more sophisticated capabilities than basic statistical learning to qualify under this category.</p><p>Second, logic and knowledge-based approaches encompass systems that learn from encoded expert knowledge, utilise symbolic representation, and include deductive and inductive reasoning engines. Third, deterministic methods must demonstrate more sophisticated analysis than basic optimisation and show capability for pattern analysis and autonomous output adjustment.</p><p>The Commission explicitly excludes several types of systems from the AI definition. Basic mathematical optimisation systems using established formulas, simple data processing following predefined human instructions, classical heuristic systems using predefined rules, and basic prediction systems using only statistical learning rules all fall outside the scope of the regulation.</p><p><strong>6. System outputs – impact and influence</strong></p><p>AI systems must generate outputs that can include predictions, content, recommendations, or decisions. These outputs should demonstrate more nuanced capabilities than conventional systems, showing an ability to leverage learned patterns or expert-defined rules. The Commission emphasises that AI systems typically offer more sophisticated analysis and adaptation than traditional software.</p><p><strong>7. Environmental impact – active influence required</strong></p><p>Systems must actively impact their operating environment to fall within the scope of the regulation. This impact can occur in physical environments through tangible objects, or in virtual environments through digital spaces, data flows, and software ecosystems. Passive systems without environmental impact fall outside the definition, emphasising the Commission's focus on systems that create meaningful change in their operating context.</p><p><strong>Practical implications for businesses</strong></p><p>For businesses developing or deploying potentially AI-regulated systems, thorough documentation becomes crucial, particularly when claiming exclusion from the AI system definition. Companies should maintain detailed technical documentation explaining why their system falls outside the scope and assess systems individually, considering their specific architecture and functionality rather than applying blanket categorisations.</p><p>Special attention should be paid to autonomous operation capabilities and human oversight requirements, as these may trigger additional compliance obligations. Companies should also review both explicit and implicit objectives of their systems, as both can bring a system within scope of the regulation.</p><p style=\"text-align: justify\">The Commission indicates that these guidelines may be updated based on implementation experience, national regulatory interpretations, and Court of Justice of the European Union decisions. Businesses should monitor for such developments and adjust their compliance strategies accordingly, maintaining flexibility in their approach while ensuring robust documentation of their compliance rationale.</p><p style=\"text-align: justify\"> </p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k2zj\" />",
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"html": "<p style=\"text-align: justify\">As you browse the internet, you may notice an increasing number of tech companies promoting their ‘privacy-friendly’ services. This shift toward personal data protection has also caught the eye of regulators. Indeed, the recognition of data protection as a competitive factor is evident in the cooperation between the French Competition Authority (ADLC) and the French Data Protection Authority (CNIL). While, strictly speaking, competition law and data protection law pursue distinct objectives – with the ADLC ensuring fair competition to benefit consumers through innovation, diverse offerings and competitive prices, and the CNIL safeguarding users from harmful data practices – they ultimately share a common goal: empowering citizens to make free choices. However, these areas can sometimes conflict, as data protection is a fundamental right in EU law while free competition is not.</p><p style=\"text-align: justify\">The European Data Protection Board (EDPB) recently reinforced this trend in its <a href=\"https://www.edpb.europa.eu/system/files/2025-01/edpb_position-paper_20250116_interplay-between-data-protection-and-competition-law_en.pdf\">position paper</a>, emphasising the need for closer collaboration between competition authorities and data protection regulators. In this regard the Digital Markets Act (DMA) could further strengthen cooperation between the ADLC and the CNIL by establishing a framework for collaboration. Indeed, when their responsibilities overlap, the ADLC must consult the CNIL, making it an essential partner in implementing the DMA.</p><p style=\"text-align: justify\">In the following, we explore how we expect the relationship between competition law and data protection law to evolve in France in the near future.</p><p style=\"text-align: justify\"><strong>1. A familiar relationship: the link between competition law and data protection law </strong></p><p style=\"text-align: justify\">The cooperation between the ADLC and the CNIL has traditionally taken the form of cross-referrals.<strong> </strong>The ADLC is legally required to consult the CNIL on cases involving data protection aspects, a mechanism it has used in several instances. For example, in 2014, the ADLC ordered <a href=\"https://www.autoritedelaconcurrence.fr/fr/decision/relative-une-demande-de-mesures-conservatoires-presentee-par-la-societe-direct-energie#:~:text=Pr%C3%A9sentation%20de%20la%20d%C3%A9cision&text=Aux%20termes%20de%20cette%20d%C3%A9cision,de%20gaz%20et%20d'%C3%A9lectricit%C3%A9.\">GDF Suez</a> to grant competitors access to certain personal data it had collected as an incumbent company, aiming to ensure effective competition (decision no. 14-MC-02). In this case, the ADLC sought the CNIL’s recommendations on data protection requirements, specifying that personal data could only be shared with competitors if customers were informed and given the opportunity to object before the transfer.</p><p style=\"text-align: justify\"><strong>2. Rethinking the relationship between competition law and data protection law in the digital age</strong></p><p style=\"text-align: justify\">The rise of tech companies that collect, process and use personal data at scale has shifted the relationship between competition law and data protection law. These companies’ business models often rely heavily on processing customer data.</p><p style=\"text-align: justify\">In this context, the level of protection of personal data is becoming a competitive factor. If consumers perceive data protection as a quality feature of a service, it influences their choices in the same way as price. However, this dynamic is complicated by the ‘privacy paradox’: the gap between consumers’ stated preference for privacy and their actual behavior, where they continue to enjoy digital services despite privacy risks.</p><p style=\"text-align: justify\">To address this paradox, the ADLC and the CNIL are collaborating on two fronts: (i) to creating incentives to make data protection a genuine competitive factor; and (ii) considering the economic context of market players in CNIL’s enforcement practice. The two authorities have issued several opinions and recommendations in the tech sector:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\">In June 2023, the ADLC issued an opinion on the cloud sector highlighting that GDPR compliance could justify a national or EU market delimitation. Customers often prefer cloud providers with EU or national infrastructures for data protection and geopolitical reasons. This finding is even more relevant given the rise of AI and cloud-hosted foundation models that require GDPR-compliant cloud infrastructures, as well as <a href=\"https://technologyquotient.freshfields.com/post/102jvhg/final-agreement-on-the-european-health-data-space-cross-border-access-to-eu-heal\">developments in the EU health data space</a>.</li><li style=\"text-align: justify\">The ADLC also issued an opinion in June 2023 on the <a href=\"https://www.autoritedelaconcurrence.fr/en/press-release/generative-artificial-intelligence-autorite-issues-its-opinion-competitive\">competitive dynamics of the generative AI sector</a>, showing that while GDPR compliance can be a competitive factor, it also creates a tension. On one hand, competition law pushes for greater data accessibility, while on the other, privacy law restricts it. </li><li style=\"text-align: justify\">In September 2023, the CNIL published <a href=\"https://www.cnil.fr/fr/applications-mobiles-la-cnil-publie-ses-recommandations-pour-mieux-proteger-la-vie-privee\">recommendations on mobile apps</a>, assessing data protection concerns while also considering competition implications. This marked the CNIL’s first formal request for an opinion from the ADLC.</li><li style=\"text-align: justify\">In a joint statement in December 2023, the CNIL and the ADLC emphasised that the creation of a High-Level Group as part of the DMA should help consolidate European regulators’ networks, particularly the European Competition Network (ECN) and the EDPB, to provide technical expertise and guidance on the interaction between the DMA and sectoral regulations, such as data protection.</li></ul><p style=\"text-align: justify\">However, balancing competition law and data protection law is complex. On one hand, weak data protection can distort competition, giving certain tech companies an unfair advantage. For example, unlawful data processing can help a company strengthen, maintain or acquire a dominant market position. On the other hand, stricter data protection rules may also restrict competition. Limiting access to personal data—which is often crucial for service delivery—can make it harder for competitors to enter or remain in the market. </p><p style=\"text-align: justify\">The ADLC must therefore ensure that strong data protection is not merely ‘privacy washing’, while also considering whether there are less restrictive ways to achieve privacy goals without unduly impacting competition. A notable example is an interim measures case where the ADLC recognized a tech player’s ‘privacy-friendly’ approach as a legitimate business objective, making it a key milestone in integrating data protection into competitive analysis.</p><p style=\"text-align: justify\"><strong>3. The ‘new normal’: integration of competition law and data protection law </strong></p><p style=\"text-align: justify\">To effectively address the challenges of the digital economy, the CNIL and the ADLC have identified the need for deeper cooperation.</p><p style=\"text-align: justify\">In November 2022, the CNIL’s chairman tasked Bruno Lasserre (former ADLC chairman and now a CNIL board member) with conducting a study (<a href=\"https://www.cnil.fr/sites/cnil/files/2024-12/rapport_mission_lasserre.pdf\">the ‘Lassere Mission’</a>) on the relationship between data protection law and competition law. Its conclusions, published in late 2024, proposes reinforcing the links between data protection law and competition law without modifying the current legal framework. The recommendations centre around three pillars:</p><ul style=\"list-style-type: disc\"><li style=\"text-align: justify\"><strong>Legal concepts</strong>:<ul style=\"list-style-type: circle\"><li style=\"text-align: justify\">The CNIL could rely on ADLC and European Commission decisions defining market products/services to inform its GDPR compliance assessments. </li><li style=\"text-align: justify\">The CNIL could consider past anti-competitive practices as potential complementary indicators of data protection breaches such as:<ul style=\"list-style-type: square\"><li style=\"text-align: justify\">Abuse of dominance through excessive data accumulation, which could violate the minimisation principle.</li><li style=\"text-align: justify\">Anticompetitive agreements leading to unlawful data combination, breaching the fairness principle.</li></ul></li><li style=\"text-align: justify\">The ADLC could consult the CNIL:<ul style=\"list-style-type: square\"><li style=\"text-align: justify\">In merger control cases where privacy and personal data concerns arise, to better assess market impacts.</li><li style=\"text-align: justify\">In antitrust cases involving data pooling or data combination, to assess whether GDPR non-compliance could amount to an abuse of dominance.</li></ul></li><li style=\"text-align: justify\">The CNIL and the ADLC could harmonise their approach to calculating fines.</li></ul></li><li style=\"text-align: justify\"><strong>Legal doctrine</strong>:<ul style=\"list-style-type: circle\"><li style=\"text-align: justify\">The CNIL could consider competition issues when drafting non-binding rules, such as recommendations and codes of conduct. </li><li style=\"text-align: justify\">The CNIL and ADLC could enhance collaboration by jointly analysing market risks and exchanging expertise. </li></ul></li><li style=\"text-align: justify\"><strong>Implementation</strong>: Beyond case-specific cooperation, the ADLC and the CNIL could define an annual work programme to address emerging issues. A dedicated point of contact within each authority could oversee the implementation of this reinforced cooperation.</li></ul><p style=\"text-align: justify\">The evolving relationship between competition law and data protection law signals a shift in regulatory cooperation. As data protection becomes an increasingly influential factor in consumer choices, authorities like the ADLC and CNIL recognize its competitive significance. Their collaboration, supported by frameworks such as the DMA, EDPB guidance and the Lasserre Mission, is essential to ensuring both fair competition and strong data protection. However, striking a balance between consumer privacy and market dynamics remains a challenge. Looking ahead, we can expect not only closer cooperation but also a future where data protection plays a central part in competitive strategy, fundamentally reshaping the online business landscape.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k2tn\" />",
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"text": ", emphasising the need for closer collaboration between competition authorities and data protection regulators. In this regard the Digital Markets Act (DMA) could further strengthen cooperation between the ADLC and the CNIL by establishing a framework for collaboration. Indeed, when their responsibilities overlap, the ADLC must consult the CNIL, making it an essential partner in implementing the DMA."
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"text": "The cooperation between the ADLC and the CNIL has traditionally taken the form of cross-referrals."
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"text": "The ADLC is legally required to consult the CNIL on cases involving data protection aspects, a mechanism it has used in several instances. For example, in 2014, the ADLC ordered "
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"text": " to grant competitors access to certain personal data it had collected as an incumbent company, aiming to ensure effective competition (decision no. 14-MC-02). In this case, the ADLC sought the CNIL’s recommendations on data protection requirements, specifying that personal data could only be shared with competitors if customers were informed and given the opportunity to object before the transfer."
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"text": "In this context, the level of protection of personal data is becoming a competitive factor. If consumers perceive data protection as a quality feature of a service, it influences their choices in the same way as price. However, this dynamic is complicated by the ‘privacy paradox’: the gap between consumers’ stated preference for privacy and their actual behavior, where they continue to enjoy digital services despite privacy risks."
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"text": ", showing that while GDPR compliance can be a competitive factor, it also creates a tension. On one hand, competition law pushes for greater data accessibility, while on the other, privacy law restricts it. "
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"text": ", assessing data protection concerns while also considering competition implications. This marked the CNIL’s first formal request for an opinion from the ADLC."
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"text": "In a joint statement in December 2023, the CNIL and the ADLC emphasised that the creation of a High-Level Group as part of the DMA should help consolidate European regulators’ networks, particularly the European Competition Network (ECN) and the EDPB, to provide technical expertise and guidance on the interaction between the DMA and sectoral regulations, such as data protection."
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"text": "However, balancing competition law and data protection law is complex. On one hand, weak data protection can distort competition, giving certain tech companies an unfair advantage. For example, unlawful data processing can help a company strengthen, maintain or acquire a dominant market position. On the other hand, stricter data protection rules may also restrict competition. Limiting access to personal data—which is often crucial for service delivery—can make it harder for competitors to enter or remain in the market. "
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"text": "The ADLC must therefore ensure that strong data protection is not merely ‘privacy washing’, while also considering whether there are less restrictive ways to achieve privacy goals without unduly impacting competition. A notable example is an interim measures case where the ADLC recognized a tech player’s ‘privacy-friendly’ approach as a legitimate business objective, making it a key milestone in integrating data protection into competitive analysis."
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"html": "<p style=\"text-align: justify\">The EU AI Act introduces a new regulatory framework that distinguishes between, among others, deployers and providers. Employers will typically assume the role of deployers when using AI systems to manage their workforce. However, they may also act as providers if they create or significantly modify the AI systems they use in the workplace. This dual role presents distinct challenges and obligations under the EU AI Act.</p><p style=\"text-align: justify\">In this blog post, we will explore the key differences between acting as deployers or providers and outline the specific obligations that each role entails for employers. </p><p style=\"text-align: justify\">(Check out all the previous articles in our <a href=\"https://technologyquotient.freshfields.com/tag/eu%20ai%20act%20series\" target=\"_blank\" rel=\"noopener noreferrer\">EU AI Act unpacked blog series</a>).</p><h3><strong>Employers as deployers</strong></h3><p style=\"text-align: justify\"><strong>Employers</strong> will <strong>typically act as deployers</strong> when they merely purchase and use existing and externally pre-trained AI systems. </p><p style=\"text-align: justify\">However, it remains unclear whether employers will qualify as deployers if their employees are permitted to use freely accessible AI systems via a browser (eg AI-based translation tools). This ambiguity stems from the AI Act's definition of a deployer as an entity that uses an AI system under its own authority for professional purposes. If employers merely allow or tolerate the use of such systems, they may arguably lack the necessary authority to be classified as deployers. Conversely, if these systems are integral to employees’ work performance or company operations, this may suggest that their use occurs under the employer’s authority, leading to a classification as deployers.</p><p style=\"text-align: justify\">In a previous <a href=\"https://technologyquotient.freshfields.com/post/102jm55/eu-ai-act-unpacked-16-risks-associated-with-ai-systems-used-in-the-workplace\" target=\"_blank\" rel=\"noopener noreferrer\">blog</a>, we noted that many (though not all) workplace uses of AI may fall under the high-risk AI system category. Employers should therefore be mindful of the <strong>obligations associated with deploying</strong> high-risk AI systems, which include:</p><ul><li style=\"text-align: justify\"><strong>Compliance and monitoring: </strong>use and continuously monitor high-risk AI system based on the provider’s instructions for use; immediately suspend use and fulfil specific reporting obligations if there are reasons to believe that the system may present a risk to individuals’ health, safety, or fundamental rights or, similarly, in cases of a ‘serious incident’ (Articles 26(1) and (5));</li><li style=\"text-align: justify\"><strong>Human oversight</strong>: assign individuals with the necessary competence, training, authority and support to oversee high-risk AI systems (Article 26(2));</li><li style=\"text-align: justify\"><strong>Input data control: </strong>where the employer exercises control over the input data, ensure it is relevant and sufficiently representative for the system’s intended purpose (Article 26(4)); </li><li style=\"text-align: justify\"><strong>Data logging: </strong>keep logs automatically generated by the high-risk AI system for a minimum of six months (Article 26(6)); </li><li style=\"text-align: justify\"><strong>Employee information: </strong>where required,<strong> </strong>inform affected employees and relevant employee representatives before putting into service or using a high-risk AI system (Article 26(7)). For further details on this aspect, please check our previous <a href=\"https://technologyquotient.freshfields.com/post/102jnt2/eu-ai-act-unpacked-17-the-role-of-employee-representatives\">blog</a> ; </li><li style=\"text-align: justify\"><strong>Transparency: </strong>fulfil additional information obligations in the case of high-risk AI system that make or assist in decisions about natural persons, including informing employees that they are subject to the use of such AI systems (Article 26(11)). Employees impacted by decisions based on such high-risk AI systems (e.g. rejected applicants) may also have the right to receive clear and meaningful explanations regarding the AI system’s role in the decision-making procedure and the main elements of the decision (Article 86);</li><li style=\"text-align: justify\"><strong>Data protection: </strong>incorporate the information provided by the provider into a data protection impact assessment, where applicable (Article 26(9)).</li></ul><h3><strong>Understanding the shift from deployer to provider</strong></h3><p style=\"text-align: justify\">While employers will typically serve as deployers, Article 25 of the EU AI Act establishes that a <strong>shift</strong> <strong>from deployer to provider</strong> may occur when employers:</p><ul><li style=\"text-align: justify\"><strong>Put their name</strong> <strong>or trademark</strong> on high-risk AI systems that have already been placed on the market;</li><li style=\"text-align: justify\">Make a <strong>substantial modification</strong> to an existing high-risk AI system in such a way that it remains classified as a high-risk AI system, or </li><li style=\"text-align: justify\"><strong>Modify the intended use </strong>of a non-high-risk AI system<strong> </strong>in such a way that <strong>it becomes </strong>a<strong> high-risk</strong> AI system.</li></ul><p style=\"text-align: justify\">This can include cases where employers, unsatisfied with existing market solutions, choose to ‘customise’ high-risk AI systems, either independently or in collaboration with developers. Determining whether these modifications trigger a reclassification from deployer to provider will often require <strong>case-by-case analysis</strong>. </p><p style=\"text-align: justify\">For instance, consider an employer intending to create an ‘AI Assistant’ to answer employee questions about internal policies by providing a general-purpose AI (GPAI) system developed by a third party (eg ChatGPT or Gemini) with specific instructions and the relevant policies. If the employer puts the AI Assistant into service under its own name or trademark, it could be classified as a provider. Conversely, if the employer uses the third-party GPAI system without rebranding it and simply adds its own data to customise the answers, without altering the pre-training data and the architecture of the third-party system, the employer would likely remain a deployer. In any case, any modification or fine-tuning of existing GPAI systems should be carefully assessed before implementation.</p><p style=\"text-align: justify\">Another scenario could involve an employer using a chatbot, originally designed for non-high-risk applications by a third party, for a high-risk use case such as recruitment.</p><h3><strong>Employers as providers</strong></h3><p style=\"text-align: justify\">Employers classified as <strong>providers</strong> must comply with the <strong>additional obligations</strong> outlined in Articles 9-22 of the AI Act, which are much stricter than those for deployers.</p><p style=\"text-align: justify\">These obligations include ensuring that any high-risk AI system meets the general requirements for trustworthy AI in terms of data governance, technical documentation and record-keeping, transparency, human oversight, accuracy, cybersecurity and robustness. Employers must also conduct a conformity assessment, implement a quality management system and adhere to strict registration, documentation, and information-sharing obligations. For further details on this aspect, please check our previous <a href=\"https://technologyquotient.freshfields.com/post/102jm55/eu-ai-act-unpacked-16-risks-associated-with-ai-systems-used-in-the-workplace\">blog</a>.</p><h3 style=\"text-align: justify\"><strong>AI literacy </strong></h3><p style=\"text-align: justify\">Regardless of their classification as providers or deployers, employers will be required under Article 4 of the EU AI Act to <strong>ensure </strong>that their <strong>employees</strong> and other individuals dealing with the operation and use of AI systems on their behalf <strong>have a</strong> <strong>sufficient level of AI literacy</strong>. This obligation has taken effect from 2 February 2025. </p><p style=\"text-align: justify\">The AI Act does not specify how companies should achieve AI literacy, giving employers flexibility to design their own approaches. AI literacy initiatives should cover basic AI concepts and skills, such as an understanding of how AI systems function, the types of AI products available, and their uses, risks, and benefits. </p><p style=\"text-align: justify\">Training should be tailored to the employees’ knowledge levels and to the extent and context of AI use within the company. For internal use of tools such as ChatGPT or Gemini, a brief overview of AI Act obligations and responsible AI usage could be sufficient. However, when using AI tools in sensitive areas like HR, more comprehensive training may be required to address specific risks (e.g. discrimination; impact on diversity) and obligations (e.g. human oversight) associated with such use. </p><p style=\"text-align: justify\">For more details on AI literacy see our <a href=\"https://technologyquotient.freshfields.com/post/102jxwq/eu-ai-act-unpacked-21-the-ai-act-starts-biting-ai-literacy-and-prohibited-pra\" target=\"_blank\" rel=\"noopener noreferrer\">blogpost</a>. In addition, more guidance from the AI Office is expected later in the year.</p><h3 style=\"text-align: justify\"><strong>Conclusion</strong></h3><p style=\"text-align: justify\">The EU AI Act establishes distinct roles and responsibilities for employers as AI deployers and providers, necessitating a thorough understanding of compliance obligations for each role. 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"html": "<p>The Government has now launched its <a href=\"https://www.gov.uk/government/consultations/ransomware-proposals-to-increase-incident-reporting-and-reduce-payments-to-criminals/ransomware-legislative-proposals-reducing-payments-to-cyber-criminals-and-increasing-incident-reporting-accessible\">consultation</a> (the Consultation), which proposes an ‘entirely new approach’ to ransomware, aimed at ‘disrupting the business model of the ransomware gangs’. The consultation ends on 8 April 2025.</p><p><strong>Background</strong></p><p>The Home Office has defined ransomware as the use by threat actors of malware to (i) prevent (including by means of encryption) the victim from accessing their systems or data, (ii) impair the use of systems or data, and/or (iii) facilitate theft of data held on the victim’s systems or devices. The threat actors then demand a ‘ransom’ for the return, non-destruction and/or non-publication of this data, though payment of the ransom does not guarantee that outcome.</p><p>By way of indication of the scale of this activity, a Chainanalysis paper in 2024 <a href=\"https://www.chainalysis.com/blog/ransomware-2024/\" target=\"_blank\" rel=\"noopener noreferrer\">estimated </a>that ransom payments of over $1bn were made from victims globally in 2023. The Cyber Security Breaches Survey 2024 found that half of businesses reported experiencing at least one cyber-attack, and also that nearly half of businesses have a policy not to pay ransoms. 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This would require victims (who fall outside the ban) to engage with authorities and report their intention to make a ransomware payment <u>before</u> making such a payment. Once this report is made, the victim would receive support and guidance (including discussing non-payment options), and the authorities would review the proposed payment ‘to see if there is a reason it needs to be blocked eg where it could go to criminals subject to sanctions designations, or in violation of terrorism finance legislation’. If it was not blocked, the victim would then have the choice as to whether to proceed with payment. Again, the Consultation seeks views on the best way to ensure compliance with this regime, including whether to impose criminal and/or civil penalties ‘especially where a payment is made after the victim has been told it has to be blocked’, and whether to apply a threshold in terms of organisation or ransom size.<br /> </li><li><strong>A ransomware incident reporting regime</strong> for victims. This would require victims to:<ul style=\"list-style-type: circle\"><li><strong>within 72 hours, </strong>file an initial report which specifies: if a ransom demand has been received, if the organisation can recover from existing resilience measures, and if the ransomware group is identifiable.</li><li><strong>within 28 days,</strong> file a full report with further details including the vector of access, if resilience measures have been implemented, and any further details on the attack.<br />Again, the Consultation invites views as to whether a threshold should be applied (with others encouraged to voluntarily report through the same mechanism).</li></ul></li></ul><p><strong>Next steps / takeaways</strong></p><p>The Consultation has the laudable aim of seeking to disincentivise expensive and potentially devastating attacks on public bodies. However, it remains to be seen how effective this is, particularly given certain threat actors have non-financial motives (eg state-sponsored intelligence gathering), and whether this inadvertently leads to an increased number of attacks on private organisations.</p><p>Helpfully, the Consultation adopts a pragmatic approach to certain issues– such as:</p><ul style=\"list-style-type: disc\"><li>seeking to streamline reporting obligations to ensure victims only need to report a ransomware incident once (as far as possible), and seeking to discourage payments; and</li><li>somewhat unusually, creating a hierarchy among criminal enterprises in seeking to stop payments to the worst offenders (those targeted by sanctions or terrorist financing legislation).</li></ul><p>In other areas, industry feedback may encourage a more realistic focus on the ‘art of the possible’ in the immediate aftermath of a ransomware attack. An element of flexibility in the reporting timelines would likely be desirable, particularly if criminal penalties are to be introduced. In this regard:</p><ul style=\"list-style-type: disc\"><li>while the Consultation suggests that multiple reports may not be needed for organisations in scope of the Network Information System Regulations, if a ransomware attack affected personal data, victims will be faced with notifications to the ICO on similar 72 hour timeframes, as well as notifications to affected data subjects ‘without undue delay’.</li><li>the Home Office may need to accept that victims of complex attacks that are in crisis mode may not fully understand the background to the attack within 28 days, for the ‘full report’, and may therefore not be in a position during that timeframe to identify or implement resilience measures or provide additional useful information that might help with the Home Office’s intelligence gathering efforts.</li></ul><p>Finally, the Home Office indicated it will work with the Department for Science, Innovation and Technology to ensure their proposals are ‘aligned and complementary’ to those in the anticipated <a href=\"https://www.gov.uk/government/collections/cyber-security-and-resilience-bill\">Cyber and Security Resilience Bill</a>. 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"html": "<p style=\"text-align: justify\">As technology evolves, so do challenges in effectively regulating it. In an era where there is increasing focus on effective oversight of digital platforms, legislators are turning to audits as a go-to tool. This blog explores the reasons behind the growing adoption of audits in digital regulation, focusing on key legislative frameworks such as the <a href=\"https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/europe-fit-digital-age/digital-services-act_en\"><u>EU's Digital Services Act</u></a> (DSA) and the <a href=\"https://www.legislation.gov.uk/ukpga/2023/50\"><u>UK's Online Safety Act</u></a> (OSA), and also explores the scope of audits in AI and other digital regulation. It also includes some practical tips for businesses navigating these new audit regimes.</p><h2 style=\"text-align: justify\">Audits in context</h2><p style=\"text-align: justify\">Audits in digital regulation typically fall into three categories: internal audits, external audits and regulator-driven information gathering. </p><ul><li><strong>Internal audits:</strong> audits typically conducted by a business’ assurance function to self-assess compliance, helping it identify and address compliance or controls gaps proactively. </li><li><strong>External audits: </strong>audits performed by independent third party auditors who provide an objective assessment of a business’ compliance to a specified standard. </li><li><strong>Regulator-driven information gathering:</strong> regulatory bodies may also be empowered to conduct or direct audits or reviews of a business’ compliance, which may involve direct access to a business’ systems and records. </li></ul><p style=\"text-align: justify\">This blog focuses on the second and third categories, while touching on the first in the context of existing regulation.</p><h2 style=\"text-align: justify\">Why audits? </h2><p style=\"text-align: justify\">Audits have been used as a regulatory tool since at least the 19th century, initially emerging in the context of financial oversight. The UK’s Companies Act of 1844 was one of the first to mandate external audits for corporate financial records to protect shareholders and enhance accountability. In the United States, the role of audits expanded following the creation of the Securities and Exchange Commission (SEC) in 1934.</p><p style=\"text-align: justify\">The rise of digital platforms has ushered in challenges that traditional regulatory frameworks may struggle to address. In particular, the complexity of new technologies presents challenges for regulators seeking to understand the operation of systems, and their compliance with laws, in an efficient and accurate manner. </p><p style=\"text-align: justify\">External audits are increasingly being encouraged, and in some cases required, as a potential means to address these challenges. There are various factors that may be contributing to a growing recognition of audits as essential tools within the digital regulatory toolkit:</p><ul><li><strong>Accountability and transparency:</strong> The belief that independent audits can increase trust by involving external examiners who offer objective insights into an organization’s practices and compliance measures, offering a comparative basis for public scrutiny. </li><li><strong>Cost effectiveness: </strong>The belief that audits enable companies to independently manage compliance assessments, reducing the regulatory burden while ensuring a thorough review process. This theoretically allows regulatory bodies to focus their resources on higher-priority tasks, such as developing standards, reviewing audit results and enforcement. On the other hand, audits place significant financial and operational demands on businesses, particularly smaller operations that may struggle to allocate the necessary resources without compromising growth-focused priorities.</li><li><strong>Standardization: </strong>The belief that independent audits can bring a uniform approach to assessing compliance, applying consistent criteria across the industry, and making it easier to identify trends, spot systemic risks and ensure fair enforcement across the board. Standardization, however, is an area in need of development in this space, as discussed in the next section. This can present challenges in industries without existing standardization and may risk incentivizing certain practices even where no genuine ‘best practice’ standard yet exists.</li></ul><h2 style=\"text-align: justify\">DSA and OSA audits</h2><p style=\"text-align: justify\">The DSA, which fully came into effect in February 2024, is a landmark digital regulation (to learn more about the DSA, read our <a href=\"https://www.freshfields.com/en-gb/our-thinking/campaigns/technology-quotient/tech-and-platform-regulation/eu-digital-strategy/digital-services-act/\"><u>DSA Decoded Blog Services</u></a>). Audits form a key component of the DSA’s compliance and enforcement architecture, requiring very large online platforms and search engines (VLOPSEs), ie those with over 45 million active EU users, to undergo annual external audits conducted by independent third party auditors. The first round of audits were finalized in mid-2024, focusing on the platforms' compliance approach to illegal content and systemic risks, transparency in advertising and the protection of user rights – capturing the obligations under Chapter III of the DSA. Audit reports and implementation reports, the latter addressing how VLOPs and VLOSEs would remediate gaps, were published in November 2024.</p><p style=\"text-align: justify\">The <a href=\"https://digital-strategy.ec.europa.eu/en/library/delegated-regulation-independent-audits-under-digital-services-act\"><u>delegated regulation on the performance of DSA audits</u></a> (DR), adopted by the European Commission in October 2023, outlines the audit procedures and framework to guide VLOPSEs and auditing organizations in preparation of the audit reports. Despite the global significance of the DSA’s audit regime, key concerns remain about implementation and verification, particularly due to the lack of standard methodologies or benchmarks in the DR, its overambitious expectations and challenges related to auditor independence and eligibility.</p><p style=\"text-align: justify\">Operating alongside the DSA, the <a href=\"https://digital-strategy.ec.europa.eu/en/library/2022-strengthened-code-practice-disinformation\"><u>2022 Code of Practice on Disinformation (EU CoP)</u></a>, which has been signed by a broad range of actors including major online platforms such as Google, Meta and TikTok, is a voluntary and co-regulatory instrument. It monitors platforms across areas such as political advertising, financial disinformation and misleading content. While the EU CoP is voluntary, it will soon become a recognized Code of Conduct under the DSA. As a result, any commitments undertaken voluntarily under the EU CoP will form part of the DSA audit. </p><p style=\"text-align: justify\">Similar to the DSA, the OSA empowers Ofcom to issue notices requiring providers to commission an audit of the provider’s compliance. Unlike the DSA, however, such audits are not automatically mandated. In a consultation undertaken in November 2023, Ofcom sought feedback on a proposal to impose an annual risk management audit requirement alongside its information gathering powers. Ofcom is also consulting on plans to assess the accuracy of proactive content moderation technologies through an audit-based assessment.</p><p style=\"text-align: justify\">As other jurisdictions look to adopt laws related to content moderation, the approach of the OSA and DSA to audits may influence policy approaches globally.</p><h2 style=\"text-align: justify\">Auditing AI systems </h2><p style=\"text-align: justify\">Artificial intelligence is another context where legislators are looking to audits as a potential regulatory tool. Some academics and third sector stakeholders have emphasized the importance of AI auditability is important for assessing compliance with standards in areas such as ethics and data security.</p><p style=\"text-align: justify\">The EU AI Act enables third party <a href=\"https://eur-lex.europa.eu/eli/reg/2024/1689/oj#anx_VII\"><u>Notified Bodies</u></a> and <a href=\"https://eur-lex.europa.eu/eli/reg/2024/1689/oj#art_74\"><u>Market Surveillance Authorities</u></a> to, under particular risk and monitoring conditions, access a system provider’s technical documentation, source code and training datasets - to be assessed for a reasonable assurance of compliance under various fairness, biases and accuracy principles. This is a relatively novel audit requirement. </p><p style=\"text-align: justify\">In the United States, the New York City Department of Consumer and Worker Protection in November 2022 implemented <a href=\"https://rules.cityofnewyork.us/wp-content/uploads/2023/04/DCWP-NOA-for-Use-of-Automated-Employment-Decisionmaking-Tools-2.pdf\"><u>regulations</u></a> mandating employers utilizing AI in hiring practices to undergo independent audits to verify that their systems are free from racial or gender biases. By contrast, in California, a <a href=\"https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202320240SB1047\"><u>bill proposing mandatory annual third-party audits</u></a> for AI models was vetoed by Governor Newsom in September 2024. The main criticism of the proposed auditing requirement, and the stringent obligations of the bill as a whole, were the substantial compliance costs and potential impacts on innovation, with Governor Newsom calling for adaptable and differentiated oversight to avoid a disproportionate regulatory burden on smaller developers – a reminder that one size does not fit all.</p><h2 style=\"text-align: justify\">Other digital regulation with audit requirements</h2><p style=\"text-align: justify\">Audits are gaining traction as a critical oversight mechanism in various domains of digital regulation. </p><ul><li>In the domain of cybersecurity, the <a href=\"https://www.nist.gov/cyberframework\"><u>NIST Framework</u></a>, mandated for federal agencies and voluntarily adopted by the private sector, requires regular audits to ensure compliance and maintain strong defences against cyber threats. </li><li>Similarly, the <a href=\"https://eur-lex.europa.eu/eli/dir/2022/2555#art_32\"><u>NIS2 Directive 2022</u></a> in the EU equips national competent authorities with the power to demand ad hoc and regular independent audits of ‘essential entities’, alongside the authority to issue requests for information and conduct the audits themselves. </li><li>The <a href=\"https://cppa.ca.gov/meetings/materials/20241004_item3_draft_text.pdf\"><u>regulations proposed</u></a> by the California Privacy Protection Agency (CPPA) in November 2024 mandate annual independent cybersecurity audits for certain businesses that meet revenue and personal data processing thresholds.</li></ul><p style=\"text-align: justify\">By embedding audits into compliance structures, these regulations may set a precedent for their expansion into other areas, such as algorithmic transparency and ethical AI use. </p><h2 style=\"text-align: justify\">Practical tips for tech businesses</h2><p style=\"text-align: justify\">As audits become an increasingly common feature of digital regulation, tech companies should proactively prepare to manage risks. Specifically, we recommend:</p><ol><li><strong>Advocate thoughtfully:</strong> Engage in regulatory consultations to provide feedback on proposed audit requirements, particularly to highlight disproportionate burdens to the innovation focused approach of emerging technologies.</li><li><strong>Prepare for audit obligations:</strong> If subject to audits, ensure robust internal compliance and assurance systems are in place, and allocate resources to meet external audit demands effectively–including explaining legal requirements to external auditors who may be new to the regulatory regime in question.</li><li><strong>Plan for adverse outcomes:</strong> Develop contingency plans to address findings from negative audits, including transparent remediation strategies and stakeholder communication to rebuild trust.</li><li><strong>Leverage audit insights:</strong> Use audit reports constructively to identify areas for improvement, streamline operations and enhance compliance efforts, turning audits into a tool for innovation and growth.</li></ol><p style=\"text-align: justify\">With preparation and strategic engagement, businesses can better navigate the challenges and opportunities audits bring. Our team at Freshfields has extensive experience guiding businesses through complex regulatory landscapes, from advising on compliance with established frameworks like the OSA, DSA, and privacy laws to preparing for emerging audit requirements. We help clients anticipate challenges, develop practical strategies and leverage audits as opportunities to strengthen trust and innovation. Reach out to explore how we can support your organization in staying ahead of regulatory developments.</p><input type=\"hidden\" id=\"passle-remote-hosting-tracking-shortcode\" value=\"102k1bd\" />",
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"html": "<p><strong>Revolutionizing Healthcare: The Rise of AR and VR in MedTech</strong></p>\n<p>Augmented Reality (AR) and Virtual Reality (VR) are revolutionizing medical devices and healthcare delivery. AR technologies are increasing surgical efficiency and safety by enabling real-time 3D visuals and integrated patient data. AR is also enhancing remote consultations by overlaying diagnostics during telemedicine visits. Meanwhile, VR is revolutionizing medical training through platforms that enable surgeons to practice procedures in a risk-free, simulated environment, leading to performance improvements of over 230 percent compared to traditional training methods. In rehabilitation, VR engages patients with interactive, motion-based therapy, accelerating recovery and boosting adherence to rehabilitation programs. VR is also proving effective in pain management, offering distraction during treatments such as burn care and labor pain management.</p>\n<p>The adoption of AR/VR in MedTech has accelerated rapidly. As of September 6, 2024, FDA has authorized 69 AR/VR-based medical devices for US marketing, with nearly 80% concentrated in radiology and orthopedics. This marks a significant uptick since the first FDA approval in 2015. Between 2019 and 2023, the AR/VR medical device market achieved an extraordinary 68% compound annual growth rate, a trend expected to continue as these technologies are further deployed in surgical planning, diagnostics and patient care management.</p>\n<p>As AR/VR becomes increasingly integrated into healthcare, the collection of substantial amounts of personal data has the potential to raise significant privacy concerns, particularly if this data is not adequately secured. Users have also raised potential concerns with respect to personal autonomy, highlighting the need for AR/VR device companies to implement data protection policies that clearly outline the types of data being collected and define users’ rights to manage and restrict usage of such data. While other challenges such as cost, limited reimbursement and the need for specialized training to deploy such technologies remain, the transformative potential of AR and VR continues to reshape healthcare, driving substantial gains in precision, efficiency and patient outcomes.</p>\n<p><strong>The Role of AI Assurance Labs in Safeguarding Healthcare Innovation</strong></p>\n<p>As artificial intelligence (AI) transforms healthcare, ensuring the safety, accuracy, and fairness of AI models has become a critical regulatory focus. The UK government’s newly launched AI assurance platform aims to bolster its AI sector and establish reliable testing frameworks. Designed to mitigate risks like biases and security vulnerabilities, the platform empowers businesses to deploy AI responsibly while complying with ethical and legal standards.</p>\n<p>At the Consortium for Healthcare AI Global Summit in October, 2024, industry leaders, researchers, and regulators discussed creating a national network of AI assurance labs across the US. Such labs would validate AI models prior to FDA review, serving as a vital checkpoint for systems that assist in diagnosing diseases, recommending treatments, and various other clinical applications. AI models, driven by machine learning, evolve based on the data they process, posing unique validation challenges compared to traditional medical technologies. By rigorously testing models for reliability, fairness, and compliance with FDA and American Medical Association standards, AI assurance labs could streamline approvals and mitigate deployment risks.</p>\n<p>Critics of the proposed AI assurance labs initiative in the US have raised several concerns around intellectual property, data confidentiality, and potential conflicts of interest—particularly if the labs are linked to significant tech companies. Republican lawmakers have cautioned against regulatory overreach, inefficiencies in government-managed AI evaluation systems, and the risk of favoritism toward established tech players. They argue that government-managed frameworks could stifle innovation and create barriers for smaller firms and instead advocate for private-sector-led governance and solutions.</p>\n<p>In 2025, we will continue to monitor the emergence of AI assurance labs as well as other proposals to minimize algorithmic bias, enhance model robustness, and ensure transparency.</p>\n<p><strong>Transforming Supply Chains with AI-Driven Technology</strong></p>\n<p>AI and machine learning are rapidly transforming supply chains, driving significant improvements in accuracy, efficiency and resilience. Modern supply chain and manufacturing platforms now integrate real-time insights, generative AI-powered performance reporting, and advanced tools for maintenance and order management. Real-time alerts empower businesses to address performance issues or disruptions in complex supply chains, thereby enhancing operational reliability.</p>\n<p>Leveraging untapped data is an emerging trend in biopharma supply chains. To unlock AI’s full potential, companies must transition from fragmented digital initiatives to a cohesive, strategically driven digitalization agenda. Aligning technology investments with supply chain operations aid the achievement of end-to-end transformation, with defined ROI benchmarks and measurable success metrics driving progress and accountability.</p>\n<p>Large language models can be used to automatically process large volumes of data, including from certificates of analysis, invoices and other supplier documentation to assess supplier performance and the likelihood of a supply disruption. AI solutions can assist in course correction and restoration of operations after manufacturing or other deviations. 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"html": "<p><strong>Transformative MedTech industry trends are reshaping the way we approach patient care and medical research. MedTech companies continue to leverage AI to improve care delivery and streamline workflows, while also navigating a complex regulatory environment to ensure safety and compliance.</strong></p>\n<p>The accelerated development of regulatory frameworks is being driven by concerns about the lack of oversight and potential harms arising from AI and data-driven technologies, including increased cybersecurity threats and attacks that jeopardize patient health data and the systems meant to safeguard such data.</p>\n<p>This, in turn, puts the pressure on companies operating in the space to implement the technologies as part of a larger strategy that optimizes for consumer demand while prioritizing compliance with the latest regulatory guidance, as evidenced by some of the key trends observed in Q3, along with the associated legal considerations.</p>\n<p><strong>A new normal in the virtual care market</strong></p>\n<p>The past few months witnessed a number of shake-ups in the telehealth market, with Walmart shuttering its health centers and virtual care services, Optum shutting down its virtual care division and Teladoc posting an $838m loss in the second quarter. The COVID-19 pandemic had accelerated the acceptance of virtual care in the healthcare industry; however, since 2021, telehealth has largely been on the decline. According to a recent <a title=\"More information. \" href=\"https://www.trillianthealth.com/market-research/studies/telehealth-demand-an-update-four-years-after-the-onset-of-the-covid-19-pandemic\" target=\"_blank\" rel=\"noopener\">update</a> by healthcare analytics group Trilliant Health, telehealth visits have fallen from their peak of more than 60 million in 2020 to less than 30 million in the third quarter of 2023. The decline in telehealth demand may indicate that, with the exception of behavioral health, consumers do not view telehealth as an appropriate substitute for in-person care.</p>\n<p>As the virtual care market evolves and moves away from commoditized models, such as virtual urgent care, healthcare providers may need to learn to use telehealth to complement, rather than replace, in-person care. Similarly, digital health companies that serve specific patient segments such as fertility and diabetes management would be well-advised to reevaluate their business strategies to adapt to current and future supply and demand. More generally, we are seeing many traditional inpatient procedures shifting to outpatient settings and increasing engagement in the direct-to-consumer setting, such as through new sleep and hearing health features in broadly-used consumer technology, and greater access to continuous glucose monitors.</p>\n<p><strong>New U.S. regulation of tech, data and AI with proposed HHS rule and reorganization</strong></p>\n<p>Following the <a title=\"More information.\" href=\"https://www.hhs.gov/about/news/2023/12/13/hhs-finalizes-rule-to-advance-health-it-interoperability-and-algorithm-transparency.html\" target=\"_blank\" rel=\"noopener\">finalization</a> of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Rule, earlier this year, the Health and Human Services (HHS) Office of the National Coordinator for Health IT released its proposed <a title=\"More information.\" href=\"https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-patient-engagement\" target=\"_blank\" rel=\"noopener\">HTI-2 rule</a>. HTI-2 introduces new standards and updates to enhance healthcare interoperability and data sharing. Specifically, the rule establishes certification criteria designed to enable health IT for public health, as well as health IT for payers to be certified under the ONC Health IT Certification Program. Both sets focus heavily on standards-based application programming interfaces to improve end-to-end interoperability.</p>\n<p>In addition to its ongoing work in health IT, HHS <a title=\"More information.\" href=\"https://www.hhs.gov/about/news/2024/07/25/hhs-reorganizes-technology-cybersecurity-data-artificial-intelligence-strategy-policy-functions.html\" target=\"_blank\" rel=\"noopener\">announced</a> a reorganization of its technology, cybersecurity, data and AI strategy and policy functions under the newly named Assistant Secretary for Technology Policy and Office of the National Coordinator for Health IT (ASTP/ONC). The ASTP/ONC will establish an Office of the Chief Technology Officer to oversee department-level and cross-agency technology, data and AI strategy and policy, as well as an Office of the Chief AI Officer, Office of the Chief Data Officer and an Office of Digital Services.</p>\n<p>Together, the offices will have increased responsibilities to ensure the safe and appropriate use of technology, data and AI, which has been an ongoing concern in light of the rapid adoption of AI in the healthcare industry. A recent study <a title=\"More information.\" href=\"https://www.nature.com/articles/s41591-024-03203-3\" target=\"_blank\" rel=\"noopener\">published</a> in <em>Nature Medicine</em> revealed that approximately half of the tools authorized by the U.S. Food and Drug Administration lacked reported clinical validation data. 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Pfizer’s move follows Eli Lilly’s <a title=\"Learn more.\" href=\"https://www.prnewswire.com/news-releases/lilly-launches-end-to-end-digital-healthcare-experience-through-lillydirect-302025738.html\" target=\"_blank\" rel=\"noopener\">launch</a> of a similar platform, LillyDirect, earlier this year for certain of its obesity, diabetes and migraine medications. LillyDirect partners with online pharmacies including Truepill and Amazon Pharmacy to dispense its medicines, offering more options for how and where patients can access medicines. 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"text": "Deliberate AI’s assessment tool for anxiety and depression, the AI-generated Clinical Outcome Assessment or AI-COA™, will receive support to become a qualified drug development tool (DDT) through Innovative Science and Technology Approaches for New Drugs (ISTAND), an FDA pilot program. The ISTAND program was designed to create a new pathway for FDA to provide support for unconventional drug development tools, including tools that implement AI algorithms, wearables, and other digital health technologies. AI-COA™ leverages multimodal behavorial signal processing and machine learning technology to record mental health symptoms and assess the severity of anxiety and depression cases. FDA’s inclusion of this assessment tool in the ISTAND program signifies the agency’s commitment to fostering innovation in drug development and evaluation, particularly in the field of mental health. We expect FDA engagement in this space to pave the way for increased use of AI to enhance mental health therapy at scale as MedTech companies are encouraged to explore innovative approaches to effective mental health therapy."
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"text": " J.P. Morgan Healthcare Conference brought together thousands of professionals in the biopharma, biotech, and MedTech industries, setting the stage for new partnerships and exciting product launches. AI was a major topic of discussion, with tech and life sciences companies coming together to develop AI tools for drug discovery and development as AI proves its value in target identification, clinical trial design, and more. In the digital health space, tools developed for diabetes management, including continuous glucose monitoring devices and virtual speciality care services, received considerable attention. Increasing numbers of health-monitoring partnerships between companies like Amazon and Omada aim to introduce virtual care benefits for individuals with chronic conditions, such as diabetes and hypertension. In addition to these collaborations, a number of MedTech acquisitions were announced, including Veracyte’s acquisition of C2i Genomics and its cancer-detecting technology, and GE HealthCare’s acquisition of medical imaging company MIM Software. The exciting therapeutic developments, along with the surge in M&A activity, provided a sense of optimism for a dynamic and successful 2024 for the MedTech sector."
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"html": "<p><strong>As the MedTech industry continues to assess the opportunities and risks of AI in healthcare, regulators around the world are stepping up efforts to regulate the development and use of the technology. On December 8, 2023, the European Union reached a provisional agreement on the <a href=\"https://technologyquotient.freshfields.com/post/102ilm9/agreement-on-eu-ai-act-reached-what-does-it-mean-for-businesses\">AI Act</a>, the world’s first comprehensive AI regulation, potentially creating a blueprint for AI governance that expands to large foundation models underpinning general purpose AI services.</strong></p>\n<p>In parallel, innovators and regulatory authorities continue to focus on addressing inequities in the healthcare system and the data used to train AI-based solutions. This quarterly update focuses on recent U.S. regulatory initiatives on digital health and AI technology and efforts to address gender inequities through digital health technologies.</p>\n<h3>U.S. Executive Order on Safe, Secure and Trustworthy AI</h3>\n<p>The Biden administration recently <a href=\"https://www.whitehouse.gov/briefing-room/statements-releases/2023/11/01/fact-sheet-vice-president-harris-announces-new-u-s-initiatives-to-advance-the-safe-and-responsible-use-of-artificial-intelligence/\" target=\"_blank\" rel=\"noopener\">launched</a> a federal organization dedicated to evaluating the safety of artificial intelligence. Operating under the National Institute of Standards and Technology (NIST), the AI Safety Institute will develop technical guidance for future regulatory rulemaking and enforcement efforts. This announcement builds on an <a href=\"https://www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence/\" target=\"_blank\" rel=\"noopener\">executive order</a> signed by the Biden administration, which calls for new federal standards with respect to AI safety, security and trustworthiness and seeks to require AI developers to share their safety test results with the U.S. government. The order also prioritizes NIST’s development of standards to ensure that AI systems are safe, secure and trustworthy before public release. Beyond these mandates, the order acknowledges the potential for AI to drive the future of healthcare, particularly in drug discovery, while recognizing the risk that unregulated AI could lead to greater inequality in access to healthcare. These recent initiatives represent the U.S. government’s most expansive attempt at regulating AI technology and follows the efforts of other governments around the world to regulate AI, including the European Union’s AI Act and China’s new regulations for generative AI systems.</p>\n<h3>Regulatory Updates on AI in Digital Health</h3>\n<p>The U.S. Food and Drug Administration (FDA) recently <a href=\"https://www.fda.gov/news-events/press-announcements/fda-establishes-new-advisory-committee-digital-health-technologies\" target=\"_blank\" rel=\"noopener\">announced</a> the formation of a Digital Health Advisory Committee focused on navigating the scientific and technical issues related to digital health technologies, including AI/ML, virtual and augmented reality and remote patient monitoring. This committee will advise the FDA on policies and regulations with respect to these technologies by providing relevant expertise and perspective on the benefits, risks and clinical outcomes associated with their use. Additionally, the US Office of the National Coordinator for Health Information Technology recently <a href=\"https://www.hhs.gov/about/news/2023/12/13/hhs-finalizes-rule-to-advance-health-it-interoperability-and-algorithm-transparency.html\" target=\"_blank\" rel=\"noopener\">finalized</a> its rulemaking titled, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” or the HTI-1 Rule. As previewed in our <a href=\"https://www.freshfields.com/en/our-thinking/briefings/2023/06/medtech-update-q2-2023/\" target=\"_blank\" rel=\"noopener\">update</a> for Q2 2023, the HTI-1 Rule establishes first-of-its kind transparency requirements for AI and other predictive algorithms that are part of the Health IT Certification Program. In light of the continued regulatory oversight on AI in digital health, MedTech companies should continue to evaluate their AI compliance practices to ensure that they align with the evolving regulations and guidance.</p>\n<h3>Equitable Women’s Health Initiatives in Digital Health</h3>\n<p>The White House recently unveiled a new <a href=\"https://www.whitehouse.gov/briefing-room/presidential-actions/2023/11/13/memorandum-on-the-white-house-initiative-on-womens-health-research/\" target=\"_blank\" rel=\"noopener\">initiative</a> aimed at furthering research into women’s health. The White House Initiative on Women’s Health Research is expected to deliver recommendations that the Biden administration can follow to improve how research into women’s health is conducted and find ways to maximize investments in that research. A lack of research and data on women’s health has left providers without the tools to adequately diagnose and treat conditions, including cardiovascular disease, autoimmune disorders and mental health conditions in women. A recent Deloitte <a href=\"https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-health-gender-gap.pdf\" target=\"_blank\" rel=\"noopener\">report</a> found that employed women face as much as $15.4 billion more each year in out-of-pocket costs compared to men, with only a portion of that amount being attributable to maternal care needs. In parallel, MedTech companies have been collaborating to provide technologies aimed at improving women’s health outcomes. In the coming years, we expect MedTech innovators and regulators to continue to work collaboratively to address gender-based and other inequities in the healthcare system.</p>",
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"html": "<p>Recent efforts to integrate generative AI into the medical field are revolutionizing healthcare delivery. This technology empowers personalized monitoring, preventative care, chronic disease management and early disease detection. At the same time, concerns are emerging among regulators and industry leaders regarding the ethical and operational aspects of AI development and implementation. These concerns encompass consumer data privacy and transparency issues.</p>\n<p>In response to these challenges, regulators and policymakers around the world are prioritizing the regulation of generative AI technology. They are also closely scrutinizing the data privacy and AI compliance practices of MedTech companies, as evidenced by some of the key trends observed in Q3, along with the associated legal considerations.</p>\n<h3>Generative AI Applications in Healthcare</h3>\n<p>Advancements in generative AI continue to draw attention to the technology’s potential benefits, though also raising ethical concerns and clinical risks as roadblocks to adoption and rollout. A recent McKinsey <a title=\"Recent McKinsey report.\" href=\"https://www.mckinsey.com/industries/healthcare/our-insights/tackling-healthcares-biggest-burdens-with-generative-ai\" target=\"_blank\" rel=\"noopener\">report</a> suggests that generative AI has the potential to unlock up to $1 trillion in value for the healthcare industry. In the MedTech space, by automatically and immediately summarizing large volumes of unstructured data, generative AI can streamline the work of call centers, health insurance prior authorization and claims processing. This, in turn, frees up healthcare providers to dedicate more time to addressing complex needs.</p>\n<p>Generative AI is also being studied for clinical use cases. A recent <a title=\"Recent MGH study.\" href=\"https://www.massgeneralbrigham.org/en/about/newsroom/press-releases/chatgpt-shows-impressive-accuracy-in-clinical-decision-making#:~:text=The%20researchers%20found%20that%20overall,was%20only%2060%20percent%20accurate.\" target=\"_blank\" rel=\"noopener\">study</a> led by Mass General Brigham found that ChatGPT exhibited approximately 72 percent accuracy in overall clinical decision-making, encompassing possible diagnoses and final diagnoses, as well as care management decisions. Still, in a <a title=\"Link to poll. \" href=\"https://www.bain.com/insights/getting-the-most-out-of-generative-ai-in-healthcare/\" target=\"_blank\" rel=\"noopener\">poll</a> of 94 health system executives conducted by Bain, only 6 percent of health system executives claim to have a generative AI strategy in place. These executives point to resource and cost constraints, lack of expertise and regulatory and legal considerations as the primary barriers to embracing generative AI.</p>\n<p>As the technology continues to mature and prove its value, we expect that companies that prioritize generative AI’s various use cases, particularly for administrative and operational efficiency, and build robust governance structures will reap the dividends of such upfront investments.</p>\n<h3>Recent Advances in Wearables</h3>\n<p>The wearable technology market is <a title=\"Wearable tech market prediction. \" href=\"https://www.globaldata.com/media/medical-devices/medical-healthcare-next-step-wearable-technology-set-worth-156-billion-2024-says-globaldata/?_gl=1*1ubuue2*_ga*OTM3MjIyNTU0LjE2ODg1Njk1NzA.*_ga_DDG872KFQP*MTY4ODU2OTU3NC4xLjEuMTY4ODU2OTYzMC40LjAuMA..\" target=\"_blank\" rel=\"noopener\">predicted</a> to be worth $156 billion by 2024. Medical wearables play a pivotal role in driving this growth, fueled by factors such as an aging population, growth in remote patient care and increased use of internet of things in hospitals. The rise of continuous glucose monitors (CGMs) has gone hand in hand with an increase in the popularity of medical wearable technology.</p>\n<p>CGMs are wearable devices equipped with a sensor under the skin to provide real-time glucose level monitoring. These devices transmit this vital information to a linked handset or mobile phone. The recent push for CGM use beyond the diabetic population has spurred innovations in monitoring device technologies. Apple is <a title=\"Apple developing non-invasive tech. \" href=\"https://www.bloomberg.com/news/articles/2023-02-22/apple-watch-blood-glucose-monitor-could-revolutionize-diabetes-care-aapl?sref=10lNAhZ9&uuid=Yt97b4x7eHEc5l6O1118\" target=\"_blank\" rel=\"noopener\">reportedly</a> developing a non-invasive technology that uses chip-based silicon photonics and optical absorption spectroscopy to measure glucose levels for diabetic and non-diabetic consumers. CGM use is gaining traction outside of the U.S. as well, with <a title=\"Dexcom G7 Receives Health Canada Approval: Next-Generation Continuous Glucose Monitoring System With Unmatched Accuracy Coming to Canadians\" href=\"https://investors.dexcom.com/news/news-details/2023/Dexcom-G7-Receives-Health-Canada-Approval-Next-Generation-Continuous-Glucose-Monitoring-System-With-Unmatched-Accuracy-Coming-to-Canadians/default.aspx#:~:text=Dexcom%20G7%20is%20the%20most,range2%2C3%2C4.\" target=\"_blank\" rel=\"noopener\">Health Canada</a> approving the Dexcom G7 CGM device for people with all types of diabetes aged two years and up, while <a title=\"South Korea approves first local CGM device\" href=\"https://www.mobihealthnews.com/news/asia/south-korea-approves-first-local-cgm-device\" target=\"_blank\" rel=\"noopener\">South Korea</a> has approved its first locally developed CGM device.</p>\n<p>We expect the integration of generative AI into healthcare to foster further innovation in wearable technology. This trend will continue to push MedTech companies to adopt direct-to-consumer marketing strategies for their wearables in response to rising consumer demand for virtual and personalized healthcare solutions.</p>\n<h3>U.S. Regulatory Focus on Privacy and Security Risks from Online Tracking Technologies</h3>\n<p>The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) have taken significant steps to address privacy and security concerns related to the use of online tracking technologies. These agencies recently sent <a title=\"HHS Office for Civil Rights and the Federal Trade Commission Warn Hospital Systems and Telehealth Providers about Privacy and Security Risks from Online Tracking Technologies.\" href=\"https://www.hhs.gov/about/news/2023/07/20/hhs-office-civil-rights-federal-trade-commission-warn-hospital-systems-telehealth-providers-privacy-security-risks-online-tracking-technologies.html\" target=\"_blank\" rel=\"noopener\">warning letters</a> to approximately 130 hospital systems and telehealth providers. The OCR and FTC expressed concerns that the entities could be impermissibly disclosing consumers’ sensitive personal health information to third parties, including multi-national tech companies. Such actions could potentially violate the Health Insurance Portability and Accountability Act of 1996 or the FTC Health Breach Notification Rule. The warning letters follow recent FTC enforcement <a title=\"Q2 MedTech update- Freshfields.\" href=\"https://www.freshfields.com/en/our-thinking/briefings/2023/06/medtech-update-q2-2023/\">actions</a> against BetterHelp, GoodRx and other companies, as well as the FTC’s proposed changes to strengthen its Health Breach Notification Rule.</p>\n<p>As the unauthorized disclosure of consumer health data remains an enforcement priority for U.S. regulatory agencies, companies processing and using health data from patients in the United States should ensure that any online tracking technologies are implemented in compliance with the FTC’s latest guidance and settlement orders.</p>",
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"title": "Dexcom G7 Receives Health Canada Approval: Next-Generation Continuous Glucose Monitoring System With Unmatched Accuracy Coming to Canadians",
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"html": "<p class=\"lead\">Recent AI-based advances, particularly in generative AI, coupled with the challenging macroeconomic environment, have put the spotlight squarely on AI and data-driven offerings, shifting the focus away from other subsectors of digital health. We are seeing increased interest among biopharmaceutical, tech and MedTech companies in AI applications in healthcare, as innovators discover use cases in drug discovery and development, personalized medicine, and other applications.</p>\n<p>At the same time, regulatory authorities around the world have stepped up efforts to oversee the development, deployment and use of such applications. Our latest MedTech insights delve further into the proposed regulatory oversight of AI applications in digital health, recently expanded federal and state protections of consumer health data and updates from the UK Westminster Health Forum on the future of diagnostics and medical devices.</p>\n<h2><strong>Proposed Regulatory Oversight on AI in Digital Health</strong></h2>\n<p>Recent months have witnessed a heightened interest in AI-based solutions, including in the healthcare context, as <a href=\"https://cloud.google.com/blog/topics/healthcare-life-sciences/sharing-google-med-palm-2-medical-large-language-model\" target=\"_blank\" rel=\"noopener\">tech giants</a> and <a href=\"https://www.reuters.com/business/healthcare-pharmaceuticals/hippocratic-health-raises-50-mln-seed-funding-build-ai-model-2023-05-16/\" target=\"_blank\" rel=\"noopener\">start-ups</a> alike test out generative AI tools and large language models in an effort to improve the patient care experience. In response, US federal agencies have proposed policies seeking to optimize, while also addressing the potential risks inherent in, the development of AI-based solutions, including in healthcare. Following the White House’s Blueprint for an AI Bill of Rights published last year, the National Telecommunications and Information Administration issued a <a href=\"https://www.federalregister.gov/documents/2023/04/13/2023-07776/ai-accountability-policy-request-for-comment\" target=\"_blank\" rel=\"noopener\">Notice and Request for Comment</a>, seeking input on regulatory measures and policies that would support the development of AI audits, assessments and certifications to ensure the safety, trustworthiness and effectiveness of AI systems. Additionally, the US Office of the National Coordinator for Health Information Technology recently released a proposed <a href=\"https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and\" target=\"_blank\" rel=\"noopener\">rulemaking</a> titled, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing,” or the HTI-1 Rule. The HTI-1 Rule is designed to increase interoperability, transparency and trust in predictive decision support interventions and use of electronic health information. Notably, the HTI-1 Rule proposes to require AI developers to satisfy additional “decision support interventions” certification criterion under the Health IT Certification Program, including with respect to algorithm transparency. In response, we expect MedTech companies to continue to work collaboratively with regulatory authorities to help shape the future of AI regulation in healthcare, as well as design AI governance and accountability structures that integrate AI policies into their day-to-day operations.</p>\n<h2><strong>Expansion of Federal and State Protections of Consumer Health Data</strong></h2>\n<p>Recent data privacy developments on both the federal and state levels may add additional complexity for digital health companies and their data management practices. Last month the Federal Trade Commission (FTC) <a href=\"https://www.ftc.gov/news-events/news/press-releases/2023/05/ftc-proposes-amendments-strengthen-modernize-health-breach-notification-rule\" target=\"_blank\" rel=\"noopener\">announced</a> its plans to strengthen the Health Breach Notification Rule’s applicability with respect to health records collected by digital health apps. The announcement was made in response to the FTC’s enforcement <a href=\"https://www.ftc.gov/news-events/news/press-releases/2023/05/ovulation-tracking-app-premom-will-be-barred-sharing-health-data-advertising-under-proposed-ftc\" target=\"_blank\" rel=\"noopener\">action</a> against the ovulation tracking app Premom for sharing sensitive personal information with third parties and failing to notify consumers of these unauthorized disclosures. Along with clarifying that such unauthorized disclosures constitute a security breach, the FTC proposed that companies use electronic means to notify consumers of such breaches. At the state level, the state of Washington recently enacted the <a href=\"https://housedemocrats.wa.gov/blog/2023/04/27/governor-inslee-signs-wa-my-health-my-data-act-into-law/\" target=\"_blank\" rel=\"noopener\">My Health, My Data Act</a>, which is set to take effect in March 2024 and designed to provide heightened protections for consumer health data that falls outside the scope of HIPAA, a US federal law that required the creation of national standards to protect sensitive patient health information from being disclosed by particular entities in specific situations. Notably, the Act grants a private right of action for individuals to seek damages for violations. The FTC actions and new Washington state law add to the ever-growing patchwork of laws and regulations that digital health companies need to navigate in the United States as federal and state authorities seek to expand protections for consumer health data.</p>\n<h2><strong>Westminster Health Forum Policy Conference: Next Steps for Diagnostics and Medical Devices in England</strong></h2>\n<p>In April, the UK Westminster Health Forum held a conference on “Next steps for diagnostics and medical devices in England.” The conference focused on steps for improving the development and delivery of diagnostics and medical devices in the UK in the context of the UK government’s inaugural <a href=\"https://technologyquotient.freshfields.com/post/102i98w/uk-government-announces-first-medtech-strategy\" target=\"_blank\" rel=\"noopener\">MedTech Strategy</a> announced in February. One key topic of discussion was the current regulatory challenges and uncertainties around CE/UKCA conformity markings, including the possibility of cooperation among regulators to implement UKCA markings on an international level. In terms of diagnostics, the discussion touched on recent developments in the achievement of earlier and more accurate diagnoses, including in the field of <a href=\"https://technologyquotient.freshfields.com/post/102hzq2/uk-nhs-publishes-first-ever-genomics-strategy\" target=\"_blank\" rel=\"noopener\">genomics</a> and particularly, the use of AI-based solutions, as well as next steps for the decentralization of diagnostics away from NHS hospitals and introduction at the community level. Overall, the conference highlighted the current momentum in the UK to overhaul the MedTech regulatory landscape, as both regulators and innovators alike continue to prioritize cooperation among all relevant stakeholders to contribute to better patient outcomes.</p>",
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"html": "<p>The combination of rapid development in healthcare technology and increased consumer demand for tech-enabled care is continuing to fuel innovation in the MedTech industry. Whether it’s digital health, wearables, and AI-driven offerings in healthcare, or diagnostics, telemedicine, and health IT solutions, there is no shortage of innovation at the intersection of technology and life sciences. We are seeing increasing deal volume in MedTech M&A around the world, as COVID-19 related revenue enables MedTech acquirors to add assets and consolidation trends continue in the digital behavioral health and health IT markets. Innovators adopting a global approach to the development and commercialization of their MedTech offerings continue to face a patchwork of laws, regulatory guidance and ethical quandaries across the world, as evidenced by some of the key trends in Q2 and associated legal considerations.</p>\n<h2><strong>Focus on Increasing Diversity in Clinical Research</strong></h2>\n<p>Despite being disproportionately affected by certain diseases, racial and ethnic minority groups are frequently underrepresented in clinical research. The MedTech Industry is working to provide technologies and tests that result in accurate diagnosis of disease and improved patient outcomes across all populations. Recently, Pfizer and Headlands Research announced a partnership to open research sites in diversely populated areas, and Abbott and Women as One launched a new program to train underrepresented physicians to pursue clinical trial research and to help recruit clinical trial participants from historically underrepresented groups. In parallel, we are seeing increased interest from regulators to boost participation of diverse populations in clinical trials, as evidenced by the US FDA’s draft guidance for product manufacturers on how to develop diverse recruitment plans for clinical trials early in the drug development process. Because different people may have different reactions to the same treatment based on their age, gender, race, ethnicity and other factors, clinical trials must include a diverse pool of participants so that everyone can benefit from the latest scientific advances. Without diverse data inputs, resulting analyses may be biased, leading to potentially inaccurate conclusions and other consequences. As regulators and innovators increasingly acknowledge the problem of underrepresentation in clinical research, MedTech companies may consider leveraging technology-enabled tools and practices, such as decentralized clinical trials and digital endpoints, to help boost clinical trial diversity.</p>\n<h2><strong>FemTech </strong> </h2>\n<p>The U.S. Supreme Court’s decision to overturn Roe v. Wade may serve as a catalyst for consumer health tech adoption for reproductive care. FemTech companies such as Maven Clinic and Hey Jane are expanding their virtual fertility and pregnancy, telemedicine and other services to patients. At the same time, FemTech companies need to consider how their data collection and tracking practices may trigger privacy and security concerns among their patients and the wider public. The Female Talent for Tech team at Freshfields recently hosted a global MedTech-focused event featuring Shannon Klinger, CLO of Moderna and President of the Moderna Foundation. The event brought together women from the healthcare and technology sectors to discuss, among other topics, the key issues facing FemTech and other healthcare technology companies in today’s rapidly evolving digital health landscape.</p>\n<h2><strong>Launch of European Health Data Space</strong></h2>\n<p>The European Commission recently launched the European Health Data Space (EHDS), which will allow individuals to access, and make certain decisions with respect to, their health data in any EU member state. The EHDS will also provide a legal framework for the use of health data research, innovation, policymaking and regulatory activities. Data holders, such as healthcare providers, must make certain electronic health data available for secondary use by data users, who must meet obligations with respect to data anonymization and pseudonymization, security, and publication. MedTech companies operating in Europe will need to assess the impact of the EHDS on their data use and sharing practices while navigating the emerging patchwork of rules governing health data, including the interplay between this latest proposal and other data legislation, including the GDPR, Medical Device Regulation, Data Act and AI Act. We expect MedTech companies to invest in data-related infrastructure, work collaboratively to address existing barriers to data sharing, and advocate for the adoption of international interoperability standards. Learn more about <a href=\"https://technologyquotient.freshfields.com/post/102ho8u/making-the-most-of-health-data-commission-publishes-proposal-for-a-european-heal\" target=\"_blank\" rel=\"noopener\">the European Commission’s EHDS proposal</a>.</p>",
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"html": "<p class=\"lead\">The insurtech landscape has evolved rapidly in recent years. There are now more than 20 insurtech unicorns globally and insurtechs are increasingly plugged into the full insurance value chain. Why have they been seemingly so successful in disrupting the insurance industry and how will they develop from here?</p>\n<h2 id=\"growth\"><strong>The keys to growth and disruption</strong></h2>\n<p>Innovation has been key to the success of insurtechs, which are transforming insurance products by making them more accessible, more customer-centric and more user-friendly. Existing and new insurance users are choosing these beneficial solutions and are able to engage with insurance in new ways that are more suited to their needs, often via smartphone apps. This aligns with the ‘CARE’ equation proposed in the World Insurtech Report 2021, which suggests that by prioritising ‘CARE’ – that is, <strong>c</strong>onvenience, <strong>a</strong>dvice and <strong>re</strong>ach – of their insurance products, insurtechs are better positioned to impact the future of the insurance value chain.</p>\n<p>Accessibility means more than simply providing digital access for existing or new products; it also means promoting accessibility for more diverse groups of people (for example, Marshmallow devised an algorithm enabling it to offer lower car insurance premiums to UK migrants) and ever greater geographical diversity (with insurtech funding growing in countries such as Botswana, Mali and Vietnam).</p>\n<p>The acceleration of the digitisation of almost every aspect of our lives, for which the pandemic has been a catalyst, has undoubtedly played to the strengths of insurtechs. These companies are nimbler, more digitally focused and are able to identify new trends and gaps in the market much more quickly than traditional players. Given their growth potential, we anticipate sectors such as health/wellness tech, ESG/sustainability and the future of digital (eg the metaverse, Web3 and NFTs) to grow in 2022, with digitally focused insurtechs well-placed to capitalise.</p>\n<p>One of the biggest challenges facing the insurance industry is the ‘protection gap’ and the ability of insurers to offer products to consumers to insure against their biggest risks. Aon’s 2021 Global Risk Management Survey lists cyber-attacks/data breaches as the top risk facing businesses, and this is an area that many insurtechs (including Vouch, CyberCube CFC Underwriting, Coalition and UpGuard) have been focused on. Unsurprisingly, a number of the other top 10 risks are pandemic-related, with business interruption second, pandemic risk seventh and supply chain or distribution failure eighth. It will be interesting to see what products and solutions insurtechs develop to help consumers with these challenges.</p>\n<h2 id=\"next\"><strong>What’s next for the insurtech landscape?</strong></h2>\n<p>More funding and an ever-growing pool of potential investors. According to the CB Insights Insurance Tech quarterly reports and State of Fintech 2021 report, in the first half of 2021, investors poured $7.4bn into insurtechs, surpassing by more than $300m the $7.1bn raised throughout the whole of 2020. Funding in Q3 of 2021 did fall from its previous record high but remained elevated, raising $3.1bn across 113 deals, with Q4 of 2021 reaching another record high with $5.3bn of insurtech funding across 139 deals.</p>\n<p>So how will this funding be deployed and what are the key insurtech trends for 2022? These are the questions the Freshfields insurtech team have been considering and you can read our primary conclusions below (some of which were previewed in our <a href=\"https://technologyquotient.freshfields.com/post/102hga6/freshfields-fintech-predictions-for-2022-3-fintech-growth\" target=\"_blank\" rel=\"noopener\">2022 fintech predictions mini series</a>):</p>\n<p><strong>1. BigTech’s (further) expansion into insurtech</strong> ­– Tesla has offered auto insurance products in California since 2019, and in 2021 expanded this to Texas. It seems unlikely that its foray into the auto insurance world will stop there, particularly with its access to real-time driving data for all of its cars allowing highly individualised pricing for products. Amazon has been ever more active in the space since selling its own-brand protection insurance in 2016 and has now established the ‘Amazon Insurance Accelerator’ a digital insurance initiative which has seen Amazon offer business insurance in the US and the UK (through partnerships with insurers). There are plenty of other examples and it makes perfect sense as these BigTech companies have the three most important elements to being a successful insurance carrier: (i) access to, and ability to process, a vast amount of data; (ii) a digital insurance ecosystem that the product offerings can be plugged into and sold from; and (iii) brand loyalty (consumers feel safe purchasing insurance from these companies). </p>\n<p><strong>2. More full carrier insurtechs</strong> – initial insurtech offerings consisted of products and add-on services or technology to established insurers. These included tools to help collect and analyse data, customer engagement applications (for example, insurance ‘check-up’ services) and digital claims handling and fraud prevention services. However, the World Insurtech Report notes that full carriers are the fastest growing and most funded category by volume for insurtechs in both US and Europe – and this is a trend we think is likely to continue. Full carrier insurtechs, for example, Lemonade, Root and Metromile, are benefiting from higher revenue valuation multiples and, it would seem, an acceptance from shareholders/investors that growth and disruption is more important than short-term profits (which is not the case for traditional insurers). Crucial to the ability of insurtechs to become full carriers is access to the reinsurance market for effective risk mitigation strategies (in particular to reduce the amount of regulatory capital which needs to be held by the insurtech). For now, reinsurers seem willing and available to tap into and support this growing insurtech space.</p>\n<p><strong>3. Greater access to funding</strong> – this may seem an obvious prediction given the funding statistics but we think it is worth a place on our list. Insurtechs are getting access to increasing amounts of funding – with the range and growth of potential funding events (particularly with the <a href=\"https://blog.freshfields.us/post/102hgzy/2021-de-spac-debrief\" target=\"_blank\" rel=\"noopener\">growth of the SPAC market</a>) and investors (private equity houses are looking at ever more insurtech targets, for example EQT recently made a significant investment alongside Vitruvian into CFC Underwriting). We have previously looked at the <a href=\"https://technologyquotient.freshfields.com/post/102g9w5/lemonade-sweet-on-ipo-plans\" target=\"_blank\" rel=\"noopener\">Lemonade IPO</a>, <a href=\"https://technologyquotient.freshfields.com/post/102gs22/hip-hip-h-ipo-2021-trends-for-insurtech-ipos\">IPO and SPAC trends for insurtechs</a> and the <a href=\"https://technologyquotient.freshfields.com/post/102gt5q/insurtechs-and-the-changing-uk-listing-landscape\">changing UK listing landscape</a> that could be advantageous to insurtechs. </p>\n<p><strong>4. Data and ‘open insurance’</strong> – in every sector, data considerations are critical. <a href=\"https://technologyquotient.freshfields.com/post/102gtvf/open-insurance-what-is-it-and-why-is-it-so-exciting\" target=\"_blank\" rel=\"noopener\">‘Open insurance’ presents many exciting benefits</a> to the insurance sector, and there are numerous opportunities in data-sharing. We think this will be a topic that will attract ever more attention, particularly as insurance becomes accessible to an ever wider and more diverse group of consumers, but it is certainly not without its challenges. We have explored the benefits and opportunities <a href=\"https://technologyquotient.freshfields.com/post/102gtvf/open-insurance-what-is-it-and-why-is-it-so-exciting\">here</a>.</p>\n<p>Each of these topics is indicative of an increasingly mature insurtech market, which often goes hand-in-hand with increased M&A activity. There are <a href=\"https://www.freshfields.com/en-gb/our-thinking/knowledge/briefing/2019/06/insurtech-insights--the-dos-and-donts-of-insurtech-ma--3963/\" target=\"_blank\" rel=\"noopener\">opportunities and pitfalls in insurtech M&A</a>, and there are signs of big-ticket deals. Large incumbent insurers have been investing, partnering and monitoring insurtechs for many years and many are well-positioned and experienced in the insurtech market (grappling with issues such as potential reputational damage and founder risks sometimes associated with these businesses), but the next – increasingly digital – era of the insurance market feels as though it has arrived.</p>\n<h2 id=\"regulatory\"><strong>Tech in the regulatory crosshairs</strong></h2>\n<p>As we look further ahead into 2022, insurtechs’ legal and compliance teams will need to take more time to consider the impacts of an increasingly tech-focused regulatory pipeline, as regulators grapple with evolving market dynamics and new players in the insurance space. European regulators in particular are taking steps to tackle tech-enabled regulatory fragmentation and to ensure that a ‘same activity, same risk, same rules’ principle is applied. Planned regulatory changes (such as those around <a href=\"https://technologyquotient.freshfields.com/post/102hekq/digital-operational-resilience-council-and-parliament-have-their-say-on-the-regu\" target=\"_blank\" rel=\"noopener\">operational resilience</a>) will not be limited to the insurance landscape. For example, <a href=\"https://ec.europa.eu/info/sites/default/files/business_economy_euro/banking_and_finance/documents/210202-call-advice-esas-digital-finance_en.pdf\" target=\"_blank\" rel=\"noopener\">EIOPA</a> is currently feeding into the <a href=\"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0591\" target=\"_blank\" rel=\"noopener\">EU’s ‘Digital Finance Strategy’</a>, which focuses on how to future-proof the broader financial services ecosystem and in particular on how to supervise: (i) fragmented value chains; (ii) platform business models; and (iii) mixed-activity groups (ie Big Techs participating in financial services). In the UK, the PRA has said that it is <a href=\"https://www.bankofengland.co.uk/speech/2021/may/anna-sweeney-association-of-british-insurers-prudential-regulation\" target=\"_blank\" rel=\"noopener\">considering barriers to entry</a> for small insurtech start-ups, and as part of its review of <a href=\"https://www.bankofengland.co.uk/prudential-regulation/key-initiatives/solvency-ii\" target=\"_blank\" rel=\"noopener\">Solvency II</a>, the regulator is looking into how it can create a more proportionate regime that helps to mobilise new entrants, provide more space to innovate, and bring new products to the market.</p>\n<h2 id=\"market\"><strong>Still a challenging market for insurtechs</strong></h2>\n<p>It is clear that the insurance industry is ripe for disruption, and a number of insurtechs have successfully started that journey. However, given the huge scale of the insurance industry – with $700bn a year in premiums in the US alone – and the fact it is largely dominated by ‘traditional’ insurance companies, most of which were founded decades ago, breaking the mould will not be simple. The main reason for this being that size and experience matter in insurance; it is beneficial to have greater diversification of risk, for example with policyholders spread further around the globe and/or multiple insurance lines written. New technologies, particularly those powered by AI, are closing the gap, but can they really match the vast amounts of claims history data and experience of underwriting that the incumbent insurers possess? These are just some of the challenges being grappled with by the insurtech community.</p>\n<p>The Freshfields insurtech team believe there will be some new big names in the insurance industry from the insurtech space – but this is more likely to be in the medium term rather than the short term, and these names could come from the next wave of insurtechs.</p>",
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"text": "The acceleration of the digitisation of almost every aspect of our lives, for which the pandemic has been a catalyst, has undoubtedly played to the strengths of insurtechs. These companies are nimbler, more digitally focused and are able to identify new trends and gaps in the market much more quickly than traditional players. Given their growth potential, we anticipate sectors such as health/wellness tech, ESG/sustainability and the future of digital (eg the metaverse, Web3 and NFTs) to grow in 2022, with digitally focused insurtechs well-placed to capitalise."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "One of the biggest challenges facing the insurance industry is the ‘protection gap’ and the ability of insurers to offer products to consumers to insure against their biggest risks. Aon’s 2021 Global Risk Management Survey lists cyber-attacks/data breaches as the top risk facing businesses, and this is an area that many insurtechs (including Vouch, CyberCube CFC Underwriting, Coalition and UpGuard) have been focused on. Unsurprisingly, a number of the other top 10 risks are pandemic-related, with business interruption second, pandemic risk seventh and supply chain or distribution failure eighth. It will be interesting to see what products and solutions insurtechs develop to help consumers with these challenges."
}
]
},
{
"type": "heading-two",
"id": "next",
"children": [
{
"text": "What’s next for the insurtech landscape?",
"bold": true
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "More funding and an ever-growing pool of potential investors. According to the CB Insights Insurance Tech quarterly reports and State of Fintech 2021 report, in the first half of 2021, investors poured $7.4bn into insurtechs, surpassing by more than $300m the $7.1bn raised throughout the whole of 2020. Funding in Q3 of 2021 did fall from its previous record high but remained elevated, raising $3.1bn across 113 deals, with Q4 of 2021 reaching another record high with $5.3bn of insurtech funding across 139 deals."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "So how will this funding be deployed and what are the key insurtech trends for 2022? These are the questions the Freshfields insurtech team have been considering and you can read our primary conclusions below (some of which were previewed in our "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102hga6/freshfields-fintech-predictions-for-2022-3-fintech-growth",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "2022 fintech predictions mini series"
}
]
},
{
"text": "):"
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "1. BigTech’s (further) expansion into insurtech",
"bold": true
},
{
"text": " ­– Tesla has offered auto insurance products in California since 2019, and in 2021 expanded this to Texas. It seems unlikely that its foray into the auto insurance world will stop there, particularly with its access to real-time driving data for all of its cars allowing highly individualised pricing for products. Amazon has been ever more active in the space since selling its own-brand protection insurance in 2016 and has now established the ‘Amazon Insurance Accelerator’ a digital insurance initiative which has seen Amazon offer business insurance in the US and the UK (through partnerships with insurers). There are plenty of other examples and it makes perfect sense as these BigTech companies have the three most important elements to being a successful insurance carrier: (i) access to, and ability to process, a vast amount of data; (ii) a digital insurance ecosystem that the product offerings can be plugged into and sold from; and (iii) brand loyalty (consumers feel safe purchasing insurance from these companies). "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "2. More full carrier insurtechs",
"bold": true
},
{
"text": " – initial insurtech offerings consisted of products and add-on services or technology to established insurers. These included tools to help collect and analyse data, customer engagement applications (for example, insurance ‘check-up’ services) and digital claims handling and fraud prevention services. However, the World Insurtech Report notes that full carriers are the fastest growing and most funded category by volume for insurtechs in both US and Europe – and this is a trend we think is likely to continue. Full carrier insurtechs, for example, Lemonade, Root and Metromile, are benefiting from higher revenue valuation multiples and, it would seem, an acceptance from shareholders/investors that growth and disruption is more important than short-term profits (which is not the case for traditional insurers). Crucial to the ability of insurtechs to become full carriers is access to the reinsurance market for effective risk mitigation strategies (in particular to reduce the amount of regulatory capital which needs to be held by the insurtech). For now, reinsurers seem willing and available to tap into and support this growing insurtech space."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "3. Greater access to funding",
"bold": true
},
{
"text": " – this may seem an obvious prediction given the funding statistics but we think it is worth a place on our list. Insurtechs are getting access to increasing amounts of funding – with the range and growth of potential funding events (particularly with the "
},
{
"type": "link",
"url": "https://blog.freshfields.us/post/102hgzy/2021-de-spac-debrief",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "growth of the SPAC market"
}
]
},
{
"text": ") and investors (private equity houses are looking at ever more insurtech targets, for example EQT recently made a significant investment alongside Vitruvian into CFC Underwriting). We have previously looked at the "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102g9w5/lemonade-sweet-on-ipo-plans",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "Lemonade IPO"
}
]
},
{
"text": ", "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102gs22/hip-hip-h-ipo-2021-trends-for-insurtech-ipos",
"children": [
{
"text": "IPO and SPAC trends for insurtechs"
}
]
},
{
"text": " and the "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102gt5q/insurtechs-and-the-changing-uk-listing-landscape",
"children": [
{
"text": "changing UK listing landscape"
}
]
},
{
"text": " that could be advantageous to insurtechs. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "4. Data and ‘open insurance’",
"bold": true
},
{
"text": " – in every sector, data considerations are critical. "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102gtvf/open-insurance-what-is-it-and-why-is-it-so-exciting",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "‘Open insurance’ presents many exciting benefits"
}
]
},
{
"text": " to the insurance sector, and there are numerous opportunities in data-sharing. We think this will be a topic that will attract ever more attention, particularly as insurance becomes accessible to an ever wider and more diverse group of consumers, but it is certainly not without its challenges. We have explored the benefits and opportunities "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102gtvf/open-insurance-what-is-it-and-why-is-it-so-exciting",
"children": [
{
"text": "here"
}
]
},
{
"text": "."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Each of these topics is indicative of an increasingly mature insurtech market, which often goes hand-in-hand with increased M&A activity. There are "
},
{
"type": "link",
"url": "https://www.freshfields.com/en-gb/our-thinking/knowledge/briefing/2019/06/insurtech-insights--the-dos-and-donts-of-insurtech-ma--3963/",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "opportunities and pitfalls in insurtech M&A"
}
]
},
{
"text": ", and there are signs of big-ticket deals. Large incumbent insurers have been investing, partnering and monitoring insurtechs for many years and many are well-positioned and experienced in the insurtech market (grappling with issues such as potential reputational damage and founder risks sometimes associated with these businesses), but the next – increasingly digital – era of the insurance market feels as though it has arrived."
}
]
},
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"type": "heading-two",
"id": "regulatory",
"children": [
{
"text": "Tech in the regulatory crosshairs",
"bold": true
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "As we look further ahead into 2022, insurtechs’ legal and compliance teams will need to take more time to consider the impacts of an increasingly tech-focused regulatory pipeline, as regulators grapple with evolving market dynamics and new players in the insurance space. European regulators in particular are taking steps to tackle tech-enabled regulatory fragmentation and to ensure that a ‘same activity, same risk, same rules’ principle is applied. Planned regulatory changes (such as those around "
},
{
"type": "link",
"url": "https://technologyquotient.freshfields.com/post/102hekq/digital-operational-resilience-council-and-parliament-have-their-say-on-the-regu",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "operational resilience"
}
]
},
{
"text": ") will not be limited to the insurance landscape. For example, "
},
{
"type": "link",
"url": "https://ec.europa.eu/info/sites/default/files/business_economy_euro/banking_and_finance/documents/210202-call-advice-esas-digital-finance_en.pdf",
"target": "_blank",
"rel": "noopener",
"children": [
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"text": "EIOPA"
}
]
},
{
"text": " is currently feeding into the "
},
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"type": "link",
"url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0591",
"target": "_blank",
"rel": "noopener",
"children": [
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"text": "EU’s ‘Digital Finance Strategy’"
}
]
},
{
"text": ", which focuses on how to future-proof the broader financial services ecosystem and in particular on how to supervise: (i) fragmented value chains; (ii) platform business models; and (iii) mixed-activity groups (ie Big Techs participating in financial services). In the UK, the PRA has said that it is "
},
{
"type": "link",
"url": "https://www.bankofengland.co.uk/speech/2021/may/anna-sweeney-association-of-british-insurers-prudential-regulation",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "considering barriers to entry"
}
]
},
{
"text": " for small insurtech start-ups, and as part of its review of "
},
{
"type": "link",
"url": "https://www.bankofengland.co.uk/prudential-regulation/key-initiatives/solvency-ii",
"target": "_blank",
"rel": "noopener",
"children": [
{
"text": "Solvency II"
}
]
},
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"text": ", the regulator is looking into how it can create a more proportionate regime that helps to mobilise new entrants, provide more space to innovate, and bring new products to the market."
}
]
},
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"id": "market",
"children": [
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"text": "Still a challenging market for insurtechs",
"bold": true
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]
},
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"type": "paragraph",
"children": [
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"text": "It is clear that the insurance industry is ripe for disruption, and a number of insurtechs have successfully started that journey. However, given the huge scale of the insurance industry – with $700bn a year in premiums in the US alone – and the fact it is largely dominated by ‘traditional’ insurance companies, most of which were founded decades ago, breaking the mould will not be simple. The main reason for this being that size and experience matter in insurance; it is beneficial to have greater diversification of risk, for example with policyholders spread further around the globe and/or multiple insurance lines written. New technologies, particularly those powered by AI, are closing the gap, but can they really match the vast amounts of claims history data and experience of underwriting that the incumbent insurers possess? These are just some of the challenges being grappled with by the insurtech community."
}
]
},
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"type": "paragraph",
"children": [
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"text": "The Freshfields insurtech team believe there will be some new big names in the insurance industry from the insurtech space – but this is more likely to be in the medium term rather than the short term, and these names could come from the next wave of insurtechs."
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"html": "<p>In a <a href=\"https://www.lawcom.gov.uk/project/automated-vehicles/\">joint report</a> published on 26 January 2022, the Law Commission of England and Wales and the Scottish Law Commission have proposed introducing a new Automated Vehicles Act to regulate automated, i.e. self-driving, vehicles (<em><strong>AVs</strong></em>) on roads or other public places in Great Britain (<strong><em>GB</em></strong>).</p>\n<p>The report anticipates that, in the future, Automated Driving Systems (<strong><em>ADS</em></strong>) will develop to a point where a vehicle will be able to drive itself without a human driver paying attention for at least part of a journey. As a result, the proposed Act would create a new and ambitious regulatory scheme that is radically different from the current system. The report’s 75 recommendations tackle a broad range of issues to bring about that change.</p>\n<h2 id=\"newregulation\"><strong>i. A new regulatory and liability framework </strong></h2>\n<p>The proposed regulatory regime envisages three key legal actors:</p>\n<p>1. the user-in-charge – the human in the driving seat;</p>\n<p>2. the no user-in-charge (<em><strong>NUIC</strong></em>) operator – the organisation that oversees the vehicle when a NUIC feature is engaged; and</p>\n<p>3. the authorised self-driving entity (<strong><em>ASDE</em></strong>) – the vehicle manufacturer or software developer that puts the vehicle forward for authorisation or a partnership between the two. This is the entity which must respond to regulatory action and oversee any recall activity.</p>\n<p>Crucially, once a vehicle is authorised as having self-driving ADS features, and the ADS is engaged, the system of legal accountability will change under the proposals. In particular:</p>\n<ul>\n<li>The person in the driving seat will no longer be a driver but will become a ‘user-in-charge’. They will have immunity from a wide range of offences related to the way the vehicle drives, ranging from dangerous or careless driving, to exceeding the speed limit or running a red light. That recommendation marks a seismic change in approach and has unsurprisingly garnered significant press attention. The user-in-charge would, however, retain responsibility for maintaining insurance, as well as exchanging insurance details following an accident.</li>\n<li>If the ADS features are authorised for use without a user-in-charge, any occupants of the AV will simply be passengers. Responsibility for overseeing the journey will be undertaken by a licensed NUIC operator.</li>\n<li>If an ADS feature results in the vehicle driving in a manner that would be criminal if performed by a human driver, the ASDE would bear responsibility. Compensation for victims who suffer injury would be provided via the existing provisions of Part 1 of the Automated and Electric Vehicles Act 2018. Insurers are, and would remain, directly liable to the insured person, or any other injured person, without the need to prove fault regardless of whether the user-in-charge or automated driving system was in control of the AV.</li>\n</ul>\n<h2 id=\"newav\"><strong>ii. A new AV approval and authorisation scheme</strong></h2>\n<p>The proposals recommend introducing a new two-stage approval and authorisation process before an AV with ADS features is permitted to enter use. The proposals suggest an approach which sensibly complements the existing approvals framework. </p>\n<p>First, ASDEs would be given the choice of either obtaining: (1) international UNECE systems approval from any UNECE approval authority; or (2) a GB AV technical approval under a new British domestic scheme. Whatever the ASDE’s election, GB whole vehicle approval would then be required under the post-Brexit scheme overseen by the VCA replacing the EU whole vehicle approval scheme. </p>\n<p>Second, an authorisation authority will also need to be satisfied that the vehicle “as a whole” is equipped with an ADS feature or features capable of meeting the threshold for being self-driving. The report recommends a “high test” for a vehicle to be authorised as having self-driving features: it must be safe even if a human user is not monitoring the driving environment, the vehicle, or the way it drives.</p>\n<p>The report anticipates that, initially, an ASDE may wish to operate its own AVs. They have therefore designed a system where the ASDE and NUIC operator roles can be combined without undue bureaucratic duplication. It recommends that, where the ASDE and NUIC operator are the same entity, the entity may submit a single safety case to be assessed by the authorisation authority. It will also however be possible for the NUIC operator to be separate from the ASDE. If so, the ASDE will need to set out what is required for the safe operation of its vehicles, and the NUIC operator will need to show how it meets the operational requirements.</p>\n<h2 id=\"apportioning\"><strong>iii. Apportioning legal responsibility between the ASDE and the user-in-charge</strong></h2>\n<p>The report is very clear that, when the ADS feature is engaged, the user-in-charge is to be granted immunity from “any criminal offence or civil penalty which arises out of dynamic driving” and, as such, responsibility for traffic infractions would fall squarely on the ASDE. A range of new mechanisms will need to be developed by those in industry operating ASDEs in order to address that new potential liability. </p>\n<p>There are also likely to be challenges in determining which party bears responsibility when the ASDE encounters a situation which it cannot handle and control needs to be returned to the user-in-charge. The report’s solution is that a user-in-charge should be required to respond to a clear and timely signal to take over driving (a “transition demand”). At the end of the transition period, legal responsibility for driving will shift to the user-in-charge, even if they have not taken control of the AV. Offence immunity for the user-in-charge ceases at the end of the period. By way of example, the report envisages that, if an AV stops in a busy motorway lane as a result of a user-in-charge’s failure to response to a transition demand, the user-in-charge would be liable (including criminally). Scope for argument as to whether the transition demand was sufficiently clear, properly engaged, and responded to appropriately seems inevitable. Where civil liability results, we assume that insurers would carefully consider whether secondary claims could be pursued against AV manufacturers.</p>\n<p>Another key issue discussed in the report is whether a user should have any responsibility to passively ‘monitor’ their surroundings in the absence of a “transition demand”. The report advises not, suggesting that it would expect too much from the user-in-charge and violate the general principle that users-in-charge should not need to pay attention when the ADS is engaged. The report also warns that drivers tend to panic when confronted with emergency situations and that the ADS may well be better placed than the user to remedy the situation. Interestingly, that approach differs from other jurisdictions. For instance, in Germany, the user-in-charge must remain “ready to perceive” (“<em>wahrnehmungsbereit</em>”) obvious circumstances indicating that the conditions for the ADS’s use are not met. </p>\n<p>The report’s approach places a significant burden on the ADS (and by extension ASDEs), which may not be able to recognise every possible road sign or react to novel situations. Conscious of this, the report recognises that this “does not mean that the ADS feature must be able to deal with absolutely everything” because some events are “so unlikely that they do not need to be considered”. That does however raise challenging questions as to where responsibility would lie if (and presumably when) such extraordinary events do occur. Again, where civil liability results we imagine that impacted insurers would consider secondary claims against AV manufactures. </p>\n<h2 id=\"newpenalties\"><strong>iv. A new penalties regime</strong></h2>\n<p>The report also suggests a range of penalties to ensure compliance of the various actors under the new regime throughout the AV lifecycle. </p>\n<h3><strong>Marketing</strong></h3>\n<p>The report suggests a range of offences targeted at preventing misleading advertising in relation to AVs. These include enacting new criminal offences for:</p>\n<ul>\n<li>describing unauthorised vehicles using certain terms such as “self-driving” and “automated vehicle”; and</li>\n<li>engaging in a commercial practice which is likely to confuse drivers into thinking that an unauthorised driving automation technology does not need to be monitored when on a public road or place.</li>\n</ul>\n<p>The report proposes that a person would have a defence if the commercial practice that gave rise to the offence originated from outside GB and it had taken all reasonable precautions and exercised due diligence to prevent GB drivers from being misled. Enforcement is anticipated to involve criminal prosecutions as well as via civil enforcement orders and voluntary undertakings.</p>\n<h3><strong>Breach of licensing conditions</strong></h3>\n<p>The report proposes that new regulatory offences be enacted so as to allow an “in-use regulator” to investigate any traffic infractions/complaints which amount to a breach of licensing conditions, and apply sanctions where appropriate to ensure compliance.</p>\n<p>The in-use regulator will have the power to apply for a search warrant to obtain information as well as request for further information from ASDEs and NUIC operators. Importantly, the report suggests that penalties “will not be automatic”, i.e. per vehicle fines will not apply in the same way that they do presently with human drivers. Instead, it is proposed that the regulator will decide on the appropriate sanction in light of discussions with the appropriate actor. Where a single organisation acts as both an ASDE and a NUIC operator, the report envisages that the regulator can impose sanctions on the combined organisation, without having to establish in which role it was responsible for the fault.</p>\n<p>Possible sanctions suggested include warnings, civil penalties, redress orders, compliance orders and (in the most serious cases) suspension or withdrawal of authorisation, with a concurrent appeals process.</p>\n<h3><strong>The duty of candour</strong></h3>\n<p>The report aims to promote a no-blame safety culture that learns from mistakes. Central to that objective is the establishment of the “duty of candour”, which is intended to ensure the honesty and transparency of the ASDE and NUIC operator in sharing information with regulators. </p>\n<p>Where that does not occur, the report envisages a new criminal offence being enacted, that of failing to provide safety information or providing misleading information to a regulator when putting forward a vehicle for authorisation or responding to a request from a regulator.</p>\n<p>Where the ASDE/NUIC is guilty of the non-disclosure or misrepresentation offences above, the person who signed the relevant safety case or response to the request for information (“the nominated person”) would also commit the offence. Senior managers would also be guilty of the above offence if it took place with their consent or connivance. The report suggests that the ASDE/NUIC operator/nominated person would have a defence if shown that it took reasonable precautions and exercised all due diligence to prevent the wrongdoing. The report does not make any specific recommendations about the maximum penalties, but draws parallels with offences under the Human Medicines Regulations 2012, which carry a penalty of an unlimited fine and/or up to two years’ imprisonment.</p>\n<h3><strong>Aggravating factors</strong></h3>\n<p>The report also considers aggravating factors. Where an actor commits any of the offences above, it recommends that the offence should be aggravated where the misrepresentation or non-disclosure is:</p>\n<ul>\n<li>related to an increased risk of a type of adverse incident;</li>\n<li>an adverse incident of that type occurred; and</li>\n<li>the adverse incident caused a death or serious injury.</li>\n</ul>\n<p>The report does not make any specific recommendations as to maximum penalties for the aggravated offences, observing instead that the decision is “best made by the UK Government”. That said, the authors note that they viewed the aggravated offence as the equivalent to causing death by dangerous driving, which carries a maximum prison term of 14 years. They also note, however, that legislation currently before Parliament would increase the maximum penalty for causing death by dangerous driving from 14 years to life.</p>\n<p>The report’s approach to penalties is as characteristically innovative as its other proposals. The suggestion that the penalties regime move away from the blunt fixed penalties per infringement approach used for human infractions to a more flexible system of co-operative dialogue between the relevant actor and regulator is clearly to be welcomed. That said, the development of concepts such as the duty of candour will inevitably pose significant challenges for ASDEs, NUICs and their personnel. Given the serious criminal penalties envisaged, rigorous internal compliance regimes will need to be established and strictly adhered to so as to ensure compliance. Determining the precise edges of the duty of candour is likely to be no easy task, and the relevant regulator may face challenges properly assessing a mass of disclosures if industry responds by cautiously over-reporting. </p>\n<h2 id=\"setting\"><strong>v. Setting the safety standard expected of an AV</strong></h2>\n<p>The report also considers a core issue concerning AVs: how much safer than a user-driven vehicle must an AV be to be considered ‘safe’? While there is broad agreement that AVs should be “safer than human drivers in general”, the report notes that opinions remain divided on the exact safety standard that should be demanded. For example, should the standard be that of a “competent and careful human driver”, or that of “the average driver” which would include the full range of drivers currently on the road? Consultation responses universally indicated that a positive risk balance was the minimum acceptable standard and the report is clear that comparisons must be made by reference to British, rather than worldwide, standards on the basis that deaths in some US states and EU nations were observed to be over four times higher than on British roads. </p>\n<p>One possibility floated in the report is that legislation could require a percentage improvement on human drivers’ safety standards. The report observes that that there “is an attraction to the idea that AVs should be required to drive more safely over time: for example the standard could require a percentage improvement every five years over the next two decades.” Such an approach would also mirror, for instance, the approach taken in relation to legislation driving incremental reductions in vehicle emissions over time. However, care will clearly need to be taken to ensure that any safety standard is genuinely achievable so as to not stifle AV development and safety gains given that the lack of agreement as to the ‘correct’ percentage is notable. The report refers to consultation responses which variously suggested a very wide range of percentage improvements ranging from 5% to 75%.</p>\n<p>Ultimately, the report recommends that the new Act should require the Secretary of State for Transport to publish a safety standard against which the safety of AVs can be measured. The report states that ‘how safe an AV should be’ is a political question that will depend on the level of risk acceptable to the public. That is probably about as much as could realistically be expected given the real uncertainties as to the efficacy of future ADS in AVs. </p>\n<h3><strong>The road ahead</strong></h3>\n<p>Overall, the report should be lauded for offering a set of radical, nuanced and comprehensive legislative proposals. It will no doubt play a central role in the debate on how to regulate ADS in AVs going forward. </p>\n<p>If it is minded to act on the Law Commissions’ review, the Government will need to liaise with industry in order to address a number of difficult issues identified by the report, as it moves forward towards legislation. An interim response is due from Government within six months, with a final response due within a year. Legislative clarity can only assist in driving innovation, improving safety and facilitating the introduction and uptake of ADS in AVs on the UK’s roads. That is particularly key given, under the proposals, industry would face additional responsibilities. </p>\n<p>As the report makes clear, there are difficult decisions to be made on the road ahead. As ever, the devil will be in the detail of the legislation. Legislators, and ultimately regulators, will need to liaise with manufacturers, developers and insurers – and even, in relation to liability issues in particular, lawyers - to understand the state of development and limitations of self-driving technologies, so as to craft regulation that best apportions risk and liability. </p>",
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"text": " published on 26 January 2022, the Law Commission of England and Wales and the Scottish Law Commission have proposed introducing a new Automated Vehicles Act to regulate automated, i.e. self-driving, vehicles ("
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"text": ") on roads or other public places in Great Britain ("
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"text": "The report anticipates that, in the future, Automated Driving Systems ("
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"text": ") will develop to a point where a vehicle will be able to drive itself without a human driver paying attention for at least part of a journey. As a result, the proposed Act would create a new and ambitious regulatory scheme that is radically different from the current system. The report’s 75 recommendations tackle a broad range of issues to bring about that change."
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"text": "1. the user-in-charge – the human in the driving seat;"
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"type": "paragraph",
"children": [
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"text": "2. the no user-in-charge ("
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"text": ") operator – the organisation that oversees the vehicle when a NUIC feature is engaged; and"
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"text": "3. the authorised self-driving entity ("
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"text": ") – the vehicle manufacturer or software developer that puts the vehicle forward for authorisation or a partnership between the two. This is the entity which must respond to regulatory action and oversee any recall activity."
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"type": "paragraph",
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"text": "Crucially, once a vehicle is authorised as having self-driving ADS features, and the ADS is engaged, the system of legal accountability will change under the proposals. In particular:"
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"text": "The person in the driving seat will no longer be a driver but will become a ‘user-in-charge’. They will have immunity from a wide range of offences related to the way the vehicle drives, ranging from dangerous or careless driving, to exceeding the speed limit or running a red light. That recommendation marks a seismic change in approach and has unsurprisingly garnered significant press attention. The user-in-charge would, however, retain responsibility for maintaining insurance, as well as exchanging insurance details following an accident."
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"text": "If the ADS features are authorised for use without a user-in-charge, any occupants of the AV will simply be passengers. Responsibility for overseeing the journey will be undertaken by a licensed NUIC operator."
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},
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"type": "list-item",
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"text": "If an ADS feature results in the vehicle driving in a manner that would be criminal if performed by a human driver, the ASDE would bear responsibility. Compensation for victims who suffer injury would be provided via the existing provisions of Part 1 of the Automated and Electric Vehicles Act 2018. Insurers are, and would remain, directly liable to the insured person, or any other injured person, without the need to prove fault regardless of whether the user-in-charge or automated driving system was in control of the AV."
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"text": "ii. A new AV approval and authorisation scheme",
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"type": "paragraph",
"children": [
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"text": "The proposals recommend introducing a new two-stage approval and authorisation process before an AV with ADS features is permitted to enter use. The proposals suggest an approach which sensibly complements the existing approvals framework. "
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"type": "paragraph",
"children": [
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"text": "First, ASDEs would be given the choice of either obtaining: (1) international UNECE systems approval from any UNECE approval authority; or (2) a GB AV technical approval under a new British domestic scheme. Whatever the ASDE’s election, GB whole vehicle approval would then be required under the post-Brexit scheme overseen by the VCA replacing the EU whole vehicle approval scheme. "
}
]
},
{
"type": "paragraph",
"children": [
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"text": "Second, an authorisation authority will also need to be satisfied that the vehicle “as a whole” is equipped with an ADS feature or features capable of meeting the threshold for being self-driving. The report recommends a “high test” for a vehicle to be authorised as having self-driving features: it must be safe even if a human user is not monitoring the driving environment, the vehicle, or the way it drives."
}
]
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{
"type": "paragraph",
"children": [
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"text": "The report anticipates that, initially, an ASDE may wish to operate its own AVs. They have therefore designed a system where the ASDE and NUIC operator roles can be combined without undue bureaucratic duplication. It recommends that, where the ASDE and NUIC operator are the same entity, the entity may submit a single safety case to be assessed by the authorisation authority. It will also however be possible for the NUIC operator to be separate from the ASDE. If so, the ASDE will need to set out what is required for the safe operation of its vehicles, and the NUIC operator will need to show how it meets the operational requirements."
}
]
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"text": "iii. Apportioning legal responsibility between the ASDE and the user-in-charge",
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"text": "The report is very clear that, when the ADS feature is engaged, the user-in-charge is to be granted immunity from “any criminal offence or civil penalty which arises out of dynamic driving” and, as such, responsibility for traffic infractions would fall squarely on the ASDE. A range of new mechanisms will need to be developed by those in industry operating ASDEs in order to address that new potential liability. "
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "There are also likely to be challenges in determining which party bears responsibility when the ASDE encounters a situation which it cannot handle and control needs to be returned to the user-in-charge. The report’s solution is that a user-in-charge should be required to respond to a clear and timely signal to take over driving (a “transition demand”). At the end of the transition period, legal responsibility for driving will shift to the user-in-charge, even if they have not taken control of the AV. Offence immunity for the user-in-charge ceases at the end of the period. By way of example, the report envisages that, if an AV stops in a busy motorway lane as a result of a user-in-charge’s failure to response to a transition demand, the user-in-charge would be liable (including criminally). Scope for argument as to whether the transition demand was sufficiently clear, properly engaged, and responded to appropriately seems inevitable. Where civil liability results, we assume that insurers would carefully consider whether secondary claims could be pursued against AV manufacturers."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "Another key issue discussed in the report is whether a user should have any responsibility to passively ‘monitor’ their surroundings in the absence of a “transition demand”. The report advises not, suggesting that it would expect too much from the user-in-charge and violate the general principle that users-in-charge should not need to pay attention when the ADS is engaged. The report also warns that drivers tend to panic when confronted with emergency situations and that the ADS may well be better placed than the user to remedy the situation. Interestingly, that approach differs from other jurisdictions. For instance, in Germany, the user-in-charge must remain “ready to perceive” (“"
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"text": "wahrnehmungsbereit",
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"text": "”) obvious circumstances indicating that the conditions for the ADS’s use are not met. "
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"type": "paragraph",
"children": [
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"text": "The report’s approach places a significant burden on the ADS (and by extension ASDEs), which may not be able to recognise every possible road sign or react to novel situations. Conscious of this, the report recognises that this “does not mean that the ADS feature must be able to deal with absolutely everything” because some events are “so unlikely that they do not need to be considered”. That does however raise challenging questions as to where responsibility would lie if (and presumably when) such extraordinary events do occur. Again, where civil liability results we imagine that impacted insurers would consider secondary claims against AV manufactures. "
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]
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"text": "iv. A new penalties regime",
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"text": "The report also suggests a range of penalties to ensure compliance of the various actors under the new regime throughout the AV lifecycle. "
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"children": [
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"text": "Marketing",
"bold": true
}
]
},
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"type": "paragraph",
"children": [
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"text": "The report suggests a range of offences targeted at preventing misleading advertising in relation to AVs. These include enacting new criminal offences for:"
}
]
},
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"children": [
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"text": "describing unauthorised vehicles using certain terms such as “self-driving” and “automated vehicle”; and"
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},
{
"type": "list-item",
"children": [
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"text": "engaging in a commercial practice which is likely to confuse drivers into thinking that an unauthorised driving automation technology does not need to be monitored when on a public road or place."
}
]
}
]
},
{
"type": "paragraph",
"children": [
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"text": "The report proposes that a person would have a defence if the commercial practice that gave rise to the offence originated from outside GB and it had taken all reasonable precautions and exercised due diligence to prevent GB drivers from being misled. Enforcement is anticipated to involve criminal prosecutions as well as via civil enforcement orders and voluntary undertakings."
}
]
},
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"children": [
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"text": "Breach of licensing conditions",
"bold": true
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]
},
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"type": "paragraph",
"children": [
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"text": "The report proposes that new regulatory offences be enacted so as to allow an “in-use regulator” to investigate any traffic infractions/complaints which amount to a breach of licensing conditions, and apply sanctions where appropriate to ensure compliance."
}
]
},
{
"type": "paragraph",
"children": [
{
"text": "The in-use regulator will have the power to apply for a search warrant to obtain information as well as request for further information from ASDEs and NUIC operators. Importantly, the report suggests that penalties “will not be automatic”, i.e. per vehicle fines will not apply in the same way that they do presently with human drivers. Instead, it is proposed that the regulator will decide on the appropriate sanction in light of discussions with the appropriate actor. Where a single organisation acts as both an ASDE and a NUIC operator, the report envisages that the regulator can impose sanctions on the combined organisation, without having to establish in which role it was responsible for the fault."
}
]
},
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"type": "paragraph",
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"text": "Possible sanctions suggested include warnings, civil penalties, redress orders, compliance orders and (in the most serious cases) suspension or withdrawal of authorisation, with a concurrent appeals process."
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"text": "The report aims to promote a no-blame safety culture that learns from mistakes. Central to that objective is the establishment of the “duty of candour”, which is intended to ensure the honesty and transparency of the ASDE and NUIC operator in sharing information with regulators. "
}
]
},
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"type": "paragraph",
"children": [
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"text": "Where that does not occur, the report envisages a new criminal offence being enacted, that of failing to provide safety information or providing misleading information to a regulator when putting forward a vehicle for authorisation or responding to a request from a regulator."
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"type": "paragraph",
"children": [
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"text": "Where the ASDE/NUIC is guilty of the non-disclosure or misrepresentation offences above, the person who signed the relevant safety case or response to the request for information (“the nominated person”) would also commit the offence. Senior managers would also be guilty of the above offence if it took place with their consent or connivance. The report suggests that the ASDE/NUIC operator/nominated person would have a defence if shown that it took reasonable precautions and exercised all due diligence to prevent the wrongdoing. The report does not make any specific recommendations about the maximum penalties, but draws parallels with offences under the Human Medicines Regulations 2012, which carry a penalty of an unlimited fine and/or up to two years’ imprisonment."
}
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},
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"bold": true
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"text": "The report does not make any specific recommendations as to maximum penalties for the aggravated offences, observing instead that the decision is “best made by the UK Government”. That said, the authors note that they viewed the aggravated offence as the equivalent to causing death by dangerous driving, which carries a maximum prison term of 14 years. They also note, however, that legislation currently before Parliament would increase the maximum penalty for causing death by dangerous driving from 14 years to life."
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"text": "The report’s approach to penalties is as characteristically innovative as its other proposals. The suggestion that the penalties regime move away from the blunt fixed penalties per infringement approach used for human infractions to a more flexible system of co-operative dialogue between the relevant actor and regulator is clearly to be welcomed. That said, the development of concepts such as the duty of candour will inevitably pose significant challenges for ASDEs, NUICs and their personnel. Given the serious criminal penalties envisaged, rigorous internal compliance regimes will need to be established and strictly adhered to so as to ensure compliance. Determining the precise edges of the duty of candour is likely to be no easy task, and the relevant regulator may face challenges properly assessing a mass of disclosures if industry responds by cautiously over-reporting. "
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"text": "One possibility floated in the report is that legislation could require a percentage improvement on human drivers’ safety standards. The report observes that that there “is an attraction to the idea that AVs should be required to drive more safely over time: for example the standard could require a percentage improvement every five years over the next two decades.” Such an approach would also mirror, for instance, the approach taken in relation to legislation driving incremental reductions in vehicle emissions over time. However, care will clearly need to be taken to ensure that any safety standard is genuinely achievable so as to not stifle AV development and safety gains given that the lack of agreement as to the ‘correct’ percentage is notable. The report refers to consultation responses which variously suggested a very wide range of percentage improvements ranging from 5% to 75%."
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"type": "paragraph",
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"text": "Ultimately, the report recommends that the new Act should require the Secretary of State for Transport to publish a safety standard against which the safety of AVs can be measured. The report states that ‘how safe an AV should be’ is a political question that will depend on the level of risk acceptable to the public. That is probably about as much as could realistically be expected given the real uncertainties as to the efficacy of future ADS in AVs. "
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