Life sciences year in review and what's ahead

2025 was eventful in the life sciences space – and key trends are expected to continue in the new year. Below, we outline key areas to watch in 2026.

Product liability

The EU Product Liability Directives

Across the European Union and the United Kingdom, the threat of litigation for life sciences companies, including mass action by consumers, continues to increase. 

Jurisdictions across Europe have enacted new collective redress procedures, which have already resulted in high-profile medical device actions, including in Netherlands and the UK.

The EU Product Liability Directive, which came into force in 2025, is now being implemented by various Member States. The directive expands the scope of liability for healthcare companies by amending product definitions, extending limitation periods, and shifting the burden of proof in complex cases.  For example, statutory claims for slow-emerging health damage can now be brought up to 25 years after product placement. The UK is reviewing similar reforms.

Litigation funding in the UK

The recent instability for UK litigation funders continued in 2025.  Settlement of a high-profile class action in the Competition Appeals Tribunal was unsuccessfully challenged by the funder and, in spite of recommendations this year from a statutory body, funders continue to await government intervention on the enforceability of their funding agreements.

Contaminants in pharmaceuticals and medical devices

In the United States, plaintiffs’ lawyers continued the recent trend of filing lawsuits predicated on the potential harm of trace levels of contaminants in pharmaceuticals and medical devices, based largely on studies involving the contaminants rather than the products themselves.  Nevertheless, US courts have been increasingly receptive to screening procedures that require plaintiffs to provide proof of exposure and proof of injury to ensure that the claims that proceed in coordinated litigation are meritorious, which blunts the growth of multi-jurisdictional litigations, though the use of screening orders is more common in federal court than in state courts.

Intellectual property

Disclosure requirements and subject matter eligibility: Key patent issues for life sciences companies

In 2025, US patent practice in life sciences continued to be defined by rigorous enablement and written-description scrutiny – particularly for antibody, genomic, and platform claims –  with Amgen v. Sanofi continuing to shape the scope of functional genus claims. 

In the last quarter of 2025, at least two Federal Circuit cases – Seagen v. Daiichi and Duke University v. Allergan – called into question the adequacy of disclosure as it relates to genus claims from both a written description and an enablement perspective.   Subject matter eligibility challenges persist at the margins for diagnostics and biomarker-based methods, even as sponsors refine claim drafting towards concrete, data-supported embodiments. 

Looking ahead to 2026, stakeholders are encouraged to remain aware of the continued judicial refinement of enablement and written description standards for complex biologics and modality-agnostic claims. Courts may further delineate the boundaries for diagnostic and method-of-treatment claims, making robust experimental support, claim specificity, and strategic portfolio structuring more critical than ever. 

In Europe, the Amgen v. Sanofi dispute centers on the patentability standard for broad functional antibody inventions for cholesterol, with ongoing litigation before the Unified Patent Court (UPC) and national courts, with challenges at the European Patent Office (EPO) based on the validity of the patents including second medical use claims. In late 2025, the UPC Court of Appeal delivered an important decision, upholding Amgen's key patent (reversing the earlier decision that invalidated it) setting an important precedent for the inventive step for antibody inventions and following an approach similar to that of the EPO on both sufficiency and inventive step.

In Australia, whether a patent is subject to the lower sufficiency – and support thresholds applicable where examination of the patent application was requested before April 15, 2013 (prior to “raising the bar” (RTB) patents) – or the higher, EU/UK thresholds applicable thereafter (post-RTB patents) remain largely determinative of whether those thresholds are met.  For example, the broad functional genus claims in a pre-RTB patent were found sufficient and supported in Amgen v. Sanofi. This distinction may continue in 2026 and beyond. 

In relation to subject matter eligibility, unlike in the US, Australia's High Court is expected in 2026 to hear an appeal to address the unsatisfactory state of the law in Australia regarding this issue, which arose from a 3–3 decision the last time the High Court addressed it.

Global developments in the PTE/SPC landscape

Extensions of patent term remain an important means of compensating life sciences companies for the loss of effective patent term stemming from regulatory delays. In 2025, there continued to be important developments in this area of law around the world.

US Patent Term Extensions (PTE) under the Hatch-Waxman Act provide up to five years of additional protection for pharmaceuticals and medical devices delayed by US Food and Drug Administration (FDA) approval. A key development in 2025 included a Federal Circuit decision confirming that Hatch-Waxman PTE for reissued patents is based on the original patent’s issue date.

Europe's Supplementary Protection Certificates (SPCs), which provide up to five-year extensions and pediatric bonuses, continued to evolve through the European Commission's proposals to create a unitary SPC and centralized examination procedures for all SPC's, and to create Court of Justice of the European Union (CJEU) and national case law clarifying eligibility rules for extended patent protection for products like combination therapies. There has also been further litigation arising from the SPC manufacturing waiver with contradicting decisions from Belgium, Germany, Netherlands, and the UK touching on whether long term storage is possible and whether manufacture to export to is permitted.

In Australia, a landmark decision from the Full Federal Court ruled formulation patents ineligible for PTEs.

Looking to 2026, ongoing stability in the US may be expected for Hatch-Waxman Act PTEs, in addition to potential EU SPC reforms advancing toward centralized and unitary procedures; a judgment from the CJEU on whether a substance categorized as an excipient in a marketing authorization can be considered an active ingredient in the context of an application for an SPC; and in Australia, tighter PTE scrutiny and potentially attempts by generics to accelerate market entry.

The growing impact of AI on the patent eligibility and patentability of life sciences inventions

In 2025, artificial intelligence (AI) continued to increase its role in all aspects of the business of life sciences companies, from drug discovery to drug supply. This growing role continues to be reflected in patent filings, and patent offices around the world are facing questions surrounding whether inventions involving AI, or for which AI has made an inventive contribution, are patent eligible or patentable.

However, the potential influence of AI on the “patent-scape” does not stop there. Patent offices around the world are also considering the potential impact of AI on many other fundamental aspects of patent law. For example, for questions of inventive step/obviousness, it must be determined whether the “common general knowledge” can be said to include things obtainable through large language models (LLMs), or whether an LLM can be a person skilled in the art. Patent offices must also consider the impact of AI on the various disclosure requirements of patent law around the world, such as enablement, support, sufficiency, and written description.

Patent offices, and ultimately courts, around the world will continue to face such issues arising from the growing role and prevalence of AI through 2026 and beyond.

Mergers and acquisitions

The second half of 2025 saw an uptick in the number of larger transactions, most of which have been in the pharma space. However, due to fewer transactions in the first half of the year, deal count may not trouble the record books this year. This reflects a shift toward fewer, but more substantial, acquisitions, as companies prioritized quality over quantity and targeted high-value assets, driven by the combination of readily available “dry powder,” approaching patent cliffs, and the desire for transformative technologies. 

The uncertainty that characterized the first half of the year gave way to increased comfortability with market conditions for deal-making.  Optimism in deal flow may continue into 2026, which may result in more robust activity than was seen at the start of 2025, with both US and international companies pursuing strategic acquisitions to expand their portfolios and accelerate innovation.  Heightened cross-border transactions may be expected, particularly as organizations seek access to emerging technologies and global talent pools, in addition to continuing to use earnouts and contingent value rights to bridge valuation gaps. Licensing deals may also remain a key driver for inorganic growth – in China in particular, partnerships with local biotechs, distributors, and contract research organizations (CROs) are a critical part of the deal ecosystem, although there is also outbound interest from investors in China for assets in the sector.  

Capital markets

International exchanges

Certain Asian exchanges, particularly in Hong Kong and India, experienced a strong 2025 and are set to continue into 2026. Life sciences companies, particularly those headquartered in, or with significant exposure to, Asia looked to take advantage of this funding surge through initial public offerings (IPOs), secondary listings, and divisional carveouts.

European exchanges had a much softer 2025, despite record high Financial Times Stock Exchange (FTSE) and EURO STOXX 50 (EU50) indices driven largely by their exposure to the banking, defense, and energy sectors (and the US tech sector to a lesser extent). Consequently, emerging life sciences companies struggled to utilize the otherwise active public markets, while those already listed drew attention from overseas private equity (PE) and trade buyers.

However, at the end of 2025 and going into 2026, IPOs and secondary fundraisings across Europe increased (as has deal-making more generally). With competitive tension for attractive assets increasing and policy makers committing to public investment in healthcare, partly in response to US tariffs and most-favored-nation pricing, the deal environment in private and public capital markets may improve. The trend of established Europe, the Middle East, and Africa (EMEA)-based life sciences companies strategically focusing on organic and inorganic investment into the US market may also continue.

US markets

In the US, 2025 proved to be the year of market uncertainty and caution as it related to the IPO market and capital market transactions in general. Given continued changes at FDA and other government agencies, and the growing risk that China could gain further traction in biopharma, uncertainty may persist at least through the first half of 2026.  However, there is optimism for the life sciences sector as mergers and acquisitions (M&A) activity in 2025 recorded the most deal volume in the last decade.  This uptick shows that the sector has strong clinical results and successful commercial results while deregulation around pricing and heavy investment in biotech is expected to continue. Therefore, there is cautious optimism that the sector is primed for strong capital markets activity starting in the second quarter of 2026.

Strategic collaborations

2025 saw strategic collaborations as a key driver of growth across the life sciences industry. Key deal types include AI-enabled drug and target discovery collaborations, cross-border licensing and distribution to open new markets, and collaborations to leverage the value of data. A key trend is looking to these collaborations to diversify risk and introduce robustness into development pathways and supply chains. Supply chain reorganization in response to tariff and geopolitical considerations has been a large focus across the industry. Post M&A activity, which includes reorganizations and strategic disposals, is also encouraging the exploration of new partnerships. In 2026, we may continue to see cost pressure and the need to accelerate timelines, which will drive strategic collaborations, particularly those between life sciences and technology companies.

Antitrust

Despite policy changes by the Trump Administration in other sectors, antitrust enforcement in life sciences continued to be a major focus for US agencies in 2025.  On the commercial side, both the Antitrust Division of the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) continued to closely scrutinize pricing, distribution, and patent extending practices.  The FTC continued to investigate the role of pharmacy benefits managers and its effects on consumer pricing, as well as other bundling and discount strategies by pharmaceutical suppliers more broadly.  The Commission also pursued Orange Book listing practices and other patent-extending strategies, while the DOJ challenged alleged price-fixing of generic drugs.

M&A in life sciences also continued to be subject to heightened scrutiny.  In addition to maintaining its traditional focus on combinations of direct competitors, the FTC has also pursued less common theories of harm.  In one case, for example, the agency challenged a merger that did not involve competitors but that, according to the FTC’s complaint, could have facilitated unlawful bundling or tying practices by the post-closing company.

Considering the importance of life sciences issues on the political landscape, these trends toward aggressive antitrust enforcement in the sector may likely continue.

Outside of the US, competition authorities, such as the European Commission, continued to focus on enforcement in life sciences with a particular focus on practices that may restrict market entry by generics and other forms of abuse of dominance. The European Commission is currently in the process of adopting new guidelines on abuse of dominance, which are expected to underline its stricter approach in this area.

FDA regulatory

US updates

• In 2025, FDA launched the Commissioner’s National Priority Review Voucher (NPRV) pilot, enabling a team‑based, ultra‑rapid review for applications aligned with national priorities, with a total of 15 vouchers issued to date. The first drug approved under the NPRV program (Augmentin XR) was completed in two months. While industry sees potential speed and predictability gains, questions remain about agency bandwidth and whether expedited reviews are sustainable at scale.
• In January 2025, FDA published draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” which provides expectations when sponsors use AI and machine learning (ML) tools to generate, process, or analyze data relied upon in regulatory submissions. Specifically, this guidance provided a seven-step, risk-based credibility assessment framework for establishing and evaluating the credibility of an AI model for a particular context of use (COU). This guidance generated significant interest within the drug and biologics industry. See our DLA Piper alert for more details on this AI guidance.
• The agency’s push for “radical transparency” included bulk publication of redacted Complete Response Letters (CRLs), which raised a number of questions for companies and heightened the stakes for investor communications and trade secret protection strategies. See our DLA Piper alert for more details on FDA’s approach to CRLs.
• FDA issued new draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” to reduce or eliminate comparative efficacy and switching studies for many biosimilars, reflecting confidence in advanced analytics and aligning with practice trends. There is also a proposal to deem all biosimilars interchangeable via statutory change, effectively creating “biologic generics.” This shift may likely compress timelines and costs, with greater emphasis on analytical rigor and modeling to support interchangeability.
• Supply chain integrity continues to be a focus area, with the Drug Supply Chain Security Act (DSCSA) phased exemptions ending in 2025. Some entities, such as small dispensers and their trading partners, are exempt from certain DSCSA requirements in section 582 of the Federal Food, Drug, and Cosmetic Act (FDCA) until November 27, 2026. For more details, see our DLA Piper alert.

Medical devices

• In January 2025, FDA issued a draft guidance on AI-enabled device software functions titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff.” The draft guidance, discussed in detail here, provided insights on how FDA plans to apply total product life cycle (TPLC) principles that have historically applied to traditional hardware medical devices and AI-enabled software device functions.
• Cybersecurity continues to be a priority for medical devices. In June 2025, FDA finalized its guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff,” detailing expectations for cyber devices under amended section 524B of the FDCA. It details recommended practices for cybersecurity risk management, documentation (including software bill of materials), testing, labeling, and post market vulnerability management.
• The long saga over FDA’s regulation of laboratory developed tests (LDTs) ended in 2025. A federal court vacated FDA’s LDT final rule, holding that LDTs are professional services rather than “devices,” and remanded the matter to the US Department of Health and Human Services (HHS). FDA subsequently rescinded the rule, reestablishing the prior status quo. FDA’s device program also acknowledged the court’s outcome in its broader device updates.

Advertising and promotion

• As detailed in a previous DLA Piper alert, FDA enforcement around direct-to-consumer (DTC) prescription drug advertising surged in September 2025 following a Presidential Memorandum directing HHS and FDA to take a more aggressive enforcement posture with respect to DTC ads. This led to a large batch of approximately 100 Untitled and Warning Letters. Several key themes in the letters included inadequate or minimized risk presentation; lack of clear, conspicuous, and neutral major statements; benefit overstatements; unapproved therapeutic equivalence claims; failure to submit FDA‑2253 at initial dissemination; and the use of distracting visuals and rapid scene changes that impair risk comprehension.
• FDA finalized its guidance on Scientific Information on Unapproved Uses (SIUU) to healthcare professionals (HCPs), clarifying boundaries for firm communications, the requirement to rely on “scientifically sound” source publications, and the in‑scope and out‑of‑scope techniques (e.g., excluding celebrity endorsements and unrelated emotional appeals). FDA also emphasized appropriate separation between promotional and SIUU materials in digital environments and encouraged firms to provide access to the underlying source publications as part of the communication package.

EU updates

• In 2025, the December 11 agreement reached by the EU Council and Parliament on the reform of the EU Pharma Law avoided massive erosion of the regulatory data periods in place since 2004. In addition, new initiatives that recently launched – such as the European Health Data Space, life sciences strategy; Critical Medicines Act; and Biotech Act – may open opportunities for innovative and rare disease treatments. Furthermore, the European Medicines Agency (EMA) increasingly used evidence-generating methods like extrapolation, modeling, and simulation, supported by real-world data platforms such as DARWIN EU®.
• EMA recently qualified an AI tool that analyses liver biopsies to assess NASH/MASH activity. Both innovators and regulators are required to ensure that algorithms and datasets comply with ethical, technical, and regulatory standards.
• New concerns were expressed by industry over parallel trade and medicine compounding. Council proposals in the EU Pharma Law reform (Articles 1(5) and 1(6) of the new Directive 2001/83) could allow pharmacies to produce complex medicines, including biotech products, for up to four weeks, and encourage cross-border supply of compounded preparations. This development entails risks of large-scale manufacturing by pharmacies outside standard EU controls, adding to the implications of the recently released opinion from the Advocate-General at the Court of Justice suggesting that a biological product may, in principle, be regarded as a reference product for a generic copy manufactured by chemical synthesis, an interpretation so far ruled out under Article 10 of Directive 2001/83.
• To increase competitiveness, the European Commission introduced measures to reduce duplication of activities and controls under three different regulations, with an aim to streamline approval of combined products like medicines, medical devices, and in vitro diagnostics. It also added simplifications and exemptions for small- to mid-cap enterprises handling personal data under the EU’s General Data Protection Regulation (GDPR), the general body of EU rules on personal data protection.

Drug pricing, BIOSECURE, and innovation

• In the EU, amid difficulties pursuing affordable healthcare policies, the new tariffs imposed by the US government on medicinal products boosted the EU rush to recover competitiveness against other global players. Good progress in terms of harmonization of practices among the 27 Member States was made in the context of the Accelerating Clinical Trials in the EU (ACT-EU) program. The European Commission recently introduced some measures aimed at reducing duplications of compliance activities and streamlining the development of combined products (e.g., a medicine and a medical device, or in vitro diagnostic). Some simplifications and exemptions were also introduced for small- to mid-cap enterprises processing personal data.
• The European pharmaceutical legislation reform is nearing approval, and the research and development (R&D)-based industry will be relieved to note that the European Parliament and Council have dismissed the Commission's attempt to significantly shorten the EU standard regulatory data protection periods. In parallel, the Commission also published their proposals for a Biotech Act and a Critical Medicines Act, both important for the development of new advanced therapies and the maintenance of a secure supply chain for a list of active ingredients and finished products. However, due to national pricing and reimbursement mechanisms, access to medicines across the EU continued to be an issue, despite the initial implementation in 2025 of the Health Technology Assessment Regulation, which is intended to facilitate faster and uniform access to innovative products throughout the EU. 

Current geopolitical environment

US–EU outlook

The current transatlantic challenges facing the pharmaceuticals industry present an opportunity to reshape priorities in 2026. Participants are looking towards investments in the industry as a strategy for driving economic growth and strengthening the collective competitive edge. For US companies, forging business connections in the EU may prove to be critical in pharmaceutical development and supply, as European governments continue to acknowledge the economic potential of strategic health investment.

US policy

With the upcoming congressional midterm election year and the second year of the Trump Administration, healthcare policy may likely play a key role – from affordability to pricing and transparency.

Congress and the Trump Administration may focus on addressing increasing healthcare costs in the US. In 2026, we may see the scaling back of the Medicare Part D Premium Stabilization Demonstration, in addition to the expiration of the Affordable Care Act (ACA) enhanced subsidies, both of which could have a notable impact on Americans’ healthcare spending. The Trump Administration made deals with multiple pharmaceutical companies to bring most-favored-nation (MFN) drug pricing to Americans and multiple pilot programs are in development related to applying MFN pricing more broadly within the Medicare Parts B and D programs and within the Medicaid program. The White House may announce additional deals with pharmaceutical companies in 2026, in addition to the launch of TrumpRx, which would offer DTC medication access.

Furthermore, this past year focused a spotlight on FDA, where frequent changes in leadership raised concerns over timeliness of drug approvals and the priorities of the agency. Together with the MFN conversations, the continuation of the Medicare Drug Price Negotiation Program, and ongoing concerns about affordability and the availability of funds for bench research at higher education research institutions, investment capital is increasingly moving to China and pharmaceutical companies are going to other countries for first approval over the US. Federal healthcare agencies, supported by the White House and Congress, may seek to reverse these trends through innovation-forward policy.

Trade and tariffs

IEEPA and CBP

In 2025, the Trump Administration upended the US customs regime by imposing sweeping tariffs pursuant to the International Emergency Economic Powers Act (IEEPA), among other authorities.  These tariffs were particularly difficult to navigate for industries, including the life sciences sector, which had historically enjoyed duty free treatment when importing goods into the US.  Although the question of President Donald Trump’s ability to impose tariffs under IEEPA is before the US Supreme Court, the Trump Administration has at its disposal other statutory authorities to impose tariffs.  Thus, even if the Supreme Court strikes down the President Trump’s use of IEEPA, other authorities may likely be used, if not to replace the IEEPA tariffs, to employ a patchwork of sector- and country-specific tariffs to achieve the Trump Administration’s trade policy agenda. As a result, tariffs may remain for the foreseeable future.

Furthermore, customs enforcement underwent changes that may crystallize in 2026. The  DOJ’s new criminal unit tasked to investigate and prosecute trade and customs fraud  (including tariff evasion) may be active – especially given the inter-agency task force between the Customs and Border Protection (CBP), the Department of Homeland Security, and the DOJ, along with modifications to the DOJ’s whistleblower program. Together, these factors may be expected to contribute to an uncertain tariff environment and a meaningful increase in enforcement by CBP and DOJ in 2026.

Tariffs and drug prices

In 2025, trade tensions and tariffs posed challenges across the pharmaceuticals industry related to managing drug prices and development costs. In response to the US Executive Order introducing MFN drug pricing, companies may consider raising European drug prices, delaying launches, or even shifting production locations. Proposed tariffs only add to this uncertainty. As US policymakers attempt to balance benefits to patients, payers, and the industry, the EU may resist paying more due to their budget constraints and existing deficits. Americans currently pay approximately 2.5 times more than Europeans for medications. Industry participants are encouraged to monitor the situation for further developments from policymakers, in addition to developments related to the introduction of impactful technologies within the industry, such as AI.

Enforcement

In the US, enforcement priorities remained focused on “fraud, waste, and abuse,” with healthcare and life sciences industries coming under scrutiny. The DOJ and HHS have relaunched a False Claims Act (FCA) Working Group to drive investigations in these sectors, focusing on pricing practices for drugs, devices, and biologics – such as discounts, rebates, service fees, formulary placement, and price reporting. Additionally, the government’s Trade Fraud Task Force is investigating tariff evasion, customs fraud, and smuggling schemes, signaling that life sciences companies with global supply chains could expect enforcement using both criminal statutes and the FCA.

Globally, enforcement trends reflected increasing cross-border coordination and evolving compliance risks. In Europe, environmental, social, and governance (ESG)-related enforcement gained traction, with regulators enforcing against greenwashing and sustainability misstatements under new directives. In Asia, China’s healthcare anti-corruption campaign continued to expand, with stricter penalties under the amended Anti-Unfair Competition Law and sector-specific compliance guidelines highlighting high-risk activities such as HCP interactions and kickbacks. Other regions, including Australia and Southeast Asia, are strengthening anti-corruption frameworks and whistleblower protections. For life sciences companies, these developments underscore the need for robust, multi-jurisdictional compliance programs that integrate ESG controls and advanced monitoring tools to navigate a rapidly shifting enforcement landscape.

Artificial intelligence

US updates

The US life sciences marketplace continued to expand the diversity of use cases for the application of AI. AI-enabled tools were used to assist in workflow management and patient care delivery, to help researchers engage with scientific content more efficiently, and to directly interact with patients and end users. AI was also used to analyze data to accelerate the identification and validation of therapeutic targets, molecules, and biomarkers, while using other tools to optimize the design, conduct, monitoring, and analysis of clinical trials. These tools may be used to generate evidence for regulatory submissions, automate patient recruitment, or monitor ongoing studies. At the same time, the industry navigated the risks and challenges that AI poses, such as managing data privacy and security issues and monitoring and addressing inherent biases, reliability, and accuracy concerns. As these issues evolve, agencies are turning to deeper and more sophisticated governance mechanisms to help the industry into compliance, including deploying AI within their own practices.

International updates

The adoption of AI in the life sciences outside of the US in 2025 was uneven but has been accelerating. Going into 2026, a key focus for the development and deployment of AI in the EU will be compliance with the EU AI Act, which prioritizes ethical principles, risk assessment, and transparency. This may impact timeframes for deployment, especially compared to the US. Throughout Asia and the Asia-Pacific region, especially in China and India, the implementation of AI in the life sciences saw continued use, including in drug discovery and development, the optimization of clinical trials, and in diagnostics, leveraging vast patient pools and government supported AI initiatives (such as AI Plus in China).

Compliance

Compliance programs in life sciences continued to evolve to incorporate AI and data analytics, both to ensure that elements remain effective and to help support overall program objectives in identifying and mitigating gaps or areas of non-compliance.  Expectations articulated by governments and law enforcement agencies around the world, such as the US DOJ Guidance released towards the end of 2024 and the UK's “Guidance to organizations on the offence of failure to prevent fraud,” continued to drive this change, as did the rapid uptake of analytics and AI by government agencies to identify enforcement initiatives.  For example, in the US, the reinvigorated DOJ and HHS FCA Working Group adopted data analytics as a key enforcement tool, reinforcing the DOJ Criminal Division’s articulated priority at the outset of the Trump Administration to focus on “Waste, Fraud, and Abuse, including Healthcare Fraud” when identifying corporate crimes to prosecute. While these trends are expected to continue, ethical considerations and human oversight will remain key.