A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 and Beyond

How Companies Develop Their Products

• The FDA’s rare pediatric disease priority review voucher (PRV) program began to sunset on December 20, 2024, on failure to pass a continuing resolution package that included its reauthorization. Under the amended statutory sunset provisions, after December 20, 2024, the FDA may award a PRV for an approved rare pediatric disease product application only if the sponsor has rare pediatric disease designation for the drug and if that designation was granted by December 20, 2024. After September 30, 2026, the FDA may not award any rare pediatric disease PRVs. As recently as March 2025, companies have continued to announce the receipt of rare pediatric disease designation, so it appears that the FDA continues to review and grant these designations. In the new Congress, the Give Kids a Chance Act of 2025 was introduced by Republicans in both the House and Senate (H.R.1262 and S.932), with 84 cosponsors in the House alone. However, reauthorization was not included in the funding bill that was signed into law on March 15, 2025. As a result, this remains an area to watch in the new administration, given its objectives are generally aligned with the Trump administration’s support for innovation in new treatments and cures.
• HHS published a list, updated on March 21, 2025, identifying grants terminated by the Trump administration. It is unclear whether this list will be further updated in the weeks and months ahead, so this remains an area to monitor. On February 7, 2025, the NIH also issued the immediately effective “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates,” deviating from the negotiated indirect cost rate for new and existing grant awards and setting a standard indirect cost rate of 15% across all NIH grants in lieu of a separately negotiated rate for indirect costs in every grant.
• In February 2025, the FDA, together with the HHS Office for Human Research Protections (OHRP), issued final guidance, “Institutional Review Board (IRB) Written Procedures,” to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures. The final guidance includes a “Written Procedures Checklist” addressing regulatory requirements and recommendations for compliance. The FDA concurrently issued final guidance in an information sheet format to provide answers to “Institutional Review Boards Frequently Asked Questions.” This information may be helpful for research sponsors to review, as well.
• On January 7, 2025, the FDA issued a draft guidance called “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.” The document clarifies how sponsors, manufacturers, and other industry developers should approach artificial intelligence (AI) to support safe, effective development and marketing of AI-based tools. The FDA seeks public comment on this draft guidance until April 7, 2025. Read our client alert about this draft guidance here.
• Following an executive order issued by the Trump administration related to diversity, equity, and inclusion, the FDA’s long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies,” was removed from the FDA’s website. However, the draft guidance was restored to the website on February 11, 2025, following a court order, as currently noted on the FDA’s website. The draft guidance addresses the preparation of diversity action plans for Phase 3 or pivotal studies of drugs, biologics, and devices (whether conducted under investigational device exemptions or not), pursuant to Section 3601 of FDORA (the Food and Drug Omnibus Reform Act). The draft guidance describes the format and content of diversity action plans, the medical products and clinical studies for which a diversity action plan is required, and the timing and process for submitting diversity action plans to the FDA. The draft guidance also outlines the criteria and process that developers can use for seeking a waiver. Stakeholders had until September 26, 2024, to submit comments on the draft guidance, which the FDA will now review with the aim to issue final guidance. Read our blog on the FDA’s draft guidance. Under its current statutory requirements, the FDA is set to issue a final guidance by mid-2025; however, the future implementation of any diversity action plan requirements will be subject to any decisions by the Trump administration to stall implementation, such as through the use of further executive orders, enforcement discretion, or otherwise. This remains an area to watch in the second quarter.
• On December 12, 2024, the UK government introduced a legislative proposal — the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 — that, if implemented, will replace the current regulatory framework for clinical trials in the UK. The proposal aims to provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK, and make clinical trials more patient-centered. The legislative proposal has been reviewed and approved by the UK Parliament. Once the legislative proposal is adopted into UK law, it will come into force after a 12-month implementation period.
• US Department of Justice (DOJ) regulations implementing Executive Order 14117 on Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern go into effect on April 6, 2025. The regulations target foreign access to “bulk sensitive personal data” of US persons by countries of concern (i.e., the People’s Republic of China [including Hong Kong and Macao], Russia, Iran, North Korea, Cuba, and Venezuela) and certain entities and individuals connected to these countries. Specifically, the regulations prohibit transactions involving data brokerage or human genomic and other “‘omic” data with “covered persons” associated with countries of concern, and they restrict certain transactions involving vendors, employees, and investors affiliated with countries of concern that would allow access to sensitive personal data — including health data — meeting “bulk” thresholds. The bulk thresholds vary by data type: For example, the threshold for human genomic data is 100 US persons, while the threshold for personal health data is 10,000 US persons. Transactions that are restricted (but not prohibited) can proceed subject to the implementation of prescribed cybersecurity requirements. While the rules include exemptions for certain activities relating to clinical research, including transactions involving deidentified data that are necessary for regulatory approvals, the narrow scope of such exemptions could implicate commercial relationships with counterparties that have ties to the listed countries, including for clinical trial data (for details, see our Client Alert).
• We are monitoring the effects of the Rare Therapies Launch Pad (RTLP) that was launched in November 2023 in the UK. The RTLP aims to help identify a sustainable and scalable approach to delivering individualized therapies for children with rare conditions, including establishing a proportionate regulatory pathway. This end-to-end pathway would cover diagnosis, the design and rapid manufacturing of these therapies, and treatment. The programme also aims to help establish potential reimbursement for these therapies.
• We are monitoring the effects of the Innovative Licensing and Access Pathway (ILAP) that was relaunched in January 2025 in the UK. The ILAP aims to accelerate the time to patient care for transformative new medicines and drug-device combinations by providing a single integrated platform for collaboration between developers, the Medicines and Healthcare products Regulatory Agency (MHRA), the UK Health Technology Assessment (HTA) bodies, and the National Health Service (NHS). Companies that are granted access to the ILAP will benefit from tailored guidance and support from the regulatory bodies involved in ILAP from the early stages of clinical development, with the aim of reducing the end-to-end timeline for research and development, regulatory approval, and access to the medicine or technology for patients. The MHRA published guidance in January 2025 on the updated ILAP.

Deciding Whether a Company Can Market or Sell a Specific Product

Pharmaceuticals and Biologics

• In January 2025, the FDA’s drug, biologic, and veterinary centers jointly issued draft guidance, “Considerations for Complying With 21 CFR 211.110,” describing manufacturing considerations for complying with the requirements to ensure batch uniformity and drug product integrity as well as quality considerations for drug products that are manufactured using advanced manufacturing. The FDA is accepting comments through April 7, 2025.
• In January 2025, the FDA issued final guidance, “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” to help establishments making donor-eligibility determinations understand applicable regulatory requirements.
• We are continuing to monitor the implementation of the European Commission’s legislative proposals — Regulation 2023/0131 and Directive 2023/0132 — to replace the current EU regulatory framework for medicines (including those for rare diseases and for children). The proposals, announced on April 26, 2023, aim to reduce costs, expedite the introduction of new medicines, and prevent medicine shortages. Read our summary of these proposals here. The European Commission provided the legislative proposals to the European Parliament and the European Council for their review and approval, and in April 2024, the European Parliament proposed amendments to the legislative proposals. Read our summary of these proposed amendments here. Once the European Commission’s legislative proposals are approved (with or without amendment), they will be adopted into EU law.
• We are continuing to monitor the implementation of the Windsor Framework in the UK. The medicines aspects of the Windsor Framework have applied since January 1, 2025. This new framework fundamentally changes the previous system under the Northern Ireland Protocol, including the regulation of medicines in the UK. In particular, the MHRA is now responsible for approving all medicines destined for the UK market (i.e., Great Britain and Northern Ireland), and the European Medicines Agency (EMA) no longer has a role in approving medicines destined for Northern Ireland under the EU centralized procedure. The MHRA may grant a single UK-wide marketing authorization for all novel medicinal products sold in the UK, enabling medicines to be sold in a single pack and under a single authorization throughout the UK. Medicines marketed in the UK are also required to carry a “UK only” label to differentiate them from those sold within the EU. The MHRA has published a collection of guidance notes on the main changes introduced by the Windsor Framework relating to medicines.
• We are continuing to monitor the effects in the UK of the International Recognition Procedure (IRP) (effective January 1, 2024), which replaced the European Commission Decision Reliance Procedure. The IRP allows the MHRA to consider the expertise and decision-making of medicine regulators in Australia, Canada, the EU, Japan, Singapore, Switzerland, and the US when approving a new medicine. The decentralized and mutual recognition reliance procedure, which allowed the MHRA to have regard for approvals in the EU under these procedures, has been incorporated under the umbrella of the IRP.

Medical Devices and Medtech

• In January 2025, the FDA issued draft guidance, “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” providing recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI) – enabled device software functions including documentation and information that will support the FDA’s evaluation of safety and effectiveness. The FDA is accepting comments through April 7, 2025. Read our client insight “FDA Approvals of AI Medical Devices Rise Rapidly.”
• In January 2025, the FDA issued final guidance, “Premarket Approval Application and Humanitarian Device Exemption Modular Review,” providing information on the modular review program and procedures for submitting or reviewing a modular Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE).
• In March 2025, the FDA issued an update to its Total Product Lifecycle Advisory Program (TAP). The FDA reports that as of March 26, 2025, there are currently 75 devices enrolled in the TAP. The FDA reports that the TAP is now accepting enrollment requests for Breakthrough Designated devices reviewed by the Division of Ophthalmic Devices (DHT1A), the Office of Cardiovascular Devices (OHT2), the Office of Neurological and Physical Medicine Devices (OHT5), the Office of Orthopedic Devices (OHT6), and the Office of Radiological Health (OHT8).
• In January 2025, the FDA issued final guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which addresses notifications during or in advance of a public health emergency. The final guidance also includes a list of product codes for which a manufacturer must notify the FDA of a permanent discontinuance or interruption.
• We are continuing to monitor the effects of Regulation (EU) 2017/745 (the European Medical Device Regulation, or MDR), which has been applicable in the EU since May 26, 2021. Medical devices with a valid certificate under the previous EU Medical Devices Directive must be fully transitioned to the MDR (subject to fulfillment of certain conditions) by December 31, 2027, for higher-risk medical devices (except for custom-made Class III implantable devices, for which the relevant date is May 26, 2026) and by December 31, 2028, for lower-risk medical devices. The MDR also requires the use of the EU’s medical-device database, EUDAMED, which effectively outlines the life cycle of medical devices by collating and processing information about those medical devices and related companies, such as the manufacturers of those devices. EUDAMED will contain six modules related to: (1) actor registration (e.g., manufacturer, authorized representative, distributor, or importer); (2) unique device identification/device registration; (3) notified bodies and certificates; (4) clinical investigations and performance studies; (5) vigilance and post-market surveillance; and (6) market surveillance. Modules (1), (2), and (3) are already available, and modules (4), (5), and (6) are under development. The use of EUDAMED is not yet mandatory. There will be a gradual rollout of EUDAMED, requiring manufacturers to provide information about their products to available EUDAMED modules without needing to wait for the remaining modules to be developed. This mandatory registration is expected to take effect in early 2026.
• We are monitoring the introduction of changes to the medical devices legislation in Great Britain, following a public consultation on the future regulation of medical devices (see here). The first piece of legislation will come into force on June 16, 2025, and implements changes to the post-market surveillance requirements for medical devices in Great Britain, with the aim of facilitating greater traceability of incidents. Further legislation will be put in place in 2025 and 2026 to introduce new pre-market requirements, including an international reliance procedure for approval of certain medical devices for the Great Britain market.

In Vitro Diagnostics and Laboratory Testing

• We are monitoring the FDA’s efforts to reclassify most in vitro diagnostics (IVDs) that are currently Class III (high risk), including infectious disease and companion diagnostic IVDs, into Class II (moderate risk). According to a press release dated January 31, 2024, the FDA intends to propose reclassification of IVDs for which it believes there is sufficient information to establish special controls that, in combination with general controls, provide a reasonable assurance of safety and effectiveness for the tests. For example, on September 25, 2024, the FDA issued a proposal to reclassify antigen, antibody, and nucleic acid – based Hepatitis B virus assay devices from Class III to Class II.
• The transition periods under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for in vitro diagnostic medical devices have been extended (subject to fulfillment of certain conditions) until December 31, 2027, for higher-risk IVDs and until December 31, 2029, for lower-risk IVDs. The IVDR requires manufacturers to submit by May 26, 2025, all applications for higher-risk IVDs that they want to transition to the IVDR; applications for the transition of lower-risk IVDs must be submitted by May 26, 2027. The IVDR also requires manufacturers to have in place a quality management system in accordance with the IVDR by May 26, 2025, and a signed contract with an EU notified body for review and conformity assessment by September 26, 2025, for higher-risk IVDs, and by September 26, 2027, for lower-risk IVDs.
• On December 12, 2024, the European Commission launched a public consultation on the EU’s MDR and IVDR as part of a targeted evaluation of these rules. The evaluation will look at how effective the rules are and the costs and administrative burden of the rules. The consultation was closed on March 21, 2025, and the feedback received is accessible here.

How Companies Manufacture, Promote, and Monitor Their Approved Products

• In January 2025, the FDA issued final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The final guidance supersedes the agency’s revised draft guidance of the same title issued in October 2023 and includes several key updates, including describing further the scientific standards for appropriate source publications, providing additional examples of the separate dissemination of information on approved and unapproved uses in different scenarios, and expanding the section on firm-generated presentations with further context on what is permitted and what would be viewed as inappropriate when an SIUU (scientific information on unapproved uses) communication includes a source publication and firm-generated content. Read our blog on the final guidance here.
• The FDA issued an “exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners” beyond the prior-issued stabilization period for the Drug Supply Chain and Security Act (DSCSA). The FDA defined “eligible trading partners” as “trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.” The FDA indicated its goal was to avoid supply chain disruptions to medicine distributions. Importantly, trading partners utilizing the exemption do not need to notify the FDA. The exemption period varies by eligible trading partner as follows:
  • Manufacturers and Repackagers: May 27, 2025 (note: ending soon)
  • Wholesale Distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025
  The FDA has also issued exemptions for small dispensers (pharmacies) and their trading partners, providing additional time for implementation until November 27, 2026. Specifically, the FDA defines small dispensers as those where, as of November 27, 2024, the company owning the dispenser had 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. Importantly, the FDA notes that pharmacies must make their own determination whether they qualify as a small dispenser under this definition, and no submission is necessary to inform the FDA of utilization of this exemption. Trading partners that do not qualify under one of these exemptions and require additional time can submit to the FDA a request for a waiver or exemption, but while such exemption or waiver is pending, they must still continue efforts to meet the FDA’s requirements. As the exemption period for manufacturers and repackagers is ending this quarter, companies whose systems are not yet compliant will need to seek a waiver or exemption from the FDA while actively continuing to progress their implementation efforts.
• In February 2024, the FDA published its final rule harmonizing its device good manufacturing practice requirements to align more closely with the international consensus standard for devices by converging with the quality management system requirements used by other regulatory authorities from other jurisdictions. The final rule will take effect February 2, 2026.

Whether Government or Commercial Payers Are Willing to Pay for a Product, How Much They Are Willing to Spend, and Under What Circumstances

On March 3, 2025, HHS rescinded its more than 50-year policy known as the “Richardson Waiver.” This policy applied procedural rulemaking requirements under the Administrative Procedures Act that allowed for the use of notice-and-comment rulemaking for matters related to public property, loans, grants, benefits, or contracts. The rescission of this policy means that HHS will no longer require notice-and-comment requirements for many types of rulemaking, unless required by law. The Federal Register notice is available here.

We are monitoring the policy positions and public statements of officials nominated by President Trump and approved by the US Senate to run America’s key healthcare agencies.

Most recently, in his March 2025 confirmation hearings, Dr. Mehmet Oz — nominee for the Centers for Medicare & Medicaid Services (CMS) Administrator — made the following clarifications regarding his policy positions:

1. Targeting fraud, waste, and abuse in Medicare Advantage programs will be a top priority for CMS under the Trump administration.
2. Misuse and excessive use of prior authorization as a tool to limit coverage in Medicare Advantage will be a focus of the Dr. Oz CMS.
3. Inappropriate upcoding for patients in Medicare Advantage will be a target of his.
4. The Inflation Reduction Act’s (IRA) drug price negotiation program will continue to be implemented and rolled out under Dr. Oz.
5. Medicaid work (or other similar qualifying requirements) will remain on the table as CMS continues to grapple with the Medicaid program.

In addition, also in March 2025, CMS announced that it would end several of its Innovation Center Models (i.e., “time-limited experiments that provide a controlled environment to determine, through rigorous evaluation, what approaches [to various Medicare & Medicaid payment and coverage requirements] should be expended nationwide.” CMS, noting that “not every model will work,” aims to end four models related to the delivery of primary care and end-stage renal disease treatment, among other areas, as well as to scale back a model to provide integrated care to kids. The agency will not implement two previously announced but not implemented models (i.e., the Medicare $2 drug list and a program to accelerate clinical evidence). CMS clarified that ending these programs early should save American taxpayers almost $750 million. Information is available here.

Pharmaceuticals and Biologics

• Via our IRA web page, we are continuing to follow how the IRA of 2022 will affect Medicare and commercial reimbursement for pharmaceutical and biologic products. On March 14, 2025, CMS announced that companies manufacturing all 15 drugs covered under Medicare Part D have signed agreements to participate in the Medicare Drug Price Negotiation Program. CMS also released in March 2025 the statutorily mandated public explanation of the negotiated “maximum fair prices” for the first round of drug negotiations. We are also actively tracking ongoing constitutional challenges to the IRA’s drug price negotiation program, as detailed on our IRA web page.
• Congress is considering numerous proposed pharmacy benefit manager (PBM) reforms in both the House and the Senate. Legislative proposals include, but are not limited to, eliminating rebates; divorcing service fees from the price of a drug, discount, or rebate; prohibiting spread pricing; limiting administrative fees; requiring PBMs to report formulary placement rationale; promoting transparency; requiring health insurers that own PBMs to divest those PBMs; and many others. PBM reform and transparency measures have become a key policy topic in Washington and continue to be front and center for policymakers.
• We are monitoring the implementation of Regulation (EU) 2021/2282 (the HTA Regulation) on health technology assessment (HTA), which has been applicable since January 12, 2025. An HTA is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, and robust manner. Previously, after obtaining the respective authorization for health technologies, a manufacturer was required to apply to different HTA agencies in various EU member states before new health technologies are broadly accessible. The HTA Regulation aims to harmonize various procedures and standards by ensuring that health technology developers can submit only once and at the EU level any information, data, analyses, and other evidence required for the contemplated joint clinical assessment. The HTA Regulation will have a phased rollout but will eventually become applicable for all medicines with a new active substance that receives a marketing authorization in the EU under the centralized procedure. The rollout will be as follows: (i) January 12, 2025, for oncology and advanced therapy medicinal products; (ii) January 12, 2028, for orphan medicinal products; and (iii) January 12, 2030, for all other applicable medicinal products.

Medical Devices and Medtech

• We continue to monitor whether and how CMS intends to implement the final Transitional Coverage for Emerging Technologies (TCET) rule, released on August 6, 2024, and which describes a process for leveraging the current national coverage determination and coverage with evidence development protocols to speed up Medicare coverage of medical technology that has been granted “breakthrough” status by the FDA. Notably, CMS anticipates accepting around five TCET candidates each year, with quarterly review cycles depending on when applications are received.

Companies’ Interactions With Their Customers and Other Stakeholders

• Recent Fraud and Abuse and Compliance-Related Actions:
• On January 24, 2025, Pfizer (on behalf of its subsidiary Biohaven) agreed to pay close to $60 million to resolve DOJ allegations that it paid kickbacks to healthcare providers to prescribe the Pfizer drug Nurtec. DOJ’s allegations centered on the payment of improper remuneration in the form of speaker honoraria and meals at high-end restaurants, with the US alleging that Pfizer selected providers to be part of the Nurtec speaker bureau with the intent of inducing them to prescribe Nurtec. The US government also alleged that prescribers attended multiple programs on the same topic, thereby receiving no educational benefit from attending repeat programs, as well as attendance at these programs by speakers’ spouses, family members, or friends. The DOJ press release is available here.
• In January 2025, the HHS Office of Inspector General (HHS-OIG) issued Advisory Opinion 25-01, a favorable opinion regarding a drug company’s program to provide certain patients with free access to a drug if they meet financial and other eligibility criteria but do not have adequate insurance coverage for the product.
• In December 2024, the HHS-OIG issued Advisory Opinion 24-12, a favorable opinion regarding a pharmaceutical company’s program to sponsor genetic testing, related genetic counseling, and disease-state awareness education for a certain ultra-rare hereditary condition based on pre-set qualifications.
• In December 2024, the HHS-OIG issued Advisory Opinion 24-13, a favorable opinion regarding a drug company’s program to provide assistance for certain travel, lodging, meals, and associated expenses for qualifying patients receiving a cell therapy product based on patients who meet pre-set qualifications.
• In February 2025, the HHS-OIG issued a modification to Advisory Opinion 21-13, originally issued in October 2021, regarding the subsidization of beneficiary cost-sharing obligations for Medicare-covered services provided as part of a medical device company’s clinical trial.

Companies’ Interactions With Patient Data

• States are continuing to propose laws to protect consumer health information. For example, on January 22, 2025, the New York legislature passed the New York Health Information Privacy Act, which would, if signed by the governor, impose significant limitations on entities’ processing of “regulated health information.” The New York bill is modeled closely on Washington’s My Health My Data Act, which came into effect last year (see Goodwin’s client alert for more information). The New York governor has not yet signed the bill and has faced significant pressure from the industry not to sign it into effect. Health and sensitive data privacy bills are being debated in other states, including Texas and California.
• With AI legislation proliferating across states, policymakers are focusing on AI making “consequential decisions.” AI laws define decisions concerning health care services as high-risk consequential decisions, subject to prescriptive obligations — for example, under Colorado’s AI Act. With companies collecting patient data on a global basis, we closely follow the latest privacy law developments around the world. In the EU, the UK, and Switzerland, we are tracking evolving case law and guidance surrounding the EU and UK General Data Protection Regulation and the Swiss Federal Act, as well as implications for companies collecting and handling patient data.
• The Dobbs decision overturning Roe v. Wade is continuing to lead to regulatory uncertainty regarding protections for reproductive health data, particularly in the context of law enforcement access to health data. For example, after amendments to the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) came into force in December 2024 that would prohibit covered entities and business associates from disclosing information about reproductive health services to law enforcement in cases where the procedures were lawful in the state in which they occurred, 15 states have launched legal challenges to block enforcement of the amendments. As noted above, states are continuing to propose new health privacy laws designed to protect against law enforcement access to reproductive health data, and several states have implemented “shield” laws to block out-of-state subpoenas, search warrants, and other legal process related to reproductive health.
• As discussed in the Preclinical and Clinical Research section above, the DOJ’s regulations implementing Executive Order 14117 on Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern go into effect on April 8, 2025. These rules regulate access to certain sensitive data categories — including, notably, health data, human “omic” data, and biospecimens — by people and entities associated with “countries of concern,” including the People’s Republic of China.
• On January 21, 2025, the European Council formally adopted the European Health Data Space (EHDS) Regulation, marking the penultimate step in the Regulation’s adoption process. The final Regulation is expected to be published within the next few weeks. The next phase (between 2025 and 2027) will focus on drafting secondary legislation, including implementing and delegating acts that will define the technical specifications required for EHDS operations. Following this (between 2027 and 2029), the process will involve member states preparing to meet their obligations under the EHDS (such as creating data hubs and integrating with EU-wide data frameworks). The main objectives of the EHDS are to improve individual access to and control over patient health data in the EU and to facilitate cross-border research and innovation in health. See Goodwin’s blog posts here and here for further details.
• Last year, the number of proposed class actions under Illinois’ Genetic Information Privacy Act (GIPA) of 1998 has increased, with dozens of cases filed or moved to federal court. These cases challenge the practice of businesses to require medical exams to ensure job seekers would be able to handle job requirements. Plaintiffs claim certain family medical history questions could trip GIPA. In two major cases, involving United Airlines and Union Pacific, the US District Court for the Northern District of Illinois declined defendants’ motions to dismiss GIPA class actions by job seekers.