Insights

Days after President Trump issued an executive order (EO) taking aim at diversity, equity, and inclusion (DEI) programs and prohibiting federal recognition of gender identity apart from biological sex, previously issued draft guidance on diversity in clinical trials was removed from the website of the U.S. Food and Drug Administration (FDA). While the removed guidance was in draft form, it is highly unusual for FDA to revoke or alter draft guidance without issuing a statement or further guidance. This move raises questions about the applicability of statutory obligations to submit clinical trial Diversity Action Plans and the agency’s current thinking on best practices for clinical development.

On January 17, 2025, the Departments of Labor, Health and Human Services, and Treasury (the “Tri-Agencies”) released the 2024 Mental Health Parity and Addiction Equity Act (“MHPAEA”) Report to Congress (the “Report”). The Report is the third report made by the Tri-Agencies to Congress in accordance with the mandate set forth in the 2021 Consolidated Appropriations Act (“CAA”). The CAA requires that, each year starting in 2021, the Tri-Agencies submit a report to Congress summarizing their activity in the prior year to collect comparative analyses from plans and issuers and any findings made with respect to noncompliance with MHPAEA.[1] Under the CAA, the Report is due by October 1 of each year. This year’s version was published on the last working day of the Biden Administration.

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Final Rule), and create a new Information Blocking exception under Protecting Care Access (HTI-3 Final Rule), on December 16thand 17th, respectively.