Insights

On July 23, 2025, the Trump Administration issued an artificial intelligence (AI) action plan titled “Winning the Race: America’s AI Action Plan” (the Plan) to guide AI innovation in the U.S. The Plan includes 90 policy recommendations that will shape future AI guidance and policies impacting a range of entities and industry sectors, including health care/life sciences and entities involved in clinical research.

On July 4, President Trump signed into law the “One Big Beautiful Bill Act” (“the Act”), or H.R. 1, which makes significant changes to federal healthcare programs, including Medicaid, Medicare, and Health Insurance Marketplaces. As proposed in previous versions of the Act, the Act includes cuts to the Medicaid program and imposes new requirements on beneficiaries, states, and healthcare providers.

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.