On August 6, 2025, the Assistant Secretary for Technology Policy (ASTP) at ONC publicly announced its release of the TEFCA Organizational Map, a beta search tool that allows users to look up which organizations are participating in the Trusted Exchange Framework and Common Agreement (TEFCA). For the first time, the public can search by
The European Commission Publishes an EU Life Sciences Strategy
On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy’), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.
For pharmaceutical, MedTech, and biotech companies, the Strategy may, at least in theory, represent a positive shift towards a more innovation-driven
Federal Health Law Enforcement in 2025
Much has been written about the healthcare policy changes implemented by the 2025 Trump administration. President Trump has issued numerous Executive Orders that establish new policies and rescind actions taken by previous administrations. Robert F. Kennedy, Jr. is overhauling and refocusing Health & Human Services. Dr. Mehmet Oz is implementing new policies at the Center
What Life Sciences and Digital Health Companies Need to Know About CMS’s New Health Technology Ecosystem Initiative
On July 30, 2025, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) announced a new Health Technology Ecosystem Initiative—a collaborative effort between government and industry to unlock innovation by modernizing healthcare data flows among patients, providers, payers, and technology platforms. The new initiative does not contemplate any
CMS Launches WISeR Model to Target Waste by Leveraging (Broken) Prior Authorization System
The Centers for Medicare & Medicaid Services (CMS) recently announced the launch of the Wasteful and Inappropriate Service Reduction (WISeR) Model – a six-year pilot program designed to reduce Medicare spending on select “wasteful (low-value) services shown to have little to no clinical value.” The WISeR Model will run from January 1, 2026, through December
Expert Witness Report in FCA Case Afflicted with AI Hallucinations
The epidemic of out-of-control generative artificial intelligence in litigation filings has metastasized to a False Claims Act (FCA) lawsuit against a group of Utah anesthesiologists. On July 25, Mountain West Anesthesia, LLC and individual defendants in the case moved to bar the testimony of a medical billing expert whose report was riddled with AI-generated errors,
Virtual and Digital Health Digest – July 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2025 from the United Kingdom and European Union.
There has been a flurry of new guidance from the Medical Device Coordination Group this month,
Navigating New Jersey’s Medical Spa Regulatory Landscape: Key Compliance and Risk Management Considerations
The medical spa industry is thriving, but with growth comes complexity, particularly in New Jersey where healthcare and professional licensing rules intersect with business and real-estate regulations. For physicians, nurses, or allied health professionals exploring a new medical spa venture, expanding an existing practice, or preparing for a sale, understanding the state’s unique requirements is
Texas Enacts Responsible AI Governance Act Adding to Patchwork of AI Laws
At the end of June, Texas enacted the “Texas Responsible Artificial Intelligence Governance Act” (the “Act”), adding to the patchwork of growing AI laws. This summary addresses the Act’s most significant provisions.
Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development
Introduction
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This initiative formalizes the agency’s long-building effort to incorporate New Approach Methodologies (NAMs) into regulatory review and follows the release of draft guidance