US and Europe reshape life sciences regulation

The European Union has delayed high-risk AI requirements under its Digital Omnibus law, moving application to December 2, 2027, for standalone systems and August 2, 2028, for systems embedded in products. The law also provides mechanisms to limit overlapping requirements under sectoral legislation. In the UK, a healthcare AI commission issued 44 proposals calling for proportionate, lifecycle-based oversight, continuous monitoring and stronger use of real-world evidence.

US agencies are expanding their technology oversight and deployment efforts. CMS established an Office of Health Technology and Products to lead digital strategy, cybersecurity and AI implementation. A presidential executive order contemplates federal access to covered frontier models for up to 30 days before their planned release to trusted partners. Separately, a White House policy limits federal funding for specified high-risk life sciences research.

Drug pricing measures include the finalized GLOBE model for certain Medicare Part B medicines and broader state interest in the GENEROUS Medicaid initiative. A pharmaceutical tariff proclamation imposes a 100% ad valorem duty on certain patented medicines and associated ingredients, with reduced rates and exemptions. FDA proposals and draft guidance also seek to modernize distributed manufacturing and support more flexible clinical development.

Medical device reforms include mandatory use of specified EUDAMED modules, proposed UK requirements covering cybersecurity and software changes, and closer MHRA-FDA cooperation. A proposed CMS-FDA coverage pathway would align evidence expectations earlier in development. The UK’s Life Sciences Sector Plan also backs regulatory modernization with over £2 billion of government funding.