Summary
Updates the European Union’s horizontal, risk-based AI law through the 2026 Digital Omnibus on AI, clarifying implementation and conformity pathways, revising selected governance and transparency provisions, and changing the application timetable for high-risk AI requirements.
Healthcare Implications
Medical-device and in vitro diagnostic AI remains subject to coordinated AI Act and MDR or IVDR compliance. Chapter III high-risk duties now apply on 2 December 2027 for Annex III systems and 2 August 2028 for Annex I product systems, requiring vendors and healthcare deployers to update conformity, documentation, data-governance, human-oversight, and post-market plans.