What the research found
The EU AI Act classifies AI used for diagnosis, clinical decision support, triage and patient monitoring as high-risk — mostly via its medical-device route, with emergency triage listed directly — and its safety obligations (risk management, human oversight, conformity assessment) were due to apply from 2 August 2026. The Digital Omnibus on AI (Regulation 2026/1744, in force 27 July 2026) defers those obligations: to 2 December 2027 for standalone high-risk systems and to 2 August 2028 for AI embedded in regulated products such as medical devices — the category covering most clinical AI.
The high-risk classification survives but enforcement recedes by 1.5–2 years while adoption accelerates — the gap between AI deployment and the safety rules meant to govern it just got officially wider. Also corrects a claim now circulating that these obligations already apply.