Medical AI at Risk: Digital Omnibus Amendments Undermine Safeguards in Healthcare

Abstract

Members of the European Parliament are about to take a decision that will fundamentally shape how artificial intelligence (AI) is governed in European healthcare. The Internal Market and Consumer Protection (IMCO) and Civil Liberties, Justice and Home Affairs (LIBE) compromise amendments propose deleting Annex I, Section A of the AI Act and shift medical devices into Annex I, Section B. If adopted, AI medical devices would remain labelled as “high-risk”, but would no longer be subject to meaningful high-risk obligations. In a domain where AI directly affects diagnosis, treatment, and patient health, this creates a serious regulatory gap with real risks for patients. The proposed solution – “mirroring” AI Act requirements into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – does not address this gap, as it makes safeguards dependent on future delegated acts and standards, with no guarantee as to their timing or scope. This risks delaying and weakening protections while medical AI systems are already in use. This is not “simplication”, but a structural weakening of safeguards for medical AI.

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