Med-Tech Innovation September 16, 2022
Alejandro Bes, head of legal, Novartis, Francisco Javier García Pérez, counsel, Uría Menéndez look at the proposed EU AI Act. This new proposal has raised many concerns such as if medical devices using AI shall also be notified to other bodies and the liability regime applicable to medical device manufacturers.
Medical technology concept. Remote medicine. Electronic medical record.
The European Union is currently making considerable efforts to update its current legislative framework and adapt it to the digital era. On 21 April 2021, the European Commission issued a Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence and amending certain union legislative acts (AI...
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