Artificial intelligence, medical devices and GDPR in healthcare: Everything you need to know about the current legal frame

There is no doubt that healthcare is one of the areas where the use of Artificial Intelligence (AI) systems is highly growing. As well, there is full awareness that this growth offers high potential, but also high risks. In this respect, the EU Commission's recent proposal for a Regulation on AI (which is currently under discussion of the EU Council, and will be soon passed on first reading by the UE Parliament) is undoubtedly a legislative framework that could increase trust and security in the use of this technology in patient care. It is therefore important to highlight the current regulatory framework into which the new IA Regulation will fit. It is important to highlight that the current normative framework on medical software appears already quite complete, if correctly applied.