The Proposal on artificial intelligence regulates in detail systems classified as high risk, which includes medical devices.  We analyse the implications of a high-risk artificial intelligence system from a data governance perspective.

The aim of European legislation on AI is to ensure - as stated in the Explanatory Memorandum of the Proposal for a Regulation on AI - that 'European citizens can benefit from new technologies developed and operated in accordance with the values, fundamental rights and principles of the Union'.  Among these rights, the right to the protection of personal data certainly plays a primary role.