Obligation for AI Systems in Healthcare: Prepare for Trouble and Make it Double?

Abstract

The Artificial Intelligence Act is the first EU proposal to impose binding provisions for AI Systems. As AI is now used in several different fields, those provisions setting AI legal standards might interact with other Regulations, especially in risky sectors, i.e. healthcare. This paper offers a brief analysis of what standards are to be considered if an AI system was intended to be used as a medical device. It shows the intersection between the Medical Device Regulation and the Artificial Intelligence Act, presenting which opportunities and challenges the new proposal might bring. Three case studies will test the intersection and report the practical outcomes in terms of classifications and obligations.