On the one hand, AI has its advantages: it facilitates accurate diagnosis of patients and it makes it possible to hold e-consults. On the other hand, it brings along risks for patients’ rights and privacy. Current European regulation insufficiently trackles these risks. The newly proposed Artificial Intelligence Act aims to better regulate AI in healthcare. However, the proposed Act lacks of a human-centric approach: the proposal centres on companies rather than people.

Although certainly not perfect, the proposed Act is a step forward toward better regulation of AI in healthcare. Given the ongoing digitalisation of healthcare and rapid developments in AI, it surely will not be the last.

This article was published in the Tijdschrift voor Gezondheidsrecht.