The Artificial Intelligence (AI) Act is a much-discussed piece of innovative European Union (EU) legislation that is generating global interest. The law was adopted by the European Parliament in March 2024 and, at the time of writing, only subject to linguistic changes. The AI Act will have major implications for healthcare, making it essential to understand what it means for the sector. In this fact sheet we list some of the protections that the Act will bring to health AI, as well as gaps that still remain.

This overview shows that AI in healthcare is left out of protections on multiple fronts, which will compromise patient’s rights and leaves serious gaps in oversight and accountability for the sector. Despite this, it is a step forward for protecting patients against the harmful effects of AI while reaping the benefits of trustworthy technologies that can advance healthcare. We will continue to encourage policymakers to centralise health when developing their plans for the Act’s implementation.

To find out more, read the full fact sheet here.