Mapping the regulatory landscape for artificial intelligence in health within the European Union

This article presents a synthesis of 141 binding policies applicable to AI in these areas within the European Union (EU) and 10 European countries.

While the EU AI Act provides the overarching regulatory framework for AI, other legislations address specific concerns such as social, health, and human rights standards, technology safety, innovation implementation, and data protection.

Although regulation directly targeting AI is still in its early stages, a combination of existing data, technology, innovation, and health-related policies has formed a foundational regulatory framework.

Future work should delve into specific regulatory challenges, particularly those related to AI medical devices, data protection, and data enablement.