What is the EU AI Act in healthcare?

The EU AI Act, Regulation (EU) 2024/1689, is the European Union's horizontal law on artificial intelligence. It takes a risk-based approach, banning a small set of unacceptable practices, imposing detailed obligations on high-risk systems, and setting transparency rules for limited-risk systems. Healthcare is heavily affected because AI systems that are medical devices, or safety components of medical devices, requiring notified body assessment under the MDR or IVDR are generally classified as high risk. Such systems must meet requirements on risk management, data governance, technical documentation, transparency, human oversight, and accuracy and robustness. The AI Act applies alongside the MDR and IVDR rather than replacing them, so manufacturers of AI-enabled medical devices must satisfy both regimes. Its obligations phase in over a multi-year timeline following entry into force in 2024.