The EU passes the AI Act and its implications for digital medicine are unclear

Abstract

On 13 March 2024, the much-anticipated AI Act was passed by the EU parliament and will soon be adopted as EU law. It will apply new requirements for developers and deployers of AI-enabled digital health tools (DHTs), including for a defined class of high-risk AI systems and for general-purpose AI. Although the text of the law is available, complete in all but the final checks of legal wording much is still not known about how the AI Act will affect the digital health landscape in the EU and beyond. The wording of many aspects of the Act is ambiguous, and often high-level objectives are stated, with the detail to come later in associated guidance, standards, and member state law and policy. It is also uncertain how the Act will intersect with pre-existing sector-specific legislation for medical AI. There are future steps in the legislative process that can clarify ambiguity, including standards, guidelines, and implementing laws, and the author remains optimistic the EU will get the implementation right.