Navigating the European Union Artificial Intelligence Act for Healthcare

• DOI: 10.1038/s41746-024-01213-6
• Publication Date: 2024-08-12T09:03:33Z
• Authors: Felix Busch; Jakob Nikolas Kather; Christian Johner; Marina Moser; Daniel Truhn; Lisa C. Adams; Keno K. Bressem
• Keywords: 03 medical and health sciences; 0302 clinical medicine; Computer applications to medicine. Medical informatics; Comment; R858-859.7

The European Union's recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This particularly important for healthcare domain, as other existing harmonisation legislation, such Medical Device Regulation, do not explicitly cover medical AI applications. Given far-reaching impact of this regulation sector, commentary provides an overview key elements Act, with easy-to-follow references to relevant chapters.