Navigating the European Union Artificial Intelligence Act for Healthcare

Felix Busch; Jakob Nikolas Kather; Christian Johner; Marina Moser; Daniel Truhn; Lisa C. Adams; Keno K. Bressem

doi:10.1038/s41746-024-01213-6

Navigating the European Union Artificial Intelligence Act for Healthcare

Felix Busch
, Jakob Nikolas Kather
, Christian Johner
, Marina Moser
, Daniel Truhn
, Lisa C. Adams
, Keno K. Bressem

Institute of Radiology

University Hospital Heidelberg
Technische Universität Dresden
Universitätsklinikum Carl Gustav Carus Dresden
Johner Institut GmbH
District Court of Cologne
University Hospital
Technical University of Munich

Research output: Contribution to journal › Comment/debate

80 Scopus citations

Abstract

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

Original language	English
Article number	210
Journal	npj Digital Medicine
Volume	7
Issue number	1
DOIs	https://doi.org/10.1038/s41746-024-01213-6
State	Published - Dec 2024

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10.1038/s41746-024-01213-6

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Navigating the European Union Artificial Intelligence Act for Healthcare

Abstract

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