Navigating the European Union Artificial Intelligence Act for Healthcare

Navigating the European Union Artificial Intelligence Act for Healthcare

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...

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Veröffentlicht in:NPJ digital medicine 2024-08, Vol.7 (1), p.210-6, Article 210
Hauptverfasser: Busch, Felix, Kather, Jakob Nikolas, Johner, Christian, Moser, Marina, Truhn, Daniel, Adams, Lisa C., Bressem, Keno K.
Format: Artikel
Sprache:eng
Schlagworte:
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Artificial intelligence
Biomedicine
Biotechnology
Comment
Health care industry
Legislation
Market entry
Medical equipment
Medicine
Medicine & Public Health
Regulation
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Beschreibung
Zusammenfassung: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.
ISSN:2398-6352
2398-6352
DOI:10.1038/s41746-024-01213-6