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Navigating the European Union Artificial Intelligence Act for Healthcare
npj Digital Medicine ( IF 12.4 ) Pub Date : 2024-08-12 , DOI: 10.1038/s41746-024-01213-6
Felix Busch 1 , Jakob Nikolas Kather 2, 3, 4 , Christian Johner 5 , Marina Moser 6 , Daniel Truhn 7 , Lisa C Adams 1 , Keno K Bressem 8
Affiliation  

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.

中文翻译:


遵守欧盟医疗保健人工智能法案



欧盟最近通过的人工智能(AI)法案是第一个专门针对人工智能的综合法律框架。这对于医疗保健领域尤其重要,因为其他现有的协调立法(例如医疗器械法规)并未明确涵盖医疗人工智能应用。鉴于该法规对医疗人工智能领域的深远影响,本评论概述了人工智能法案的关键要素,并提供了易于理解的相关章节参考。
更新日期:2024-08-12
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