Navigating the European Union Artificial Intelligence Act for Healthcare

IF 12.4 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES NPJ Digital Medicine Pub Date : 2024-08-12 DOI:10.1038/s41746-024-01213-6
Felix Busch, Jakob Nikolas Kather, Christian Johner, Marina Moser, Daniel Truhn, Lisa C. Adams, Keno K. Bressem
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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.

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欧盟人工智能医疗法案导航
欧盟最近通过的《人工智能法案》是首个专门针对人工智能的全面法律框架。这对医疗保健领域尤为重要,因为现有的其他协调立法(如《医疗设备法规》)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》的主要内容,并提供了相关章节的简明参考。
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来源期刊
CiteScore
25.10
自引率
3.30%
发文量
170
审稿时长
15 weeks
期刊介绍: npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics. The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.
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