解读欧盟人工智能医疗法案

Navigating the European Union Artificial Intelligence Act for Healthcare.

作者信息

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

机构信息

School of Medicine and Health, Department of Diagnostic and Interventional Radiology, Klinikum rechts der Isar, TUM University Hospital, Technical University of Munich, Munich, Germany.

Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany.

出版信息

NPJ Digit Med. 2024 Aug 12;7(1):210. doi: 10.1038/s41746-024-01213-6.

DOI:10.1038/s41746-024-01213-6

PMID:39134637

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11319791/

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.

摘要

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，因为其他现有的协调立法，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行业的深远影响，本评论概述了《人工智能法案》的关键要素，并对相关章节进行了便于理解的引用。