解读欧盟人工智能法案：对受监管数字医疗产品的影响
Navigating the EU AI Act: implications for regulated digital medical products.
作者信息
Aboy Mateo, Minssen Timo, Vayena Effy
机构信息
Centre for Law, Medicine, and Life Sciences (LML), Faculty of Law, University of Cambridge, Cambridge, UK.
Translational Health Sciences, Medical Sciences Division, University of Oxford, Oxford, UK.
出版信息
NPJ Digit Med. 2024 Sep 6;7(1):237. doi: 10.1038/s41746-024-01232-3.
Abstract
The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.
摘要
新通过的欧盟人工智能法案是一个关键的里程碑，预示着各行业人工智能监管新时代的到来。这部全面的立法因其广泛的地域范围和适用性，对人工智能系统提出了严格要求。在本文中，我们分析了人工智能法案对数字医疗产品（如医疗设备）的影响：人工智能法案如何适用于基于人工智能/机器学习的医疗设备？它们如何分类？合规要求是什么？以及，这些人工智能系统的“提供者”有哪些义务？在解决这些基本问题后，我们讨论了人工智能法案对受监管数字医疗产品未来的更广泛影响。
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