Navigating the EU AI Act: implications for regulated digital medical products

被引：22

作者：

Aboy, Mateo ^{[1
,2
]}

Minssen, Timo ^{[1
,3
]}

Vayena, Effy ^{[4
]}

机构：

[1] Univ Cambridge, Fac Law, Ctr Law Med & Life Sci LML, Cambridge, England

[2] Univ Oxford, Med Sci Div, Translat Hlth Sci, Oxford, England

[3] Univ Copenhagen, Fac Law, Ctr Adv Studies Biosci Innovat Law, Copenhagen, Denmark

[4] Swiss Fed Inst Technol, Dept Hlth Sci & Technol, Zurich, Switzerland

来源：

NPJ DIGITAL MEDICINE | 2024年 / 7卷 / 01期

关键词：

D O I：

10.1038/s41746-024-01232-3

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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.

引用

页数：6

共 22 条

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