驾驭欧盟人工智能法案：对受监管数字医疗产品的影响

IF 12.4 1区医学 Q1 HEALTH CARE SCIENCES & SERVICES

NPJ Digital Medicine Pub Date : 2024-09-06 DOI:10.1038/s41746-024-01232-3

Mateo Aboy, Timo Minssen, Effy Vayena

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引用次数: 0

摘要

新通过的《欧盟人工智能法》是一个关键性的里程碑，预示着各行各业进入人工智能监管的新时代。这项全面的立法具有广泛的地域范围和适用性，为人工智能系统制定了严格的要求。在本文中，我们将分析《人工智能法》对数字医疗产品（如医疗设备）的影响：人工智能法》如何适用于人工智能/人工智能医疗设备？它们如何分类？有哪些合规要求？这些人工智能系统的 "提供者 "有哪些义务？在解决了这些基础问题后，我们将讨论《人工智能法》对未来受监管数字医疗产品的广泛影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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

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.

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来源期刊

NPJ Digital Medicine Multiple-

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.