The EU Artificial Intelligence Act (2024): Implications for healthcare

IF 3.6 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES Health Policy Pub Date : 2024-09-07 DOI:10.1016/j.healthpol.2024.105152

Hannah van Kolfschooten , Janneke van Oirschot

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Abstract

In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As the world's first extensive legal framework on AI, it aims to boost innovation while protecting individuals against the harms of AI. Since healthcare is one of the top sectors for AI deployment, the new rules will significantly reform national policies and practices on health technology. In this article, we highlight the implications of the AI Act for the healthcare sector. We give a comprehensive overview of the new legal obligations for various healthcare stakeholders (tech developers; healthcare professionals; public health authorities). We conclude that, due to its horizontal approach, it is necessary to adopt further guidelines to address the unique needs of the healthcare sector. To this end, we make recommendations for the upcoming implementation and standardization phase.

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欧盟人工智能法案（2024 年）：对医疗保健的影响

2024 年 8 月，《欧盟人工智能法案》（AI 法案）正式生效。这项具有法律约束力的文书为欧盟人工智能系统的开发、投放市场、投入使用和使用制定了规则。作为世界上首个广泛的人工智能法律框架，该法案旨在促进创新，同时保护个人免受人工智能的危害。由于医疗保健是人工智能部署的首要领域之一，新规则将极大地改革各国在医疗技术方面的政策和实践。在本文中，我们将重点介绍《人工智能法》对医疗保健行业的影响。我们全面概述了各医疗保健利益相关方（技术开发商、医疗保健专业人士、公共卫生机构）的新法律义务。我们的结论是，由于其横向方法，有必要通过进一步的指导方针来满足医疗保健行业的独特需求。为此，我们为即将到来的实施和标准化阶段提出了建议。

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来源期刊

Health Policy 医学-卫生保健

CiteScore

6.40

自引率

6.10%

发文量

157

审稿时长

3-8 weeks

期刊介绍： Health Policy is intended to be a vehicle for the exploration and discussion of health policy and health system issues and is aimed in particular at enhancing communication between health policy and system researchers, legislators, decision-makers and professionals concerned with developing, implementing, and analysing health policy, health systems and health care reforms, primarily in high-income countries outside the U.S.A.