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.

欧盟最近通过的《人工智能（AI）法案》是第一个专门针对人工智能的综合法律框架。这对于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的应用。

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..

鉴于该法规对医疗人工智能部门的深远影响，本评论概述了人工智能法案的关键要素，并易于阅读相关章节。。

IntroductionThe European Union (EU) has taken a critical step towards regulating artificial intelligence (AI) with the adoption of the AI Act by its 27 member states on March 13, 20241. First proposed in April 2021 by the European Commission2, the AI Act emerged from the growing recognition of AI’s transformative potential and the need to address associated risks and ethical concerns, building on previous EU initiatives, including the 2018 Coordinated Plan on AI3 and the 2020 White Paper on AI4.

引言欧盟（EU）在20241年3月13日27个成员国通过了人工智能法案，朝着规范人工智能（AI）迈出了关键的一步。《人工智能法案》于2021年4月由欧洲委员会2首次提出，它源于人们越来越认识到人工智能的变革潜力以及解决相关风险和道德问题的必要性，并以之前的欧盟举措为基础，包括2018年AI3协调计划和2020年AI4白皮书。

The Council issued its position in December 20225, followed by the European Parliament’s adoption of its negotiating position in June 20236. After revising the draft, the final negotiations between the Commission and Council resulted in a provisional agreement in December 2023, which was endorsed by Member States in February 20241.As the world’s first comprehensive legal framework specifically on AI, the AI Act aims to promote human-centred and trustworthy AI while protecting the health, safety, and fundamental rights of individuals from the potentially harmful effects of AI-enabled systems (Article (Art) 1 (1)).

20225年12月，欧盟理事会发表了其立场，随后，欧洲议会于20236年6月通过了其谈判立场。修订草案后，委员会和理事会之间的最终谈判于2023年12月达成了一项临时协议，并于20241年2月得到会员国的认可。作为世界上第一个专门针对人工智能的综合法律框架，《人工智能法》旨在促进以人为本和值得信赖的人工智能，同时保护个人的健康、安全和基本权利免受人工智能系统的潜在有害影响（第（1）条）。

The Act sets out harmonised rules for the placing on the market, putting into service and use of AI systems and has become binding law in all EU Member States 20 days after its publication in the Official Journal of the EU (published on July 12th 2024), irrespective of existing national laws and guidelines on AI (Art 1 (2a), Art 113).

该法案规定了人工智能系统投放市场、投入使用和使用的统一规则，并在欧盟官方公报（2024年7月12日发布）发布20天后成为所有欧盟成员国具有约束力的法律，而不考虑现有的国家人工智能法律和指南（第1（2a）条，第113条）。

Most parts of the regulation will take effect within 24 months, with prohibitions, i.e., bans on AI applications deemed to pose an unacceptable risk, taking effect already within 6 months (Art 113 (a–c)).In its current form, the AI Act has a far-reaching scope, not only in the internal market but also extraterritorially, as it applies to a.

该法规的大部分内容将在24个月内生效，禁止，即禁止被认为构成不可接受风险的人工智能应用，并在6个月内生效（第113（a–c）条）。在目前的形式下，AI法案不仅在国内市场，而且在域外都具有深远的意义，因为它适用于a。

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The EU passes the AI Act and its implications for digital medicine are unclear. NPJ Digit. Med. 7, 135 (2024).Article .

欧盟通过了AI法案，其对数字医学的影响尚不清楚。NPJ数字。医学杂志7135（2024）。文章。

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(2023, accessed 15 June 2024). https://www.isaca.org/resources/isaca-journal/issues/2023/volume-2/the-potential-impact-of-the-european-commissions-proposed-ai-act-on-smes.Download referencesFundingOpen Access funding enabled and organized by Projekt DEAL.Author informationAuthor notesThese authors contributed equally: Lisa C.

（2023年，2024年6月15日访问）。https://www.isaca.org/resources/isaca-journal/issues/2023/volume-2/the-potential-impact-of-the-european-commissions-proposed-ai-act-on-smes.DownloadreferencesFundingOpen Access资金由Projekt DEAL启用和组织。作者信息作者注意到这些作者做出了同样的贡献：Lisa C。

Adams, Keno K. Bressem.Authors and AffiliationsSchool of Medicine and Health, Department of Diagnostic and Interventional Radiology, Klinikum rechts der Isar, TUM University Hospital, Technical University of Munich, Munich, GermanyFelix Busch & Lisa C. AdamsDepartment of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, GermanyJakob Nikolas KatherElse Kroener Fresenius Center for Digital Health, Technical University Dresden, Dresden, GermanyJakob Nikolas KatherDepartment of Medicine I, University Hospital Dresden, Dresden, GermanyJakob Nikolas KatherJohner Institut GmbH, Konstanz, GermanyChristian JohnerDistrict Court, Cologne, GermanyMarina MoserDepartment of Diagnostic and Interventional Radiology, University Hospital Aachen, Aachen, GermanyDaniel TruhnSchool of Medicine and Health, Department of Cardiovascular Radiology and Nuclear Medicine, German Heart Center, TUM University Hospital, Technical University of Munich, Munich, GermanyKeno K.

亚当斯，基诺·K·布雷塞姆。作者和附属机构慕尼黑工业大学医学与健康学院，诊断与介入放射学系，慕尼黑工业大学医学与健康学院，慕尼黑，德国费利克斯·布希和丽莎·C·阿达斯医学系，国家肿瘤疾病中心（NCT），海德堡海德堡大学医院，德国雅各布·尼古拉斯·凯瑟丽斯·克朗纳·费森尤斯数字健康中心，德累斯顿工业大学，德累斯顿，德国雅各布·尼古拉斯·凯瑟尔·约翰纳研究所GmbH，Konstanz，GermanyChristian JohnerDistrict Court，科隆，GermanyMarina MoserDepartment of Diagnostic and Interventional Radiology，University Hospital，亚琛，亚琛，GermanyDaniel TruhnSchool of Medicine and Health，Department of Cardiovascular Radiology and Nuclear Medicine，GermanyKeno K.德国慕尼黑工业大学附属德国心脏中心，TUM大学医院。

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PubMed Google ScholarContributionsL.C.A. and K.K.B. contributed equally to this work as co-senior authors. Conceptualisation: F.B., J.N.K., C.J., M.M., D.T., L.C.A., K.K.B.; project administration: F.B., K.K.B.; resources: F.B., L.C.A., K.K.B.; validation: F.B., L.H., C.J., M.M., D.T., L.C.A., K.K.B.; visualisation: F.B., L.C.A., K.K.B.; writing—original draft preparation: F.B., C.J., L.C.A., K.K.B.; writing—review & editing: F.B., L.H., C.J., M.M., D.T., L.C.A., K.K.B.Corresponding authorCorrespondence to.

PubMed谷歌学术贡献l。C、 A.和K.K.B.作为联合高级作者对这项工作做出了同样的贡献。概念化：F.B.，J.N.K.，C.J.，M.M.，D.T.，L.C.A.，K.K.B。；项目管理：F.B.，K.K.B。；资源：F.B.，L.C.A.，K.K.B。；验证：F.B.，L.H.，C.J.，M.M.，D.T.，L.C.A.，K.K.B。；可视化：F.B.，L.C.A.，K.K.B。；撰写初稿准备：F.B.，C.J.，L.C.A.，K.K.B。；写作评论与编辑：F.B.，L.H.，C.J.，M.M.，D.T.，L.C.A.，K.K.B。相应作者回复。

Keno K. Bressem.Ethics declarations

基诺·K·布雷塞姆。道德宣言

Competing interests

相互竞争的利益

J.N.K. declares consulting services for Owkin, France; DoMore Diagnostics, Norway; Panakeia, UK, and Scailyte, Basel, Switzerland; furthermore J.N.K. holds shares in Kather Consulting, Dresden, Germany; and StratifAI GmbH, Dresden, Germany, and has received honoraria for lectures and advisory board participation by AstraZeneca, Bayer, Eisai, MSD, BMS, Roche, Pfizer and Fresenius.

J、 英国宣布为法国奥金提供咨询服务；挪威多莫尔诊断公司；英国Panakea和瑞士巴塞尔的Scailyte；此外，J.N.K.持有德国德累斯顿Kather Consulting的股份；和德国德累斯顿的StratifAI GmbH，并因阿斯利康，拜耳，卫材，MSD，BMS，罗氏，辉瑞和费森尤斯的讲座和咨询委员会的参与而获得酬金。

D.T. has received honoraria for lectures by Bayer and holds shares in StratifAI GmbH, Dresden, Germany. Johner Institut offers consulting services for medical device and IVD manufacturers. C.J. advises policymakers, is a member of an IEC working group, and wrote a guideline for AI-based medical devices that has been adopted by notified bodies and the WHO.

D、 T.因拜耳的演讲而获得酬金，并持有德国德累斯顿StratifAI GmbH的股份。约翰纳研究所为医疗器械和IVD制造商提供咨询服务。C、 J.为决策者提供咨询，是IEC工作组的成员，并编写了一份基于人工智能的医疗器械指南，该指南已被通报机构和世卫组织采用。

K.K.B. has received honoraria for lectures by GE HealthCare and Canon Medical Systems Corporation. The remaining authors declare no competing interests..

K、 K.B.因GE HealthCare和佳能医疗系统公司的讲座而获得酬金。其余作者声明没有利益冲突。。

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Reprints and permissionsAbout this articleCite this articleBusch, F., Kather, J.N., Johner, C. et al. Navigating the European Union Artificial Intelligence Act for Healthcare.

转载和许可本文引用本文Busch，F.，Kather，J.N.，Johner，C。等人，浏览欧盟人工智能医疗法案。

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