• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

合格评定与上市后监管:审计在拟议的欧洲人工智能法规中的作用指南

Conformity Assessments and Post-market Monitoring: A Guide to the Role of Auditing in the Proposed European AI Regulation.

作者信息

Mökander Jakob, Axente Maria, Casolari Federico, Floridi Luciano

机构信息

Oxford Internet Institute, University of Oxford, 1 St Giles', Oxford, OX1 3JS UK.

UK All Party Parliamentary Group on AI (APPG AI), London, UK.

出版信息

Minds Mach (Dordr). 2022;32(2):241-268. doi: 10.1007/s11023-021-09577-4. Epub 2021 Nov 5.

DOI:10.1007/s11023-021-09577-4
PMID:34754142
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8569069/
Abstract

The proposed European Artificial Intelligence Act (AIA) is the first attempt to elaborate a general legal framework for AI carried out by any major global economy. As such, the AIA is likely to become a point of reference in the larger discourse on how AI systems can (and should) be regulated. In this article, we describe and discuss the two primary enforcement mechanisms proposed in the AIA: the that providers of high-risk AI systems are expected to conduct, and the that providers must establish to document the performance of high-risk AI systems throughout their lifetimes. We argue that the AIA can be interpreted as a proposal to establish a Europe-wide ecosystem for conducting AI auditing, albeit in other words. Our analysis offers two main contributions. First, by describing the enforcement mechanisms included in the AIA in terminology borrowed from existing literature on AI auditing, we help providers of AI systems understand how they can prove adherence to the requirements set out in the AIA in practice. Second, by examining the AIA from an auditing perspective, we seek to provide transferable lessons from previous research about how to refine further the regulatory approach outlined in the AIA. We conclude by highlighting seven aspects of the AIA where amendments (or simply clarifications) would be helpful. These include, above all, the need to translate vague concepts into verifiable criteria and to strengthen the institutional safeguards concerning conformity assessments based on internal checks.

摘要

拟议的欧洲人工智能法案(AIA)是全球任何主要经济体首次尝试制定人工智能通用法律框架。因此,AIA可能会成为关于如何(以及应该如何)监管人工智能系统的更大范围讨论的参考点。在本文中,我们描述并讨论了AIA中提出的两种主要执行机制:高风险人工智能系统供应商预期要进行的 ,以及供应商必须建立的用以记录高风险人工智能系统在其整个生命周期内性能的 。我们认为,AIA可以被解释为一项建立全欧洲范围人工智能审计生态系统的提议,尽管表述有所不同。我们的分析有两个主要贡献。首先,通过用从现有人工智能审计文献中借用的术语描述AIA中包含的执行机制,我们帮助人工智能系统供应商了解他们在实践中如何证明遵守AIA规定的要求。其次,通过从审计角度审视AIA,我们试图从先前的研究中提供可借鉴的经验教训,以进一步完善AIA中概述的监管方法。我们通过强调AIA中需要修正(或仅仅是澄清)的七个方面来得出结论。其中最重要的包括将模糊概念转化为可验证标准的必要性,以及加强基于内部检查的合格评定的制度保障。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/0064b39020dd/11023_2021_9577_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/829a8691085d/11023_2021_9577_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/0b0efcb40c88/11023_2021_9577_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/0064b39020dd/11023_2021_9577_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/829a8691085d/11023_2021_9577_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/0b0efcb40c88/11023_2021_9577_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caec/8569069/0064b39020dd/11023_2021_9577_Fig3_HTML.jpg

相似文献

1
Conformity Assessments and Post-market Monitoring: A Guide to the Role of Auditing in the Proposed European AI Regulation.合格评定与上市后监管:审计在拟议的欧洲人工智能法规中的作用指南
Minds Mach (Dordr). 2022;32(2):241-268. doi: 10.1007/s11023-021-09577-4. Epub 2021 Nov 5.
2
Trustworthy Artificial Intelligence in Dentistry: Learnings from the EU AI Act.口腔医学中的可信人工智能:来自欧盟人工智能法案的启示。
J Dent Res. 2024 Oct;103(11):1051-1056. doi: 10.1177/00220345241271160. Epub 2024 Sep 23.
3
Media Forensic Considerations of the Usage of Artificial Intelligence Using the Example of DeepFake Detection.以深度伪造检测为例探讨人工智能使用中的媒体取证考量
J Imaging. 2024 Feb 9;10(2):46. doi: 10.3390/jimaging10020046.
4
An EU landmark for AI governance.人工智能治理的欧盟里程碑。
Science. 2023 Jun 23;380(6651):1203. doi: 10.1126/science.adj1627. Epub 2023 Jun 15.
5
The future regulation of artificial intelligence systems in healthcare services and medical research in the European Union.欧盟医疗服务与医学研究中人工智能系统的未来监管
Front Genet. 2022 Oct 4;13:927721. doi: 10.3389/fgene.2022.927721. eCollection 2022.
6
Governing AI in Electricity Systems: Reflections on the EU Artificial Intelligence Bill.电力系统中的人工智能治理:对欧盟人工智能法案的思考
Front Artif Intell. 2021 Jul 30;4:690237. doi: 10.3389/frai.2021.690237. eCollection 2021.
7
Artificial Intelligence in Healthcare and Medicine: Promises, Ethical Challenges and Governance.医疗保健与医学中的人工智能:前景、伦理挑战与治理
Chin Med Sci J. 2019 Jun 30;34(2):76-83. doi: 10.24920/003611.
8
Operationalising AI governance through ethics-based auditing: an industry case study.通过基于伦理的审计实现人工智能治理:一个行业案例研究。
AI Ethics. 2023;3(2):451-468. doi: 10.1007/s43681-022-00171-7. Epub 2022 May 31.
9
ARTIFICIAL INTELLIGENCE IN MEDICAL PRACTICE: REGULATIVE ISSUES AND PERSPECTIVES.人工智能在医学实践中的应用:监管问题与展望。
Wiad Lek. 2020;73(12 cz 2):2722-2727.
10
Cybersecurity of medical devices: new challenges arising from the AI Act and NIS 2 Directive proposals.医疗设备的网络安全:人工智能法案和NIS 2指令提案带来的新挑战。
Int Cybersecur Law Rev. 2022;3(1):163-180. doi: 10.1365/s43439-022-00054-x. Epub 2022 May 16.

引用本文的文献

1
Stakeholder-specific adoption of AI in HRM: workers' representatives' perspective on concerns, requirements, and measures.利益相关者在人力资源管理中对人工智能的特定采用:工人代表对担忧、要求和措施的看法。
Front Artif Intell. 2025 May 30;8:1561322. doi: 10.3389/frai.2025.1561322. eCollection 2025.
2
Challenges in Implementing Artificial Intelligence in Breast Cancer Screening Programs: Systematic Review and Framework for Safe Adoption.乳腺癌筛查项目中实施人工智能的挑战:系统评价与安全应用框架
J Med Internet Res. 2025 May 15;27:e62941. doi: 10.2196/62941.
3
Simplifying software compliance: AI technologies in drafting technical documentation for the AI Act.

本文引用的文献

1
Transparency as design publicity: explaining and justifying inscrutable algorithms.作为设计宣传的透明度:解释和论证难以理解的算法
Ethics Inf Technol. 2021;23(3):253-263. doi: 10.1007/s10676-020-09564-w. Epub 2020 Oct 20.
2
Ethics-Based Auditing of Automated Decision-Making Systems: Nature, Scope, and Limitations.基于伦理的自动化决策系统审计:性质、范围和局限性。
Sci Eng Ethics. 2021 Jul 6;27(4):44. doi: 10.1007/s11948-021-00319-4.
3
The European Legislation on AI: a Brief Analysis of its Philosophical Approach.欧洲人工智能立法:对其哲学方法的简要分析
简化软件合规性:人工智能法案技术文档起草中的人工智能技术
Empir Softw Eng. 2025;30(3):91. doi: 10.1007/s10664-025-10645-x. Epub 2025 Apr 2.
4
Shaping the Future of Healthcare: Ethical Clinical Challenges and Pathways to Trustworthy AI.塑造医疗保健的未来:伦理临床挑战与可信人工智能之路。
J Clin Med. 2025 Feb 27;14(5):1605. doi: 10.3390/jcm14051605.
5
Institutionalised distrust and human oversight of artificial intelligence: towards a democratic design of AI governance under the European Union AI Act.对人工智能的制度化不信任与人为监督:迈向欧盟人工智能法案下人工智能治理的民主设计
AI Soc. 2024;39(6):2853-2866. doi: 10.1007/s00146-023-01777-z. Epub 2023 Oct 6.
6
Trustworthy artificial intelligence and the European Union AI act: On the conflation of trustworthiness and acceptability of risk.可信人工智能与欧盟人工智能法案:论可信度与风险可接受性的 conflation(此处conflation可结合语境意译为“混淆”等,因无更多背景较难准确翻译,保留英文供进一步理解)
Regul Gov. 2024 Jan;18(1):3-32. doi: 10.1111/rego.12512. Epub 2023 Feb 6.
7
Operationalising AI governance through ethics-based auditing: an industry case study.通过基于伦理的审计实现人工智能治理:一个行业案例研究。
AI Ethics. 2023;3(2):451-468. doi: 10.1007/s43681-022-00171-7. Epub 2022 May 31.
Philos Technol. 2021;34(2):215-222. doi: 10.1007/s13347-021-00460-9. Epub 2021 Jun 3.
4
Bad machines corrupt good morals.坏机器会腐蚀良好的道德。
Nat Hum Behav. 2021 Jun;5(6):679-685. doi: 10.1038/s41562-021-01128-2. Epub 2021 Jun 3.
5
COVID-19 contact tracing apps: a stress test for privacy, the GDPR, and data protection regimes.新冠疫情接触者追踪应用程序:对隐私、《通用数据保护条例》及数据保护制度的压力测试
J Law Biosci. 2020 May 28;7(1):lsaa034. doi: 10.1093/jlb/lsaa034. eCollection 2020 Jan-Jun.
6
How AI can be a force for good.人工智能如何成为一股向善的力量。
Science. 2018 Aug 24;361(6404):751-752. doi: 10.1126/science.aat5991.