WHO《卫生健康领域人工智能伦理与治理》指南简述与启示

doi:10.19803/j.1672-8629.20230518

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 906-909.
DOI: 10.19803/j.1672-8629.20230518

WHO《卫生健康领域人工智能伦理与治理》指南简述与启示

王涛¹, 宋海波¹, 王青², 侯永芳¹, 刘红亮¹, 张琳²

¹国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076;
²清华大学药物警戒信息技术与数据科学创新中心,北京 100084

收稿日期:2023-08-21 出版日期:2024-08-15 发布日期:2024-08-21
作者简介:王涛, 男, 博士, 研究员, 药物警戒新技术与方法研究。
基金资助:
国家自然科学基金资助项目（72274065）; 国家药品监督管理局药品监管科学体系建设重点项目（RS2024G001）

Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health

WANG Tao¹, SONG Haibo¹, WANG Qing², HOU Yongfang¹, LIU Hongliang¹, ZHANG Lin²

¹Center For Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
²Pharmacovigilance Information Technology and Data Science Innovation Center of Tsinghua University, Beijing 100084, China

Received:2023-08-21 Online:2024-08-15 Published:2024-08-21

摘要/Abstract

摘要： 目的系统介绍世界卫生组织（WHO）《卫生健康领域人工智能伦理与治理》指南（简称“《指南》”）,以及国际其他主要国家地区和我国医药卫生人工智能（artificial intelligence,AI）伦理与治理现状,以期为我国药品监管领域未来制定AI相关伦理指导原则提供参考。方法介绍《指南》涉及的制定情况、主要内容、伦理原则等内容;通过查阅文献及监管机构网站,介绍美国、欧盟及我国政府部门及相关组织在医药卫生领域AI伦理与治理的概况。结果《指南》阐述了AI在医药卫生领域健康发展和使用的6项核心伦理原则;美国、欧盟及我国政府部门及相关组织围绕公平公正、尊重隐私、安全可控、共担责任、开放透明等原则已制定了一系列关于AI伦理与治理的政策法规。结论借鉴WHO及国外经验,建议我国药品监管机构积极制定并执行AI新技术在产品全生命周期的监管标准或相关指南,加强AI药品和医疗器械类产品技术的透明度等方面的AI伦理治理。

关键词: 《卫生健康领域人工智能伦理与治理》指南, 人工智能, 伦理, 治理, 指南, 世界卫生组织, 医药卫生

Abstract: Objective To systematically introduce the WHO guidance on Ethics and Governance of Artificial Intelligence for Health, as well as the status of ethics and governance of AI in medicine and health in China, other major countries and regions in the world, in order to provide a reference for formulating AI-based ethical guidelines in drug regulation in our country in the future. Methods The formulation, main contents and ethical principles of the WHO guideline were introduced. The general situation of AI ethics and governance in the medical and health field of government departments and related organization in the United States, the European Union and China through literature review and the websites of regulatory agencies was also elucidated. Results The WHO guideline elaborated 6 core ethical principles for the healthy development and use of AI in the field of medicine and health. Government departments and related organization in the United States, the European Union and China have formulated a series of policies and regulations on AI ethics and governance around the principles of fairness and justice, respect for privacy, security and control, shared responsibility, openness and transparency. Conclusion Drawing on the experience of WHO and foreign countries, it is suggested that NMPA actively formulate and implement the regulatory standards or relevant guidelines of new AI technologies in the whole life cycle of products, strengthen the transparency of artificial intelligence drugs and medical device products and other aspects to strengthen the governance of AI ethics.

Key words: Ethics and Governance of Artificial Intelligence for Health, artificial intelligence (AI), ethics, governance, guidance, World Health Organization (WHO), medicine and health

中图分类号:

R926
R994.11

王涛, 宋海波, 王青, 侯永芳, 刘红亮, 张琳. WHO《卫生健康领域人工智能伦理与治理》指南简述与启示[J]. 中国药物警戒, 2024, 21(8): 906-909.

WANG Tao, SONG Haibo, WANG Qing, HOU Yongfang, LIU Hongliang, ZHANG Lin. Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 906-909.

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参考文献

[1] Pricewaterhouse Coopers.Sizing the prize: What’s the real value of AI for your business and how can you capitalise?[EB/OL]. [2024-05-30].https://www.pwc.com/gx/en/issues/analytics/assets/pwc-ai-analysis-sizing-the-prize-report.pdf.
[2] WHO. WHO issues first global report on Artificial Intelligence (AI) in health and six guiding principles for its design and use[EB/OL]. (2021-06-28) [2024-05-30]. https://www.who.int/zh/news/item/28-06-2021-who-issues-first-global-report-on-ai-in-health-and-six-guiding-principles-for-its-design-and-use.
[3] WHO. Ethics and governance of artificial intelligence for health[EB/OL]. (2021-06-28)[2024-05-30]. https://iris.who.int/bitstream/handle/10665/350567/9789240037403-eng.pdf?sequence=1.
[4] NIST. Plan for Federal AI Standards Engagement[EB/OL].(2022-04-05)[2024-05-30]. https://www.nist.gov/artificial-intelligence/plan-federal-ai-standards-engagement.
[5] FDA. Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan[EB/OL]. (2021-01-12) [2024-05-30]. https://www.fda.gov/media/145022/download.
[6] National Academy of Medicine. Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril[EB/OL].[2024-05-30]. https://nam.edu/wp-content/uploads/2019/12/AI-in-Health-Care-PREPUB-FINAL.pdf.
[7] NIST. AI Risk Management Framework (AI RMF 1.0)[EB/OL]. (2023-01-26)[2024-05-30]. https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.100-1.pdf.
[8] European Union. Ethics Guidelines for Trustworthy Artificial Intelligence[EB/OL]. (2019-01-26)[2024-04-08]. https://digital-strategy.ec.europa.eu/en/library/ethics-guidelines-trustworthy-ai.
[9] YE ZJ, SHEN YL, JIANG X, et al.Research on the focus of ethical governance in the field of artificial intelligence in medicine[J]. Chinese Medical Ethics(中国医学伦理学), 2024, 37(1): 39-44.
[10] European Union. The EU Artificial Intelligence Act[EB/OL]. (2024-05-24) [2024-05-30]. https://artificialintelligenceact.eu/.
[11] The State Council. A new generation of artificial intelligence development plan[EB/OL]. (2017-07-20)[2024-05-30]. https://www.gov.cn/zhengce/content/2017-07/20/content_5211996.htm.
[12] Ministry of Science and Technology. A New Generation of AI Governance principles - Developing responsible AI[EB/OL]. (2019-06-17)[2024-05-30]. https://www.gov.cn/xinwen/2019-06/17/content_5401006.htm.
[13] Center For Medical Device Evaluation,NMPA. The Guideline of registration evaluation of AI medical device[EB/OL]. (2022-03-07)[2024-05-30]. https://www.cmde.org.cn//xwdt/shpgzgg/gztg/20220309090800158.html.
[14] General Office of the CPC Central Committee, General Office of the State Council. Opinions on Strengthening the Governance of Science and Technology Ethics[EB/OL]. (2019-03-20)[2024-05-30]. https://www.gov.cn/gongbao/content/2022/content_5683838.htm.
[15] WANG T, ZHENG MJ, LIU HL, et al.Current applications of artificial intelligence in pharmacovigilance in the USA and implications[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2023, 20(10): 1129-1133.

WHO《卫生健康领域人工智能伦理与治理》指南简述与启示

Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health

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