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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中文摘要：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.

外文摘要：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.

外文关键词：

Ethics and Governance of Artificial Intelligence for Healthartificial intelligence(AI)ethicsgovernanceguidanceWorld Health Organization(WHO)medicine and health

作者：

王涛、宋海波、王青、侯永芳、刘红亮、张琳

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作者单位：

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

清华大学药物警戒信息技术与数据科学创新中心,北京 100084

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

基金：

国家自然科学基金资助项目国家药品监督管理局药品监管科学体系建设重点项目

项目编号：

72274065RS2024G001

出版年：

2024

DOI：

10.19803/j.1672-8629.20230518

中国药物警戒

国家药品监督管理局药品评价中心（国家药品不良反应监测中心）

中国药物警戒

CSTPCD

影响因子：1.105

ISSN：1672-8629

年,卷(期)：2024.21(8)