摘要
近年来,随着云计算、物联网、大数据等新兴技术的快速发展,医学人工智能在预防医学、医学诊断、医学治疗、健康管理、医学科研、医学教学、医院管理、药物开发等相关方面发挥了重要作用。作为新兴事物的人工智能,中国现行法规尚无法涵盖涉及医学人工智能研究提出的伦理审查和管理要求,伦理实际审查工作缺乏可操作化的审查标准和程序。通过对国内外相关法律法规、文献等资料进行研究,对涉及医学人工智能研究的伦理审查要点进行分析,提出了目前涉及医学人工智能研究的伦理审查要点除需满足传统伦理审查的基本要求外,还应重点关注研究风险受益比、知情同意程序、数据安全和隐私保护措施、社会公平公正等内容来进一步规范医学人工智能研究。
In recent years,with the rapid development of cloud computing,Internet of things,big data and other emerging technologies,medical artificial intelligence has played an important role in preventive medicine,medical diagnosis,medical treatment,health management,medical research,medical teaching,hospital management,drug development and other medical-related aspects.As a new thing,the current regulations of our country cannot cover the ethical examination and management requirements related to medical artificial intelligence research,and the practical ethical review work lacks operational review standards and procedures.By studying relevant laws and regulations,literature and other materials at home and abroad,this paper analyzed the ethical review points involved in medical artificial intelligence research,and puts forward that the ethical review points involved in medical artificial intelligence research should not only meet the basic requirements of traditional ethical review,but also focus on the study of the risk-benefit ratio,informed consent procedures,data security and privacy protection measures,social equity and justice to further standardize the research on medical artificial intelligence.
作者
谢小萍
何晓波
张玲希
李卫
高雅洁
XIE Xiaoping;HE Xiaobo;ZHANG Lingxi;LI Wei;GAO Yajie(Ethics Office,ZheJiang Hospital,Hangzhou 310030,China;Library of ZheJiang Hospital,Hangzhou 310030,China)
出处
《中国医学伦理学》
2021年第7期844-850,共7页
Chinese Medical Ethics
关键词
医学人工智能
大数据
伦理审查
Medical Artificial Intelligence
Big Data
Ethical Review
