“健康中国”战略下医疗人工智能诊断产品技术风险及主体责任探讨

Study on Technical Risks and Primary Responsibility of Medical Artificial Intelligence Diagnosis Products under Strategy of"Healthy China"

目的为精准高效监管医疗人工智能产业提供参考。方法通过总结医疗人工智能诊断产品主体责任困境,梳理国内外相关研究,构建医疗人工智能诊断产品主体责任体系。结果构建以医疗人工智能上市许可持有人为“第一责任人”的主体责任体系,提出算法透明和可解释,分类分级监管模式、社会共治监管模式三大保障措施。结论医疗人工智能诊断产品主体责任体系有助于落实主体责任,打造“负责任的、有益的”人工智能,实现“自律”“善治”“有序”。

Objective It provides reference for accurate and efficient supervision of medical artificial intelligence industry.Methods By summarizing the main responsibility dilemma of medical artificial intelligence diagnosis products,sorting out relevant researches at home and abroad,the primary responsibility system of medical artificial intelligence diagnosis products is constructed.Results A medical artificial intelligence diagnosis products primary responsibility system with the marketing authorization holder as the"first responsible person"is established,and three safeguard measures are proposed,namely,algorithm transparency and interpretability,classification supervision mode and social co-governance supervision mode.Conclusion The medical artificial intelligence diagnosis products primary responsibility system is helpful to implement the primary responsibility,to build"responsible and beneficial"artificial intelligence,and to realize"self-discipline","good governance"and"in good order".