Mao Yangdui, Sun Gaojun
Zhejiang Pharmaceutical College, Ningbo, 315000.
China Guangfa Bank Ningbo Branch, Ningbo, 315000.
Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Feb 8;45(1):67-71. doi: 10.3969/j.issn.1671-7104.2021.01.014.
It provides reference for accurate and efficient supervision of medical artificial intelligence industry.
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.
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.
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".
为精准高效监管医疗人工智能产业提供参考。
通过总结医疗人工智能诊断产品主要责任困境，梳理国内外相关研究，构建医疗人工智能诊断产品首要责任制度。
建立了以上市许可持有人为“第一责任人”的医疗人工智能诊断产品首要责任制度，并提出算法透明与可解释性、分类监管模式和社会共治监管模式三项保障措施。
医疗人工智能诊断产品首要责任制度有助于落实首要责任，打造“负责任且有益”的人工智能，实现“自律”“善治”“有序”。
