Study on Technical Risks and Primary Responsibility of Medical Artificial Intelligence Diagnosis Products under Strategy of "Healthy China" / 中国医疗器械杂志

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.@*CONCLUSIONS@#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".

Current situation and prospect of internet medicine development / 上海预防医学

Internet medicine is not a concept of jurisprudence. China's current medical law system mainly focuses on main qualifications of the participants who conduct diagnosis and treatment. This paper focuses on several business models of the core element （diagnosis and treatment） in internet medicine， namely： online health consultation provided by internet medical platform， online diagnosis and treatment by internet hospital， and certain artificial intelligence（AI） medicine products that are specialized for diagnosis and treatment. This paper summarizes the development of these three business models， and analyzes the main problems in their development， including the legitimacy identification of online consultation， the dilemma of the development of internet hospitals， the impact of insufficient sample data on the development of medical AI， and the reverse restriction of regulatory difficulties to the development of internet medicine. The next step of developing internet medicine is to broaden the scope of internet diagnosis and treatment on the premise of medical safety， which will be based on the improvement of current regulatory system. It is urgent to build early risk warning system and supervision/ management mechanism for internet medicine.