医疗人工智能临床应用中医生告知义务的触发条件与衔接机制

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Abstract Medical AI has been gradually put into clinical application, which has a wide and profound impact on the process of medical decision-making. However, patients are always under an unconscious “dominated” state, which requires timely response from the law to specify the doctor's informing obligation under clinical application of medical AI. Through the investigation of dimension of doctor, medical AI and patient, the trigger of doctor's informing obligation should meet two conditions: firstly, doctors fail to achieve “meaningful involvement”, that is, they neither have the corresponding ability of supervision, nor they take the appropriate measures of supervision; secondly, the auxiliary decision-making of medical AI will have a significant impact on the patient, which needs to be judged according to the scene. In order to form a more concrete applicable standard, the trigger of doctor's informing obligation should be connected with the classifying management of medical AI: AI products administrated not as medical devices or medical AI administrated as class one device will not trigger the informing obligation of doctors; medical AI administrated as class two device will not trigger the informing obligation in principle, but the administrative and judicial institutions would reserve the necessary discretion; medical AI administrated as class three device will trigger the informing obligation of doctors definitely.

Key words： medical artificial intelligence clinical application obligation of inform meaningful involvement management of classification

Received: 06 July 2022

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D913

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	LI Run-sheng

Cite this article:

LI Run-sheng. On the Triggering Condition and Connecting Mechanism of Doctor's Informing Obligation under Clinical Application of Medical AI[J]. , 2023, 40(1): 92-100.

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https://xb.szu.edu.cn/EN/ OR https://xb.szu.edu.cn/EN/Y2023/V40/I1/92

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