Abstract：The emergence of medical artificial intelligence has triggered the digital transformation of physician diagnosis and treatment activities.The policy documents at the normative level demonstrate an attitude of encouraging innovation while regulating risks,which,accompanied with the dual characteristics of advantages and disadvantages of medical AI in practice,arouses the internal demand of medical AI risk regulation.The practical risks caused by medical AI in the current technical stage mainly include the judgment deviation of image recognition system,the calculation distortion of medical expert system and the out of control of medical robot behavior.The affirmation theory of medical AI subject qualification,which attempts to regulate risks on the grounds that independent consciousness will inevitably emerge in the future,is too early and has no practical significance.The principle of proportionality should be introduced into the risk regulation of medical AI,and the binary standard of the principle of appropriateness should be set according to the informed consent of patients.The dual structure of the principle of minimum infringement and the differentiated review mechanism of the principle of proportionality should be constructed by the division of medical diseases.At the same time,the analytic hierarchy process was used to quantitatively analyze the impact of AI type,disease severity,informed consent of patients,and profit and loss of AI on the limit of medical artificial intelligence application,so as to determine the feasibility and risk of AI application in a quantitative form.
游俊哲, 丁岱睿. 数智时代医疗人工智能的潜在法律风险及规制措施[J]. 中国科技论坛, 2025(3): 129-140.
You Junzhe, Ding Dairui. Potential Legal Risks and Regulatory of Medical Artificial Intelligence in the Era of Digital Intelligence. , 2025(3): 129-140.
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