医疗人工智能的前端准入规制与中后端侵权责任调适  

Front-end access regulation and liability adjustment of infringement in the middle and back-ends of medical artificial intelligence

作　　者：周文康 费艳颖[2] ZHOU Wenkang;FEI Yanying(School of Marxism,Harbin Institute of Technology〈Weihai〉,Weihai 264209,China;School of Public Administration and Policy,Dalian University of Technology,Dalian 116024,China)

机构地区：[1]哈尔滨工业大学〈威海〉马克思主义学院,山东威海264209 [2]大连理工大学公共管理学院,辽宁大连116024

出　　处：《中国医学伦理学》2025年第2期150-158,共9页Chinese Medical Ethics

摘　　要：基于医疗人工智能不同于一般医疗器械的特性,发现医疗人工智能的临床应用对前端准入监管规制、中端知情同意权设计以及后端致损后责任调适带来了不同层面的冲击。对此,有必要适当放宽准入审查,加强上市前后协同监管,同时调整医疗AI“安全、有效”的综合判定思路;厘清关于患者知情同意权的告知“广度”与披露“深度”;以现行产品责任与医疗损害责任体系为基础类型化调适责任归属于分配,同时强化医疗强制责任险的补充适用,以强化患者的损害救济、风险的合理化分配以及社会成本最小化。Based on the unique characteristics of medical artificial intelligence(AI) that differ from general medical devices,it was found that the clinical application of medical AI has brought different levels of impacts on the front-end access supervision and regulation,the mid-end informed consent right design,and back-end post-damage liability adjustment.In this regard,it is necessary to appropriately relax the admission review,strengthen the coordination of supervision before and after listing,and simultaneously adjust the comprehensive judgment ideas of “safe and effective” medical AI;clarify the “breadth” of notification and “depth” of disclosure regarding the patients' informed consent rights;based on current product liability and liability for medical malpractice system,typologically adjust the allocation of liability,while strengthening the supplemental application of medical compulsory liability insurance,so as to enhance the relief of patients' damage,rationalize risk allocation,and minimize social costs.

关 键 词：医疗人工智能 准入机制 知情同意 产品责任 医疗损害责任 

分 类 号：R-01[医药卫生]