诊断辅助人工智能应用情境下医疗损害责任认定的困境与出路
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浙江农林大学

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中共浙江省委政法委员会 浙江省法学会2025年度法学研究课题重点项目“医疗人工智能法律规制与侵权责任归属研究”(编号:2025NA32)


The Dilemmas and Solutions of Applying Medical Malpractice Liability to Diagnostic AI
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"Research on Legal Regulation of Medical Artificial Intelligence and Attribution of Tort Liability (Grant No.: 2025NA32)", a Key Project of the 2025 Annual Legal Research Program of the Politics and Law Committee of the CPC Zhejiang Provincial Committee and the Zhejiang Provincial Law Society

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    摘要:

    诊断辅助人工智能实现了从“规则驱动”到“数据驱动”的技术跃迁,其固有的自主决策性、黑箱性与动态进化性,对以“当时医疗水平”标准为核心的传统医疗损害责任认定构成挑战。对此,应将“诊断辅助人工智能的使用”定位为“新疗法”,以确认其应用的合法性基础;进而明确其输出结果不直接等同于“当时医疗水平”,且后者的内涵亦将动态演进。在此基础上,构建以“审慎再判断义务”为核心的动态过错认定框架,将评价重心转向对医务人员履行审慎使用与结果核验义务过程的审查。这一调整旨在回应当前“人机协作”模式下医疗过错的认定需求,实现技术创新与患者安全保护的规范平衡。

    Abstract:

    Diagnostic AI has undergone a technological leap from being “rule-driven” to “data-driven”. With its inherent features—autonomy, an algorithmic black-box, and dynamic evolution—it poses structural challenges to the traditional medical malpractice liability system centered on the “prevailing medical standard”. To address these challenges, the use of diagnostic AI should be positioned as the adoption of a “new therapy” to establish its legal basis. It is necessary to clarify that its outputs do not directly equate to the “prevailing medical standard”, and that the connotation of this standard will also evolve. On this basis, we propose a dynamic fault-determination framework centered on the “duty of prudent re-evaluation” . This framework shifts the focus of assessment to an evaluation of the process by which medical professionals fulfill their obligations of prudent use and substantive verification of algorithmic outputs, thereby responding to the needs of liability determination in the current “human-computer collaboration” model.

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  • 收稿日期:2026-01-15
  • 最后修改日期:2026-02-28
  • 录用日期:2026-03-02
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