摘要：

AI 应用对当前医疗决策法律框架中的权责利配置提出诸多挑战，而应对这些具体挑战的前提是明确 AI 在医疗决策中的功能定位。AI 医疗决策在大数据和机器学习等技术基础的驱动下呈现出替代决策的功能趋势。然而，该趋势下的 AI 医疗决策在准入监管、决策过程和侵权救济等方面存在多重法律困境。现代医疗决策模式的演进规律表明，AI 医疗决策的功能定位须符合尊重患者自主价值、巩固患者决策话语权和以信息为基础的医患信任保障机制建设之规律，故支持功能是 AI 医疗决策的应然定位。据此，现行法律应在医事基本法中明确 AI 医疗决策的支持性功能定位，在准入监管层面建立“医生 +AI”的整体监管思路，在决策过程中重构尊重患者自主原则的权利体系，在侵权救济中明确 AI医疗决策相关主体的归责标准。

关键词:

人工智能, 医疗决策, 功能定位, 决策替代, 决策支持

Abstract:

The application of AI in healthcare decision-making poses numerous challenges to the existing legal framework concerning rights and responsibilities allocation. Addressing these challenges requires a clear understanding of the role of AI in medical decision-making. AI medical decision-making, driven by technologies such as big data and machine learning, exhibits a trend towards substituting human decision-making. However, this trend brings about various legal dilemmas in terms of access regulation, decision-making processes, and liability for infringement. The current legal framework should clearly define the supportive role of AI medical decisionmaking in the basic medical law, establish an integrated regulatory approach encompassing “doctor + AI” in access supervision, reconstruct a rights system that respects patients’ autonomy during the decision-making process, and specify the standards of liability for AI medical decision-making in tort relief.

Key words:

artificial intelligence,  medical decision-making,  functional orientation,  decision alternative,  decision support