卫生法学

患者知情同意权概念引入我国后，经历从社群主义到个人主义的发展历程，目前已确立为以患者为中心的法律形式。我国《民法典》在表述患者知情同意权时，出现了“不能”“不宜”的情形，但对此两种情形没有进行界定，导致在发生医疗纠纷时对权利主体的责任判断出现模糊的问题。从患者知情同意权及代理行使的内涵、代理行使情形、法理基础等角度进行分析，确证了以患者为中心的“利益最佳化”原则实施患者知情同意权，并以典型案例剖析了由于患者知情同意权行使不当所引发的主要问题，提出了在代理行使范围、医师豁免权、风险预警、伦理委员会职能、“事先指令”推广等方面完善相关法律与制度的建议，以期为阻滞患者知情同意权行使纠纷问题的发生及解决提供参考。

After the introduction of the concept of patient's informed consent in our country, it has gone through the development process from communitarianism to individualism, and has been established as a patient-centered legal form. When the informed consent right of patients is expressed in the Civil Code of our country, the situation of “Can not” and “Not suitable” appears, but the two situations are not defined, it leads to the fuzzy judgment of the responsibility of the subject of rights when medical disputes occur. This article analyzes the connotation of the right of informed consent of patients and the exercise of agency, the basis of jurisprudence, etc. The principle of patient-centered “Benefit optimization” was confirmed to implement the informed consent right of patients, and the main problems caused by improper exercise of informed consent right of patients were analyzed with typical cases. This paper puts forward some suggestions on perfecting the relevant laws and systems in such aspects as the scope of agency, doctor's immunity, risk early warning, the function of ethics committee, and the promotion of “Prior instruction”, etc. The purpose of this paper is to provide reference for preventing the dispute of patients' informed consent.