脑科学视角下经颅磁刺激治疗精神障碍的法律问题及对策研究  

Legal Issues and Countermeasures of Transcranial Magnetic Stimulation for Mental Disorders from the Perspective of Brain Science

作　　者：任静[1] 李筱永[1] 梁恒瑜 赵依凡 吴佼玥 REN Jing;LI Xiaoyong;LIANG Hengyu;ZHAO Yifan;WU Jiaoyue(School of Medical Humanities,Capital Medical University,Beijing 100069,China;School of Law,China University of Political Science and Law,Beijing 100088,China)

机构地区：[1]首都医科大学医学人文学院,北京市100069 [2]中国政法大学法学院,北京市100088

出　　处：《中国全科医学》2024年第8期1015-1020,共6页Chinese General Practice

基　　金：国家社会科学基金项目(17BFX060)。

摘　　要：在我国脑科学研究战略的背景下,作为输入型脑机接口技术的经颅磁刺激技术,能够通过无创方式改善精神障碍患者的病理状态。但新技术引发的新风险被忽视,患者大脑神经数据呈现出的隐私存在泄露风险,医师忽略患者性格改变风险的告知以及经颅磁刺激仪器械超说明书使用的法律问题亟待探讨。本文采用文献研究、案例分析方法,检索并剖析健康权同隐私保护权衡、知情同意原则、数据利用、器械超说明书应用多领域文献,总结归纳经颅磁刺激仪超说明书使用和知情同意纠纷的裁判文书要点,发现应通过阐明健康权兼顾隐私保护、调适医师诊疗权与患者知情同意权、器械可及性和安全性之间的法理阐释和价值平衡,并完善新技术应用中对新风险的充分告知;明确医师及医疗机构应当尊重患者隐私及神经数据安全保障义务,扩充风险告知范围,明确性格改变风险,禁止器械超范围使用并设立风险分析及动态监测不良反应报告机制。In the context of brain science research strategy in China,transcranial magnetic stimulation,as an input brain-computer interface technology,is able to improve the pathology of patients with mental disorders in a noninvasive way.However,new risks arising from the new technology have been ignored by the legislation,and there is a risk of privacy leaks of the neurological data presented by the patient's brain.The legal issues of physicians neglecting to inform patients of the risks of personality changes and the off-lable use of transcranial magnetic stimulation devices need to be explored.The legal issues of physicians neglecting to inform patients of the risks of personality changes and off-label use of transcranial magnetic stimulator devices need to be urgently explored.Multidisciplinary literature in the fields of trade-off between the right to health and privacy protection,principle of informed consent,data and application of off-label use for devices was searched and analyzed by using literature review and case analysis methods,to summarize the key points of the adjudication documents on off-label use for transcranial magnetic stimulation devices.It was found that the legal interpretations and value balances between the right to health and protection of privacy,physician's right of diagnosis and treatment and patient's right of informed consent,as well as the accessibility and safety of the devices,should be clarified and the adequate notification of new risks in the application of new technologies should be improved;it should be clarified that physicians and medical institutions should respect the privacy of the patients and the obligation to protect the security of neurological data,expand the scope of risk notification,clarify the risks of personality,prohibit the off-label use of the devices and establish a mechanism for risk analysis and dynamic monitoring of adverse reactions.

关 键 词：经颅磁刺激 治疗学 脑机接口 脑隐私 法律责任 知情同意 器械超说明书 

分 类 号：R741.04[医药卫生—神经病学与精神病学]