中国全科医学 ›› 2024, Vol. 27 ›› Issue (08): 1015-1020.DOI: 10.12114/j.issn.1007-9572.2023.0473

• 医疗安全 • 上一篇    

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

任静1, 李筱永1,*(), 梁恒瑜1, 赵依凡2, 吴佼玥1   

  1. 1.100069 北京市,首都医科大学医学人文学院
    2.100088 北京市,中国政法大学法学院
  • 收稿日期:2023-07-23 修回日期:2023-09-12 出版日期:2024-03-15 发布日期:2023-12-19
  • 通讯作者: 李筱永

  • 作者贡献:任静、李筱永提出研究思路,设计研究方案,进行文章的构思及设计,论文修订;任静、梁恒瑜进行文献检索及整理,撰写论文;李筱永、梁恒瑜、赵依凡、吴佼玥为论文修改提供建议和思路;李筱永负责文章的质量控制及审查,对文章整体负责,监督管理。
  • 基金资助:
    国家社会科学基金项目(17BFX060)

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

REN Jing1, LI Xiaoyong1,*(), LIANG Hengyu1, ZHAO Yifan2, WU Jiaoyue1   

  1. 1. School of Medical Humanities, Capital Medical University, Beijing 100069, China
    2. School of Law, China University of Political Science and Law, Beijing 100088, China
  • Received:2023-07-23 Revised:2023-09-12 Published:2024-03-15 Online:2023-12-19
  • Contact: LI Xiaoyong

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。

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

Abstract:

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.

Key words: Transcranial magnetic stimulation, Therapeutics, Brain-computer interface, Brain privacy, Legal liability, Informed consent, Devices off label use