医疗脑机接口技术的法律规制

Legal Regulation to Brain-Computer Interfaces in Medicine

区别于其他大脑神经技术和传统治疗方法,通过脑机接口技术可以传输、解读和记录神经数据。神经数据经过解码不仅可以反映健康信息,还可以揭露思想隐私。另外,脑机接口技术可以通过刺激直接干预患者的情绪、思想、甚至行为。对于医疗脑机接口技术应该适度规制,需要兼顾生命身体健康权和人性尊严法益,神经数据合理利用和隐私保护。具体规.制路径包括:对医疗脑机接口技术研究进行严格的伦理审查,对脑机接口医疗器械进行特殊的审批监管,对知情同意的履行进行特别的程序保障,对神经数据进行专门的立法保护。

Unlike other brain neurotechnologies and traditional therapies,neurodata can be transmitted,interpreted and recorded through brain-computer interfaces.Neurodata can be decoded to not only reflect health information,but also to reveal mental privacy.In addition,brain-computer interfaces can directly intervene in patients'emotions,thoughts,and even behaviors through stimulation.Brain-computer interfaces in medicine should be moderately regulated,taking into account the rights to life and physical health and human dignity,the rational use of neurodata and privacy protection.Specific regulatory paths include:strict ethical review of the research about brain-computer interfaces in medicine,special approval and supervision of brain-computer interface medical devices,special procedural safeguards for informed consent,and specialized legislative protection of neurodata.