脑机接口治疗中知情同意规则的再思考

Reconsideration of Informed Consent Rules in Brain-Computer Interface Therapy

摘要: 医疗脑机接口技术为神经功能损伤患者带来了功能重建的医学可能，已成为我国重点布局的未来医疗产业方向，而知情同意作为医疗伦理的核心原则与患者自主决定权的核心实现路径，是该技术临床合规应用的第一道法律防线。医疗脑机接口技术具有侵入性高、专业性强、风险覆盖全生命周期、适用群体多存在决策能力受限、神经数据处理具有持续性等特征，导致我国现行以“静态一次性同意”为核心的医疗知情同意规则出现严重的适配失灵。当前，医疗脑机接口临床知情同意面临着全流程规则供给不足、告知义务履行标准模糊、特殊群体决策保障机制缺失、神经数据处理同意规则空白、侵权责任认定体系不健全等多重法律困境。结合我国现行法律体系与医疗临床实践，应当构建医疗脑机接口全生命周期动态知情同意体系，细化场景化的告知义务履行标准，完善特殊群体的决策保障规则，健全神经数据处理的专项同意机制，明确知情同意瑕疵的侵权责任划分，并配套多学科伦理审查与全流程监管机制，最终在保障患者人格尊严与自主决定权的同时，为医疗脑机接口技术的良性发展提供清晰的法律合规指引。

Abstract: Medical brain-computer interface (BCI) technology offers medical potential for functional reconstruction in patients with neurological impairments and has become a key focus of China’s future healthcare industry development. Informed consent, as the core principle of medical ethics and the primary means to realize patients’ autonomy, serves as the first legal safeguard for the compliant clinical application of this technology. However, BCI technology is characterized by high invasiveness, specialized requirements, risks spanning the entire life cycle, limited decision-making capacity among diverse patient populations, and continuous neural data processing, rendering China’s current “static, one-time consent” framework for medical informed consent severely inadequate. Currently, clinical BCI informed consent faces multiple legal challenges, including insufficient comprehensive procedural guidelines, ambiguous standards for disclosure obligations, a lack of decision-making safeguards for vulnerable groups, an absence of consent protocols for neural data processing, and an incomplete tort liability framework. In light of China’s legal system and clinical practices, it is imperative to establish a dynamic, lifecycle-based informed consent framework for BCI. This framework should specify scenario-specific disclosure obligations, enhance decision-making safeguards for special populations, refine dedicated consent mechanisms for neural data processing, clarify liability allocations for informed consent deficiencies, and incorporate multidisciplinary ethical review and full-process regulatory mechanisms. Such measures will safeguard patients’ dignity and autonomy while providing clear legal guidance for the responsible advancement of BCI technology.