我国脑机接口政策的演进脉络、现实问题与优化对策:从战略布局到产业培育的十年回顾OA
Policy evolution,practical challenges,and optimization strategies of China's brain-computer interface:a decade review from strategic planning to industrial cultivation
目的 脑机接口(brain-computer interface,BCI)作为医学领域最具代表性的颠覆性创新技术,已成为全球科技竞争的战略制高点.本研究梳理分析我国脑机接口发展的政策脉络与现实问题,提出针对性优化建议,为推动脑机接口高质量发展提供参考借鉴.方法 通过文献综述,总结梳理脑机接口的概念、分类与技术发展趋势;基于时间序列,梳理我国脑机接口相关政策的演进脉络与核心内容;结合文献证据,对政策实施效果及存在问题进行综合研判.结果 我国脑机接口政策体系呈现明显的阶段性演进特征:①战略布局阶段(2016-2020年),政策重点集中于基础研究与前沿技术布局,正式将脑科学纳入国家科技创新战略体系;②医工融合阶段(2021-2024年),政策重心转向技术转化与应用场景拓展,重点推动脑机接口在康复医疗、智慧养老等领域的应用,并逐步推进标准化建设和医疗器械审评提速;③产业培育阶段(2025年至今),相关政策密集出台,政策内容覆盖研发、监管、医保和金融等全产业链各环节.结论 我国脑机接口发展已经初步形成了"政策-科研-监管-产业"协同联动的格局,但仍存在产业化能力有待加强、政策支持体系尚不完善、跨部门协同管理机制尚未建立、风险治理与伦理监管相对滞后等问题,亟须进一步完善全链条政策支持体系与治理机制.对策 建议聚力突破核心技术瓶颈,推动跨学科融合发展;加大财政投入并引导耐心资本进入,建立多元化投融资机制;完善顶层制度设计,构建全链条政策支持体系;建立国家层面统筹管理机构,强化跨部门协同治理;强化风险防控与伦理治理,实现脑机接口价值善用.
Objective Brain-computer interface(BCI),as one of the most representative disruptive innovations in the medical field,has emerged as a strategic high ground in global technological competition.This study systematically reviews and analyzes the policy evolution and practical challenges of BCI development in China,and proposes targeted optimization recommendations to provide a reference for promoting high-quality development.Methods Through literature review,the concept,classification,and technological development trends of BCI were summarized.Based on a time-series perspective,the evolutionary trajectory and core contents of BCI-related policies in China were analyzed.The implementation effects and existing problems of policies were comprehensively assessed in conjunction with evidence from the literature.Results China's BCI policy system exhibited distinct stage-specific evolutionary characteristics:① Strategic planning stage(2016 to 2020),during which policy priorities focused on basic research and frontier technological deployment,formally incorporating brain science into the national science and technology innovation agenda;② Medical-engineering integration stage(2021 to 2024),during which the policy focus shifted toward technology translation and application scenario expansion,with emphasis on promoting BCI applications in rehabilitation medicine,smart elderly care,and other fields,alongside gradual advancement in standardization and accelerated medical device evaluation and approval processes;③ Industrial cultivation stage(2025 to present),during which related policies were intensively introduced,covering the entire industrial chain,including research and development,regulation,medical insurance,and financial support.Conclusion China's BCI development has preliminarily formed a coordinated framework of"policy-research-regulation-industry."However,several challenges remain,including insufficient industrialization capacity,an incomplete policy support system,the absence of an effective cross-sectoral coordination mechanism,and relatively lagging risk governance and ethical regulation.There is an urgent need to further improve the full-chain policy support system and governance mechanisms.Countermeasures It is recommended to concentrate efforts on breaking through core technological bottlenecks and promoting interdisciplinary integration and development,increase fiscal investment and guide patient capital to establish diversified investment and financing mechanisms;improve top-level institutional design to construct a full-chain policy support system;establish a national-level coordinating body to strengthen cross-departmental collaborative governance;and reinforce risk prevention and ethical governance to ensure the responsible and value-oriented application of BCI technologies.
张家乐;陈俊霖;付谦;方令
华中科技大学同济医学院医药卫生管理学院,湖北武汉||湖北省人文社科重点研究基地农村健康服务研究中心,湖北武汉华中科技大学同济医学院医药卫生管理学院,湖北武汉华中科技大学同济医学院医药卫生管理学院,湖北武汉||湖北省人文社科重点研究基地农村健康服务研究中心,湖北武汉南京医科大学附属泰州人民医院,江苏泰州
医药卫生
脑机接口医工融合技术治理政策分析
brain-computer interfacemedical-engineering integrationtechnology governancepolicy analysis
《陆军军医大学学报》 2026 (10)
1396-1408,13
国家自然科学基金青年项目(72104083) Support and by the National Natural Science Foundation for Young Scholars of China(72104083).
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