Paradigm Shift in Global Governance of Medical Brain-Computer Interface: Addressing Practical Challenges Through Institutional Innovation.

The rapid advancement of medical brain-computer interface (BCI) technology necessitates the transformation and upgrading of traditional governance paradigms urgently. China, the United States, and the European Union hold prominent positions in the global medical BCI landscape and have developed three highly representative governance models. Existing research on medical BCI primarily focuses on specific countries or regions, but it has failed to conduct a comprehensive comparison of governance frameworks across different jurisdictions from a horizontal perspective. In this study, a horizontal policy text analysis was employed to comprehensively compare the divergent approaches of China, the United States, and the European Union in regulating medical BCI, focusing on regulatory frameworks, approval procedures, neural data governance, and ethical governance. China's medical BCI governance is state-led, prioritizing safety; the United States features innovation-driven flexibility; the European Union uses an empowerment model to strictly mitigate risks. Yet these three models have inherent drawbacks. To ensure the healthy development of medical BCI, we suggest China, the United States, the European Union and other jurisdictions establish a lifecycle regulatory mechanism, introduce the regulatory sandbox, promote collaborative governance among multiple subjects, build hierarchical informed consent rules, endow users with neurorights and refine BCI ethical governance.