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

  • 0School of Humanities and Arts, China University of Mining and Technology, Xuzhou, Jiangsu, People's Republic of China.
Risk Management and Healthcare Policy +

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December 2, 2025

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December 2, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

Global medical brain-computer interface (BCI) governance varies significantly. This study compares China, the US, and EU models, revealing distinct approaches and suggesting improvements for healthy BCI development.

Area Of Science

  • Neuroscience
  • Biotechnology
  • Medical Technology Governance

Background

  • Rapid advancements in medical Brain-Computer Interface (BCI) technology require updated governance frameworks.
  • China, the US, and the EU are key players in medical BCI, each with distinct regulatory models.
  • Previous research has lacked a horizontal, comparative analysis of these global governance frameworks.

Purpose Of The Study

  • To conduct a comprehensive horizontal comparison of medical BCI governance in China, the US, and the EU.
  • To analyze divergent regulatory frameworks, approval procedures, neural data governance, and ethical considerations.
  • To identify inherent drawbacks in existing models and propose recommendations for future development.

Main Methods

  • Horizontal policy text analysis of medical BCI regulations.
  • Comparative study of governance frameworks across China, the United States, and the European Union.
  • Focus on regulatory approaches, approval pathways, data management, and ethical guidelines.

Main Results

  • China employs a state-led, safety-focused model.
  • The US adopts an innovation-driven, flexible approach.
  • The EU utilizes an empowerment model for strict risk mitigation.

Conclusions

  • Each model presents inherent limitations.
  • Recommendations include lifecycle regulation, regulatory sandboxes, collaborative governance, hierarchical consent, neurorights, and refined ethical frameworks.
  • These measures are crucial for ensuring the healthy and responsible development of medical BCI technology globally.

Keywords:

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