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<p>Artificial intelligence (AI) is accelerating innovation in healthcare while raising complex questions about safety, accountability, and data governance. This study develops a three-dimensional framework—risk stratification, data governance, and regulatory implementation—to compare medical AI oversight in the European Union, the USA, China, Japan, and the UK. Drawing on legal instruments, technical guidelines, and real-world deployment evidence, the analysis identifies five distinct governance models and highlights three converging trends: expansion of risk-differentiated regulation, strengthened transparency and privacy protections, and growing adoption of life cycle mechanisms such as regulatory sandboxes and real-world evidence generation. The findings indicate a global shift toward hybrid and increasingly interoperable regulatory paradigms that aim to ensure the safe and trustworthy deployment of medical AI.</p>

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Comparative study of international medical AI regulatory policies: regional approaches and evidence from clinical practice

  • 期刊论文

  • 发表日期：

    2026年2月9日

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  • Qiwen Wei,
  • Guisheng Xu,
  • Yinlong Liu

摘要

Artificial intelligence (AI) is accelerating innovation in healthcare while raising complex questions about safety, accountability, and data governance. This study develops a three-dimensional framework—risk stratification, data governance, and regulatory implementation—to compare medical AI oversight in the European Union, the USA, China, Japan, and the UK. Drawing on legal instruments, technical guidelines, and real-world deployment evidence, the analysis identifies five distinct governance models and highlights three converging trends: expansion of risk-differentiated regulation, strengthened transparency and privacy protections, and growing adoption of life cycle mechanisms such as regulatory sandboxes and real-world evidence generation. The findings indicate a global shift toward hybrid and increasingly interoperable regulatory paradigms that aim to ensure the safe and trustworthy deployment of medical AI.