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<p>The integration of generative AI (GenAI) and large language models (LLMs) in healthcare presents both unprecedented opportunities and challenges, necessitating innovative regulatory approaches. In this perspective, we discuss the risks of GenAI and LLM-based medical devices, the limitations of current medical device regulation frameworks when applied to GenAI or LLMs, and advocate for global collaboration in regulatory science research through engaging multidisciplinary expertise and focusing on the needs of diverse populations.</p>

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Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月19日

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  • Jasmine Chiat Ling Ong,
  • Yilin Ning,
  • Mingxuan Liu,
  • Yian Ma,
  • Liang Zhao,
  • Kuldev Singh,
  • Robert T. Chang,
  • Silke Vogel,
  • John C. W. Lim,
  • Iris Siu Kwan Tan,
  • Oscar Freyer,
  • Stephen Gilbert,
  • Danielle S. Bitterman,
  • Xiaoxuan Liu,
  • Alastair K. Denniston,
  • Nan Liu

摘要

The integration of generative AI (GenAI) and large language models (LLMs) in healthcare presents both unprecedented opportunities and challenges, necessitating innovative regulatory approaches. In this perspective, we discuss the risks of GenAI and LLM-based medical devices, the limitations of current medical device regulation frameworks when applied to GenAI or LLMs, and advocate for global collaboration in regulatory science research through engaging multidisciplinary expertise and focusing on the needs of diverse populations.