What question did this study set out to answer?

The aim is to highlight the urgent need for innovative regulatory frameworks for generative AI in medical devices.

March 21, 2026Open Access

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

JOJasmine Chiat Ling Ong YNYilin NingDuke-NUS Medical School MLMingxuan LiuDuke-NUS Medical School

Key Points

The aim is to highlight the urgent need for innovative regulatory frameworks for generative AI in medical devices.
Discussed risks associated with generative AI and large language models in healthcare.
Evaluated limitations of current medical device regulations for GenAI and LLMs.
Advocated for interdisciplinary collaboration in regulatory science.
Identified significant regulatory gaps when applying existing frameworks to GenAI technologies.
Outlined the importance of engaging diverse stakeholders in developing new regulations.
Emphasized the need for adaptive regulatory science to address challenges in healthcare.

Abstract

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.

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