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

npj Digital Medicine 2026 Open access

Read full text
Authors: Jasmine Chiat Ling Ong, Yilin Ning, Mingxuan Liu, Yian Ma, Liang Zhao, Kuldev Singh, Robert T. Chang, Silke Vogel, John C. W. Lim, I Leng Tan, Oscar Freyer, Stephen Gilbert
+4 more Danielle S. Bitterman, Xiaoxuan Liu, Alastair K. Denniston, Nan Liu
DOI: 10.1038/s41746-026-02552-2
Cited by: 5
References: 62

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.

Fields of Study & Subjects

Artificial Intelligence in Healthcare and Education Genomics and Rare Diseases Biomedical Ethics and Regulation

Publication details

Journal / source
npj Digital Medicine
Publisher
Springer Science and Business Media LLC
Volume
9
Issue
1
Publication date
19 March 2026
Language
EN