Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority.
Publication
, Journal Article
Ong, JCL; Ning, Y; Liu, M; Ma, Y; Zhao, L; Singh, K; Chang, RT; Vogel, S; Lim, JCW; Tan, ISK; Freyer, O; Gilbert, S; Bitterman, DS; Liu, X ...
Published in: NPJ Digit Med
March 19, 2026
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.
Duke Scholars
Published In
NPJ Digit Med
DOI
EISSN
2398-6352
Publication Date
March 19, 2026
Location
England
Related Subject Headings
- 4203 Health services and systems
Citation
APA
Chicago
ICMJE
MLA
NLM
Ong, J. C. L., Ning, Y., Liu, M., Ma, Y., Zhao, L., Singh, K., … Liu, N. (2026). Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ Digit Med. https://doi.org/10.1038/s41746-026-02552-2
Ong, Jasmine Chiat Ling, Yilin Ning, Mingxuan Liu, Yian Ma, Liang Zhao, Kuldev Singh, Robert T. Chang, et al. “Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority.” NPJ Digit Med, March 19, 2026. https://doi.org/10.1038/s41746-026-02552-2.
Ong JCL, Ning Y, Liu M, Ma Y, Zhao L, Singh K, et al. Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ Digit Med. 2026 Mar 19;
Ong, Jasmine Chiat Ling, et al. “Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority.” NPJ Digit Med, Mar. 2026. Pubmed, doi:10.1038/s41746-026-02552-2.
Ong JCL, Ning Y, Liu M, Ma Y, Zhao L, Singh K, Chang RT, Vogel S, Lim JCW, Tan ISK, Freyer O, Gilbert S, Bitterman DS, Liu X, Denniston AK, Liu N. Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ Digit Med. 2026 Mar 19;
Published In
NPJ Digit Med
DOI
EISSN
2398-6352
Publication Date
March 19, 2026
Location
England
Related Subject Headings
- 4203 Health services and systems