Expert perspectives on US regulatory approaches to large language models in healthcare.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 42156995.
- Also identified by DOI 10.1038/s41746-026-02787-z and PMC identifier 13187061.
- Licence recorded as CC BY-NC-ND.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
Abstract
In this second article of a three-article series on interviews with Dr Shantanu Nundy, an advisor in the office of the Commissioner of the US FDA on AI governance and digital health policy, we explore the challenge of regulating large language model (LLM)-enabled medical AI, particularly where it extends beyond the usual boundaries of medical devices and therefore challenges traditional regulatory frameworks.