Unregulated large language models produce medical device-like output.
other · Level V
Where this comes from
- Record sourced from PubMed, PMID 40055537.
- Also identified by DOI 10.1038/s41746-025-01544-y and PMC identifier 11889144.
- 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
Large language models (LLMs) show considerable promise for clinical decision support (CDS) but none is currently authorized by the Food and Drug Administration (FDA) as a CDS device. We evaluated whether two popular LLMs could be induced to provide device-like CDS output. We found that LLM output readily produced device-like decision support across a range of scenarios, suggesting a need for regulation if LLMs are formally deployed for clinical use.