Unregulated large language models produce medical device-like output

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.