STAT+: A ‘historic’ FDA clearance raises the question: Is the LLM an interface or the decision-maker?

Digital health company Up Doc prompted a flurry of discussion when it announced in late June that its app for people with diabetes had received the first Food and Drug Administration clearance for medical software using “patient-facing large language models.”&#x A0; Founded in 2023, Up Doc received clearance for the device in December and is just now publicly revealing its plans to use the technology as part of a care model that helps health systems manage patients outside the clinic with the help of AI. The newly cleared device is based around an app that helps a patient manage their diabetes using a treatment plan defined by their doctor. It’s regulated in the same product category with drug dose calculators that take inputs like blood glucose levels and return insulin dosing recommendations. A big part of what makes UpDoc’s app different is a chatbot-like interface based on large language models, or LLMs. Patients can input data using voice and text, and the device responds with treatment instructions. The technology also communicates back to a doctor’s electronic medical record software to keep them in the loop.Continue to STAT+ to read the full story…