What's FDA plotting for therapy chatbot regulation?
What's FDA plotting for therapy chatbot regulation?
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What's FDA plotting for therapy chatbot regulation?

🕒︎ 2025-11-06

Copyright STAT

What's FDA plotting for therapy chatbot regulation?

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday. What to know about the FDA’s therapy bots meeting The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting to consider the topic. In a new story, I explain what’s going on, including some fresh insider intel. Advertisement The FDA wants to provide more clarity to developers of generative AI medical devices about what needs regulatory green light and how to get it. The agency is also also worried about LLM-based therapy bots that can provide unpredictable outputs. Regulators are aware about the growing concerns around general purpose bots like ChatGPT, which have been linked to delusions and allegedly to suicides.

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