The FDA’s Digital Health Advisory Committee will meet Nov. 7 to evaluate whether generative AI tools can be used safely and effectively in mental healthcare. The session marks the committee’s first in nearly a year and comes amid growing use of AI-powered chatbots by patients seeking alternatives to traditional therapy, according to a Nov. 3 report from Politico.
Here are five things to know:
- The FDA has not approved any generative AI devices for mental health treatment. However, it has authorized more than 1,200 AI-enabled tools for other clinical purposes.
- The committee will hear presentations on clinical trial data, provider and patient considerations, and use cases from other industries, according to an FDA meeting summary reviewed by Politico.
- Regulators said existing oversight frameworks must evolve to address the complexity of digital mental health tools while promoting innovation and ensuring safety.
- Committee members will consider a hypothetical case involving an adult with depression who prefers interacting with a generative AI model over a human therapist. They will discuss whether such tools should be prescribed to younger patients or sold over the counter.
- The meeting comes amid legal scrutiny of chatbot use. Several lawsuits claim unsupervised AI interaction contributed to self-harm in minors.
