The AI Chatbot Is In

FDA has authorized more than 1,200 artificial intelligence (AI)-based digital devices for marketing. To date, none of these has been indicated to address mental health. Currently there are 57.8 million adults who have a diagnosed mental illness and many do not have access to high quality and effective treatments. The use of generative AI digital devices, such as chatbots and virtual companions could close the gaps for those in need of mental health services. Recognizing the growing demand for "AI therapists," the November meeting of FDA's Digital Health Advisory Committee focused on FDA's regulatory approach for generative artificial intelligence-enabled digital mental health medical devices, taking into consideration their benefits, risks to health, and risk mitigations, including premarket evidence and post market monitoring.