The US Food and Drug Administration (FDA) Digital Health Advisory Committee held a meeting last week that focused on generative artificial intelligence-enabled digital mental health medical devices. Topics discussed included clinician perspective, evolution of FDA regulation for these devices, and best practices for AI in digital mental health.
While generative AI may be useful to psychiatric patients in treatment, the committee noted, the human susceptibility to AI outputs and risks like suicidal ideation monitoring or reporting, as well as posssible long term risks must be considered.
AI technologies can be easily accessible and available around-the-clock making it potentially transformative for the general population. However, there are major concerns surrounding ease of use, privacy, content regulation, and involvement of health care providers. The committee warned that AI-enabled devices may “confabulate, provide inappropriate or biased content, fail to relay important medical information, or decline in model accuracy,” which are essential considerations in evaluating these technologies.
The FDA has authorized use of over 1200 medical devices which use AI, but none have been authorized for mental health uses as yet. Less than 20 digital mental health, non-AI devices have been authorized. Digital mental health technologies encompass mobile health, health information technology, wearable devices, telehealth, telemedicine, and personalized medicine, according to the FDA. The term also refers to digital therapeutics and diagnostics, which the FDA oversees.
The committee focused on the unique aspect of patient-facing AI, with digital mental health medical devices that are intended to “treat and/or diagnose psychiatric conditions.” Public health concerns emerge with the safety and ability of AI products to deliver therapeutic content, make psychiatric diagnoses, or substitute a clinician.
At this meeting, committee highlighted that the FDA is committed to assuring patients and providers have prompt and continued access to safe and efficacious medical devices. The goal is to provide regulatory pathways for this growing field, keeping in mind potential unique benefits of AI-assisted medical mental health technology, and the complexity of human to digital interaction.
Reference
Summary for the Digital Health Advisory Committee meeting, November 6, 2025.