The US Food and Drug Administration (FDA) on Thursday announced its digital advisory panel would hold an advisory panel meeting in November to examine the fast-emerging class of AI-enabled digital mental health devices.
The agency's Digital Health Advisory Committee (DHAC) will hold a meeting open to the public on November 6th to focus on how digital therapy and emotional support tools can help address a widening gap in access to mental health services in the US while exploring the unique risks they pose.
The panel meeting hopes to identify key areas of concern and potential regulatory pathways, according to a document set to be published by the DHAC on Friday, citing the topic of “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices.”
There has been an explosion of growth in AI-powered digital mental health tools, from chatbots to virtual therapists. And while these technologies promise "reach, scalability, and timely intervention, regulators are grappling with how to ensure such devices are both practical and safe," explained Reuters.
According to the digital health watchdog, "There is an increasing demand for mental health services in the US and insufficient access to mental health care providers." The agency says these new devices and tools may be one way "to help address the gap, potentially improving outcomes and access."
The committee plans to discuss the benefits and risks to health, plus ways to mitigate those risks, also taking into consideration premarket evidence and postmarket monitoring, the agency said.
The FDA says it is establishing a docket for public comments on the topic, which will stay open until December 8th. However, only comments submitted before October 17th will be considered for the meeting. Background materials will be posted online at least two business days prior to the meeting.
Additionally, the DAHC said "interested persons may present data, information, or views, orally, or in writing, on issues pending before the Committee," as long as they notify the agency and submit a presentation summary by October 9th.
Pros and Cons
Cybernews has reviewed and researched several AI-powered mental health apps, as they have gained popoularity over the past few years.
And while some research shows that mental health chatbots can help treat depression symptoms, Cybernews found that some health apps may actually negatively impact your mental health – and that’s besides the privacy risks users must be wary of when using them.
“AI could help solve the mental health crisis—but only if it’s safe & ethical,” ex-Homicide Detective turned AI Entrepreneur, Elvis Espinoza, posted about the news on X. Pointing out both the pros and cons, Espinoza writes the poentials include “expanded access" and "faster care,” while listing risks as “safety, bias, privacy, human connection.”
🧠 The FDA is weighing AI mental health tools—chatbots, virtual therapists & more.
undefined Elvis Espinoza (@ElvisEsp85) September 11, 2025
✅ Potential: expand access, faster care
⚠️ Risks: safety, bias, privacy, human connection
AI could help solve the mental health crisis—but only if it’s safe & ethical.#AI #MentalHealth… pic.twitter.com/w7zOeYbHQ7
The FDA itself has begun experimenting with AI in its review work, according to Reuters.
The DHAC was created in 2023 to advise the FDA Commissioner on issues related to digital health technologies, including AI, machine learning, remote patient monitoring, digital therapeutics, and software components of medical devices, the FDA website states.
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