The U.S. Food and Drug Administration will 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 will meet on November 6 and focus on how these digital tools could help address a widening gap in access to mental health services in the United States, while also probing the unique risks they pose.
There has been a sharp growth in AI-enabled digital mental health tools from chatbots to virtual therapists. While these technologies promise reach, scalability and timely intervention, regulators are grappling with how to ensure such devices are both effective and safe.
The FDA itself has begun experimenting with AI in its review work.
The DHAC meeting aims to set the groundwork for identifying key areas of concern and potential regulatory pathways, according to a document published on Thursday.
DHAC’s charge is to advise the FDA on regulatory issues surrounding digital health technologies including AI/ML, remote patient monitoring, digital therapeutics and software components of medical devices.
The agency has opened a public docket for comments ahead of the session. Background materials will be posted online at least two business days before the meeting.
