Forbes December 11, 2025
In today’s column, I expand upon some crucial policy recommendations that have recently arisen as a result of the Food and Drug Administration (FDA) seeking commentary about the AI-based mental health realm (note: these aren’t recommendations promulgated by the FDA; they are recommendations submitted to the FDA for consideration and discussion).
First, I will set the stage by describing the recent efforts of the FDA to consider how to best regulate mental health medical devices, especially those that lean into AI. Second, the FDA had an important meeting in November 2025 and sought input from those who could offer insights into the emerging matter. I have examined the posted commentaries. One of the especially thoughtful postings particularly caught my attention....
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