Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Axios, in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild,” by Sabrina Moreno.
Following is an excerpt:
- Mental health apps are also proliferating so quickly that regulators are hard-pressed to keep up.
- The American Psychiatric Association estimates there are more than 10,000 mental health apps circulating on app stores. Nearly all are unapproved.
- The technology is being deployed to analyze patient conversations and sift through text messages to make recommendations based on what we tell doctors.
- It's also predicting opioid addiction risk, detecting mental health disorders like depression and could soon design drugs to treat opioid use disorder.
- KoKo, a mental health nonprofit, recently used ChatGPT as a mental health counselor for about 4,000 people who weren't aware the answers were generated by AI, sparking criticism from ethicists.
- Other people are turning to ChatGPT as a personal therapist despite warnings from the platform saying it's not intended to be used for treatment.
- Early in the pandemic, the agency relaxed some premarket requirements for mobile apps that treat psychiatric conditions, to ease the burden on the rest of the health system.
- But its process for reviewing updates to digital health products is still slow, a top official acknowledged last fall.
- A September FDA report found the agency's current framework for regulating medical devices is not equipped to handle "the speed of change sometimes necessary to provide reasonable assurance of safety and effectiveness of rapidly evolving devices."
- And despite the guidance, "the FDA has really done almost nothing in the area of enforcement in this space," Thompson told Axios.
- "It's like the problem is so big, they don't even know how to get started on it and they don’t even know what they should be doing."
- That's left the task of determining whether a mental health app is safe and effective largely up to users and online reviews.