On Oct. 20, 2026, Tech Justice Law submitted comments to the U.S. Food and Drug Administration regarding the “Regulation of Generative AI-Enabled Medical Devices”—a recent discussion paper engaging stakeholders on the challenges associated with GenAI-enabled medical devices.
Tech Justice Law is currently representing several clients who faced extreme and ongoing harm to their mental and physical health due to their reliance on AI chatbots for psychosocial and medical advice. In most of our cases, the AI chatbot went further than simply providing medical information; it prioritized user engagement and fed off users’ profiles to better persuade the users to take its advice, highlighting the defective and manipulative design elements that make these tools so dangerous.
To best safeguard the public from these harms, TJL recommends that the FDA regulate health chatbots as medical devices and add three regulatory safeguards: “(1) improving testing rigor of safety evaluations; (2) ensuring appropriate human oversight; and (3) increasing transparency through specific company disclosures.”
These recommendations are informed by the guiding philosophy that “if it would be illegal, exploitative, or dangerous for a human actor to engage in certain conduct, it should not be immunized simply because the harm is mediated through software.”
The full comment on the FDA’s discussion paper, “Considerations for the Regulation of Generative-AI Enabled Medical Devices,” can be viewed below.