More than 100 AI chatbots are currently marketed as mental health-focused, yet experts caution that they should not replace traditional therapy due to a lack of scientific evidence. Outside researchers and company representatives have informed the FDA and Congress about the limited support for these products' efficacy. Existing studies on their effectiveness offer contradictory findings, with some research indicating that companion-focused chatbots are "consistently poor" at managing crises.
Despite the lack of proof, these AI therapy apps are a burgeoning industry, with KFF Health News identifying approximately 45 such apps in Apple's App Store in March. Many of these apps carry substantial costs, with some annual plans reaching up to $690, though they are generally more affordable than traditional talk therapy, which can cost hundreds of dollars per hour without insurance. Polling data suggests these chatbots are particularly popular among young adults; a KFF poll found about 30% of respondents aged 18 to 29 used AI chatbots for mental or emotional health advice in the past year, and nearly 60% of adult chatbot users did not follow up with a human professional.
Regulators face challenges in overseeing this rapidly expanding field. There are few legislative or regulatory frameworks governing how developers market their products or ensure their safety and effectiveness. Federal patient privacy protections often do not apply to these apps, and states like Nevada, Illinois, and California are beginning to enact laws to prevent apps from misrepresenting their chatbots as AI therapists. The FDA states that patient safety is its highest priority and that AI-based products are subject to regulations requiring demonstration of safety and effectiveness, but critics like Charlotte Blease of Uppsala University argue the FDA has not provided adequate recommendations for testing these products.
Concerns about safety are significant. Sam Altman, CEO of OpenAI, has stated that up to 1,500 people per week might discuss suicide on ChatGPT. There have been high-profile reports of the service offering harmful advice, and at least a dozen lawsuits alleging wrongful death or serious harm have been filed against OpenAI, with plaintiffs claiming they initially used the apps for other purposes before confiding in them. These cases are being consolidated into a class-action lawsuit. Despite these risks, some users, like Vince Lahey, find these chatbots appealing for their perceived non-judgmental nature and the ability to share more personal information.