In Reason, technology-policy analyst Pablo Garcia Quint argued that AI wellness chatbots like Ash should not be regulated as medical devices, framing Ash as a low-cost, around-the-clock support tool helping people amid a shortage of mental health providers.
Writing in Reason, technology-policy analyst Pablo Garcia Quint made the case against the FDA treating AI mental health chatbots as medical devices, arguing the costly classification does not fit tools designed for general wellness rather than diagnosis or treatment. He pointed to Ash, from Slingshot AI, noting the company told the FDA it aims to provide "general wellness by making mental health support more accessible," not to treat or diagnose conditions. Garcia Quint framed Ash and similar apps as a low-cost, always-available response to a shortage of mental health providers affecting millions of Americans. As evidence that the tools help, he cited a 10-week Slingshot study in which 72% of Ash users reported a decrease in loneliness, 75% reported more perceived social support, and four in five reported greater hope and engagement with their lives. The piece argues that over-regulating such beneficial tools would harm the people seeking help.
