Digital therapeutics and mental health apps, with Vaile Wright, PhD
Speaking of Psychology
The FDA's Role in Regulating Mental Health, Digital Therapeutics
FDA is tasked with regulating the space because these devices make claims that they diagnose, treat, or cure a medical disorder. The FDA primarily focuses on two things: efficacy and safety. And one of those pathways is deemed quote unquote prescription. So in the case of mental health, digital therapeutics, that could be a psychologist, a social worker, or it could be a primary care physician.
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