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Digital therapeutics and mental health apps, with Vaile Wright, PhD

Speaking of Psychology

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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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