Policy challenges and opportunities for digital therapeutics in the mental health and substance use crisis

Mental health and substance use conditions have reached a crisis during the COVID-19 pandemic, with Black, Indigenous, and People of Color, LGBTQ+, and rural populations facing the greatest challenges in accessing needed care.

Telehealth has increased connections to care (while facing equity in access issues for many), but other innovations such as digital therapeutics (DTx), also referred to as “software as a medical device” (SaMD), have not achieved the same scale.

The Digital Therapeutics Alliance defines DTx as evidence-based, clinically evaluated software that delivers medical interventions to treat, manage, and prevent a broad spectrum of diseases and disorders. Several DTx have been developed for mental health and substance use conditions, but they are not widely accessible by the individuals that face the greatest barriers to care. What could the role be for DTx in the mental health and substance crisis and in closing disparities in access? What policy challenges and opportunities face DTx in advancing mental health and substance use care and equity?

Hear perspectives from provider, payer, consumer, industry, and academia as well as dialogue with leaders from the Food and Drug Administration and the Centers for Medicare and Medicaid Services.