Digital Therapeutics in Behavioral Health: Clinical Applications, Evidence, and Regulatory Considerations

Digital Therapeutics in Behavioral Health: Clinical Applications, Evidence, and Regulatory Considerations CE Course (PDF document) – Online CE Course

Digital Therapeutics in Behavioral Health: Clinical Applications, Evidence, and Regulatory Considerations CE Course objectives, description, and outline

Course Objectives:

• Describe at least two key clinical, regulatory, and equity considerations when selecting and integrating digital therapeutics into behavioral health care settings.

Course Description:

The last decade has seen immense changes in digital health, with the expanded use of computing platforms, electronic medical records, mobile applications, and wearable devices in health care. During the COVID-19 pandemic in particular, telehealth expanded access to care for millions of people and was a critical resource to meet the behavioral healthcare needs of individuals with mental health conditions and substance use disorders. Another example of the use of technology to facilitate care is digital therapeutics (DTx). DTx are health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health. DTx may be used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. DTx may or may not require a prescription and are generally considered medical devices subject to regulatory oversight by the Food and Drug Administration (FDA).

Course Outline:

1. 1. Introduction
      1. Key Messages
      2. Definitions
   2. Overview of Digital Therapeutics
   3. Benefits of DTx
   4. Research, Regulatory, and Reimbursement Considerations for DTx
   5. Considerations for Selecting and Implementing DTx in Care Delivery
   6. Increasing Equity in Digital Therapeutics
   7. Resources

Instructors: Nicole Hiltibran, MA, LMFT; Julie Campbell, Phd

Author: SAMHSA

The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services that leads public health efforts to advance the behavioral health of the nation. SAMHSA’s mission is to reduce the impact of substance abuse and mental illness on America’s communities.

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