Prescription Digital Therapeutics (PDT) are computer-based solutions to medical conditions that are viewed as comparable to pharmaceuticals.
Features of a prescription digital therapeutic:
(1) a digital solution developed using Good Manufacturing Practices (GMP)
(2) have shown safety and efficacy in randomized clinical trials
(3) approved by the Food and Drug Administration or comparable regulatory body
(4) prescribed by a licensed provider
(5) used to prevent, diagnose and/or treat a medical condition
(6) reimbursed as a therapeutic product
Examples of therapeutics:
(1) depression
(2) substance abuse
(3) diabetes
(4) insomnia
