Digital Therapeutics (DTx) are a high-growth subset of SaMD that deliver evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder. Unlike a general wellness app, a DTx is "prescribed" by a physician and must prove its efficacy through clinical trials. Common applications include Cognitive Behavioral Therapy (CBT) apps for insomnia or depression, and behavioral modification software for chronic conditions like hypertension.

The technical complexity of DTx lies in "Patient Engagement" and "Adherence." If the patient does not use the software as intended, the therapeutic dose is not delivered. Trends in gamification and personalized "Nudge" mechanics within DTx are explored in the Software as a Medical Device Market outlook.

As DTx gains reimbursement codes from insurers, it is being integrated into the "Pharmacy Benefit" model. This means a doctor can prescribe a piece of software just as they would a pill. This shift marks the culmination of the SaMD evolution, where software is no longer just a tool for the doctor to use, but a direct therapeutic agent capable of altering the course of a disease.