Digital Therapeutics (DTx): Software as a Prescription
In 2025, "Software as a Medical Device" (SaMD) has gained significant regulatory traction. Physicians can now officially prescribe Digital Therapeutics—clinically validated software programs that treat specific conditions like insomnia, ADHD, or substance use disorders. These programs often use gamified cCBT to engage patients in a way that traditional worksheets cannot.
The 2025 landscape features "Prescription-Only" apps that are reimbursed by insurance, just like pharmaceuticals. These tools are particularly valuable for rural and underserved populations where specialized therapists are unavailable. By 2025, data shows that cCBT-based apps can lead to a 45% reduction in depressive symptoms, providing a scalable solution to the global mental health crisis.