Digital Therapeutics vs Wellness Apps

Two kinds of health app

Both live on a phone and both can look alike. The difference is what they claim and what has been tested. A digital therapeutic delivers an intervention for a disease or condition through software that has been clinically evaluated. A wellness app supports general health habits such as relaxation, activity or sleep tracking. This page compares them as information only. Evidence labels: approved or cleared product, promising but limited, mixed and marketing claim (see how we label evidence).

Side by side

Digital therapeutics: what the label means

A review describes digital therapeutics as software that delivers interventions directly to patients, using an evidence-based, clinically evaluated program to treat, manage or prevent disease. [1] A 2025 analysis of FDA-cleared prescription digital therapeutics reports they were identified through the FDA's De Novo or 510(k) pathways. [2] Clearance is for a named product and use, not for apps in general. See regulatory status of digital health products.

Evidence example, promising but limited: a meta-analysis of randomized trials of game-based digital therapeutics for children with ADHD found small improvements in rated inattention compared with control, by parents and teachers (standardized differences 0.28, 95% confidence interval 0.14 to 0.41, and 0.21, 0.03 to 0.39). [3] Indirect comparison found medication improved teacher-rated inattention more than the game-based therapy (-0.62, -1.04 to -0.20). [3] A cleared digital therapeutic is therefore evidence for a defined use, not a replacement for other care. For another defined use, see digital CBT for insomnia.

Wellness apps: what the label means

The FDA's general wellness policy defines such products by two factors: they are intended only for general wellness use and present a low risk. [4] Listed general wellness claims include relaxation or stress management, mental acuity and sleep management. [4] The FDA's software policy says it focuses on the software that could pose greater risk if it fails, and it does not expect premarket review for many minimal-risk functions, such as ones that help users self-manage a condition without giving specific treatment suggestions. [5]

Evidence is mixed and depends on the app. A meta-analysis of randomized trials of mindfulness apps in college students (2,974 participants across outcomes) found stress fell by about 0.44 standard deviations, with small effects on depression and anxiety. [6] Yet researchers also describe a research-to-retail gap: many publicly available well-being apps have yet to be empirically tested. [7]

Reading a claim

• "Treats," "prescription" or a named condition: look for a named FDA decision and a matching trial.
• "Supports," "relaxation," "healthy habits": a general wellness claim, which is not a medical claim.
• Check the privacy policy, since health data may be shared. See digital health data privacy.

No universal winner

A cleared digital therapeutic has been tested for a specific condition. A wellness app may help with habits or stress, but its trial evidence varies. Neither is better in general. See also clinical validation of health software.