Digital therapeutics (DTx) are software products that deliver the clinical intervention themselves, rather than just supporting one. Examples include software-based cognitive behavioral therapy (CBT) for insomnia, prescription apps for substance-use disorder, and game-based therapy for ADHD. The defining feature is that the software is the treatment — it claims a measurable therapeutic effect on a disease or condition, which sets it apart from a wellness app that merely encourages healthy behavior without claiming to treat anything.
That therapeutic claim is what pulls DTx onto the regulated path. Because a DTx asserts a clinical effect, it generally sits on the FDA medical-device track, frequently as Software as a Medical Device (SaMD), and carries clinical-evidence requirements — the product is expected to demonstrate its effect through studies, not just assert it. This is a meaningfully higher bar than a wellness app faces, both in development cost and in the obligations that follow it through its lifecycle.
For a platform builder, the practical implication is that integrating a DTx is closer to integrating a regulated device than to embedding ordinary content. You inherit considerations around the device's intended use, its labeling, adverse-event handling, and the boundaries of what claims your own product can make about it. The data exchanged is protected health information (PHI) when handled in a covered relationship, so HIPAA and Business Associate Agreements (BAAs) still apply on top of the device framework. The common pitfall is blurring the line between a DTx and a wellness feature in marketing — describing a general-wellness app as if it treats a condition can retroactively trigger device-regulation obligations the product was never built to meet.
The handbook · 7 volumes
Fora Soft Video Engineering Handbook
Digital therapeutics are regulated as the treatment itself, so every AI component and every video session has to be traceable and validated. We wrote seven volumes covering the whole video stack, and for DTx teams start with Volume 7: production AI pipelines, agents, serving, regulation and vertical playbooks. Volume 6 covers the AI feature lifecycle and Volume 3 video delivery. Written by Nikolay Sapunov, CEO at Fora Soft.
Building digital therapeutics with video or AI components?
We will scope your DTx product with the video, AI and data-capture parts structured for a regulated development path, plus a timeline. 250+ video products shipped since 2005.
