Digital Therapeutics
Also known as: DTx, Prescription Digital Therapeutics
Software that delivers an evidence-based therapeutic intervention to prevent, manage, or treat a medical condition.
Full Definition
Digital therapeutics deliver treatment through software, rather than simply providing information or monitoring. Examples include software that delivers cognitive behavioral therapy for insomnia or substance use disorder. Digital therapeutics intended to treat medical conditions are generally regulated as medical devices and require clinical evidence supporting their therapeutic claims.
Reimbursement is a central challenge. Although billing pathways are emerging, many payers lack established coverage and payment policies for software-based treatments. Teams need to identify the economic buyer, understand who will pay, and establish a viable payment model early in development.
A team developing an app for people with chronic low back pain considers two approaches. One provides general exercise guidance, educational content, and activity tracking without making medical treatment claims. It is unlikely to be regulated as a medical device. The other delivers personalized therapeutic exercises intended to treat chronic low back pain and may require FDA authorization supported by clinical evidence.
The team evaluates the regulatory and evidence requirements for each approach while testing whether employers, health plans, or patients will pay for the program. The choice of intended use and claims shapes both the development plan and commercialization strategy.