The Consumer Technology Association (CTA) has announced a new standard for the use of digital therapeutics (DTx). With this new standard, the association hopes to bring greater clarity to currently nebulous terminology being used to describe software-based interventions that either enhance or provide care.
What is Digital Therapeutics?
Put succinctly, DTx is a term used to described evidence-based, standalone or combination software products intended for the management, maintenance, prevention or treatment of a disease, disorder or condition, acting directly as a medical intervention of guiding the delivery of a medical intervention, according to the CTA. This encompasses a broad range of technological solutions from digital exercise programs designed as an element of treatment for patients with diabetes to virtual reality (VR)-based mental health apps for patients with PTSD.
“The biggest challenge in the digital therapeutics industry is the wide variety of terms used to define it, from digital devices to digital medicine,” said Kerri Haresign, director of technology and standards at CTA. “A clear standard will eliminate industry confusion, making these technologies more widely available for use and adoption. Greater access will lead to better health outcomes for patients. Establishing a common vocabulary allows our industry to focus on the more complex problems, such as evidence-based performance criteria that allow doctors and clinicians to integrate digital therapeutics in their practices.”
Stakeholders Help Craft the New Standard
As part of the efforts to reign in many of the interpretations as to what constitutes DTx, CTA brought together a diverse set of industry stakeholders for the first American National Standards Institute accredited standard for digital therapeutics.
Those who had a hand in helping implement this standard include Amalgam Rx, Amptify, AudioCardio, Bose Corporation, CareWear, Curelator, Ginger, GlucoseZone by Fitscript, Happify Health, Healium, MindMaze, MyndVR, Philips, Propeller Health, ResMed, The Omega Concern, TouchPoint Solution, Valencell, Validic, Welldoc and several others. The effort also included the Digital Therapeutics Alliance.
For those interested in learning more about the new standard, or digital therapeutics as a whole, the full document on the Definitions and Characteristics of Digital Therapeutics can be explored through the link provided.