Arlington, VA, October 21, 2021 – The Consumer Technology Association’s (CTA)® today announced standards for the use of digital therapeutics (DTx) – an emerging field that uses software-based interventions to enhance or provide care.
Digital Therapeutics (DTx) is an evidence-based, standalone or combination software product intended for management, maintenance, prevention or treatment of a disease, disorder or condition acting directly as a medical intervention or guiding the delivery of a medical intervention. Digital Therapeutics encompass everything from digital exercise programs specifically designed as an element of treatment for patients with diabetes to virtual reality-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.”
CTA’s effort brought together a diverse set of industry stakeholders for the first American National Standards Institute accredited standard for digital therapeutics. CTA member organization that worked to create 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.
View the full Definitions and Characteristics of Digital Therapeutics here.
CTA members have been at the forefront of applying and defining digital therapeutics. In 2020, CTA released the first-ever digital health standard on the use of artificial intelligence in health care, developed by more than 50 tech and health organizations. CTA also released standards on performance requirements for physical activity and stress monitoring that year.
CES 2022 will include a panel session focused on DTx, Digital Therapeutics and Road Ahead: Defining Health Outcomes Through Data and Tech. Registration information for CES is available here.