Digital Therapeutics Stakes its Claim to the Fast Growing mHealth Marketplace

The Consumer Technology Association has created standards for the use of digital therapeutics in an effort to define and establish value for the mHealth platform.

“The biggest challenge in the digital therapeutics industry is the wide variety of terms used to define it, from digital devices to digital medicine,” Kerri Haresign, the CTA’s director of technology and standards, said in a press release issued this week. “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.”

The organization, which oversees the massive Consumer Electronics Show (CES) each January in Las Vegas, defines digital therapeutics as “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.” The definition groups together everything from mHealth apps integrated with virtual reality to virtual exercise programs for chronic care management.

The standards are the by-product of an initiative launched in August 2020 by the CTA and roughly two dozen mHealth and telehealth companies intent on carving out a niche in the digital health lexicon. At the time, Haresign said the COVID-19 pandemic was pushing innovation to new heights, and supporters needed to develop a common language and understanding of how the technology is used.

“This field takes the application of technology beyond just wellness tracking,” added CTA President and CYTO Gary Shapiro. “Companies are now developing solutions that can manage pain, allergies and even address mental health problems. As more people take control of their own health in the comfort and safety of their homes, we must understand what this technology means and how to advance its adoption.”

The industry even has its own trade group, the Digital Therapeutics Alliance, which was launched in 2016 to more tightly define what was then being called “software as a drug.”

One of the founding members of that group is DarioHealth, which markets a line of digital therapeutics products for chronic care management. The company’s chief medical officer, Omar Manejwala, MD, recently sought to differentiate digital therapeutics from other technologies like telehealth.

“It’s analogous, although not perfectly, to the difference between Facetime calls and Facebook,” he said in an e-mail to mHealthIntelligence. “With Facetime you need the other person to be ready and willing to connect with you. With Facebook you communicate with whomever you want, broadly, and at the time and format that works for you.”

“Most people understand that doctors’ visits are important, but that most decisions that impact health are made outside of the doctor’s visit,” he added. “Digital therapeutics support people in their lives to make the changes they need to so they can live healthier lives. Digital therapeutics are scalable, high value, and allow for a level of personalization that is not generally possible at scale with video or telephone doctor visits.”

“As the pandemic resolves we are already seeing a reversion of telehealth back to face-to-face visits for many folks - and that’s a good thing in many cases,” he concluded. “But with digital health there is no analog correlate - the value that digital therapeutics unlocks is not available in an analog format - which is why we see acceleration even as the pandemic waxes and wanes.”