The term “health tech” is an umbrella term that encompasses a vast spectrum of technologies ranging from personal health trackers to off-road wheelchairs to living, 3D printed human tissue. Digital therapeutics, an important category that falls under the health tech umbrella, refers specifically to clinically-validated, software-based therapeutic medical interventions. The Consumer Technology Association (CTA) has announced an initiative to develop a set of standards focused explicitly on this rapidly expanding field.

Because the COVID-19 pandemic has driven innovation in digital therapeutics, companies are quickly bringing products to market. These include solutions that manage pain, address mental health issues, ensure consistent delivery of medications, and perform many other critical functions. 

Many types of health tech are already required to meet established national and international standards; they are also subject to FDA clearance in the United States or CE-marking in Europe. However, no standards that categorically target digital therapeutics exist at present. In light of the sudden digital therapeutics expansion, industry leaders have concerns about the limitations of more general standards.

Chaired by MindMaze, a digital therapeutics company that focuses on neurological conditions, a consortium of more than 20 health technology companies will participate in the CTA initiative. This team of industry leaders, including Google, HP, and Philips, will establish the parameters of the field and identify best practices for the purpose, application, and performance of digital therapeutic solutions. By defining the scope and definition of digital health, and implementing these standards, the initiative hopes to facilitate ongoing innovation that significantly improves patient outcomes and lowers healthcare costs.

The CTA recently established standards for non-therapeutic digital health solutions that involve AI in health care and monitoring of physical activity and stress. The organization is hosting the upcoming Technology & Standards Fall Forum, on September 21 through 24, which features a panel discussion about the science and application of digital therapeutics.