COVID-19 Accelerated Use of Digital Therapeutics, but Coverage Issues and Regulatory Questions Could Slow Their Momentum

"Digital therapeutics — clinically tested tools that deliver medical interventions via software — have been gaining traction for years, with products that treat a range of conditions, including diabetes, mental health issues and cancer. Now, the digital health field’s explosive growth during the COVID-19 pandemic is helping these companies carve out a space for their products, but the young sector still faces regulatory and payer-side challenges that could slow its widespread adoption.

The first prescription digital therapeutic to be approved by the Food and Drug Administration was Pear Therapeutics Inc.’s mobile app in 2017 for patients with substance abuse disorders; today there are roughly 35 to 40 products on the market, though the FDA doesn’t clearly define digital therapeutics. Another tool from Cognoa Inc., for example, helps doctors diagnose autism more quickly by having parents submit information about their young children’s behavior in an app that also takes into account physician responses.

The difference between such products and the thousands of wellness apps or non-prescription digital health tools that are available is that “they’re going to deliver a clinical outcome, or heavily facilitate that outcome delivery in a really direct way,” said Bill Evans, the chief executive of Rock Health, a venture fund focused on digital health startups..." Lire la suite