An Insider’s Look Into DTx for Regulatory Professionals

Digital Therapeutics (DTx) is a small but powerful category of digital health that makes healthcare more accessible through the novel digitalization of proven, offline therapies, as well as new therapies made possible through patient-facing technology. DTx has risen in prominence, especially since the outset of the COVID-19 pandemic. Yet the current regulatory environment is still evolving to address the nuances of DTx and similar digital health offerings.

With all of the changes Digital Therapeutics brings to healthcare, regulatory professionals need to be fully conversant in DTx’s potential to transform the landscape. An in-depth understanding of the pros – and pitfalls – of DTx will serve regulatory professionals in propelling their organizations forward. The Regulatory Affairs Professionals Society (RAPS), an organization dedicated to advancing the profession of regulatory affairs in healthcare, invited Orthogonal to deliver a hands-on workshop aimed at giving their members an insider’s look into DTx.

On September 11th, at the RAPS Convergence 2022, Randy Horton, Orthogonal’s Chief Solutions Officer, and Brian Binkowski, Director of Quality at Twill, led a day-long session on understanding DTx, derived from Orthogonal’s DTx eBook. They were joined by a variety of experts and players in the DTx space, including Sindhu Rajan of HabitNu, Ethan Wergelis-Isaacson of McKesson, Jennifer Newberger, JD, MPH of Cognito Therapeutics, Inc, Krys Zaluski, and Guarav Gupta of MSquare Healthcare. 

Attendees at this session left with the following:

• An understanding of DTx from a number of relevant dimensions.
• The ability to have an effective conversation on how DTx can fit into their organizations’ overall regulatory portfolio and future strategy.
• The vocabulary and framework for critically assessing new information about DTx that will aid their future work.