Boston, MA, March 1, 2023 –

Today, the Digital Medicine Society (DiMe) announced free resources to help innovators optimize their regulatory strategy to drive the development of high-quality, trustworthy digital health products that best meet their commercial goals and the needs of patients. The resources – including U.S. RegPath, the world’s first tool for navigating U.S. regulatory pathways for digital health products – were developed as part of a DiMe’s collaborative project, Digital Health Regulatory Pathways, with partners including Abbott, the Consumer Technology Association (CTA), Google, and the Harvard-MIT Center for Regulatory Science.

A fit for purpose regulatory strategy that includes a bespoke timeline and approach to if, when, and whether to seek regulatory oversight offers end users, patients, and clinicians confidence about the tools and products they are using. It can also improve market access, support payment strategies, and optimize the impact on patient care and outcomes. Finding ways to help innovators navigate regulations and incorporate a robust regulatory strategy into their business plans is critical to addressing some of the most pressing and persistent challenges in healthcare.

Yet, when DiMe’s Digital Health Regulatory Pathway project kicked off in June 2022, DiMe surveyed the digital medicine stakeholders and found that 25% of medical product developers didn’t know whether their digital health product should be regulated. Of those surveyed who did know their product should be regulated, 75% reported not knowing the optimal regulatory pathway. The new resources announced today address these challenges by helping innovators understand the key differences between pathways and the commercial benefits to regulatory engagement and acceptance.

“Digital health product developers seeking to differentiate themselves in this increasingly crowded and competitive market must embrace regulatory strategy as a core component of good business strategy. As economic headwinds increase and end users of digital health products are increasingly discerning, dodging regulatory oversight or performatively pursuing regulatory consideration will undermine the trust not only in individual digital health products, but the field more broadly,” said Jennifer Goldsack, CEO of DiMe. “Fortunately, these free, open access resources not only clarify the variety of well defined regulatory pathways available to industry today, but also provide information, education, and support for successfully pursuing the most fit-for-purpose regulatory pathway to optimize the impact of new digital health products on the patients our industry exists to serve.”

“We believe these resources will help digital health innovators leverage new technologies to advance more accessible and equitable care,” said Linda Peters, Vice President of Quality, Regulatory & Safety, Health at Google. “We’re proud to have worked with DiMe and other leading digital health innovators to develop unprecedented resources that can support the innovation ecosystem, speed commercial success, and create more comfort for end users.”

The development of these resources adds to DiMe’s portfolio of implementation work to support broad acceptance of digital health tools and optimization of regulatory strategy. 

Partners on this project are Abbott, Abbvie, Aetion, American Medical Association (AMA), Amgen, AstraZeneca, the Consumer Technology Association (CTA), the Digital Therapeutic Alliance (DTA), Genentech – a member of the Roche Group, Google, the Harvard-MIT Center for Regulatory Science, Janssen, Otsuka Pharmaceuticals, Rock Health, Sidekick Health, and Tidepool.

DiMe is not only committed to creating and disseminating new digital health tools, but also sharing user experiences with the broader community. We encourage users to contribute to Dime’s “Resources in Action” case study hub by sharing how you are using these resources to further the safe, effective, equitable, and ethical use of digital medicine to redefine healthcare and improve human health.