A new collaboration brokered by the Digital Medicine Society (DiMe) aims to help regulate digital health solutions in the United States.
The new partnership brokered by DiMe, an industry group, will bring representatives from the public and private sectors and industry associations together to inform future digital health regulatory strategies.
Joining the DiME on this project are Google, pharma giants Abbott, Amgen, Genentech and Janssen, the Consumer Technology Association (CTA), the U.S. Food and Drug Administration (FDA), the Harvard-MIT Center for Regulatory Science, and digital health company, Sidekick Health.
The FDA launched a center in 2020 seeking to “modernize” its approach to regulating digital health technologies such as apps and wearables, but many of the more than 300,000 health apps available fall outside of its regulatory scope.
A DiMe survey found 25% of developers didn’t know whether their product should be regulated. Of those that did,75% were unaware of the optimal regulatory pathway.
“We need to flip the script and see regulatory strategy become a differentiator for digital health solution providers,” Jennifer Goldsack, Digital Medicine Society CEO, said in a statement. “As we anticipate a tightening of funding for digital innovators, the importance of selecting optimal regulatory pathways for individual products and product portfolios becomes critically important to ensure market access, trust, and adoption.”
Goldsack said the society hopes the collaborative will help define the optimal regulatory pathways. It will first develop a decision support tool for developers and digital solution providers that will be available in early 2023.
The framework will aim to help companies explore the right regulatory strategies for their products, as well as determine the pros and cons of pursuing a regulatory pathway.
