A digital health collaborative that includes Google, the FDA and the Harvard-MIT Center for Regulatory Science plans to release an interactive, open-access regulatory support tool for healthcare tech companies.
The Digital Medicine Society's Digital Health Regulatory Pathways will consolidate guidance from government agencies for increasingly popular — but often unregulated — healthcare options like remote monitoring, virtual reality and digital diagnostics and therapeutics. The tool will be publicly available early next year.
There are more than 300,000 health apps using varying degrees of evidenced-based practices, the society said. A quarter of developers said they did not know whether their products should be regulated, and of those that did, 75 percent reported not knowing the proper regulatory pathway, according to a Digital Medicine Society survey.
"We need to flip the script and see regulatory strategy become a differentiator for digital health solution providers," said Jennifer Goldsack, CEO of Digital Medicine Society, in a June 14 news release from the collaborative. "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."