Friday, June 16, 2017

Brief Blog: FDA Burst of Activity on Digital Health Regulation vs Innovation

On June 15, 2017, FDA Commissioner Dr. Scott Gottlieb issued a blog on the FDA's plans for a new Digital Health Innovation Plan.  It sounds like the plan will consolidate several years of planning on regulation of apps and digital health software, some legislative changes in 21st Century Cures, and Dr. Gottlieb's vision toward this kind of agency problem-solving.
  • The June 15 Gottlieb blog is here.
  • Coverage at Biopharma Dive here.
  • Coverage at MedCityNews here.
  • Coverage at MobiHealthNews, here.
  • In addition, MedCityNews on "avoiding legal misteps" in digital health, here; see also here.
  • In addition, a May 2017 article in WIRED on the same topic, here.  Interview with Bakun Patel, "associate center director for digital health."  For another current WIRED article on mobile health apps, here.
  • FDALawBlog on 21st Century Cures legislation and its effect on healthcare software regulation, here, here.
  • In past months, the Clinical Decision Support (CDS) Coalition proposed its own draft validation guidelines (absent clear guidance form FDA; here) and filed a Citizens Petition urging guidance to be released from FDA (here).

As quoted in WIRED: "As Patel, now the associate center director for digital health at FDA, was digging through the guidance’s 1,400 comments, he had a lightbulb moment. “We’ve been trying to translate the current regulation paradigm for digital,” he says. “But what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.”

Gottlieb writes that he wants to continue to rapidly clarify what is NOT regulated by the FDA, and to introduce innovative and rapid processes for things that ARE regulated (third party reviewers, exemptions from review for minor updates.)