FDA to mobile health community: “Help us be a partner”
Federal regulators are not particularly well liked by many in Silicon Valley. The FDA is often described as a “roadblock” or a “big bad wolf” in the press, and viewed as an enemy to the explosive growth of so-called innovative medical startups.
But FDA’s Bakul Patel, the agency’s associate center director for digital health, is no stranger to health conferences frequented by startup founders. At USC’s Body Computing conference today, he provided some clarity in noting that the agency is most concerned with ensuring that the health data analyzed by companies is accurate (not just the step counts themselves).
FDA’s @_bakulpatel: It’s not about collecting info about steps. It’s about the "next-level analytics" that need to be accurate. #USCBCC10
— Christina Farr (@chrissyfarr) September 23, 2016
He also shared that the agency is coming up with a “new paradigm” to accommodate mobile medical apps that make updates every few weeks.
The @US_FDA "needs to come up w/ new paradigm [to accommodate] app updates every 2 weeks" @_bakulpatel #USCBCC10 w/ @mkrupnic @ManeeshJuneja
— CATALAIZE (@CATALAIZE) September 23, 2016
Finally, he asked for startups to get involved with the agency as it adapts. “Help FDA be a partner in this journey,” he urged. CF