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The FDA’s Newest Unit Looks Beyond Food and Drugs…

Washington, D.C.—In a recent Wired article, Bakul Patel shared a glimpse into the new team he’s building within the FDA—completely focused on new developments in digital. As the organization’s Associate Director for Digital Health, he’s planning for his squad of 13 tech engineers to sit outside of the Administration’s traditional siloes arranged by specialty. That way, his team of computing gurus and AI experts will be able to focus on the tech aspects of potential digital therapies and simply coordinate with medical experts in each field when necessary.

With numerous tech giants from Apple to Google investing heavily in digital health, getting this new team running at full speed can’t soon enough. Add to that load the estimated 100,000 apps brought to market in 2016 by mobile health publishers that are currently under-regulated, and the term “job security” is likely in the mouths of recruiters for Patel’s team.

Why This Matters—

This growing demand leads to questions of feasibility and adaptability. Even if this new FDA team can cover the growing digital workload, it also has to figure out how to wrangle and regulate this constantly evolving market. Here’s the good news: Patel has a plan. “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.”

His proposed approach is actually similar to the strategy used by the TSA. Much like the Pre-Check program, Patel plans to vary the level of scrutiny the team applies to each new application. For new developers or any companies with a checkered past of shoddy work, substantial time and attention will be administered (think a version of shoes off, empty your pockets), but if a company is a known entity with a strong track record of safe, effective digital health products, they’re put in the fast lane for a quick, effective scan. “The idea is to get safe products to market faster, by having people compete on excellence rather than compliance,” he says. “The trick is not to get bogged down by stuff you’ve never seen before.”

If this model proves effective here, could it also point to more efficient processes for traditional pharmaceutical molecules?