FDA Official Envisions New Regulatory Approach to Digital Health

Snail-paced regulators get up to Silicon Valley speed

To get federal regulators off snail-paced Washington time and up to Silicon Valley speed, the FDA’s Dr. Bakul Patel is creating a new unit dedicated to digital health, according to an article posted on the Wired website. He plans to hire 13 engineers—including software developers and experts in artificial intelligent (AI)—to prepare his agency to regulate a future in which health care is increasingly mediated by machines. Patel also has plans to reimagine the path these machines will take to regulatory approval.

The FDA has issued several documents describing its current thinking on digital health. These documents help device developers understand what the agency does and does not regulate as a medical device, and they reflect a largely hands-off approach, according to Wired. The most recent of the FDA’s proposed rules address software as a medical device—a category that would include medical apps, which are largely unregulated.

Rather than reviewing each medical device or line of code on its own merits for each of its intended uses, Patel wants to flip that framework on its head, the article says. Instead, he envisions a model more like the Transportation Security Administration (TSA) security lines at airports: New developers or manufacturers with spotty track records would still have to take off their shoes and go through the body scanner. But trusted companies with demonstrated histories of excellence could keep their footwear and stroll through the metal detector.

Patel is not yet sure how it would work, but it’s one of the ideas he’s toying with and running by industry stakeholders. “The idea is to get safe products to market faster by having people compete on excellence rather than compliance,” he said.

“We’re headed toward a zero code world, where AI writes it for you or you just say what you want, and natural language processing takes care of the rest,” Patel said. “The pace will be tremendously faster than what we’re seeing today. The question is, how do we align our regulations to that radically different development timeline?”

Whatever the approval process winds up looking like, the Wired article says, it will fall to Patel’s new digital health unit to oversee and coordinate it among different offices within the FDA. Right now, those efforts are fragmented by specialty. For example, experts in the cardiology group would be in charge of a device that uses AI to quantify blood flowing through the heart, while a radiology group would review AI-powered software that reads magnetic resonance imaging (MRI) scans. Breaking out of those silos is the goal for Patel’s group, since the same technologies will increasingly apply to products that reach across specialties.

Patel has been given the go-ahead to start bringing new people into key positions. More jobs will be announced in October, when the new Medical Device User Fee Amendment goes into effect. Every four years, the FDA renegotiates this agreement with the industry. The latest one established the formation of Patel’s digital health unit. The user fees will provide him with the money to make his hires.

Source: Wired; May 22, 2017.