The regulatory agency for drugs and medical devices is creating a new unit dedicated strictly to digital health.
WHEN BAKUL PATEL started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well.
But as computer code took on more complex tasks, like spotting specious moles and quantifying blood flow, their duties began to accelerate. Software developers needed months, not years, to make it to the market. And there were a lot of them. It got harder to match pace. And then came artificial intelligence.
Today, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly. For most regulators, an ever-changing algorithm is their worst nightmare. But Patel is one of those rare Washington bureaucrats who’s also a fervently optimistic futurist. And he’s got big plans to get federal regulators off Washington time and up to Silicon Valley speeds.
To do that, the FDA is creating a new unit dedicated strictly to digital health. Patel will be hiring 13 engineers—software developers, AI experts, cloud computing whizzes—to prepare his agency to regulate a future in which health care is increasingly mediated by machines. (He’s using funds generated by the medical device division’s user fee system, which is the FDA’s only other revenue stream besides congressional appropriations.) He’s also got plans to reimagine the path these machines will take to regulatory approval.
For technology giants getting into the health care game, the timing couldn’t be better. Last year Google’s venture capital arm (which manages around $2.4 billion) spent one-third of its investments in the health care space. Its spinoffs Calico and Verily are pursuing ambitious projects like smart contact lenses, Project Baseline—oh, and beating death. Apple, in addition to its wellness through wearables play, is already working closely with the FDA on an app to diagnose Parkinson’s. And IBM is employing its artificial intelligence engine, Watson, to do everything from treating cancers to discovering new drugs.
Over the last year, FDA has put out a number of documents describing the agency’s current thinking on digital health. These guidance help developers understand what FDA does and what it doesn’t regulate as a medical device, and they reflect a largely hands-off approach. The FDA focuses its limited resources mostly on high-risk products, and the most recent of its proposed rules addresses software as a medical device—a category that would include medical apps, which remain largely unregulated.
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.”
Rather than reviewing each line of code or medical device on its own merits for each of its intended uses, Patel wants to flip that framework on its head. Instead, he envisions a model something more like the TSA security line at the airport: 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’s not yet sure exactly 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 says. The trick is not to get bogged down by stuff you’ve never seen before.