By Clifton Leaf
July 9, 2018

Consider the following assessment of mobile medical apps:

[They] may help overcome the siloed, episodic, reactive nature of US health care, whereby patients seek care only after potentially costly health complications occur, and physicians are only reimbursed for expensive in-person office visits that may not reflect the day-to-day reality of the patient experience of living with complex chronic conditions.”

Now consider the authors of that brief summary—which is about as blunt about the dysfunction of the American health care system as it is optimistic about the modern tech that might cure it. They are: Jeffrey Shuren, Bakul Patel, and Scott Gottlieb, writing in a July 2 commentary in the medical journal JAMA.

Shuren, for those of you who don’t obsessively parse org charts of the federal government, oversees the Food and Drug Administration’s Center for Devices and Radiological Health, as he has since 2010. Patel is the associate director for the FDA’s new center on Digital Health. And Gottlieb, of course, is the FDA Commissioner.

The op-ep is striking not just for how it captures our American health pathology, but also for how it describes the lack of regulatory clarity that seems to hover over much of it—an uncertainty that, historically, has made health care “slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” the authors say.

Gottlieb, a Trump appointee who has earned high marks all around, has been signaling for a while now that he wants a lighter hand on several areas of drug and device regulation. That’s not news, exactly. But the push to lift the fetters in the fast-growing arena of digital health—particularly when it comes to apps that let consumers better manage their own care as well as record and keep track of their health-related data—is an effort that seems to run up and down the FDA food chain. (Shuren, it’s worth noting, is not a Trumpee, but rather an appointee of former FDA commissioner Margaret Hamburg, who herself was an Obama appointee.) And that suggests at least a quiet revolution at the agency.

So what are the key takeaways from the new laissez-faire stance? For one, the FDA says it plans to largely restrict its hands-on involvement to medical apps and software in which the risk of patient harm, if something goes wrong, is greatest. (While the authors don’t exactly spell it out, the implication is that the FDA may not try to weigh in on applications that are probably harmless, even if they don’t make much of a difference in patient lives.) In other words, the key here is a reasonable assurance of product safety, not efficacy—an essential approach, it would seem, at a time when developers are releasing tens of thousands of mobile health apps each year and where “commercial cycles for new product introductions and modifications” are by necessity compressed, as the JAMA authors note.

Second, and perhaps most interesting, Gottlieb and crew say the FDA will test a pilot “precertification program” in which developers of “software as a medical device” (SaMD) products are accredited as a firm (based on the overall quality of their software design, testing protocols, and presumably track record), rather than insist that each individual product go through its own separate regulatory review. The latter practice, they say, would just “stifle the development of, and access to” innovative apps, even as it provided “limited patient safeguards.”

The latest commentary follows a slew of guidance and hints from last year (see my December 2017 essay, “To Be (a Device) Or Not to Be? That Is the Question”) and earlier. And while there are clearly some issues that need more creative thinking and resolution—notably, cybersecurity—the FDA does seem to be creating a regulatory framework that will encourage progress in digital health, not quash it.

Remarkably, the FDA is even enlisting an international consortium of regulators to help it sort through the issues and harmonize policies around the globe—a move that seems to fall outside the Trump administration’s standard playbook. The International Medical Device Regulators Forum already has government-agency members from Europe, Australia, Brazil, China, Japan, Russia, Singapore, South Korea, and that longstanding American enemy, Canada.

Who says diplomacy is dead?

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