FDA's Gottlieb Presents Outline for Digital Health, PreCert Pilot

FDA Commissioner Scott Gottlieb, MD, today presented his agency’s plan to adapt to the rise of digital health technology, offering a blueprint for regulatory steps and a pilot program to precertify software programs and updates, which would get them to the market quickly and let regulators examine data later.

Gottlieb explained the program in a blog post, saying it offers a “pragmatic approach” that will let portions of the digital health world function more like Silicon Valley than Big Pharma, with product launches and updates that keep things moving. Gottlieb said he wants the focus to be on the needs of consumers and providers, “to supersede the traditional physical constraints of healthcare delivery and exploit the opportunities offered by mobile technology.”

Two key items were announced today;

• The Digital Health Software Precertification (PreCert) Program. FDA will select 9 companies for a pilot to test its new approach to software regulation. The pilot program is voluntary, and will lead to a “tailored approach” that will be geared toward regulating software developers based on their demonstrated track record, not each product. The Center for Devices and Radiological Health (CDRH) will hold a workshop August 1, 2017 to answer stakeholder questions on the process.
• A Digital Health Innovation Action Plan. This is the overall blueprint from CDRH, which outlines its approach to digital going forward. Already, FDA has said it does not plan to focus oversight on low-risk products like wellness apps or those that simply store data. Instead, FDA will concentrate on those products that help higher-risk patients manage chronic disease. Besides the PreCert pilot, FDA will build out its Digital Health unit within CDRH and issue a guidance on medical software provisions of the 21^st Century Cures Act. Today’s document promises guidance by the first quarter of 2018 that will pull back clinical decision support software from FDA jurisdiction.

In total, the FDA will be moving quickly to spell out when digital health needs to check in and when they don’t, but Gottlieb’s message today was that the agency will err on the side of letting technology evolve on its own schedule, store data, and allow regulators to check in to see that everything is working. It requires a whole new way of regulating, Gottlieb wrote.

“FDA’s traditional approach to medical devices is not well suited to these products. We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation. Recognizing this, and understanding that the potential of digital health is nothing short of revolutionary, we must work toward establishing an appropriate approach that’s closely tailored to this new category of products,” he wrote.

“We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

Gottlieb hopes that greater use of digital health could mean fewer trips to the doctor, greater awareness of illness, or better communication between doctors and patients. There’s also peace of mind for parents if they can get prompts when dealing with a sick child.

The commissioner seems well aware of what’s possible. “I’m delighted to be helping lead FDA at a critical moment, when I have the opportunity to help advance innovation in digital health and to make sure patients can benefit from these remarkable technologies.”