FDA builds out digital health program
The Food and Drug Administration in September created a new center tasked with coordinating and supporting the agency’s efforts to “modernize” its regulation of digital health technologies categorized as medical devices.
The Digital Health Center of Excellence builds on the FDA’s previous division of digital health and will sit within the FDA’s Center for Devices and Radiological Health.
Staff from the digital health division will continue to work at the center as full-time employees.
The center of excellence structure is designed to centralize activities related to digital health, including work related to software-as-a-medicaldevice regulations, interoperability and medicaldevice cybersecurity, said Bakul Patel, the digital health center’s director, in an interview with Modern Healthcare. He called the launch a “milestone” and “natural evolution” of the FDA’s digital health work.
The FDA’s vision for the center is to provide digital health product manufacturers, agency staff and others with resources to help speed development of safe and effective digital technologies, such as by developing new regulatory approaches and sharing best practices.
Much of the center’s operations and structure are still under development, but one of its initial efforts will involve creating a network of volunteer digital health experts that the FDA can tap for feedback on issues and priorities.
Figuring out how to regulate such digital health products as apps and wearables has been an ongoing area of focus for the FDA. Agency officials have long said digital health products can be tricky to regulate, since their software tends to be updated more frequently than traditional devices.
Not all health apps and wearables are considered medical devices, as defined by the FDA.
Generally speaking, clinical decision-support software that’s designed to help healthcare providers and patients manage serious or critical conditions are considered part of the agency’s purview, according to guidelines on medical software the agency released last year, while software designated as low-risk—such as apps that encourage healthy lifestyles—are excluded.
That means consumer fitness trackers like the Apple Watch aren’t regulated by the agency; however, the Apple Watch’s electrocardiogram app that’s specifically designed to detect atrial fibrillation is, and received FDA clearance in 2018.