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FDA Chief Announces New Plan for Post-Market Regulation of Digital Health Products

Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has announced the FDA will be launching a new, risk-based regulatory framework in the fall for overseeing connected medical technology, including health apps and medical devices.

The FDA wants to encourage and promote innovation that will lead to the development of new and beneficial medical technologies; however, it is essential that these technologies can benefit patients without placing their health or privacy at risk.

Gottlieb said the FDA has now developed a new Digital Health Innovation Plan that will foster “innovation at the intersection of medicine and digital health technology.” The plan includes a novel post-market approach that will allow the regulation of digital medical devices and health-related apps.

In a recent blog post, Gottlieb pointed out that close to 165,000 health-related apps have now been released for Smartphones and Apple devices, with forecasts estimating the apps will be downloaded 1.7 billion times by the end of this year. These apps have the potential to improve the health of patients, empowering them to make better day-to-day heath decisions and manage their health conditions more effectively.

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There has been an explosion in the number and types of connected digital health devices in recent years, including health-tracking apps, fitness trackers and medical devices. There has been considerable innovation in the field, although Gottlieb said there is currently some ambiguity about how the FDA regulates apps and medical devices which results in some innovators steering clear of healthcare and focussing efforts on other ventures.

The FDA’s aim is to release clear guidance for developers that will enable them to understand all regulatory requirements on their own without having to obtain answers from the FDA on each individual technological change they wish to make.

The new guidance will cover a wide range of digital health products with multiple software functions, including some apps and devices that currently fall outside the scope of FDA regulation.

Gottlieb said, “Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.”

The FDA will be running a pilot program for its new, risk-based regulatory framework this fall. The pilot program is still under development and the FDA is currently determining how a third-party certification program can be developed that will allow low-risk digital health products to be marketed without the need for a premarket review by the FDA.

High-risk products will still require a pre-market review, although the FDA is looking at ways the process can be streamlined. The FDA is considering a certification program that would assess companies on their products to determine whether they are reliably and consistently engaging in high quality software design and have been diligently validating their software products.

Gottlieb said, “Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”

“Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry.”

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.