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FDA Moving Forward with New Regulatory Approach to Digital Health

June 16, 2017
by Heather Landi
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The U.S. Food and Drug Administration (FDA) is moving forward on a broad initiative focused on fostering new innovation in digital health, and one major part of this initiative will be a Digital Health Innovation Plan outlining how devices will be regulated, according to FDA Commissioner Scott Gottlieb, writing in a blog post.

In the blog post, published Thursday, Gottlieb wrote that the Digital Health Innovation Plan will include a “novel, post-market approach to how we intend to regulate these digital medical devices” that will provide digital medical device developers and health IT startups clarity on the regulations. “To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development,” Gottlieb wrote.

Further, the FDA will take steps to advance the goals of the 21st Century Cures Act, he said. The Act revised FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation.

“Such technologies tend to pose low risk to patients but can provide great value to the health care system. FDA, led by the FDA’s Center for Devices and Radiological Health (CDRH), is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies,” Gottlieb wrote

The FDA also plans to provide guidance to clarify its position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements, Gottlieb stated. “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,” he wrote.

What’s more, the FDA also will initiate a pilot program exploring the creation of a third-party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.

“Certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. 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,” Gottlieb wrote.

Further, he stated, “This will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies.”

The FDA also wants to explore leveraging the post-market collection of real-world data, which developers could use to support new and evolving product functions. Developers of digital health tools could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently, Gottlieb said.

He described NEST as a “federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources.”

The Medical Device Innovation Consortium (MDIC), a public-private partnership, is serving as an independent coordinating center that operates NEST. In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government, he stated. Further, he wrote that although FDA does not own or operate NEST, the agency has been establishing strategic alliances among data sources to accelerate NEST’s launch with the initial version of a fully operational system anticipated by the end of 2019.

“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. Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources,” Gottlieb wrote.

The health IT community generally seems to support the direction that the FDA is taking. Eric Topol, M.D., a cardiologist, geneticist, digital health researcher, and director of the Scripps Translational Science Institute, tweeted “Really good to see FDA, Gottlieb prioritizing digital health to catalyze medicine’s future.”


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