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Gottlieb Promises Clarity, New Initiatives in FDA Approach to Digital Health Tech


In the name of an “efficient, risk-based approach” to regulation in order to “promote health” through innovation, Gottlieb detailed a number of initiatives underway or soon to be.

In a recent blog post, new FDA Commissioner Scott Gottlieb, MD indicated that his agency would move to encourage development of, and access to, digital health technologies. It was reported last month that the organization was bringing on a new team of digital health experts to reform their approach to digital health.

Now, some actions are beginning to come into focus.

In the name of an “efficient, risk-based approach” to regulation in order to “promote health” through innovation, Gottlieb’s posting detailed a number of initiatives underway or soon to be. An overall Digital Health Innovation Plan “will include a novel, post-market approach to how we intend to regulate these digital medical devices.” The FDA, Gottlieb writes, will work to implement the digital health tenants of the 21st Century Cures Act, and will publish guidance “to further clarify what falls outside the scope of FDA regulation.”

The last part is key, because all indications from the FDA head’s writing seem to point to an effort to mostly remove the Administration from the sort of health apps they deem “low risk.” Health monitoring apps and clinical support apps may now fall under the oversight 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.”

Gottlieb has written extensively in past editorials that FDA oversight of health apps can stifle innovation and participation among some of the tech market’s biggest players, arguing that fear of FDA oversight prevented companies like Apple from building health capabilities into their smartphones. “There’s a big difference between apps that help you manage your medical information and draw clues from your own bodies, and those that seek to actively doctor you,” he wrote in a 2015 Forbes editorial.

At the post-market level, Gottlieb’s new posting details the National Evaluation System for health Technology (NEST), currently under the Medical Device Innovation Consortium (MDIC), a 501(c)(3) public-private partnership. Gottlieb points out that the FDA does not own or operate MDIC, but emphasizes strategic alliances with the group. He says that MDIC will soon be announcing a Governing Committee for NEST, and an initial launch of a fully operational system could happen before the end of 2019.

One theme in the post is Gottlieb's desire to clarify the FDA’s stance on evolving technology, and to not chill innovation by casting uncertainty.

“FDA will help innovators navigate a new, modern regulatory process so that promising, safe and effective developments in digital health can advance more quickly and responsibly,” he writes in the post.

Gottlieb has for years written about the need for the FDA to shift to a more risk-based approach. Now, it seems, his hypotheses will be getting the opportunity to undergo trials of their own.

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