Last month Commissioner Scott Gottlieb of the U.S. Food and Drug Administration made several announcements about the agency’s brand new plans to further its goal to cultivate innovation and competition in the pharmaceutical and medical device industries. The first initiative put forth by the FDA was the Digital Health Innovation Plan, which was unveiled in a blog post written by the Commissioner on June 15.

As the number of digital health technologies (like medical devices with digital software and health-related mobile applications) rises and the number of users benefitting from these technologies rises even higher, the value that they provide to customers, patients, administrators, and clinicians continues to grow exponentially. As part of the Digital Health Innovation Plan, the FDA is setting out to promote innovation within this newly emerging category of medical technology so that the growth of its invaluability to the healthcare industry remains unhindered.

Here are the 3 of the most important highlights of the Digital Health Innovation Plan:

 

  • The FDA will pilot a “risk-based regulatory framework for overseeing [digital] medical technologies” in the fall.

 

The agency plans to provide guidance and regulatory policies for all types of digital health products, from low risk to high risk. The FDA will also clarify which products pose risks so low that they will not have to abide by any premarket requirements.

 

  • A third-party certification program may be implemented to streamline or, in some cases, eliminate the premarket review process.

 

Through this program, “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.” Delegating this “approval” process to a third-party will reduce the length of the approval process and the cost of market entry for these digital health products.

 

  • The National Evaluation System for health Technology (NEST) will provide real-world data to help “expedite market entry and [the] subsequent expansion of indications more efficiently.”

 

To support new developments, the National Evaluation System for health Technology (NEST), a virtual system for evidence generation that will source its data from registries, electronic health records, payer claims, and other sources, will be created and operated by the Medical Device Innovation Consortium (MDIC). The hope is that this collection of “real-world data” will be used to accelerate market entry for new digital health products.

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