A planning board convened on behalf of the U.S. Food and Drug Administration outlines a strategy for governing and overseeing an independent “coordinating center” to guide the development and management of a National Evaluation System for health Technology (NEST) in a report published Tuesday.
Building on the idea that the NEST--a voluntary network of data partners sharing information to better understand the performance of medical devices--can improve device innovation and influence related regulations, the report’s authors say a coordinating center should be governed by a “transparently selected” board of 11 to 15 stakeholders from across the healthcare industry.
The board urges the use of demonstration projects in two phases by the coordinating center for NEST’s initial development. Phase one projects, which should be completed in three years, would focus on balancing pre- and postmarket device evidence development and creating an “active surveillance system.” Projects in phase two, which should be completed in five years, would focus on “enhancing data collection” and developing capabilities to measure device value within the NEST, the report’s authors say.
“These projects should be used to show the value of the Coordinating Center, build the shared resources of NEST, as well as be an opportunity to test and refine the Center’s foundational priorities, process designs, and governance policies,” the board writes.
Early data partners within the NEST include PCORnet, Sentinel, coordinated registry networks (CRNs), payers and large healthcare systems, among others, according to the report. The planning board also says that the coordinating center should “leverage efforts by [the Centers for Medicare & Medicaid Services] to promote use of registry information for regulatory purposes.”
A commentary published in the Journal of the American Medical Association by FDA officials Robert Califf and Jeffrey Shuren calls the idea of such a national evaluation system for health IT essential to improved decision making about medical devices.
“[A] strategic approach to linking and using clinically based data sources, such as registries, electronic health records, and claims data, could potentially reduce the burdens of obtaining appropriate evidence across the life cycle of a device,” Califf and Shuren write. “By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices.”