FDA to Roll Out Modernization Plan in Push for Data Interoperability

Regulatory NewsRegulatory News | 23 August 2019 |  By 

An action plan will be rolled out in the coming months to define the US Food and Drug Administration’s (FDA) approach to modernizing its technology infrastructure and framework, FDA Principal Deputy Commissioner Amy Abernethy said during a Thursday keynote at the Office of the National Coordinator for Health Information Technology’s (ONC) 3rd interoperability forum.

FDA modernization efforts have been underway in recent years, with the reorganizations of the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. The plan that FDA intends to roll out soon is a cross-center approach.

Abernethy said that FDA’s plan contains an agency-wide objective—advancing interoperability to inform regulatory decision-making in real-time. This, in turn, is intended to expedite determinations on submissions and improve regulatory oversight to increase patient access to medical products deemed to be safe and effective at a faster pace, as well as to enable earlier product interventions in the post-market setting.

Critically evaluating interoperable technologies, matching the best solutions to the characteristics of a patient at the point of care and ensuring that data are “available, reliable and well-characterized” are the next steps in the journey toward interoperability, said Abernethy. As such, the focus of the plan is centered on modernizing FDA’s tech infrastructure and framework and promoting interoperability use cases.

Abernethy noted the agency’s vision for interoperability within the context of real-world evidence. This seeks to make use of application programming interfaces to create efficiencies around regulatory review processes and track medical products throughout their lifecycle by leveraging data sources like electronic health records (EHRs) to create a totality of evidence that better informs benefit-risk profiles.

The agency is “taking a thoughtful and proactive approach to help advance” the interoperability story partly via “appropriate and fit to scale use of technology within a modernized review infrastructure,” as well as “building and ensuring that technology is in place at a modern FDA,” said Abernethy. "We are building a dynamic regulatory environment across the entire cycle of product development to help us meet the pace of medical innovation.”

As part of the work to update how the agency interfaces with the stakeholder community, the plan will look to better engage with the tech community. “We need to define the interfaces so that there is a core understanding” of how information can be passed into FDA “as efficiently as possible,” she added.

Abernethy also pointed to “a world where FDA and ONC are working together as sister agencies to provide an actual roadmap” of how data sets can be generated as well as pressure testing “what happens when a data element traverses from the EHR all the way through the process into clinical research.” She noted the potential of an envisioned project she calls “the life of a data element,” to chart a path that helps FDA identify areas where it should provide guidance to sponsors and EHR vendors. 


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