The Food and Drug Administration is working on a plan to improve its relationships with the tech sector by modernizing its infrastructure, promoting the benefits of interoperability and changing how the FDA interacts with tech organizations.
Dr. Amy Abernethy, FDA's Principal Deputy Commissioner of Food and Drugs, on Thursday told an audience at the Office of the National Coordinator for Health Information Technology's third interoperability forum in Washington, D.C. that the two agencies want to establish guideposts around interoperability and create a streamlined regulatory process for health tech organizations.
"We envision that we want to have a single mechanism through which we can engage the tech industry and have these conversations so that we can all move together," Abernethy said. "We're building a dynamic regulatory environment across the entire cycle of product development to help us meet the pace of medical innovation."
Tech companies have complained regulatory uncertainty, excessive regulatory burden and lack of interoperability are slowing the development of new technologies and therapies, especially those related to personalized healthcare and precision medicine.
Abernethy envisions a future where trial data is transferred to the FDA through an application programming interface and allows reviewers to exchange messages with sponsors in real time. Ultimately, that real world data as well as data from electronic health records could work with other trials and help the agency, developers and providers see how medical products perform over time, she said.
The efforts will rely on data quality, the ability to aggregate data, interoperability and the traceability of source data.
Abernethy said she "can imagine a world in which FDA and ONC are working together as sister agencies" and that there are many ways the two agencies could work to solve interoperability issues.
But that remains a work in progress.
During the Q&A session following Dr. Abernathy's keynote address, Dr. Steven Lane, Co-Chair of the ONC Interoperability Standards Priorities Task Force commented, "We actually worked with the ONC to try to reach out to the FDA to have you guys come and talk to us about your needs with regards to interoperability and standards. And we couldn't find anybody to respond."
