The Food and Drug Administration is in discussions with multiple stakeholders to create a universal unique medical device identifier to be stored in electronic health records and linked to patient outcomes to improve medical device surveillance, said FDA principal deputy commissioner Amy Abernethy, M.D.
Speaking at the Office of the National Coordinator for Health IT's 3rd Interoperability Forum in Washington, D.C., Abernethy, who also serves as the FDA's acting CIO, said the agency wants to advance interoperability and speed the development of new therapies and medical technologies.
The FDA also is looking to provide regulatory relief to technology companies, she said.
The FDA is in discussions with ONC as well as the Centers for Medicare & Medicaid Services, and the National Institutes of Health National Library of Medicine on interoperability initiatives to improve the surveillance of medical devices over time by having a universal device identifier in the EHR, Abernethy said.
"I believe interoperability is key to all types of processes going forward at the FDA and the FDA can continue to collaborate with ONC on this," she said.
In the next few months, FDA will roll out a plan to modernize its technical infrastructure and how the agency interfaces with stakeholders, including technology companies, Abernethy said. This work is part of the FDA's shift to becoming more agile to keep pace with innovation, and interoperability plays a key role, she said.
In 2013, the FDA released a final rule to establish a unique device identifier system designed to adequately identify medical devices through distribution and use. Device labelers, often, the manufacturer, must include a UDI on device labels and packages and submit device identification information about these devices to the FDA's Global Unique Device Identification Database.
Many stakeholders have complained that the UDI has had limited effect because it is available in neither EHRs nor administrative claims data. As such, medical devices cannot be easily identified, tracked, or associated with patients, preventing population-level analyses of their safety and effectiveness, according to one assessment published in the Annals of Internal Medicine.
Abernethy said the FDA and ONC could collaborate in other areas, including providing guidance to clinical trial sponsors and EHR vendors on the use of EHR data in clinical trial datasets.
FDA and ONC also can work together to develop a road map on the use of data developed from artificial intelligence algorithms and the validation of those algorithms, she said.
Abernethy says she's focused on promoting examples and use cases that show what interoperable data at play looks like.
As the healthcare industry moves towards more personalized care and precision medicine tailored to each individual patient, those efforts will require matching patient data in EHRs with technology solutions.
"There are opportunities to personalize patient health enabled by new technology platforms, AI-enabled devices, and targeted medicines. These technologies offer transformative opportunities, but we also need to think about steps to get there," she said. Healthcare providers need real-time information about technology solutions as well as details about patients at the point of care.
"Now that we have EHRs in place, we need interoperability in service of core tasks and in service of the data," she said.
The agency also is focused on building a dynamic regulatory environment across the entire lifecycle of product development to match the pace of medical innovation, Abernethy said.
"We can combine real-world data from EHRs with clinical trial data, and we're putting together guidelines on how that'll work. That will enable a totality of evidence on how a product is performing across its life cycle," she said.
"Data quality is key and ability to aggregate data from multiple sources also is key," she added.
The FDA also wants to make the slow and arduous drug review process "more fluid and efficient," she said, citing the FDA's real-time oncology review program that enables clinical trial sponsors to send data pre-submission before the final application is ready.
Similar to ONC's approach to pushing the use of application programming interfaces with EHR data, Abernethy said her goal is to enable clinical trial sponsors to submit data via APIs.