Of Infrastructure and Interoperability
The U.S. Food and Drug Agency (FDA) has big plans for future modernization efforts, which will involve a cross-center approach. The agency is going to roll out an action plan in the near future to modernize its infrastructure and advance interoperability according to roll out an action plan in the coming months to modernize its infrastructure and advance interoperability, according to FDA Commissioner Amy Abernethy who spoke at the Office of the National Coordinator for Health Information Technology’s (ONC) third interoperability forum.
The FDA has had recent transformation efforts underway, with the reorganizations of the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research. Now the agency-wide objective is “to inform regulatory decision-making,” which will then lead to expedited determinations on submissions and improved regulatory oversight, Abernethy said. The FDA expects that patients will be able to access to safe, effective medical products faster, and product interventions in the post-market setting will occur more expeditiously.
Next, the FDA will critically evaluate interoperable technologies, harmonizing the best solutions with the characteristics of a patient at the point of care, and being certain that data are available, reliable and well-characterized. The key to the plan will to modernize the technology infrastructure and promote interoperability use cases.
In addition, the FDA will advance interoperability in the context of real-world evidence. Application programming interfaces (APIs) will create efficiencies around regulatory review processes and track medical products throughout their lifecycle by leveraging EHRs to better fit benefit-risk profiles. In the past, the FDA has attempted to increase the use of real-world data to improve regulatory processes and care delivery. In February 2019, the agency said it would expand its research collaboration agreement with Flatiron Health and the Information Exchange and Data Transformation (INFORMED) program. The partnership works at understanding how real-world evidence from de-identified EHR data can inform healthcare policy decisions.
FDA Oncology Center of Excellence Director Richard Pazdur, MD, explained, “The FDA recognizes the tremendous importance of analyzing treatment data from the real world. Traditional clinical trials have long provided the high-quality evidence the FDA needs to determine whether a product is safe and effective for its intended use, but traditional trials do not always represent the real world, lack clinical context, and may not provide sufficient follow-up to truly understand the impact of a new therapy on real-world patients. We believe that regulatory-grade real-world data can help inform our decision-making so that we can provide cancer patients with better care.”
The new plan will advance interoperability and ensure that the technology works for the FDA. The agency will engage with the technology community, providing a core understanding of passing information into the FDA efficiently.
The FDA will also help to identify areas where the agency should provide guidance to sponsors and vendors. It will advance interoperability within the FDA and accelerate the development of new solutions to improve care.
Abernethy concluded, “We are building a dynamic regulatory environment across the entire cycle of product development to help us meet the pace of medical innovation.”
