The Food and Drug Administration wants to take advantage of the real-world data available from electronic health records to more fully evaluate medical products in the post-market setting, according to FDA Commissioner Scott Gottlieb, MD.
The agency is seeking $100 million in its Fiscal Year 2019 budget request to build a system that would include electronic records from about 10 million individuals, supplementing the FDA’s active post-market monitoring systems—the National Evaluation System for health Technology (NEST) for medical devices and Sentinel system for drugs and biologics—which depend largely on the secondary use of claims data.
“Previously, our investments in post-market data have mostly focused on the development of systems to consolidate and analyze information derived from healthcare payer claims,” writes Gottlieb in a July 10 blog post. However, he notes that claims data has inherent limitations.
“Now, we have the capacity to use clinical data derived from electronic health records to develop faster reporting on the performance of medical products in real world medical settings,” contends Gottlieb. “The FY 2019 budget request seeks to address some of these limitations by giving the agency the ability to access the clinical medical information contained in de-identified electronic health records.”
“Investments in such a system can become a national utility for improving medical care, allowing the FDA to optimize its regulatory decisions,” according to Gottlieb. “It would give patients and providers the access to near-real-time, post-market information that can better inform their decisions. Such an enterprise can not only support our evaluation of safety and benefit using data derived from real-world settings, but it can also make the development of new innovations more efficient.”
At the same time, he notes that real-world data comes from sources other than EHRs, including claims and billing, product and disease registries, patient-related activities in outpatient or in-home use settings, as well as mobile health devices—all of which must be able to communicate electronically, requiring full interoperability.
“The FY 2019 budget request seeks to establish these building blocks and assemble the data into an interoperable platform,” Gottlieb adds. Nonetheless, the FDA chief acknowledges that eliminating the data silos will not be an easy task.
According to Gottlieb, a key component of this effort will be the development of data standards.
“Standardizing this information—and assembling it into formats that can allow for easier analysis and integration—will take additional investment in systems that can consolidate this information and make it interoperable,” he writes. “Part of our proposed investment will go toward building these new capabilities to assemble real world data into formats to make this information more accessible.”
In addition to developing better data standards and achieving interoperability, the FDA’s goal is to improve the quality of data, Gottlieb concludes. “Investing in the creation of a national resource that leverages real-world data, establishes data standards to facilitate interoperability, and promotes data quality for the integration of this evidence into medical product development and clinical care is a key national investment.”
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