The data in electronic health records can be harnessed to help the U.S. Food and Drug Administration (FDA) better promote and protect public health, according to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
In a blog post dated June 23, Woodcock explained that the agency has created an active surveillance system, called Mini-Sentinel, to monitor the safety of FDA-regulated medical products. The pilot program uses claims and EHR data from 18 large healthcare organizations, serving as data partners, to provide answers to FDA questions about drug safety.
"The Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters," Woodcock said. "Thanks to the ability to access data from various sources, the Mini-Sentinel system can use the information from potentially more than 150 million covered lives in our nation's healthcare system to help answer important drug safety questions."
She added that participating partners include Kaiser Permanente, Aetna, the University of Pennsylvania and Weill Cornell's School of Public Health.
Woodcock acknowledged that the lack of interoperability among EHRs hampers both the FDA's and others' research, saying that in order to "understand and combine" data from different sources, further standardization of the data and how it is exchanged is necessary. She added that these efforts will enable systems to better "talk" to each other, which "will lead to better treatment decisions as clinicians will have a more complete picture of their patients' medical histories."
The FDA is not the only entity that has expressed concern about the inability of EHRs to share data effectively. There have been recent calls for the government to investigate business practices that limit interoperability.