The FDA is moving ahead with its Mini-Sentinel pilot program after five years, making it a full-fledged program that will utilize access to EHRs of some 178 million patients and the claims data contained within them.
The data, which will be used by researchers to track safety information on drugs and vaccines, comes from 18 U.S. payer and provider organizations, among them Aetna, Humana and Kaiser Permanente and will likely expand as a full Sentinel project, according to the agency. The names of patients have been protected and de-identified.
In a blog post from late December, the FDA’s Director of the Center for Drug Evaluation, Janet Woodcock, M.D., said the mini-Sentinel, started in 2009, was a “long journey toward the challenging goal of developing a full-scale medical product safety monitoring program.”
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The goal is to have active surveillance that can compliment the current FDA Adverse Event Reporting System, Woodcock said, noting that the current efforts rely on patients, providers and product manufacturers to report potential safety issues. The Sentinel program would not replace FAERS.
“However, the Sentinel System offers us the exciting possibility of not waiting for safety information to come to us in the form of reports, but rather it enables us to go out and get that information, adding greatly to our safety monitoring capability,” Woodcock said. “This is active surveillance.”
Information from the Sentinel program has been lest to “valuable input in decision-making on drugs and vaccines,” she said.
