Under the initiative, the FDA wants to create a national, integrated electronic system that will enable the agency to access and query multiple existing data systems for de-identified product safety information. These existing data systems could include electronic health records systems and medical claims databases, among other sources. The goal is to improve the monitoring of medical products after they have received FDA approval.
The new survey is designed to identify data sources that could participate in the Sentinel Initiative. "The proposed system will enable queries of distributed data sources quickly and securely for relevant product safety information," according to a newly published FDA notice. Data will continue to be managed by its owners, and only data of organizations that agree to participate in this system will be included, the FDA says, adding assurance that strict privacy safeguards will be followed.
The FDA estimates that about 250 respondents will participate in the voluntary survey. They will include federal agencies, insurers, health information exchanges, large multi-specialty group practices, large hospital systems, pharmacies, medical societies, consumer-oriented Web sites, research networks, commercial data sets, laboratories and registries. The agency also estimates the survey will take 24.5 hours to complete.
Full text of the FDA's notice is available in the March 9 Federal Register at gpoaccess.gov/fr/index.html.
The FDA last May published a white paper explaining the Sentinel Initiative. For a copy, click here.
--Joseph Goedert
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