Sentinel Initiative Boosts FDA Safety Oversight

The FDA Sentinel data mining system is still in the beginning stages and the explanation of how it works sounds interesting in the fact that it will be able to query and mine data to create an overall reference, but the article states they are not creating a data base, but more or less a data mining application. It almost sounds like some sort of a VPN situation whereby the data engines of the system will be able to sign on and authorize to get firewall access to the records of the voluntary participants, but details were still a bit sketchy. BD

To conduct the queries, the Sentinel System will operate using a public-private partnership model with stakeholders, such as pharmaceutical, biologics and medical device manufacturers, insurance plans, the Veterans Health Administration, Medicare, academics, and patient organizations. Queries, such as how many patients taking a specific antibiotic had a certain adverse event, will be constructed centrally, and data owners who house such information will be solicited to participate in the query voluntarily. The results will then be returned to FDA for analysis. No personal information will be transferred.

The Sentinel System will enable FDA to conduct product safety queries proactively from multiple existing data sources from remote locations, such as electronic health record systems, medical claims databases, and possibly clinical trial databases if they overlap with those of marketed products. “Data sources will be maintained by their owners and will remain behind the firewall of the data owner. We are not creating one big database,” she says.

How organizations become stakeholders and how the Sentinel System will work from an IT perspective has not been fleshed out, but will be more fully defined as the governance structure is developed. As envisioned, the Sentinel System can be achieved with minimal transfer of data and will build upon investments made by The Department of Health and Human Services (HHS) in health information technology programs that have already been launched. To start, there are several pilot projects and most recently, FDA granted eight contracts to external organizations such as Harvard Pilgrim Health Care, IMS Government Solutions, and Booz Allen Hamilton.