FDA Sentinel Initiative

FDA Seeks Input on Sentinel Privacy Report

The report Analysis of Legal Issues Related to Structuring FDA Sentinel Initiative Activities offers a two-part legal analysis of privacy issues concerning Sentinel.  Part I  looks at the current scenario, in which data holders queried by Sentinel will only release summaries of the analysis results. Part II examines ways in which individual privacy would continue to be rigorously protected in possible future scenarios.  We are interested in hearing from you about this report.

FDA Seeks Response on Sentinel Governance Report

FDA engaged eHI to produce the report Developing a Governance and Operations Structure for the Sentinel Initiative in order to explore the range of governance and operational options available to Sentinel. The report's recommendations are based on various sources, including feedback received from the FDA-sponsored December 16, 2008 public meeting and docket submissions associated with that meeting, publicly available Sentinel-related documents and a review of initiatives similar to Sentinel. The report discusses what the public views as critical success factors for Sentinel's establishment, launch, and evolution, as well as approaches for FDA to consider in launching this collaborative effort (e.g., a government-run and controlled entity vs. a private-sector-run entity with government collaboration). General principles of good governance, roles and responsibilities of a governance entity, as well as potential funding sources and factors influencing an estimated annual operating budget are also examined.  FDA welcomes your comments and proposals on this important report.

FDA Launches Sentinel Discussion Room

A national electronic system that will dramatically enhance FDA’s ability to monitor the safety of drugs, biologics, medical devices—and, ultimately, all FDA-regulated products once they reach the market—is now on the horizon. Launched in 2008, FDA’s Sentinel Initiative has the goal of developing and implementing a proactive system that will build on existing reporting systems that the Agency has in place to track reports of adverse events and problems linked to its regulated products.

 

Monitoring the safety of FDA-regulated products is a major part of the Agency’s mission to protect the public health. As currently envisioned, the Sentinel System will enable FDA to actively query remote electronic healthcare data holders—like health record systems, administrative claims databases, and registries. Data would continue to be managed by its owners, and questions would be sent to the participating data holders, who would, within established privacy and security safeguards, evaluate their information and send summary results to FDA.

Since the Sentinel Initiative’s launch, FDA has created a broad public forum for considering Sentinel-related issues. Multiple meetings have been held with a wide spectrum of stakeholders on a range of topics.  This Discussion Room serves as yet another means of fostering a transparent public exchange of ideas and perspectives on the scientific, technological, and policy challenges surrounding the developing Sentinel System.

We invite everyone to review the materials FDA is making available in the Discussion Room and to share your ideas with one another and with us.  Although FDA does not intend to use the Discussion Room to comment on submitted information, we will consider all input carefully as Sentinel evolves.

All Discussion Room documents are also available in FDA’s Sentinel Docket (FDA-2009-N-0192). Comments can also be posted in that docket for public consideration.  The Discussion Room is not intended to replace FDA’s currently available methods of receiving comment; it is an additional means of enabling the public to comment and initiate dialogue on Sentinel-related topics. 

All comments submitted in the docket or to the Discussion Room will be considered equally.  Periodically, we will include in the Sentinel Docket all comments posted in the Discussion Room.  Please note that this will only include those comments posted for display on the Web site (i.e., only remarks respecting the established Comment Policy can be viewed in the Discussion Room or in the Docket).

Initially, this pilot Discussion Room will focus on reports written primarily—but not exclusively—as a result of contracts FDA has awarded to further Sentinel’s development. The pilot is intended to be active through the end of September 2009.  If successful, the Discussion Room will become a fixture on the Sentinel Web site, and other documents and relevant information will also be made available.