FDA Sentinel Initiative

Sentinel Initiative and the Common Data Model

In the project report on Defining and Evaluating Possible Database Models to Implement the Sentinel Initiative, the contractor suggests utilizing a common data model for the initial implementation of the Sentinel System.  The report describes a common data model as "a set of specific definitions for the structure of databases and of data elements (i.e., specific variables)" and states that "most implementations of common data models require each contributing partner (in this case, each data owner) to transform its data into the common model, either virtually or physically."

 

Some advantages of a common data model cited in the report include that it "substantially reduces the need to centrally create and maintain complex metadata, ontology, and data mapping activities."  It also addresses issues related to "syntactic and semantic interoperability."  It creates an environment in which much of the data validation is conducted during the "initial transformations instead of requiring complex data checking effort after execution of each query."   Finally, the common data model allows you "the ability to centralize analytics as opposed to requiring each data owner to interpret and implement a set of written instructions."  However, The report also notes that a "common data model requires initial effort and expense to transform data...and to store it... In addition, to the extent that the common model does not capture the full granularity of the source data, the common model approach could result in the loss of information."

 

As the FDA works toward implementing the Sentinel Initiative, please share your thoughts of the advantages and disadvantages of the common data model.

 

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.