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eHealth Initiative's Drug Safety Collaboration to Partner With FDA on Sentinel Initiative
Date:5/22/2008

p://www.pfizer.com/home/) Along with the FDA, the Agency for Health Care Research and Quality and the Brookings Institution's Engelberg Center for Health Care Reform are working in an advisory capacity on this effort.

Research findings from the "learning laboratories" are now being documented and experiences and methods are being converted into both technical guides and a readiness assessment tool that will be made widely available to the public to advance safety efforts in the U.S. While commonly accepted principles and policies for assuring the privacy, security and confidentiality of health information are being applied within the research project, the Collaboration is also developing legal guidance documents and model agreements to support responsible handling of electronic information for monitoring post-market performance as drug safety efforts get operationalized. Communications strategies and materials are also being developed by the Collaboration to support effective communication of the importance of using electronic health information for safety and the safeguards that are in place to assure patient privacy. For more information, go to http://www.ehealthinitiative.org/drugsafety/default.mspx.

"eHealth Initiative applauds FDA for moving forward so rapidly on the Sentinel Initiative, which will play an important role in protecting and improving public health. We look forward to contributing to the development of a robust monitoring system, one that relies on the active involvement and expertise of both the public and the private sectors at the national, state and local levels," said eHealth Initiative Chief Executive Officer Janet Marchibroda.

About eHealth Initiative and its Foundation

The eHealth Initiative and its Foundation are independent, non-profit affiliated organizations whose missions are the same: to drive improvements in the quali
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