On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System”—a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. See FDA, “The Sentinel Initiative: National Strategy for Monitoring Medical Product Safety” (May 2008), available at http://www.fda.gov/oc/initiatives/advance/reports/report0508.pdf. In addition to a whitepaper on the Sentinel Initiative, FDA has published a “Questions and Answers” document, a fact sheet, and information for the consumer that are all available at http://www.fda.gov/oc/initiatives/advance/sentinel/.

The same day, the Centers for Medicare & Medicaid Services (“CMS”) announced a final rule allowing it to share prescription drug claims data for the 25 million Medicare Part D enrollees with other government agencies, as well as with “researchers.” Under the rule, shared data will be available for any purpose “deemed necessary and appropriate by the Secretary,” such as analysis, reporting, and public-health purposes, among other things. See 73 Fed. Reg. 30664 (May 28, 2008); CMS Fact Sheet “Medicare Part D Data Regulation” (CMS-4119-F) (May 22, 2008). The rule becomes effective June 27, 2008.

Download the .PDF to learn more.