tci Medicare Compliance & Reimbursement - 2008 Issue 22

Safety: Initiative Aims To Create A 'Sentinel' For Healthcare Products

Electronic system will include a huge database for research, oversight and evaluation The federal government has launched a joint initiative by the Food and Drug Administration and the Centers for Medicaid & Medicare Services that will use existing electronic claims and medical records data to improve the safety of medical products. The new electronic system, called the Sentinel Initiative, will enable agencies to "tremendously increase" their surveillance of medical products, Health & Human Services Secretary Mike Leavitt says in a May 22 press release. The FDA will use the Sentinel Initiative to identify post-market adverse events and help move...

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