(HHS: Washington, D.C.) -- Efforts are underway at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) to improve patient safety and the quality of medical care through a plan called “The Sentinel Initiative—A National Strategy for Monitoring Medical Product Safety.” The FDA white paper, calls for a public and private collaboration to develop and implement a system that would enable the FDA to analyze significantly more information by tapping into vast databases of health information to detect early signs of emerging safety problems.
“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” says Mike Leavitt, Health and Human Services secretary. “We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”…
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