**GAO-09-355**                      Published: Jun 01, 2009. Publicly Released: Jun 01, 2009.                  

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## Highlights

The Food and Drug Administration (FDA) is responsible for assessing the safety of certain medical products after approval (a process called postmarket risk surveillance). To this end, the Food and Drug Administration Amendments Act of 2007 required that FDA establish a postmarket risk identification and analysis system based on electronic health data. In May 2008, FDA began its Sentinel initiative, intended to fulfill this requirement. Additionally, the Act established a requirement for GAO to review FDA's planned system. GAO's specific objectives were to (1) describe the current status of FDA's implementation of the Sentinel system and (2) identify the key privacy and security challenges associated with FDA's plans for the Sentinel system. To do so, GAO analyzed available system documentation; reviewed key privacy and security laws, guidance, standards, and practices; and obtained and analyzed the views of privacy and security experts.

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## Topics

Health Care

DocumentationElectronic health recordsGovernment information disseminationInformation disclosureInformation managementProduct evaluationProduct safetyProgram evaluationProgram managementRight of privacyRisk assessmentRisk managementSafetySecurity assessmentsSecurity policiesStandardsSystems analysisSystems designSystems evaluationPrivacy policiesPolicies and proceduresProgram goals or objectivesProgram implementation