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Karl Wabst

GAO Reports Urge FDA To Boost Privacy, Modernize IT Systems - 0 views

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    This week, the Government Accountability Office issued a report related to privacy and security issues at FDA and another report about the agency's plans to modernize its IT systems, Government Health IT reports. Privacy and Security Report On Monday, GAO released a report suggesting that FDA has not included sufficient privacy and security protections in its plans for a medical product safety monitoring system called the Sentinel Initiative. The system would use data from insurance companies, academic institutions, government agencies and health care providers to track the performance of medications and medical devices. According to the FDA Amendments Act of 2007, the initiative would have access to data from 25 million people by mid-2010 and 100 million people by mid-2012 (Foxhall, Government Health IT, 6/2). For the report, GAO conducted an audit of FDA's planning process for Sentinel from May 2008 to May 2009.
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