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Privacy and Security: Food and Drug Administration Faces Challenges in Establishing Protections for its Postmarket Risk Analysis System

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By Gregory C. Wilshusen (au)
Year: 2009
Pages: 79
Binding Paperback

Product Code: 1437917410

Description

FDA is responsible for assessing the safety of certain medical products after approval (a process called postmarket risk surveillance). To this end, the FDA 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. This report reviews FDA's planned system; the 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. Includes recommendations. Charts and tables.

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