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

United States. Government Accountability Office.

United States. Government Accountability Office.

关键词: Government accountability -- United States.;    health care;    privacy and security;    letter report;   

RP-ID  :  GAO-09-355
RP-ID  :  290359

美国|英语

来源: UNT Digital Library

【 摘 要 】

A letter report issued by the Government Accountability Office with an abstract that begins "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."