GAO: FDA's tracking system isn't secure

The Food and Drug Administration’s planned Sentinel system for identifying health risks associated with medications and medical items needs more work to safeguard the privacy and security of personal health data, according to a report from the Government Accountability Office.

FDA approves drugs and other medical products and assesses their health risks after they become available to the public. Officials announced in May 2008 that they were developing Sentinel to monitor those risks using personal health information.

Although the agency has a preliminary design for the system, it hasn't created a governance model for oversight and enforcement, GAO said in a report released June 1. FDA also has not established an architecture for Sentinel and has not created privacy and security policies to safeguard the sensitive personal health information the system might use, GAO said.

Also, FDA doesn't have a plan or schedule for dealing with those problems. "Because the Sentinel system will rely on sensitive electronic health data, FDA will likely be faced with several significant privacy and security challenges as it continues to develop the Sentinel system,” the report states.

GAO auditors recommended that FDA develop a plan, with benchmarks, for developing Sentinel and addressing privacy and security problems. FDA officials generally agreed with the recommendations.

They said a model in which personal health information would remain with the originating entity and only analytical results would be shared would mitigate privacy and security problems.

However, they acknowledged that secondary analysis that requires access to personal health information might be necessary, and “the privacy challenges [GAO] identified would be relevant to such analysis,” the report states.