GAO: FDA's tracking system isn't secure

FDA needs to improve a new risk analysis program to ensure privacy, GAO finds.

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.

About the Author

Alice Lipowicz is a staff writer covering government 2.0, homeland security and other IT policies for Federal Computer Week.

Featured

  • Cybersecurity

    DHS floats 'collective defense' model for cybersecurity

    Homeland Security Secretary Kirstjen Nielsen wants her department to have a more direct role in defending the private sector and critical infrastructure entities from cyberthreats.

  • Defense
    Defense Secretary James Mattis testifies at an April 12 hearing of the House Armed Services Committee.

    Mattis: Cloud deal not tailored for Amazon

    On Capitol Hill, Defense Secretary Jim Mattis sought to quell "rumors" that the Pentagon's planned single-award cloud acquisition was designed with Amazon Web Services in mind.

  • Census
    shutterstock image

    2020 Census to include citizenship question

    The Department of Commerce is breaking with recent practice and restoring a question about respondent citizenship last used in 1950, despite being urged not to by former Census directors and outside experts.

Stay Connected

FCW Update

Sign up for our newsletter.

I agree to this site's Privacy Policy.