InfoSec: FDA Needs to Rectify Control Weaknesses That Place Industry and Public Health Data at Risk
For years, Congress and federal regulators have been raising concerns about FDA’s infosecurity after report of a hack in 2013. So while the FDA has been issuing lots of statements about securing medical devices and mobile apps, the GAO would like them to know that they need to do a better job on securing their own data:
Although the Food and Drug Administration (FDA), an agency of the Department of Health and Human Services (HHS), has taken steps to safeguard the seven systems GAO reviewed, a significant number of security control weaknesses jeopardize the confidentiality, integrity, and availability of its information and systems. The agency did not fully or consistently implement access controls, which are intended to prevent, limit, and detect unauthorized access to computing resources. Specifically, FDA did not always (1) adequately protect the boundaries of its network, (2) consistently identify and authenticate system users, (3) limit users’ access to only what was required to perform their duties, (4) encrypt sensitive data, (5) consistently audit and monitor system activity, and (6) conduct physical security reviews of its facilities. FDA conducted background investigations for personnel in sensitive positions, but weaknesses existed in other controls, such as those intended to manage the configurations of security features on and control changes to hardware and software; plan for contingencies, including systems disruptions and their recovery; and protect media such as tapes, disks, and hard drives to ensure information on them was “sanitized” and could not be retrieved after they are disposed of. The table below shows the number of GAO-identified weaknesses and associated recommendations, by control area.
Download the full report from GAO (59 pp, pdf), while I try to locate a recently disclosed breach involving FDA internal documents that I saw a while back, but foolishly did not download or bookmark.