The Government Accountability Office (GAO) has issued a report that calls into question the Department of Health and Human Services’ (HHS) guidance for protecting electronic health information.
The report to the U.S. Senate’s Committee on Health, Education, Labor, and Pensions, published in August but publicly released just last week, stated that while “HHS has established guidance for covered entities, such as health plans and care providers, for use in their efforts to comply with HIPAA requirements regarding the privacy and security of protected health information, it does not address all elements called for by other federal cybersecurity guidance.”
Specifically, GAO’s report read, “HHS's guidance does not address how covered entities should tailor their implementations of key security controls identified by the National Institute of Standards and Technology (NIST) to their specific needs. Such controls include developing risk responses, among others. Further, covered entities and business associates have been challenged to comply with HHS requirements for risk assessment and management. Without more comprehensive guidance, covered entities may not be adequately protecting electronic health information from compromise.”
As noted in this week’s Washington Debrief from the College of Healthcare Information Management Executives (CHIME), “Cybersecurity has been a bipartisan priority for lawmakers during the 114th Congress, but the GAO request sent by Senators Alexander and Murray was the first major indication of Congress’ intent to dig into healthcare cybersecurity.” The Debrief added, “The findings echoed one of the charges given to the HHS Cybersecurity Task Force created in Section 405 of the Cybersecurity Act of 2015, directing the group to recommend resources that are scalable across the industry to improve cyber readiness in healthcare.”
GAO noted that although HHS has established an oversight program for compliance with privacy and security regulations, actions did not always fully verify that the regulations were implemented. Specifically, HHS's Office of Civil Rights (OCR) investigates complaints of security or privacy violations, almost 18,000 of which were received in 2014. OCR also established an audit program for covered entities' security and privacy programs. However, GAO stated, “for some of its investigations it provided technical assistance that was not pertinent to identified problems, and in other cases it did not always follow up to ensure that agreed-upon corrective actions were taken once investigative cases were closed. Further, the office has not yet established benchmarks to assess the effectiveness of its audit program. These weaknesses result in less assurance that loss or misuse of health information is being adequately addressed.”
GAO said it conducted the study because while an electronic health record (EHR) can make relevant health information more readily available and usable for providers and patients, recent data breaches highlight the need to ensure the security and privacy of these records. Indeed, the agency pointed out the increase in reported healthcare breaches involving healthcare records of 500 or more individuals from 2009 (0) to 2015 (56). “HHS has primary responsibility for setting standards for protecting electronic health information and for enforcing compliance with these standards,” GAO said.
As such, GAO was asked to review the current health information cybersecurity infrastructure. The specific objectives were to (1) describe expected benefits of and cyber threats to electronic health information, (2) determine the extent to which HHS security and privacy guidance for EHRs are consistent with federal cybersecurity guidance, and (3) assess the extent to which HHS oversees these requirements. To address these objectives, GAO reviewed relevant reports, federal guidance, and HHS documentation and interviewed subject matter experts and agency officials.
In sum, GAO made five recommendations: including that HHS update its guidance for protecting electronic health information to address key security elements, improve technical assistance it provides to covered entities, follow up on corrective actions, and establish metrics for gauging the effectiveness of its audit program. HHS generally concurred with the recommendations and stated it would take actions to implement them, the report concluded.