IT Weaknesses at the National Institutes of Health Placed EHR Data at Risk

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An audit of the National Institutes of Health (NIH) conducted by the Department of Health and Human Services’ Office of Inspector General (OIG) has revealed technology control weaknesses in the NIH electronic medical records system and IT systems that placed the protected health information of patients at risk.

NIH received $5 million in congressional appropriations in FY 2019 to conduct oversight of NIH grant programs and operations. Congress wanted to ensure that cybersecurity controls had been put in place to protect sensitive data and determine whether NIH was in compliance with Federal regulations.

The audit was conducted on July 16, 2019 by CliftonLarsonAllen LLP (CLA) on behalf of OIG to determine the effectiveness of certain NIH information technology controls and to assess how NIH receives, processes, stores, and transmits Electronic Health Records (EHR) within its Clinical Research Information System (CRIS), which contained the EHRs of patients of the NIH Clinical Center.

NHS has approximately 1,300 physicians, dentists and PhD researchers, 830 nurses, and around 730 allied healthcare professionals. In 2018, the Clinical Center had more than 9,700 new patients, over 4,500 inpatient admissions, and over 95,000 outpatient visits.

CLA found NIH had implemented controls to ensure the confidentiality, integrity, and availability of health data contained in its EHR and information systems, but those measures were not working effectively. Consequently, data in its EHR system and information systems could potentially have been accessed by unauthorized individuals and data was at risk of impermissible disclosure, disruption, modification, and destruction.

The National Institute of Standards and Technology (NIST) recommends primary and alternate EHR processing sites should be geographically separated. The geographical separation reduces the risk of unintended interruptions and helps to ensure critical operations can be recovered when prolonged interruptions occur. OIG found the primary and alternate sites were located in adjacent buildings on the NIH campus. If a catastrophic event had occurred, there was a high risk of both sites being affected.

The hardware supporting the EHR system was either approaching end of life or was on extended support. Four servers were running a Windows operating system that Microsoft had stopped supporting in 2015. NIH had paid for extended support which ran until January 2020, but OIG found there was no effective transition plan. OIG also found that NIH was not deactivating user accounts in a timely manner when employees were terminated or otherwise left NIH. 19 out of 26 user accounts that had been inactive for more than 365 days had not been deactivated, the accounts of 9 out of 61 terminated users were still active, and 3 out of 25 new CRIS users had changed their permissions without a form being completed justifying the change.

NIH informed CLA that it had delayed software upgrades until system upgrades were completed. NIH was in the process of upgrading its hardware at the time of fieldwork in anticipation of upgrades to CRIS. Software updates were due to be performed after the hardware upgrade had been completed.

NIH had implemented an automated tool to scan for inactive accounts and delete them, but the tool had not been fully implemented at the time of fieldwork. There were issues with the tool, such as problems tracking individuals who changed departments.

OIG recommended implementing an alternate processing site in a geographically distinct location and to take action to mitigate risks associated with the current alternative site until the new site is established. Policies and procedures should be implemented to ensure that software is upgraded prior to end of life, and NIH must ensure that its automated tool is functioning as intended. NIH concurred with all recommendations and has described the actions that have been and will be taken to ensure the recommendations are implemented.

Author: Steve Alder has many years of experience as a journalist, and comes from a background in market research. He is a specialist on legal and regulatory affairs, and has several years of experience writing about HIPAA. Steve holds a B.Sc. from the University of Liverpool.

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