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The Department of Health and Human Services’ Office for Civil Rights (OCR) has announced a settlement has been reached with Peachstate Health Management, LLC, dba AEON Clinical Laboratories to resolve multiple violations of the HIPAA Security Rule.
Peachstate is a CLIA-certified laboratory that provides a range of services including clinical and genetic testing services through its publicly traded parent company, AEON Global Health Corporation (AGHC).
OCR launched a compliance investigation on August 31, 2016 following a breach of unsecured protected health information reported by the U.S. Department of Veterans Affairs (VA) on January 7, 2015 involving its business associates, Authentidate Holding Corporation (AHC). The VA had contracted with AHC to manage the VA’s Telehealth Services Program. The aim of the OCR investigation was to assess whether the breach was the result of the failure to comply with the HIPAA Privacy and Security Rules.
During the course of the investigation, OCR learned that AHC had entered into a reverse merger with Peachstate on January 27, 2016 and had acquired Peachstate. OCR then conducted a compliance review of Peachstate’s clinical laboratories to assess Privacy and Security Rule compliance. During that investigation OCR identified multiple potential violations of the HIPAA Security Rule.
Peachstate was discovered not to have conducted an accurate and thorough assessment to identify risks to the confidentiality, integrity, and availability of electronic protected health information (ePHI), as required by 45 C.F.R. § 164.308(a)(1)(ii)(A) and had failed to reduce risks and vulnerabilities to a reasonable and appropriate level by implementing appropriate security measures, as required by 45 C.F.R. § 164.308(a)(1)(ii)(B).
Hardware, software, and procedural mechanisms had not been implemented to record and examine activity in information systems containing or using ePHI, in violation of 45 C.F. R. § 164.312(b). Policies and procedures had not been implemented to record actions, activities, and assessments demanded by 45 C.F. R. § 164.312(b), which was in violation of 45 C.F.R. § 164.316(b) of the HIPAA Security Rule.
Peachstate agreed to settle the case and pay a $25,000 penalty and will implement an extensive corrective action plan to address all areas of noncompliance identified by OCR during the course of the investigation. Peachstate will be closely monitored by OCR for 3 years to ensure compliance.
“Clinical laboratories, like other covered health care providers, must comply with the HIPAA Security Rule. The failure to implement basic Security Rule requirements makes HIPAA regulated entities attractive targets for malicious activity, and needlessly risks patients’ electronic health information,” said Robinsue Frohboese, Acting OCR Director. “This settlement reiterates OCR’s commitment to ensuring compliance with rules that protect the privacy and security of protected health information.”