Per the notice below, the United States Office for Civil Rights (OCR) has taken action under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) against a company that allowed deletion of patient information by an unauthorized third party.  Recently, there has been a significant expansion of OCR actions under the HIPAA Security Rule.

HHS Office for Civil Rights Settles HIPAA Security Rule Investigation with USR Holdings, LLC Concerning the Deletion of Electronic Protected Health Information

Settlement resolves multiple Security Rule failures

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a $337,750 settlement with USR Holdings, LLC, a business associate in Florida, under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.  OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules, which set forth the requirements that covered entities (health plans, health care clearinghouses, and most health care providers), and business associates must follow to protect the privacy and security of protected health information (PHI).  The HIPAA Security Rule establishes national standards to protect and secure our health care system by requiring administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic PHI (ePHI).  The settlement resolves a breach investigation concerning the deletion of ePHI by an unauthorized third party.

“Health care entities need to ensure that they are proactively monitoring who is in their information systems, and that they have backup procedures in place to be able to create exact copies of the electronic protected health information they hold, in the event health information is held for ransom or deleted,” said OCR Director Melanie Fontes Rainer.  “Effective cybersecurity includes being able to restore access to electronic health information following a cybersecurity attack, so there is no interruption in the provision of health care.”

OCR initiated an investigation following the receipt of a breach report filed by USR in February 2019, which reported that from August 23, 2018, through December 8, 2018, a database containing the ePHI of 2,903 individuals was accessed by an unauthorized third party/parties who were able to delete ePHI in the database.  OCR’s investigation found potential violations of the HIPAA Security and Privacy Rules, including failures to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to ePHI in its systems; to regularly review its information system activity; and to establish and implement procedures to create and maintain retrievable exact copies of ePHI.  Under the terms of the settlement agreement, OCR will monitor USR for two years to ensure compliance with HIPAA.  In addition, USR paid $337,750 to OCR and agreed to implement a corrective action plan that identifies specific steps USR will take to resolve potential violations of the HIPAA Privacy and Security Rules and protect the security of ePHI, including:

• Conduct an accurate and thorough risk analysis to determine the potential risk and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
• Implement a risk management plan to address and mitigate security risks and vulnerabilities identified in their risk analysis;
• Develop a process to evaluate any environmental or operational changes that affect the security of ePHI;
• Develop, maintain, and revise as necessary, its written policies and procedures to comply with the HIPAA Rules; and
• Distribute any updated HIPAA policies and procedures to its workforce.

The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/usr-holdings-llc-ra-cap/index.html.

OCR recommends health care providers, health plans, clearinghouses, and business associates that are covered by HIPAA take the following best practices to mitigate or prevent cyber-threats:

• Review all vendor and contractor relationships to ensure business associate agreements are in place as appropriate and address breach/security incident obligations.
• Integrate risk analysis and risk management into business processes; conducted regularly and when new technologies and business operations are planned.
• Ensure audit controls are in place to record and examine information system activity.
• Implement regular review of information system activity.
• Utilize multi-factor authentication to ensure only authorized users are accessing ePHI.
• Encrypt ePHI to guard against unauthorized access to ePHI.
• Incorporate lessons learned from incidents into the overall security management process.
• Provide training specific to organization and job responsibilities and on a regular basis; reinforce workforce members’ critical role in protecting privacy and security.

The HHS Breach Portal: Notice to the Secretary of HHS Breach of Unsecured Protected Health Information may be found at: https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.

OCR is committed to enforcing the HIPAA Rules that protect the privacy and security of peoples’ health information.  Guidance about the Privacy Rule, Security Rule, and Breach Notification Rules can also be found on OCR’s website.  If you believe that your or another person’s health information privacy or civil rights have been violated, you can file a complaint with OCR at: https://www.hhs.gov/ocr/complaints/index.html.