HHS Office for Civil Rights Settles HIPAA Ransomware Cybersecurity Investigation with Neurology Practice

Settlement Marks OCR’s 12th Ransomware Enforcement Action and 8th Enforcement Action in OCR’s Risk Analysis Initiative

Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Comprehensive Neurology, PC (Comprehensive), a small New York neurology practice, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. The settlement resolves an OCR investigation of a ransomware attack against Comprehensive.

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 information systems by requiring administrative, physical, and technical safeguards to ensure the confidentiality, integrity, security, and availability of electronic PHI (ePHI). One of these standards, known as the “Risk Analysis provision,” requires a regulated organization to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by that organization.

“Effective cybersecurity requires proactively implementing the HIPAA Security Rule requirements before a breach or cybersecurity incident occurs,” said OCR Acting Director Anthony Archeval. “OCR urges health care entities to prioritize compliance with the HIPAA Security Rule risk analysis requirement.”

Ransomware and hacking are the primary cyberthreats to electronic health information in health care. Ransomware is a type of malware (malicious software) designed to deny access to a user’s data, usually by encrypting it until a ransom is paid. This settlement marks the 12^th ransomware enforcement action and the 8^th enforcement action in OCR's Risk Analysis Initiative. This enforcement initiative was created to focus select investigations on compliance with the HIPAA Security Rule Risk Analysis provision; to increase the number of completed investigations; and to highlight the need for more attention and better compliance with this Security Rule requirement. The HIPAA Security Rule Risk Analysis provision is a key Security Rule requirement and the foundation for effective cybersecurity practices and the protection of ePHI.

The settlement resolves OCR’s investigation of a ransomware attack against Comprehensive. In December 2020, OCR received a breach report from Comprehensive that stated that its IT network, including all of its ePHI, had been encrypted and rendered inaccessible by ransomware. Comprehensive determined that 6,800 individuals may have been affected. The compromised ePHI included patient names, clinical information, health insurance information, demographic information, Social Security numbers, as well as driver’s license and state identification numbers. OCR’s investigation found that Comprehensive failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the ePHI held by Comprehensive.

Under the terms of the settlement, Comprehensive agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $25,000 to OCR. Under the corrective action plan, Comprehensive will be required to take specific steps toward resolving potential violations of the HIPAA Security Rule, including:

• Conducting an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the ePHI in its information systems;
• Developing and implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in the risk analysis;
• Reviewing, and to the extent necessary, revising its written policies and procedures to comply with the HIPAA Rules; and
• Training its workforce on its HIPAA policies and procedures.

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

• Identify where ePHI is located in the organization, including how ePHI enters, flows through, and leaves the organization’s information systems.
• Integrate risk analysis and risk management into the organization’s business processes.
• Ensure that audit controls are in place to record and examine information system activity.
• Implement regular reviews of information system activity.
• Utilize mechanisms to authenticate information to ensure only authorized users are accessing ePHI.
• Encrypt ePHI in transit and at rest to guard against unauthorized access to ePHI when appropriate.
• Incorporate lessons learned from incidents into the organization’s overall security management process.
• Provide workforce members with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.

The resolution agreement and corrective action plan may be found at: https://www.hhs.gov/sites/default/files/ocr-hipaa-racap-np.pdf

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. Please see OCR’s guidance and webinar on the HIPAA Security Rule Risk Analysis requirement.

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.

Follow HHS OCR on X at @HHSOCR.