HHS Office for Civil Rights Settles HIPAA Security Rule Investigation with Northeast Radiology

Settlement Marks OCR’s 6th 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 Northeast Radiology, P.C. (NERAD), a professional corporation that provides clinical services at medical imaging centers in New York and Connecticut, concerning potential violations of the Health Insurance Portability and Accountability Act (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. 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 security of electronic protected health information (ePHI). The “Risk Analysis” provision requires regulated organizations (covered entities and business associates) 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.

“A HIPAA risk analysis is essential to identifying where electronic protected health information is stored, and the security measures in place to protect it,” said OCR Acting Director Anthony Archeval. “A failure to conduct a risk analysis often foreshadows a future HIPAA breach.”

The settlement, which marks the sixth enforcement action in OCR’s Risk Analysis Initiative, resolves an investigation concerning a breach of ePHI stored on NERAD’s Picture Archiving and Communication System (PACS) server for storing, retrieving, managing, and accessing radiology images.

OCR initiated its investigation of NERAD after receiving a breach report from NERAD in March 2020 about a breach of unsecured ePHI. NERAD reported that between April 2019 and January 2020, unauthorized individuals had accessed radiology images stored on NERAD’s PACS server. NERAD notified the 298,532 patients whose information was potentially accessible on the PACS server of this breach. OCR’s investigation found that NERAD had failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the ePHI in NERAD’s information systems.

Under the terms of the resolution agreement, NERAD agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $350,000 to OCR. Under the corrective action plan, NERAD will take steps to improve its compliance with the HIPAA Security Rule and protect the security of ePHI, including:

• Conducting an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
• Developing and implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in its risk analysis;
• Developing and implementing a written process to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports;
• Developing, maintaining, and revising, as necessary, its written policies and procedures to comply with the HIPAA Rules; and
• Augmenting its existing HIPAA and security training program to all of its workforce members who have access to PHI.

OCR recommends that health care providers, health plans, clearinghouses, and business associates that are covered by HIPAA take 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-settlement-nerad.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.