On April 10, the US Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with a company 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.
The HIPAA Security Rule establishes national standards to protect and secure the healthcare 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.
The settlement, which marks the sixth enforcement action in OCR’s Risk Analysis Initiative, resolves an investigation concerning a breach of ePHI stored on the company’s Picture Archiving and Communication System (PACS) server for storing, retrieving, managing, and accessing radiology images.
OCR initiated its investigation of the company after receiving a breach report in March 2020 about a breach of unsecured ePHI. The company reported that between April 2019 and January 2020, unauthorized individuals had accessed radiology images stored on its PACS server. The company notified the 298,532 patients whose information was potentially accessible on the PACS server of this breach. OCR’s investigation found that the company had failed to conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the ePHI in its information systems.
Under the terms of the resolution agreement, the company 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, the company 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.
Compliance Perspective
Issue
OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules, which set forth the requirements that covered entities and business associates must follow to protect the privacy and security of protected health information (PHI). OCR recommends that covered entities and business associates take several steps to mitigate or prevent cyber-threats. These include identifying where electronic ePHI is located within the organization, including how it enters, flows through, and leaves the organization’s information systems; integrating risk analysis and risk management into the organization’s business processes; ensuring that audit controls are in place to record and examine information system activity; implementing regular reviews of system activity; utilizing mechanisms to authenticate information and ensure only authorized users access ePHI; encrypting ePHI in transit and at rest, where appropriate; incorporating lessons learned from security incidents into the organization’s overall security management process; and providing workforce members with regular HIPAA training tailored to the organization and relevant job duties.
Discussion Points
- Review policies and procedures related to HIPAA, PHI, the Privacy and Security rules, and data integrity. Ensure that they address how to avoid falling prey to security breach efforts by unauthorized individuals, and how to guard against and detect malicious software. Update as new information becomes available.
- Train staff involved with the use and maintenance of the organization’s computer information systems regarding the HIPAA Security Rule, including the requirements for conducting risk assessments. Train appropriate staff on HIPAA, PHI, and the Privacy and Security rules, including how to avoid phishing schemes, malware exposures, unauthorized release of PHI, and how to detect malicious software and report such detections. Provide additional training at least annually and whenever new threats or security developments arise.
- Periodically audit to ensure that staff are adhering to data integrity security measures, and to ensure that the facility’s policies and procedures for HIPAA, PHI, and the Privacy and Security rules are being followed. Also periodically audit to ensure ongoing risk analysis is being conducted.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*
