On July 1, 2024, the US Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced a settlement with a health system operating in Pennsylvania, Ohio, and West Virginia, over alleged violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, following a ransomware incident.
OCR’s investigation uncovered multiple potential violations of the HIPAA Security Rule, including failure to conduct a comprehensive risk analysis, establish an adequate contingency plan for emergencies such as ransomware attacks, and enforce access controls to electronic protected health information (ePHI).
Under the terms of the agreement, the health system agreed to a settlement of $950,000 and committed to implementing a corrective action plan monitored by OCR for three years. This plan includes steps to address HIPAA Security Rule violations and enhance the protection of ePHI by:
- Conducting an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
- Implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in their risk analysis;
- Reviewing, developing, maintaining, and revising as necessary written policies and procedures to comply with the HIPAA Rules; and
- Training their workforce on their HIPAA policies and procedures.
OCR recommends healthcare providers, health plans, clearinghouses, and business associates that are covered by HIPAA take the following steps to mitigate or prevent cyberthreats:
- 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 multifactor authentication to ensure only authorized users are accessing ePHI.
- Encrypt ePHI to guard against unauthorized access.
- Incorporate lessons learned from incidents into the overall security management process.
- Provide training specific to organization and job responsibilities on a regular basis; reinforce workforce members’ critical role in protecting privacy and security.
Compliance Perspective
Issue
Ransomware and hacking are the primary cyberthreats in healthcare. Since 2018, there has been a 264 percent increase in large breaches reported to OCR involving ransomware attacks. OCR enforces the HIPAA Privacy, Security, and Breach Notification rules, which set forth the requirements that covered entities (health plans, healthcare clearinghouses, and most healthcare providers), and business associates must follow to protect the privacy and security of ePHI. The ePHI that a regulated entity creates, receives, maintains, or transmits must be protected against reasonably anticipated threats, hazards, and impermissible uses and/or disclosures.
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 when new threats and security information become known. Document that these trainings occurred, and file the signed training document in each employee’s education file.
- 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, LLC for informational purposes only and is not intended to provide legal advice.*
