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OCR Reminds Covered Entities of Security Incident Definition and Notification Requirements

The ransomware attacks and healthcare IT security incidents last month have prompted the Department of Health and Human Services’ Office for Civil Rights to issue a reminder to covered entities about HIPAA Rules on security breaches.

In its May 2017 Cyber Newsletter, OCR explains what constitutes a HIPAA security incident, preparing for such an incident and how to respond when perimeters are breached.

HIPAA requires all covered entities to implement technical controls to safeguard the confidentiality, integrity and availability of electronic protected health information (ePHI). However, even when covered entities have sophisticated, layered cybersecurity defenses and are fully compliant with HIPAA Security Rule requirements, cyber-incidents may still occur. Cybersecurity defenses are unlikely to be 100% effective, 100% of the time.

Prior to the publication of OCR guidance on ransomware attacks last year, there was some confusion about what constituted a security incident and reportable HIPAA breach. Many healthcare organizations had experienced ransomware attacks, yet failed to report those incidents to OCR or notify patients that their ePHI may have been accessed.

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OCR has reminded covered entities in its newsletter of the HIPAA definition of a security incident. The HIPAA Security Rule (45 CFR 164.304) describes a security incident as “an attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.”

OCR has taken the opportunity to remind covered entities that they need to prepare for those incidents. Policies and procedures should be developed that kick into action immediately following the discovery of a security incident or data breach.

If covered entities react quickly to security incidents and data breaches it is possible to minimize the impact and reduce legal liability and operational and reputational harm. Contingency plans should exist for a range of security incidents and emergency situations. OCR says “policies, procedures, and plans should provide a roadmap for implementing the entity’s incident response capabilities.”

When a breach occurs, the HIPAA Breach Notification Rule requirements must be followed. The HIPAA Breach Notification Rule (45 CFR 164.402) requires OCR to be notified of a breach and notifications to be sent to patients in the event of “an impermissible acquisition, access, use, or disclosure under the HIPAA Privacy Rule that compromises the security or privacy of the protected health information.”

Each month, Databreaches.net tracks healthcare data breach incidents, with the Protenus Breach Barometer report showing the time taken for covered entities to report their breaches to OCR. The past few reports show some improvement, with covered entities reporting their breaches more promptly. That said, there have been several cases where data breach notifications have been submitted late and patients have had their notification letters delayed.

OCR reminds covered entities that the HIPAA deadline for reporting security incidents and sending notifications to patients/health plan members is 60 days* from the discovery of the breach.

This is a deadline, not a recommendation. Many covered entities delay issuing notifications until day 59. OCR points out that the HIPAA Breach Notification Rule requires notifications to be issued “without reasonable delay.”

If you missed the email newsletter, you can download a copy on this link: https://www.hhs.gov/sites/default/files/may-2017-ocr-cyber-newsletter.pdf

*Breaches impacting fewer than 500 individuals can be reported to OCR annually, with the deadline 60 days after the end of the year when the breach was discovered. Breaches impacting 500 or more individuals must be reported to OCR within 60 days of the discovery of the breach. Individuals must be notified of a breach of PHI or ePHI within 60 days of the discovery of the breach, regardless of how many individuals have been impacted by the breach.

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.