On June 9, 2017, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) released a cyber-attack “Quick Response” checklist (the Checklist) for the benefit of HIPAA covered entities and business associates.
This checklist and the accompanying info-graphic is part of the ongoing HHS campaign to get out ahead of cyber-attacks in the healthcare sector. Rather than the HHS merely reacting to HIPAA-related fallout that can occur as a result of a breach, this checklist is meant to preemptively explain the steps for a HIPAA covered entity or its business associate to take in response to a cyber-related security incident. This preventative campaign by HHS has been spurred on by the increasing prevalence of cyber-attacks, particularly the May 2017 WannaCry ransomware attack in May 2017 which “rapidly affected numerous organizations across over one hundred countries.” The Checklist contains response, reporting, and assessment / notice requirements for covered entities and business associates.
1) Response: The entity must execute its response and mitigation procedures in addition to its contingency plan. See HIPAA Security Rule, 45 C.F.R. § 164.308(a)(6)−(7) (requiring the establishment of contingency plans and the entity’s response to and mitigation of security incidents). This requires that the entity immediately identify the problem, fix it, and mitigate any impermissible disclosure of public health information (PHI).
2) Report: The entity should report the crime to law enforcement agencies, which may include state or local law enforcement, the Federal Bureau of Investigations, or the Secret Service. This report should not include any PHI.
The entity should report all cyber threat indicators to federal and information sharing and analysis organizations (ISAOs), including the Department of Homeland Security, the HHS Assistant Secretary for Preparedness and Response, and private-sector cyber-threat ISAOs.
3) Assessment and Notice: If the breach affects 500 or more individuals, the entity must report it to OCR as soon as possible, but no later than 60 days after the discovery of the breach. The entity must also notify the individuals affected by the breach and the media unless a law enforcement officer has requested a delay in the reporting.
If the breach affects less than 500 individuals, the entity must notify the affected individuals without unreasonable delay, but no later than 60 days after discovery and OCR within 60 days after the end of the calendar year in which the breach was discovered.
If the PHI was encrypted or the entity determines through a written risk assessment that there was a low probability that PHI was compromised during the breach, this would not constitute a breach that would have to be reported to OCR.
In recent testimony to Congress, HHS officials testified that its cybersecurity push is meant “to engage the broader healthcare sector and ensure that IT security practitioners ha[ve] the information they need,” while additionally providing guidance and support regarding “how to manage cybersecurity incidents in this era of heightened consequences….” (See Congressional Testimony, Steve Curren, Division of Resilience in the Office of Emergency Management, HHS Office of the Assistant Secretary for Preparedness and Response). In the Checklist release, HHS specifically refers to HIPAA-related penalties, noting that “in determining the amount of any applicable civil penalty, OCR may consider mitigating factors,” including compliance with the actions encouraged by the Checklist. (See also 45 C.F.R. §160.408 (describing mitigating and aggravating factors in determining civil penalties)). The release of this “Quick Response” checklist follows the HHS establishment of the Health Cybersecurity and Communications Integration Center, demonstrating the serious commitment of the HHS to combating the occurrence and effect of these cybersecurity breaches.