What you might have thought was not a big breach (or a big deal in terms of HIPAA compliance), might end up being a big headache for covered entities and business associates. In fact, it’s probably a good idea to try to find out what “smaller” breaches your competitors are reporting (admittedly not an easy task, since the “Wall of Shame” only details breaches affecting the protected health information (PHI) of 500 or more individuals).
Subscribers to the U.S. Department of Health and Human Services Office of Civil Rights (OCR) listserv received an announcement a couple of weeks ago that OCR would begin to “More Widely Investigate Breaches Affecting Fewer than 500 Individuals”. The announcement states that the OCR Regional Offices investigate all reported breaches involving PHI of 500 or more individuals and, “as resources permit”, investigate breaches involving fewer than 500. Then the announcement warns that Regional Offices will increase efforts “to identify and obtain corrective action to address entity and systemic noncompliance” related to these “under-500” breaches.
Regional Offices will still focus these investigations on the size of the breach (so perhaps an isolated breach affecting only one or two individuals will not raise red flags), but now they will also focus on small breaches that involve the following factors:
* Theft or improper disposal of unencrypted PHI;
* Breaches that involve unwanted intrusions to IT systems (for example, by hacking);
* The amount, nature and sensitivity of the PHI involved; and
* Instances where numerous breach reports from a particular covered entity or business associate raise similar concerns
If any of these factors are involved in the breach, the reporting entity should not assume that, because the PHI of fewer than 500 individuals was compromised in a single incident, OCR is not going to pay attention. Instead, whenever any of these factors relate to the breach being reported, the covered entity (or business associate involved with the breach) should double or triple its efforts to understand how the breach occurred and to prevent its recurrence. In other words, don’t wait for the OCR to contact you – promptly take action to address the incident and to try to prevent it from happening again.
So if an employee’s smart phone is stolen and it includes the PHI of a handful of individuals, that’s one thing. But if you don’t have or quickly adopt a mobile device policy following the incident and, worse yet, another employee’s smart phone or laptop is lost or stolen (and contains unencrypted PHI, even if it only contains that of a small handful of individuals), you may be more likely to be prioritized for investigation and face potential monetary penalties, in addition to costly reporting and compliance requirements.
This list of factors really should come as no surprise to covered entities and business associates, given the links included in the announcement to recent, well-publicized OCR settlements of cases involving smaller breaches. But OCR’s comment near the very end of the announcement, seemingly made almost in passing, is enough to send chills down the spines of HIPAA compliance officers, if not induce full-blown headaches:
Regions may also consider the lack of breach reports affecting fewer than 500 individuals when comparing a specific covered entity or business associate to like-situated covered entities and business associates.”
In other words, if the hospital across town is regularly reporting hacking incidents involving fewer than 500 individuals, but your hospital only reported one or two such incidents in the past reporting period, your “small breach” may be the next Regional Office target for investigation. It will be the covered entity’s (or business associate’s) problem to figure out what their competitors and colleagues are reporting to OCR by way of the “fewer than 500” notice link.