
This article provides guidance regarding what to expect, and what you should do, once a Business Associate has notified you of a breach. By now, you should already have a plan in place that helps you respond to this dreaded predicament. However, we know from experience that many of you don't, and even if you do, read on, you may learn something new.
The approach we take in the article is to use the breach notification process as a backdrop to point out a number of "holes" you may have in your HIPAA/HITECH compliance initiative, ones that you are likely not even aware of.
Tracking Security Incidents?
The term "security incident" means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system. An attempt qualifies as an incident.
If you are not rigorously tracking incidents, then you can't possibly know when you have a breach. One of the first questions that an HHS auditor is going ask is "show me the system (i.e. the policies, processes and tracking mechanism) your organization uses to track security incident?" If you can't adequately answer this most basic of questions, you may be in
willful neglect land five minutes into the audit.
Ok, so let's assume that for the purpose of this article you, as the
covered entity, have a state of the art security incident tracking system in place. What we really want to know is "What kind of tracking system does your
business associate have in place?" If the answer is "we don't have a clue," then may the HIPAA gods help you if it turns out that in fact, despite "catching" this incident, there is no business associate system in place at all.
How Do You Know It's a Breach?
In order to determine whether Breach Notification is triggered you need to follow a methodology that is mandated by the Breach Notification Rule ("Rule"). Although the Rule contains a basic methodology that is inherent in its text, it is not presented as such in the regulations. HIPAA/HITECH remain descriptive as opposed to prescriptive. That is, the regulations inform you as to what is required, but have very little (mostly nothing) to say about how you should go about complying.
The methodology consists of a three part analytical framework which we turn our attention to next. Although the framework only consists of three parts, it is significantly more complex than it first appears.
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