1. The audit is intended as an educational tool, but if auditors discover serious noncompliance issues, they may request OCR conduct an investigation to determine if enforcement action is necessary.
HIPAA originally recognized the business associate (BA) as a contractor of a covered entity (CE), but did not mandate direct accountability to the regulations. This put the onus on a CE to ensure, contractually, that its BAs met applicable requirements and supported their CE clients' compliance. When the Privacy and Security Rules first became effective, many CEs accepted BA contracts (BAC) (sometimes also called BA agreements [BAA]) from their BAs. Some BAs were actually quite adamant about having the CE sign their BAC. Although it was the obligation of a CE to initiated the BAC and the CE was liable under the law for compliance, in most cases, BAs offered a BAC that met the legal requirements and often looked like the model offered by HHS. If this was not the case or if either party wanted additional provisions, the CE and the BA negotiated a contract. No provisions required by HIPAA could be removed or changed, but other provisions could be added.
If your organization experiences a data breach—an increasingly likely scenario—and PHI is exposed, chances are you will be hit with a lawsuit in short order.
There are compelling reasons with which to make a case to company executives of the benefits of a good data security program. It starts with return on investment calculations.