Ready or not, Phase 2 of OCR's HIPAA audit program is nearly ready to begin, and healthcare organizations and their business associates (BA) should be prepared to open their books to federal regulators.
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.
There are times when state privacy and security laws trump HIPAA, and healthcare organizations and their business associates (BA) should have a clear understanding of their compliance obligations in the midst of what can be a complex web of regulations.
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.
