It’s important to note that major purpose of the Privacy Rule is to effectively define - and ultimately limit- circumstances and situations for which an individual’s protected heath information (PHI) may be used and/or disclosed by covered entities - and also business associates, and their affiliates. As such, a covered entity may therefore not use or disclose protected health information, except either as permitted and/or required by the Privacy Rule, or by the individual - or that individual’s personal representative -who authorizes such in writing.
More specifically, a covered entity must disclose protected health information in only the following two situations: (a) to individuals (or their personal representatives) specifically when access is requested, or an accounting of disclosures of, their protected health information; and (b) to the actual Department of Health and Human Services (HHS) for purposes of a compliance investigation or review or enforcement action.
It’s also important to keep in mind that HIPAA amendments and revisions (i.e., final omnibus ruling, changes and advances in technology, other legal issues) have brought “business associates” into the scope for purposes of the HIPAA Privacy Rule. It’s a best practices to now adopt and implement many of the required policies, procedures, and practices within the HIPAA Privacy Rule - originally only intended for covered entities - to now include business associates and other their affiliates. The “downstream effect” of accountability has taken root, clearly brining other organizations into scope for the HIPAA Privacy Rule.
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