OCR delays some HIPAA requirements

The Office for Civil Rights (OCR) of the Department of Health and Human Services is delaying its enforcement of the requirement that certain HIPAA–covered laboratories revise their Notices of Privacy Practices (NPPs) to comply with the modifications made to the HIPAA rules published in the Federal Register on Jan. 25, also known as the Omnibus Rule.

The new rule comprises four final rules, according to HHS, "which have been combined to reduce the impact and number of times certain compliance activities need to be undertaken by regulated entities."

This Enforcement Delay applies to HIPAA-covered laboratories that are subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or exempt from CLIA and that are not required to provide an individual with access to his or her laboratory test reports. The Enforcement Delay does not apply to laboratories that operate as part of a larger legal entity, such as a hospital, and by virtue of that relationship, do not have their own, laboratory-specific, NPPs.

Under the HIPAA Privacy Rule, a covered entity is required to promptly revise its NPP whenever there is a material change to any of its privacy practices stated in the NPP.  The Omnibus Rule makes a number of material changes to the privacy obligations of HIPAA-covered entities, which in turn require revisions to the covered entities’ NPPs by the Sept. 23 compliance date to ensure that individuals are aware of their new health information privacy protections and rights.

In the coming months, the department anticipates publishing an amendment to the HIPAA Privacy Rule and the CLIA regulations regarding the right of individuals to receive their test reports directly from CLIA and CLIA-exempt laboratories, which was proposed for public comment in the Federal Register on Sept. 14, 2011. If the amendment is finalized as proposed, it would result in a material change to the privacy practices of the HIPAA-covered laboratories identified above. Consequently, the affected laboratories would need to ensure that their NPPs inform individuals of this new right and include a brief description of how to exercise the right.