OCR Announces Enforcement Delay for CLIA Labs

This post was authored by Brad Rostolsky and Jennifer Pike.

The Office for Civil Rights (OCR) of the Department of Health & Human Services (HHS) announced September 19, 2013 that, until further notice, it is delaying enforcement of the requirement that certain HIPAA-covered labs revise their notice of privacy practices (NPPs) to comply with modifications made by the HITECH Final Rule. The enforcement delay applies to HIPAA-covered labs that are subject to Clinical Laboratory Improvement Act (CLIA), or exempt from CLIA, and that are not required to provide an individual with access to his or her lab test reports, because the reports are subject to the exceptions to the right of access at 45 C.F.R. § 164.524. The delay does not apply to labs that operate as part of a larger legal entity, and by virtue of that relationship do not have their own NPP.

By way of background, under the Privacy Rule, covered entities must promptly revise their NPPs whenever there is a material change to the privacy practices described in the NPP. The HITECH Final Rule made a number of such material changes, necessitating that covered entities revise their NPPs.

The enforcement delay is a result of HHS’ plan to amend the HIPAA Privacy Rule and CLIA regulations regarding the rights of individuals to receive their test reports directly from CLIA and CLIA-exempt labs. If finalized as proposed, the amendment would result in a material change to the labs’ privacy practices. The purpose of the delay is to decrease the burden on and expense to HIPAA-covered labs of having to revise their NPPs twice within a short period of time.
For more information about the HITECH Final Rule and its implementation, please see our previous discussion of this topic.
 

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