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Reminder of End of NPP Enforcement Delay for CLIA Labs

Dated: October 3, 2014

On September 19, 2013, HHS announced a delay until further notice in 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 January 25, 2013 (78 FR 5566) (commonly known as the “Omnibus Rule”). The announcement, included below, explained that the Department anticipated publishing in the coming months an amendment to the HIPAA Privacy Rule and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations that could result in certain HIPAA covered CLIA and CLIA-exempt laboratories again having to revise their NPPs.  Given the proximity of the publication of the Omnibus Rule and the anticipated CLIA Final Rule, HHS announced that it would exercise its enforcement discretion to relieve the possible burden on and expense to these HIPAA-covered laboratories of having to revise their NPPs twice within a short period of time, once by September 23, 2013, to comply with the Omnibus Rule, and again by the impending issuance of any CLIA-related amendment to the HIPAA Privacy Rule. 

HHS published the CLIA Final Rule in the Federal Register on February 6, 2014 (79 FR 7290). The rule, which was announced on OCR’s website on February 3, 2014, provided notice of the end of the enforcement delay.  In particular, the rule explained that CLIA and CLIA-exempt laboratories that are HIPAA covered entities were permitted to take until the compliance date of the CLIA Final Rule, October 6, 2014, to revise their NPPs to reflect the modifications required by both the CLIA Final Rule as well as the Omnibus HIPAA Final Rule. Therefore, as of October 6, 2014, all HIPAA covered laboratories are expected to have NPPs in place that meet all applicable legal requirements.

View the CLIA Final Rule

View the Omnibus HIPAA Final Rule

 


Statement of Delay in Enforcement of HIPAA Requirement for Certain CLIA and CLIA-Exempt Laboratories to Revise their Notices of Privacy Practices (NPP)

Dated: September 19, 2013

The Office for Civil Rights (OCR) of the Department of Health and Human Services announces a delay in 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 January 25, 2013 (78 FR 5566), commonly known as the “Omnibus Rule,” until further notice. This Enforcement Delay applies to HIPAA-covered laboratories that are subject to CLIA (i.e., CLIA-certified) or exempt from CLIA (i.e., CLIA-exempt) and that are not required to provide an individual with access to his or her laboratory test reports under § 164.524 of the HIPAA Privacy Rule because the information is subject to the exceptions to the right of access at § 164.524(a)(1)(iii)(A) or (B).  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.

Background

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 September 23, 2013, 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 Clinical Laboratory Improvement Amendments of 1988 (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 September 14, 2011 (76 FR 56712). 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.

Enforcement Delay

Given the potential proximity of the two rulemakings, OCR is exercising its enforcement discretion to relieve the possible burden on and expense to the HIPAA-covered laboratories identified above of having to revise their NPPs twice within a short period of time, once by September 23, 2013, to comply with the Omnibus Rule, and again by the impending issuance of any CLIA-related amendment to the individual access requirements under § 164.524 of the Privacy Rule.  Specifically, with respect to the HIPAA-covered laboratories identified above, OCR will not take enforcement action or seek to impose civil money penalties where the HIPAA-covered laboratory has not revised its NPP by September 23, 2013, to comply with the Omnibus Rule.  OCR will issue a notice at least 30 days in advance to advise the public when this enforcement delay will end. The notice will be prominently published on OCR’s website at http://www.hhs.gov/ocr/hipaa/, and, if applicable, included in any final rule regarding a CLIA-related amendment to the Privacy Rule.  The public can check the status of any final rule amending 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 at http://www.reginfo.gov/public/.