Statement of Delay in Enforcement of HIPPA Requirement for CLIA and CLIA-Exempt Labs to Revise their NPP
19/09/13 15:49 Filed in: HIPAA | HIPAA requirement | notices of privacy practices | CLIA Laboratories | CLIA-exempt laboratories
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, 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 here.
Click the following link to find the original article.
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, 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 here.
Click the following link to find the original article.