The U.S. Department of Health and Human Services (HHS) is currently accepting comments on a proposed rule that would amend regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Under the HIPAA Privacy Rule, individuals have the right of access to their protected health information. However, the rule currently contains exceptions for CLIA-certified laboratories and CLIA-exempt laboratories. These exceptions were originally included in the Privacy Rule to avoid a conflict with CLIA requirements that limited patient access to reports, according to HHS.
HHS’s proposal would provide individuals the right to receive their test reports directly from laboratories by amending the HIPAA Privacy Rule to remove the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories. HHS explains that, because the Centers for Medicare & Medicaid Services (CMS) is proposing to amend the CLIA regulations to allow CLIA-certified laboratories to provide patients with direct access to their test reports, there is no longer a need for the exceptions. HHS believes the existing exceptions will impede individuals’ right of access to test reports, and the failure to eliminate them “would be inconsistent with the CMS proposal and the goals of HHS to improve individuals’ electronic access to their health information and have widespread adoption of EHRs by 2014.”
Comments on the proposed rule are due November 14, 2011.