Effective as of October 6, 2014, amendments to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations give patients, upon request, the right to direct access to a HIPAA-covered laboratory’s completed test reports.  According to the final rule, these changes are intended to provide patients with “a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.”  

There are several provisions of the new rule that non-hospital-based laboratories will need to understand to ensure compliance, including requirements relating to timing, scope of access, access by personal representatives and designated third parties, form and format of access, content of the test report, copying fees, and verification of identity and authentication.

Hospital-based laboratories may continue to utilize the hospital’s already established mechanism for providing access to patients requesting their test reports from the hospital laboratories, provided these mechanisms are compliant with the HIPAA access rules.  

Because the new rule constitutes a material change to privacy practices, non-hospital-based laboratories should have revised their notices of privacy practices by October 6, 2014.  In addition, these laboratories should update their policies and procedures, and staff should be trained.  These laboratories should also ensure compliance with civil rights laws which may require translation services when communicating directly with patients.  

The final rule can be accessed here.