This proposed rule (pdf) would amend the CLIA regulations to specify that, upon a patient’s request, the laboratory may provide access to completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient.
The proposed rule would also amend HIPAA to “provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information.”
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