Publication of Final Rule “Clinical Laboratory Improvement Amendments (CLIA) Program and Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule; Patients’ Access to Test Reports”
• Goal: To support the commitment of the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid
Services (CMS), and the Office of Civil Rights (OCR) that patients should have access to their personal health information,
including access to their laboratory test reports.
• Notice of Final Rule: CMS-2319-F was published in the Federal Register on February 6, 2014.
• CLIA regulations: The regulations at §493.1291(f) have been revised by replacing the phrase “individual responsible” with
“persons responsible.” A new regulation has been added at §493.1291(l) to specify that, upon a request by a patient (or the
patient’s personal representative), the laboratory may provide patients, their personal representatives, and those persons
specified under 45 CFR 164.524(c)(3)(ii), as applicable, with access to completed test reports that, using the laboratory’s
authentication process, can be identified as belonging to that patient.
• HIPAA Privacy Rule: The rule was amended at 45 CFR §164.524 to remove the exceptions that relate to CLIA and affect an individual’s
right of access. This change preempts any contrary provisions of State law.