Final rule improves patient access to lab results

To help patients be more informed partners in their healthcare, the Department of Health and Human Services (HHS) has issued a final rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient, or a person designated by the patient, his or her “personal representative,” access to the patient’s completed test reports on the patient’s or patient’s personal representative’s request.

“The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule,” said HHS Secretary Kathleen Sebelius. “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals and adhere to important treatment plans.”

The final rule also eliminates the exception under the HIPAA Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA—certified or CLIA—exempt laboratory. Patients can continue to get access to their laboratory test reports from their doctors and the new provisions give patients a new option to obtain their test reports directly from the laboratory while maintaining strong protections for patients’ privacy, according to an HHS release.

The final rule is issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA, the Centers for Disease Control and Prevention, which provides scientific and technical advice to CMS related to CLIA, and the Office for Civil Rights, which is responsible for enforcing the HIPAA Privacy Rule.