"The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act Privacy Rule," HHS Secretary Kathleen Sebelius said in a statement. "Information like lab results can empower patients to track their health progress, make decisions with their health care professionals and adhere to important treatment plans."
The final rule amends the Clinical Laboratory Improvement Amendments of 1988 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 request, Sebelius said.
At the same time, the final rule eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 Privacy Rule to an individual's right to access his or her protected health information when it is held by a Clinical Laboratory Improvement Amendments-certified or CLIA-exempt laboratory.
While patients can continue to get access to their laboratory test reports from their doctors, these changes give patients a new option to obtain their test reports directly from the laboratory while maintaining strong protections for patients' privacy, Sebelius said.
The final rule was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services, 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.
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