Expanding Patients’ Rights

The HHS has taken steps to make it easier for patients to get access to laboratory test results. “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 health care professionals, and adhere to important treatment plans.”

The final rule, announced in February 2014, changes the Clinical Laboratory Improvement Amendments (CLIA) of 1988 to allow laboratories to give a patient or person designated by the patient access to the laboratory reports. Previously, under CLIA regulations, a laboratory could only release completed test reports directly to a patient if (1) the ordering provider expressly authorized the lab to do so at the time the test was ordered; or (2) state law expressly allowed for it.

The HIPAA Privacy Rule also included an exception to a patient’s right of access for CLIA-certified or CLIA-exempt laboratories that were prohibited by law from providing such access. In the 26 states that lacked laws authorizing direct disclosure of test reports to patients and in the 13 states that expressly prohibited such access, patients did not have direct access to their test reports through CLIA laboratories. The new changes to the rule eliminate those exceptions.

Under the revised rule, patients, their designees, and their personal representatives can see or be given a copy of the patient’s protected health information, including an electronic copy, with limited exceptions. The patient or representative may have to put the request in writing and pay for copying, mailing, or electronic media on which the information is provided, such as a CD or flash drive. In most cases, the information must be provided to the patient within 30days of requesting it. The final rule is available for review at http://federalregister.gov.