New HHS Rule Gives Patients Direct Access To Lab Reports

The Department of Health and Human Services has made changes to the Clinical Laboratory Improvement Amendments of 1988, giving patients and their designees direct access to laboratory test reports.

The CLIA amendment allows labs to give a patient – or a person designated by the patient, a so-called “personal representative” – access to completed test reports upon the patient’s or patient’s personal representative’s request.

Meanwhile, the final rule also scraps the exception under the HIPAA Privacy Rule to an individual’s right to access his or her protected health information when it’s held by a CLIA-certified or CLIA-exempt laboratory, officials say.Patients can continue to get access to their laboratory test reports from their  physicians, but these new rules offer another option to obtain reports directly from the lab while still maintaining patient privacy protections.

“The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act Privacy Rule,” said HHS Secretary Kathleen Sebelius in a press 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 is issued jointly by 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.

Under the HIPAA Privacy Rule, patients, patients’ designees and patients’ personal representatives can see or obtain a copy of their protected health information, including an electronic copy, with limited exceptions.

In doing so, HHS officials point out, the patient or the personal representative may have to put their request in writing and pay for the cost of copying, mailing or electronic media on which the information is provided, such as a CD or flash drive. In most cases, copies must be given to the patient within 30 days of his or her request.

Article written by Mike Miliard