New Rule: Individuals Can Get Test Results from Labs

The Centers for Medicare and Medicaid Services has issued a proposed rule enabling patients to electronically access their laboratory test result reports directly from labs.

The rule, available here, was published Sept. 14 in the Federal Register with a 60-day comment period, affects labs that are covered entities under HIPAA. The rule amends the Clinical Laboratory Improvement Amendments of 1988 that exempted labs from provisions that give patients the right to access their protected health information.

The rule specifies that "upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient," the proposed rule states. "Subject to conforming amendments, the proposed rule would retain the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test."

While the rule says labs "may" provide access to test reports, it later specifies how "may" actually means, "must disclose." The proposed rule would require a covered lab provide access in the electronic form and format requested by the individual if it is readily producible. If not, the report must be available in a readable electronic form and format as agreed to by the covered entity and individual.

For commentary on the proposed rule, click here.