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The HIPAA Privacy Rule: Patients Access to Test Reports

Beginning April 7, 2014 patients and / or their personal representatives will have greater access to their test results. Covered entities will have until October 6, 2014 to comply with this final rule, which amends the current CLIA regulations of 1998 and the HIPAA Privacy Rule.

The changes to the HIPAA Privacy Rule will preempt a number of state laws that prohibit a laboratory from releasing a test report directly to the individual or that prohibit the release without the ordering provider’s consent. The HIPAA Privacy Rule mandates direct access by the individual. Patients and / or their representatives will now have the ability to directly contact HIPAA covered laboratories, including CLIA and CLIA exempt laboratories, for test results.

The Federal Register Summary

This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient’s personal representative), laboratories subject to CLIA may provide the patient, the patient’s personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the final rule retains the existing provisions that require release of test reports only to authorized persons and, if applicable, to the persons responsible for using the test reports and to the laboratory that initially requested the test.

In addition, this final rule amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals (or their personal representatives) with the right to access test reports directly from laboratories subject to HIPAA (and to direct that copies of those test reports be transmitted to persons or entities designated by the individual) by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.

 

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