Inside HHS Rule on Test Results From HIPAA-Covered Labs

By: Helen R. Pfister
– Law360

On Feb. 6, the U.S. Department of Health and Human Services published a final rule amending the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") regulations and the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") regulations to permit CLIA-certified laboratories to provide copies of completed test reports to patients (or their representatives) upon request. This change was effectuated by including a provision in the CLIA regulations authorizing the release of test results directly to patients, and by removing the HIPAA exceptions to an individual's right of access to information maintained by CLIA-exempt laboratories.

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