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Expert Analysis

Inside HHS Rule On Test Results From HIPAA-Covered Labs

Law360, New York ( February 24, 2014, 5:41 PM EST) -- 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,[1] and by removing the HIPAA exceptions to an individual's right of access to information maintained by CLIA-exempt laboratories.[2]...

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