On February 6, 2014, the Centers for Medicare and Medicaid Services (CMS) released a new rule, effective April 7, 2014, amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the HIPAA Privacy Rule. The new rule specifies that, at the request of a patient, laboratories subject to CLIA may provide the patient, or the patient’s personal representative, with copies of completed test reports that can be identified as belonging to the patient.
Previously, CLIA regulations authorized labs to release test results only to a person authorized under state law to order or receive results (usually only a health care provider), the person responsible for using the test results, or the lab that requested the test. The Final Rule amends these limitations to allow the lab to provide the test results directly to patients and their personal representatives. The Final Rule also amends the Heatlh insurance Portablitiy and Accountability Act Privacy Rule’s provisions on a patient’s right to access protected health information in a designated record set by removing the exceptions for CLIA-certified or exempt.
CMS states that the changes to the CLIA regulations and the HIPAA privacy rule provide individuals with a greater ability to access health information.
The full text of the rule can be found here.