The Department of Health and Human Services released an amendment to the Clinical Laboratory Improvement Amendments of 1988. The new rule specifies 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.”
In short, patients and their designated personal representatives will now have access to their test results directly from the lab. This will allow them to bypass their doctor and/or doctors office in order to get a copy of the test results. The rule also will allow the patient, or their representative, to direct copies of the test reports to be sent to entities or other people. In the long run this will allow patients more access to their health information.
The new rule takes effect 60 days from the 2/6/2014 date of publication in the Federal Register and covered entities must comply within 240 days after the publication date.
CLIA program and HIPAA Privacy Rule; Patients Access to Test Reports (https://www.federalregister.gov/articles/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports)