CLIA Lab Exception to HIPAA Going Away

Under HIPAA, individuals have a right to access all of their PHI held by covered entities, with a few limited exceptions. One exception was that CLIA-covered labs did not have to provide such access: CLIA limits those labs to only providing test results to an "authorized person." This generally means the ordering physician or the physician who will use the test results or communicate them to the patient, not the patient him/herself. Because of the CLIA limit, HIPAA contained an exception for CLIA labs, so that they were not required to provide access to their patients, the way other covered entities must. THAT WILL NOW CHANGE, TO BE EFFECTIVE LATE SEPTEMBER/EARLY OCTOBER. HIPAA will now require CLIA labs to also provide patients with copies of their PHI, if the patient requests.

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