Patient Access Rule Finalized

| May 2, 2014

On February 6, 2014, the Department of Health and Human Services (HHS) released a final amendment to both CLIA 1988 and HIPAA 1996 rules in order to allow patients direct access to their lab results. In CLIA Final Rule 42 CFR 493.1291, Patients’ Access to Test Reports and the HIPAA Rule 45 CFR 164.524, Access of Individuals to Protected Health Information, HHS specifies that upon patient (or patient representative) request, laboratories must provide copies of completed test results. As the rule does not clarify the specific process with which laboratories must comply, this has been left up to each individual laboratory.

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