HHS Amends CLIA to Broaden the Patient’s Access Rights to Lab Test Results

by Kathie McDonald-McClure and Elizabeth O’Keeffe

lab_specimensAs we have previously reported on the Wyatt HITECH Law blog on September 14, 2013 and September 23, 2011, the Department of Health and Human Services (HHS) has had in the works, for over two years now, revisions to the Clinical Laboratory Improvement Act of 1988 (CLIA) regulations concerning whether a lab may release test results directly to patients.  On February 3, 2013, HHS announced the release of a Final Rule (Final Rule) amending the CLIA regulations to allow laboratories to give a patient, or a person designated by the patient, his or her “personal representative”, access to the patient’s completed test reports upon the patient’s or patient’s personal representative’s request.  The Final Rule was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA, the Centers for Disease Control and Prevention (CDC), which provides scientific and technical advice to CMS related to CLIA, and the Office for Civil Rights (OCR), which is responsible for enforcing the HIPAA Privacy Rule. Continue reading