On February 3, 2014, the U.S. Department of Health and Human Services (HHS) released a long-awaited final rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy regulations to permit patients and their personal representatives to access laboratory test reports. By requiring expanded access, HHS rejects what some have characterized as “paternalistic” arguments that such reports are complicated and should be provided only through treating physicians. HHS justifies the rule as necessary to empower patients to take an active role in managing their health and healthcare. As anyone who has tried to interpret a laboratory test report can attest, whether the stated objectives of the new rule will be achieved has yet to be seen.
05 February 2014