On Sept. 12, 2011, the U.S. Department of Health and Human Services (HHS) announced a
proposed rule that would provide patients with direct access to their
clinical laboratory results. According to HHS, the proposed rule would expand the rights of patients to access their health information through the use
of health information technology (health IT) by removing a regulatory provision that creates a barrier to the electronic exchange of clinical
The proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
regulations to specify that, upon a patient's request, the laboratory
may provide a patient with access to completed test reports that can be
identified as belonging to that patient using a laboratory's
authentication process. The proposed rule would retain the existing provisions that provide for release of test reports to authorized persons and, if
applicable, the individuals responsible for using the test reports.
This proposed rule would also amend the Privacy Rule promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996.
Currently, the Privacy Rule exempts CLIA laboratories from the obligation to provide an individual with access to his or her own health information.
The proposed rule would remove the CLIA-certified and CLIA-exempt laboratories' exceptions, providing individuals with the right to receive their test
reports directly from laboratories.
"When it comes to healthcare, information is power. When patients have their lab results, they are more likely to ask the right questions, make better
decisions and receive better care," HHS Secretary Kathleen Sebelius said at Monday’s first-ever HHS Consumer Health IT Summit. However, the right to
obtain test results directly from clinical laboratories could create unintended consequences for patients, who may receive life-altering medical news
independent of their healthcare provider. Comments are due by Nov. 14, 2011.
For more information on this topic, or for guidance to help ensure compliance, please contact the author.