A final rule issued February 6, 2014, by the Department of Health and Human Services amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to give a patient (or his or her representative) direct access to the patient’s laboratory test reports. Additionally, the final rule eliminates the CLIA-related exception under the privacy rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Together, these changes will require laboratories to provide patients access to their test reports, which will give patients greater ability to access their health information. These changes take effect on April 7, 2014. The final rule may be found here: http://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02280.pdf
The change to the CLIA will impact laboratories in 39 states and territories, where there is either no law regarding receipt of test reports, or where reports can only go to the provider. Even if laboratories in the 7 states and territories that currently allow test reports to go to the patient with provider approval have a process in place to provide test reports to patients, their HIPAA Notice of Privacy Practices may now contain inaccurate statements about how individuals can obtain copies of their test reports, given that this final rule preempts contrary state laws. Laboratories in these 46 states and territories (and any other laboratories not already in compliance) will need to revise their Notice of Privacy Practices to inform individuals of their right to obtain reports directly from the laboratory and provide a brief description of how to exercise this right.
Please let us know if we may provide additional information or analysis regarding this rule.