The CLIA Amendments of 1988 set forth the uniform federal regulatory quality standards for clinical laboratory testing of humans, except for clinical trials and research. CLIA empowers HHS to set the rules for laboratory testing and to certify labs, which authorizes them to conduct tests on specimens derived from humans for the purpose of diagnosis, health assessments, or prevention or treatment of a disease or impairment. In February 2014, the U.S. Department of Health and Human Services (HHS) announced significant changes to the regulations implementing CLIA and the HIPAA Privacy Rule. The new regulations give patients a means of direct access to their own completed laboratory test reports, a move designed to empower patients with more information so they can take an active role in their healthcare.
We invite you to learn more about CLIA and patient's rights to access lab reports under the new regulations by reading our Fast Facts and Myth Busters on CLIA using the links below.
Fast Facts: Patients’ Right to Access Lab Reports under New CLIA Regulations
.png)