WASHINGTON – Today, the U.S. Department of Health and Human Services (HHS) announced a ruling that allows patients direct access to their completed test reports. AACC supports this new ruling and applauds the ongoing efforts of HHS to empower patients to be informed healthcare consumers.
The final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient, or a person designated by the patient, access to the patient’s completed test reports. The final rule also eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory.
For patients, this means that while they can continue to get access to their laboratory test reports from their physicians, they now – for the first time – also have the opportunity to obtain test reports directly from the laboratory.
“AACC strongly supports patient empowerment and health literacy and believes that patients should have greater access to their test results so that they can take a more active role in managing their health,” said AACC CEO Janet Kreizman. “However, providing laboratory test results without context may have limited value for some consumers, while unnecessarily alarming others. Most laboratory test reports only provide a numeric value along with a reference range for each result. AACC recommends that patients consult with their physician before making any health-related decisions based on their test results.”
AACC has long had a commitment to patient empowerment and health literacy. In 2001, the organization launched LabTestsOnline.org, an online tool for patients that provides information on the many clinical lab tests that are part of routine care as well as diagnosis and treatment of a broad range of conditions and diseases. Today, the original U.S. version of Lab Tests Online averages more than a million visits per month, and it anchors a global network of websites that have been translated to 14 languages and adapted to local policies and practice in 17 countries. Worldwide, more than 200 million visitors have used the site to learn about clinical lab tests.
About AACC
Dedicated to achieving better health through laboratory medicine, the American Association for Clinical Chemistry (AACC) brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.