WASHINGTON (CN) - Patients will soon have the right to access test results directly from labs, no matter what state they live in.
A change is being made to the Clinical Laboratory Improvement Amendments and the Health Insurance Portability and Accountability Act to give all Americans the right to access test results directly from labs. The new regulation
amends the CLIA regulations and HIPAA requirements to specify that, if a patient requests it, he or she has the right to view test reports. The rule was created specifically to provide access in states where people currently do not have this right.
More than 160 comments were made when the rule was proposed, but the majority favored the change, noting that people who know more about their health are generally healthier and can take a more active role in their health and health care decisions. Laboratories, health policy experts, health care providers, electronic health record system vendors and other stakeholders all expressed concern that the previous regulations imposed unnecessary barriers to patients.
In 1988, CLIA established nationwide quality standards to ensure the accuracy, reliability and timeliness of test results at clinical laboratories and, in 1996, HIPAA instituted national standards to protect the privacy of people's health information. Both, however, created barriers regarding to whom laboratories can, and are required to, issue test reports.
Under the new regulation, labs must provide test results, but will not be required to interpret them. Some physicians are concerned that if patients are able to read the test results without a medical professional to explain them, the patients may not understand the results and act in ways detrimental to their health.
The regulations is effective April 7 and HIPAA-covered entities must comply with the rule's requirements by Oct. 6. The change was announced by the Department of Health and Human Services and the Centers for Medicare & Medicaid Services.