Clinical laboratories must give patients access to their own lab-test results upon request, without going through the physician who ordered them, according to a new federal rule announced Monday by the Department of Health and Human Services.
The rule, first proposed in 2011, is part of an Obama administration effort to give patients more control over their own health information.
"Information like lab results can empower patients to track their health progress, make decisions with their health-care professionals and adhere to important treatment plans," said HHS Secretary Kathleen Sebelius.
The final rule amends two existing federal laws, the Health Insurance Portability and Accountability Act, known as HIPAA, and the Clinical Laboratory Improvement Amendments, or CLIA, which regulates most of the clinical testing labs in the U.S.
Patient advocacy groups had also pushed for the change.
"A number of patients are getting increasingly active in managing their own health care, and having a gatekeeper between them and their data is just baffling," said Deven McGraw, director of the Health Privacy Project at the nonprofit Center for Democracy & Technology.
Studies show that between 7 percent and 26 percent of abnormal lab results are not communicated to patients in a timely manner. "I don't think it's intentional—doctor's offices get busy," McGraw said. "But patients may assume their test results are normal if they don't hear, and that's not always the case."
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