HHS announces new rule that gives patients direct access to lab test results

February 06, 2014
Area(s) of Interest: Health Information Technology 

Patients will soon be able to obtain their medical test results directly from the laboratory, rather than having to request a copy from their physician's office, according to a new rule announced Monday by the U.S. Department of Health and Human Services (HHS).

The rule is part of a broader effort to give Americans more control over their health care. It supersedes state law and will have particular significance in 13 states that currently prohibit labs from releasing test results directly to patients. Current California law allows the release of lab results to patients if providers give approval.

Although under the Health Insurance Portability and Accountability Act (HIPAA), physicians and other covered entities were already required to provide patients with copies of their protected health information (PHI) upon request, many laboratories were exempt from this requirement.

“The right to access personal health information is a cornerstone of the [HIPAA] Privacy Rule,” said HHS Secretary Kathleen Sebelius. “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.”

While patients can continue to get access to their lab tests from their physicians, under the new rule, labs will be required to provide patients copies, including electronic copies, of their lab test results within 30 days of a request. The new rule becomes takes effect 60 days after publication in the Federal Register, which is expected to happen Thursday. HIPAA-covered labs will have 180 days from the effective date of the rule to comply.

The final rule amends the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

Before the revisions, CLIA stipulated that labs could release test results to only three types of individuals: the person authorized under state law to order or receive results, typically a physician; the person responsible for using the test results for treatment; and a referring lab that requested the test.

The final rule is available for review at www.federalregister.gov.


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