HHS Proposes to Allow Patients Direct Access to Lab Test Results


Patients may soon be allowed to get medical test results directly from labs rather than through their health care providers.

Patients may soon be able to get medical test results directly from labs rather than through their health care providers, according to new rules proposed Monday by Health and Human Services Secretary Kathleen Sebelius.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) do not allow test results to be transmitted directly to patients unless the lab is located in a state that explicitly allows this to occur. (Currently, 39 states bar labs from providing results directly to patients.)

The proposed rule changes would modify CLIA to specify that test results are to be released to patients upon request and amend a section of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) that allows patients access to their health records but makes an exception for test results from CLIA-certified labs.

The impetus for the proposed rule changes is to allow patients greater involvement in their own care. They came about specifically as the result of a review by the Health Information Technology Policy Committee, which is tasked with finding barriers to the adoption and use of health information technology.

“When it comes to health care, information is power,” said Sebelius in a press release announcing the proposed rule changes. “When patients have their lab results, they are more likely to ask the right questions, make better decisions, and receive better care.”

Requiring patients to get test results through their health care providers can have serious consequences if these results get lost in the shuffle. As Farzad Mostashari, national coordinator for health information technology at HHS, told USA Today, “About 20% of abnormal lab results never make it to the patient.”

HHS will be accepting comments on the proposed rules for 60 days from today, when they are scheduled to be published in the Federal Register.


Secretary Sebelius spotlights new efforts to empower patients to increase secure access to their health information [HHS Press Release]

CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports (pdf) [HHS]

HHS aims to improve patients' access to electronic records [USA Today]

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