Patients to Have Direct Access to Lab Reports

A new amendment to the Clinical Laboratory Improvement Amendments 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act 1996 (HIPAA) Privacy Rule will allow patients means to direct access of their laboratory test reports according to a recent announcement by the Department of Health & Human Services.

Previously, these reports were only accessible to people designated as authorized persons, such as health care providers or someone using the test results to administer treatments. But the new CLIA regulations say that labs may now allow a patient, or a patient’s personal representative, access to copies of test results upon request. Likewise, the new HIPAA Privacy Rules also allow patients test result access to Labs subject to HIPAA.

Advocates of the measure see this as an essential step for patients to make decisions regarding their health care.

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

Others see difficulties arising from the decision.

“These reports are written for the benefit of medically trained personnel and not laypersons. Many patients will find it difficult to interpret and understand such reports without the assistance of their treating physician.” Anna Spencer, Partner at Sidley Austin LLP, in a statement to DataGuidance (

For compliance of the new rule, Labs covered by HIPAA will have to update their Notices of Privacy Practices (NPP) to keep patiends informed of the their new rights. The rule takes effect on April 7th, 2014 with full compliance required by October 6th, 2014 for both the CLIA and HIPAA changes.

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