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HHS rule grants direct access to residents' lab results

February 4, 2014
by Pamela Tabar, Editor-in-Chief
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A new rule from the Department of Health and Human Services (HHS) will allow residents and their designated family members to receive access to lab test results data on request within 30 days, rather than having to request results via a physician.

Legislating direct consumer access to lab results is another step toward engaging consumer involvement in person-centered healthcare and is intended to "remove barriers…regarding personalized medicine, an individual’s active involvement in his or her own healthcare, and the widespread adoption of [electronic health records (EHRs)] by 2014," the policy states. "The [HHS] Department believes that this right is crucial to provide individuals with vital information to empower them to better manage their health and take action to prevent and control disease."

The new rule, slated to be published in the Federal Register this week, is part of the Clinical Laboratory Improvement Amendments (CLIA) and was a conjoined effort of the Centers for Medicare & Medicaid Services, the Office of the National Coordinator for Health Information Technology, the Centers for Disease Control and Prevention and the HHS Office for Civil Rights. Compliance will involve EHRs, laboratory information systems and health information data-sharing systems at provider sites.

"The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule,” Secretary Kathleen Sebelius said in an HHS statement Monday. “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans."

Any laboratory that conducts electronic transactions covered under HIPAA falls under the new rule, regardless of where the lab tests themselves are performed, the document states. Laboratories that had been granted an exception to the consumer-driven access of results in the past should recheck their status under the new rule, the document advises.

The resident and family-designee rights to lab results does not mean they have to be provided for free. The rule allows for a “reasonable, cost-based fee” to be charged to those who request lab test documents.

Read the new HHS rule on lab results access.

For more information, see CMS’ CLIA page.