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HHS Issues Final Rule that Allows Patients Direct Access to Lab Test Results

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March 3, 2014

The U.S. Department of Health and Human Services (HHS) has issued a final rule that now allows a patient, or a person designated by the patient, direct access to laboratory test reports without the need to have the tests sent to a physician first.

"The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule," says 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."

The final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient access to lab test reports. However, patients who want to can still get their test results from their doctors.

The final HHS rule on lab reports assures a patient access to test results, but the access is not necessarily automatic. Laboratories can require patients to make requests for test results in writing and may also charge for the cost of copying, mailing, or transferring the results via electronic media such as a CD or a flash drive. The final rule says that, in most cases, copies must be available to the patient within 30 days of the completion of laboratory testing. Read the HHS final rule here.

Janet Kreizman, the CEO of the American Association for Clinical Chemistry (AACC), which produces this web site (Lab Tests Online), issued a statement that AACC supports the new ruling and applauds the ongoing efforts of HHS to empower patients to be informed healthcare consumers. However, she cautioned that some additional feedback from patients' health care providers may be needed to help interpret the results and decide on any next steps or treatment that may be necessary.

"AACC strongly supports patient empowerment and health literacy and believes that patients should have greater access to their test results so that they can take a more active role in managing their health," said Kreizman. "However, providing laboratory test results without context may have limited value for some consumers, while unnecessarily alarming others. Most laboratory test reports only provide a numeric value along with a reference range for each result. AACC recommends that patients consult with their physician before making any health-related decisions based on their test results."

Resources, such as this web site, are available to aid patients in better understanding laboratory tests, including why they are ordered, how they are used, and what the results may mean. Lab Tests Online encourages patients to discuss their lab test results with their health practitioners, using this web site to help formulate their questions. For assistance in developing questions, see the article Making Informed Choices: Talking to Your Doctor.

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.

AACC Supports HHS Decision to Strengthen Patients' Right to Access Lab Reports; Consultation with Physicians Remains Essential. PR Newswire. Feb. 3, 2014. Available online through http://www.prnewswire.com. Accessed February 2014.

U.S. Department of Health & Human Services. HHS strengthens patients' right to access lab test reports. February 3, 2014. Available online at http://www.hhs.gov/news/press/2014pres/02/20140203a.html through http://www.hhs.gov. Accessed February 2014.

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