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HHS Revises Rules on Patient Access to Test Results



February 4, 2014 | The U.S. Department of Health & Human Services (HHS) announced yesterday that CLIA-certified labs – those compliant with the 1988 Clinical Laboratory Improvement Amendments – will have new responsibilities to report test results directly to patients upon request. These labs had previously been exempt from the requirement to inform patients of their test results, under the terms of the privacy rules in the Health Insurance Portability and Accountability Act of 1996. This exemption is revised under the new rule, which also supersedes laws in 13 states that currently prohibit labs from reporting test results directly to patients.

The rule change is intended to give patients new options when their immediate care providers are slow or negligent in sharing test results. “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,” said HHS Secretary Kathleen Sebelius in a statement. CLIA-compliant labs will now be required to send lab results to patients within 30 days of a request, which may be delivered by the patients or by designated personal representatives. This 30-day period gives physicians ample time to report results themselves, if they feel the tests will be better understood through a detailed doctor-patient conversation.

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