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  • CMS Proposed Rule Relating to Patients' Right to Access Laboratory Test Results

    The Centers for Medicare and Medicaid Services recently released a proposed rule that would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that a laboratory may provide access to completed test reports upon a patient's request. The tests would be subject to the lab's authentication process as confirming the tests belong to that patient. The proposal, titled CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports, also amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to provide patients the right to receive their test reports directly from laboratories (by removing the CLIA-certified and CLIA-Exempt laboratories' exceptions).  

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