HHS Issues Proposed Rule Governing Clinical Laboratories

By Cameron G. Shilling (originally published 9/26/2011)

The United States Department of Health and Human Services issued a proposed rule that expands the rights of patients to access test results directly from clinical labs covered by HIPAA.  The rule would amend the regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to require that, upon a patient’s request, the lab must provide access to completed test reports concerning the patient.  The proposed rule was published on September 14, 2011, and has a 60 day comment period.

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