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HHS Issues Joint Rule Allowing Patients and Designees Direct Access to Lab Test Results

Posted on 2/5/2014 by NTOCC ® in Public Policy Updates

Yesterday, three agencies within the Department of Health and Human Services (HHS)-- the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Office for Civil Rights – jointly issued a final rule that removes legal barriers that prevent medical laboratories from providing lab test results directly to patients or their designees.

CMS states that the final rule “amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to provide such access upon request, [and] at the same time, eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory.” Importantly, the rule does not require laboratories to interpret the test results; they may refer individuals back to their health provider for this information.

Please click here to view the final rule.