This final regulation published by the U.S. Department of Health and Human Services in February 2014 clarifies that patients have the right to directly receive their own laboratory results, overcoming rationales that used the 1996 Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to justify the withholding of such results from patients. Patients and patient’s personal representatives have the right to directly receive the laboratory results, as well as direct that the laboratory results be transmitted to persons or entities designated by the patient (or patient’s personal representative). This clarification will facilitate direct patient access to personal health information as well as facilitate increased health information exchange among health care providers. The regulation was jointly developed and published by the Office of Civil Rights, Centers for Medicare and Medicaid Services, and Centers for Disease Control and Prevention, and became effective on April 7, 2014.

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