federal_register: 2011-23525

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-23525 CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports Proposed Rule This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the proposed rule would retain the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. 2011-09-14 2011 9 https://www.federalregister.gov/documents/2011/09/14/2011-23525/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports https://www.govinfo.gov/content/pkg/FR-2011-09-14/pdf/2011-23525.pdf Health and Human Services Department; Centers for Medicare & Medicaid Services 221,45 This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication...  

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