{"abstract":"This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, the patient's personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the final rule retains the existing provisions that require release of test reports only to authorized persons and, if applicable, to the persons responsible for using the test reports and to the laboratory that initially requested the test. In addition, this final rule amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals (or their personal representatives) with the right to access test reports directly from laboratories subject to HIPAA (and to direct that copies of those test reports be transmitted to persons or entities designated by the individual) 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. These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/02/06/2014-02280.html","cfr_references":[{"chapter":null,"citation_url":null,"part":493,"title":42},{"chapter":null,"citation_url":null,"part":164,"title":45}],"citation":"79 FR 7290","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective Date: These regulations are effective on April 7, 2014.","disposition_notes":null,"docket_ids":["CMS-2319-F"],"dockets":[],"document_number":"2014-02280","effective_on":"2014-04-07","end_page":7316,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/06/2014-02280.xml","html_url":"https://www.federalregister.gov/documents/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-02280?publication_date=2014-02-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-06/2014-02280/mods.xml","not_received_for_publication":null,"page_length":27,"page_views":{"count":88171,"last_updated":"2026-10-29 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/2014-02280.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-02280.pdf?1391444529","publication_date":"2014-02-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/06/2014-02280.txt","regulation_id_number_info":{"0938-AQ38":{"issue":"201310","html_url":"https://www.federalregister.gov/regulations/0938-AQ38/clia-programs-and-hipaa-privacy-rule-patients-access-to-test-reports-cms-2319-f-","title":"CLIA Programs and HIPAA Privacy Rule; Patients' Access to Test Reports (CMS-2319-F)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0938-AQ38&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0938-AQ38"],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"HHS","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HHS-OS-2022-0008","supporting_documents_count":0,"docket_id":"HHS-OS-2022-0008","document_id":"HHS-OS-2022-0008-0397","regulation_id_number":null,"title":"HHS 2022 Archive","checked_regulationsdotgov_at":"2022-05-28T03:30:05Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":7290,"subtype":null,"title":"CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports","toc_doc":"Patients' Access to Test Reports","toc_subject":"CLIA Program and HIPAA Privacy Rule:","topics":["Administrative practice and procedure","Computer technology","Employee benefit plans","Grant programs-health","Health","Health care","Health facilities","Health insurance","Health records","Hospitals","Laboratories","Medicaid","Medical research","Medicare","Penalties","Privacy","Reporting and recordkeeping requirements"],"type":"Rule","volume":79}