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HHS/CMS | RIN: 0938-AQ38 | Publication ID: Spring 2013 |
Title: CLIA Programs and HIPAA Privacy Rule; Patients' Access to Test Reports (CMS-2319-F) | |
Abstract: This CMS-CDC-OCR rule amends 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 rule retains 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 rule also amends 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. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 42 CFR 493 45 CFR 164 | |
Legal Authority: 42 USC 263a |
Legal Deadline:
None |
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Timetable:
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Additional Information: Includes Retrospective Review under E.O. 13563. | |
Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: State |
Small Entities Affected: Businesses, Governmental Jurisdictions | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Judith Yost Director, Division of Laboratory Services Department of Health and Human Services Centers for Medicare & Medicaid Services S-2-09-27, Center for Clinical Standards and Quality, Mail Stop C2-21-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone:410 786-3531 Email: judith.yost@cms.hhs.gov |