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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
Timetable:
Action Date FR Cite
NPRM  09/14/2011  76 FR 56712 
NPRM Comment Period End  11/14/2011   
Final Action  10/00/2013   
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

 
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