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HHS/IHS RIN: 0917-AA09 Publication ID: Fall 2010 
Title: ●Confidentiality of Medical Quality Assurance Records; Qualified Immunity for Participants 
Abstract: Section 805(j)) of the Indian Health Care Improvement Act, Public Law No. 94-437 (1976), as amended by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148, section 10221 (2010) requires the Secretary of the Department of Health and Human Services, acting through the Indian Health Service (IHS), to promulgate regulations to implement section 805. Section 805 makes confidential and privileged the medical quality assurance records of Indian health programs and urban Indian organizations, with very limited exceptions. It also prohibits the testimony of individuals that review or create medical quality assurance records, with very limited exceptions. Although section 805 is immediately executable, the Secretary is required to issue regulations which could substantively affect the implementation of this provision. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 94-437, sec 805, IHCI ACT    amended by PL 111-148    sec 10221, PPAC Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  To Be Determined    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paul Fowler
IHS Risk Management Officer
Department of Health and Human Services
Indian Health Service
801 Thompson Avenue, Suite 331,
Rockville, MD 20852
Phone:301 443-6372
Fax:301 594-6213
Email: paul.fowler@hhs.gov