Research Education

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Health Insurance Portability and Accountability Act (HIPAA)
Laws & Regulations

Federal 'Security & Privacy' Regulation – 45 CFR § 164

Federal Regulation - 45 CFR  
  -  § 160 – general administrative requirements
  -  § 162 – administrative requirements
  -  § 164 – security and privacy

Wisconsin Statutes on Privacy - Chapter 146
  -  See § 81, 815, 819, 82, 83, 836 

Federal Guidance & Fact Sheets regarding Human Research

 

Clinical Research and the HIPAA Privacy Rule
  -  Includes information on activities preparatory to research, FAQ's

HIPAA Privacy Rule Booklet for Research
  -  N
IH Booklet, 4/14/03 (revised 7/13/04)

HIV & HIPAA
  -  
HIV/AIDS Bureau of HRSA Guidance for HIV services providers, 4/04

 

IRBs and the HIPAA Privacy Rule
  -  NIH Publication Number 03-5428, 08/03

IRB Review of Standalone Authorization Forms
  -  FDA Guidance, 11/7/03

Privacy Boards and the HIPAA Privacy Rule
  -  NIH Fact Sheet, 9/25/03 (reformatted 7/12/04)

Guidance on Research & Coded Private Information or Biological Specimens  
 
 - 
8/10/04

Research Repositories, Databases and the HIPAA Privacy Rule
  -  NIH Fact Sheet, 1/12/04 (reformatted 7/2/04)

HIPAA Research Standards
  -  OCR Guidance, 12/3/02 (revised 4/3/03)

Other Resources 

Research & HIPAA
  -  NIH website for the research community 

Healthcare & HIPAA
  -  OCR website for medical privacy: national standards

 

 

 

 

Impact of HIPAA on the NIH Process
  - 
NIH Guidance, 2/5/03

 

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