1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.
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U-MIC

2. requirements and waivers
HIPAA Privacy rule
requirements and waivers
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U-MIC
University of Michigan IRB Collaborative

3. HIPAA Privacy Rule HIPAA Privacy Rule
Health Insurance Portability and Accountability Act
45 CFR 160 and 164
protected health information (PHI)
health care
research
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U-MIC

4. PHI HIPAA Privacy Rule part of health care identifiable contained in
medical records
billing records
health plan records
other health care records
treatment
payment
operations
(TPO)
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U-MIC

5. HIPAA Privacy Rule IRB or Privacy Board reviews studies involving PHI
human subjects research regulations
HIPAA
or Privacy Board
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U-MIC

6. HIPAA Privacy Rule obtain signed Authorization from the individuals
for a specific study
Authorization through clinical consent does not apply to research or
demonstrate the PHI use is limited to circumstances that do not require authorization or waiver
limited data set with a Data Use Agreement
review of data preparatory to research
research on decedents' information  
receive a waiver of the Authorization requirement from the IRB or Privacy Board
may apply to all or only part of the study
may apply to all or only some subjects
no more than minimal risk to privacy
waiver is necessary
PHI is necessary
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U-MIC

7. waivers of informed consent waivers of HIPAA Authorization
HIPAA Privacy Rule
waivers of informed consent
waivers of HIPAA Authorization
HIPAA Authorization waiver for entire project
HIPAA Authorization waiver for portion of project
consent waiver for entire project
consent waiver for portion of a project
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U-MIC

8. HIPAA Privacy Rule IRB or Privacy Board review
discuss requests for HIPAA Authorization waivers
document decisions in meeting minutes
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U-MIC

9. HIPAA Privacy Rule SOURCES:
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U-MIC

10. thank you.
Lark Speyer
Brian Seabolt
IRBMED
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U-MIC