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.
Developed by:
U-MIC
1
HIPAA PRIVACY RULE
requirements and waivers
Developed by:
U-MIC
University of Michigan IRB Collaborative
HIPAA Privacy Rule
HIPAA Privacy Rule
Health Insurance Portability and Accountability Act
45 CFR 160 and 164
• protected health information (PHI)
• health care
• research
Developed by:
U-MIC
3
HIPAA Privacy Rule
PHI
• part of health care
• identifiable
• contained in
•
•
•
•
Developed by:
U-MIC
medical records
treatment
billing records
payment (TPO)
health plan records
operations
other health care records
4
HIPAA Privacy Rule
IRB or Privacy Board
•
•
•
reviews studies involving PHI
human subjects research regulations
HIPAA
Developed by:
U-MIC
5
HIPAA Privacy Rule
• obtain written 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
or
• 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
Developed by:
U-MIC
•
•
•
no more than minimal risk to privacy
waiver is necessary
PHI is necessary
6
HIPAA Privacy Rule
waivers of informed consent
waivers of HIPAA Authorization
full consent waiver
HIPAA Authorization waiver for
entire project
partial consent waiver
HIPAA Authorization waiver for
portion of project
Developed by:
U-MIC
7
HIPAA Privacy Rule
IRB or Privacy Board review
• discuss requests for HIPAA Authorization waivers
• document decisions in meeting minutes
Developed by:
U-MIC
8
HIPAA Privacy Rule
SOURCES:
http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html
http://privacyruleandresearch.nih.gov/default.asp
http://www.med.umich.edu/i/policies/umh/01-04-360.htm
Developed by:
U-MIC
9
THANK YOU.
Lark Speyer
Brian Seabolt
IRBMED
Developed by:
U-MIC
10