1 Developed by: U-MIC 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.

HIPAA PRIVACY RULE requirements and waivers Developed by: U-MIC University of Michigan IRB Collaborative

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

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

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

6 Developed by: U-MIC 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 no more than minimal risk to privacy waiver is necessary PHI is necessary

7 Developed by: U-MIC HIPAA Privacy Rule waivers of informed consent waivers of HIPAA Authorization full consent waiver partial consent waiver HIPAA Authorization waiver for entire project HIPAA Authorization waiver for portion of project

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

9 Developed by: U-MIC HIPAA Privacy Rule SOURCES:

THANK YOU. Lark Speyer Brian Seabolt IRBMED 10 Developed by: U-MIC