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. Developed by: U-MIC

2. HIPAA Privacy rule requirements and waivers Developed by: 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 Developed by: U-MIC

4. 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) Developed by: U-MIC

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

7. 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 forentire project consent waiver forportion of a project Developed by: U-MIC

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

9. 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

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