2. 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.

3. PROTECTED HEALTH INFORMATION (PHI) in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

4. 3 Developed by: U-MIC HIPAA Health Insurance Portability and Accountability Act (1996) Privacy Rule

5. 4 Developed by: U-MIC PHI part of health care identifiable contained in medical records billing records health plan records other health care records treatment payment operations (TPO)

6. 5 Developed by: U-MIC INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION physical or mental health health care health care payments identifiable COVERED ENTITIES health care providers health plans employers health care clearinghouses (for example, billing companies) Health System Medical School Dental School School of Nursing

7. 6 Developed by: U-MIC PHI subject authorization

8. 7 Developed by: U-MIC PHI without subject authorization accessing Waiver of HIPAA Authorization access presents minimal risk to privacy study can’t be conducted without waiver study can’t be conducted without PHI

9. 8 Developed by: U-MIC PHI without subject authorization accessing preparatory to research deceased subjects limited data set with data use agreement

10. 9 Developed by: U-MIC PHI subject authorization

11. 10 Developed by: U-MIC U.S. Department of Health and Human Services Office for Civil Rights http://www.hhs.gov/ocr/privacy/index.html

12. THANK YOU. Brian Seabolt IRBMED 11 Developed by: U-MIC