To start the presentation click on this button
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
PROTECTED HEALTH INFORMATION (PHI) in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative
Protected Health Information HIPAA Health Insurance Portability and Accountability Act (1996) Privacy Rule Developed by: U-MIC 3
Protected Health Information PHI • part of health care • identifiable • contained in • • Developed by: U-MIC medical records billing records health plan records other health care records treatment payment operations (TPO) 4
Protected Health Information INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION • • physical or mental health care payments identifiable Developed by: U-MIC COVERED ENTITIES • • health care providers health plans employers health care clearinghouses (for example, billing companies) • • Health System Medical School Dental School of Nursing 5
Protected Health Information PHI subject authorization Developed by: U-MIC 6
Protected Health Information accessing PHI without subject authorization Waiver of HIPAA Authorization • • • Developed by: U-MIC access presents minimal risk to privacy study can’t be conducted without waiver study can’t be conducted without PHI 7
Protected Health Information accessing PHI without subject authorization • preparatory to research • deceased subjects • limited data set with data use agreement Developed by: U-MIC 8
Protected Health Information PHI subject authorization Developed by: U-MIC 9
Protected Health Information U. S. Department of Health and Human Services Office for Civil Rights http: //www. hhs. gov/ocr/privacy/index. html Developed by: U-MIC 10
THANK YOU. Brian Seabolt IRBMED Developed by: U-MIC 11
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