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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 . Protected health information (PHI). in human subjects research. Protected Health Information. HIPAA
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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
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
Protected Health Information 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
Protected Health Information INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION COVERED ENTITIES • health care providers • health plans • employers • health care clearinghouses (for example, billing companies) • physical or mental health • health care • health care payments • identifiable • Health System • Medical School • Dental School • School of Nursing Developed by: U-MIC
Protected Health Information PHI subject authorization Developed by: U-MIC
Protected Health Information accessing PHI without subject authorization • Waiver of HIPAA Authorization • access presents minimal risk to privacy • study can’t be conducted without waiver • study can’t be conducted without PHI Developed by: U-MIC
Protected Health Information accessing PHI without subject authorization • preparatory to research • deceased subjects • limited data set with data use agreement Developed by: U-MIC
Protected Health Information PHI subject authorization Developed by: U-MIC
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
Brian Seabolt IRBMED thank you. Developed by: U-MIC