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Understanding Protected Health Information (PHI) and HIPAA Compliance in Research

This presentation, developed by U-MIC, outlines the importance of Protected Health Information (PHI) in human subjects research. It discusses the Health Insurance Portability and Accountability Act (HIPAA) and its Privacy Rule, which safeguards individual health data. Learn about the types of identifiable health information, the roles of covered entities, and the conditions under which PHI can be accessed without subject authorization. This essential knowledge is crucial for researchers and healthcare professionals to ensure compliance and protect patient privacy.

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Understanding Protected Health Information (PHI) and HIPAA Compliance in Research

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Presentation Transcript

  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. Protected health information (PHI) in human subjects research Developed by: U-MIC University of Michigan IRB Collaborative

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

  4. 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

  5. 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

  6. Protected Health Information PHI subject authorization Developed by: U-MIC

  7. 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

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

  9. Protected Health Information PHI subject authorization Developed by: U-MIC

  10. 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

  11. Brian Seabolt IRBMED thank you. Developed by: U-MIC

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