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requirements and waivers HIPAA Privacy rule requirements and waivers Developed by: U-MIC University of Michigan IRB Collaborative

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

PHI HIPAA Privacy Rule 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

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

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   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

waivers of informed consent waivers of HIPAA Authorization 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 for entire project consent waiver for portion of a project Developed by: U-MIC

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

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

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