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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
FAQ 311 What does the HIPAA Privacy Rule say about a research participant's right of access to research records or results?   Office for Civil Rights (OCR) Final
FAQ 313 Do the HIPAA Privacy Rule's requirements for authorization and the Common Rule's requirements for informed consent differ?   Office for Civil Rights (OCR) Final
FAQ 314 When is a researcher considered to be a covered health care provider under HIPAA?   Office for Civil Rights (OCR) Final
FAQ 314 When is a researcher considered to be a covered health care provider under HIPAA?   Office for Civil Rights (OCR) Final
FAQ 315 When does a covered entity have discretion to determine whether a research component of the entity is part of their covered functions, and therefore, subject to the HIPAA Privacy Rule?   Office for Civil Rights (OCR) Final
FAQ 316 If a research subject revokes his or her authorization to have protected health information used or disclosed for research, does the HIPAA Privacy Rule permit a researcher/covered health care provider to continue using the protected health informa  Office for Civil Rights (OCR) Final
FAQ 317 Can the preparatory research provision of the HIPAA Privacy Rule at 45 CFR 164.512(i)(1)(ii) be used to recruit individuals into a research study?   Office for Civil Rights (OCR) Final
FAQ 318 Does the HIPAA Privacy Rule require documentation of Institutional Review Board (IRB) or Privacy Board approval of an alteration or waiver of individual authorization before a covered entity may use or disclose protected health information for any  Office for Civil Rights (OCR) Final
FAQ 319 If research subjects' consent was obtained before the compliance date, but the Institutional Review Board (IRB) subsequently modifies the informed consent document after the compliance date and requires that subjects be reconsented, is authorizati  Office for Civil Rights (OCR) Final
FAQ 320 Can covered entities continue to disclose adverse event reports that contain protected health information to the Department of Health and Human Services (HHS) Office for Human Research Protections?  Office for Civil Rights (OCR) Final
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