Can covered entities continue to disclose protected health information to the HHS Office for Human Research Protections for purposes of determining compliance with the HHS regulations for the protection of human subjects (45 CFR Part 46)? Read More Can covered entities continue to disclose protected health information to the HHS Office for Human Research Protections for purposes of determining compliance with the HHS regulations for the protection of human subjects (45 CFR Part 46)?
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? Read More 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?
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 authorization now required from these previously enrolled research subjects under the HIPAA Privacy Rule? Read More 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 authorization now required from these previously enrolled research subjects under the HIPAA Privacy Rule?
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 of the following provisions: (1) for preparatory research at 45 CFR 164.512(i)(1)(ii), (2)for research on the protected health information of decedents at 45 CFR 164.512(i)(1)(iii), or (3) a limited data set with a data use agreement as stipulated at 45 CFR 164.51? Read More 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 of the following provisions: (1) for preparatory research at 45 CFR 164.512(i)(1)(ii), (2)for research on the protected health information of decedents at 45 CFR 164.512(i)(1)(iii), or (3) a limited data set with a data use agreement as stipulated at 45 CFR 164.51?
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? Read More 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?
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 information already obtained prior to the time the individual revoked his or her authorization? Read More 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 information already obtained prior to the time the individual revoked his or her authorization?
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? Read More 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?
When is a researcher considered to be a covered health care provider under HIPAA? Read More When is a researcher considered to be a covered health care provider under HIPAA?
Do the HIPAA Privacy Rule’s requirements for authorization and the Common Rule’s requirements for informed consent differ? Read More Do the HIPAA Privacy Rule’s requirements for authorization and the Common Rule’s requirements for informed consent differ?
What does the HIPAA Privacy Rule say about a research participant’s right of access to research records or results? Read More What does the HIPAA Privacy Rule say about a research participant’s right of access to research records or results?
