Research Uses and Disclosures Archives - HIPAA Templates

Can researchers continue to access existing databanks or repositories that are maintained by covered entities, even if those databases were created prior to the compliance date without patient permission or without a waiver of informed consent by an Institutional Review Board (IRB)?

Yes. Under the HIPAA Privacy Rule, covered entities may use [...]

Jason Russell2020-09-10T21:42:43-04:00Research Uses and Disclosures, Smaller Providers and Businesses, Transition Provisions|

May a covered entity accept documentation of an external Institutional Review Board’s (IRB) waiver of authorization for purposes of reasonably relying on the request as the minimum necessary?

Yes. The HIPAA Privacy Rule explicitly permits a covered entity [...]

Jason Russell2020-09-10T21:21:19-04:00Minimum Necessary, Research Uses and Disclosures, Smaller Providers and Businesses|

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)?

Yes. The Office for Human Research Protections is a health [...]

Jason Russell2020-09-09T00:05:16-04:00Authorizations, Research Uses and Disclosures|

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?

Yes. The Office for Human Research Protections is a public [...]

Jason Russell2020-09-09T00:05:16-04:00Authorizations, Research Uses and Disclosures|

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?

Yes. If informed consent or reconsent (ie., asked to sign [...]

Jason Russell2020-09-10T20:02:47-04:00Authorizations, Research Uses and Disclosures, Transition Provisions|

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?

No. Documentation of IRB or Privacy Board approval of an [...]

Jason Russell2020-09-08T17:21:27-04:00Authorizations, Research Uses and Disclosures|

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?

The preparatory research provision permits covered entities to use or [...]

Jason Russell2020-09-08T17:21:11-04:00Authorizations, Research Uses and Disclosures|

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?

Covered entities may continue to use and disclose protected health [...]

Jason Russell2020-09-08T17:20:16-04:00Authorizations, Research Uses and Disclosures|

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?

A covered entity that qualifies as a hybrid entity, meaning [...]

Jason Russell2020-09-08T17:19:34-04:00Authorizations, Research Uses and Disclosures|

When is a researcher considered to be a covered health care provider under HIPAA?

A researcher is a covered health care provider if he [...]

Jason Russell2020-09-08T17:19:06-04:00Authorizations, Covered Entities, Research Uses and Disclosures|