What does the HIPAA Privacy Rule say about a research participant’s right of access to research records or results?
With few exceptions, the Privacy Rule gives patients the right [...]
Does the HIPAA Privacy Rule require a covered entity to create an Institutional Review Board (IRB) or Privacy Board before using or disclosing protected health information for research?
No. The Institutional Review Board (IRB) or Privacy Board could [...]
Is documentation of Institutional Review Boards (IRB) and Privacy Board approval required by the HIPAA Privacy Rule before a covered entity would be permitted to disclose protected health information for research purposes without an individual’s authorization?
No. The HIPAA Privacy Rule requires documentation of waiver approval [...]
By establishing new waiver criteria and authorization requirements, hasn’t the HIPAA Privacy Rule, in effect, modified the Common Rule?
No. Where both the Privacy Rule and the Common Rule [...]
How does the Rule help Institutional Review Boards (IRB) handle the additional responsibilities imposed by the HIPAA Privacy Rule?
Recognizing that some institutions may not have Institutional Review Boards [...]
Does the HIPAA Privacy Rule permit the creation of a database for research purposes through an Institutional Review Board (IRB) or Privacy Board waiver of individual authorization?
Yes. A covered entity may use or disclose protected health [...]
Does the HIPAA Privacy Rule prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing protected health information?
No. The Privacy Rule does not address conditions for enrollment [...]
Are some of the criteria so subjective that inconsistent determinations may be made by Institutional Review Boards (IRB) and Privacy Boards reviewing similar or identical research projects?
Under the HIPAA Privacy Rule, Institutional Review Boards (IRBs) and [...]
Will the HIPAA Privacy Rule hinder medical research by making doctors and others less willing and/or able to share with researchers information about individual patients?
We do not believe that the Privacy Rule will hinder [...]
When is an authorization required from the patient before a provider or health plan engages in marketing to that individual?
The HIPAA Privacy Rule expressly requires an authorization for uses [...]