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?
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?
By establishing new waiver criteria and authorization requirements, hasn’t the HIPAA Privacy Rule, in effect, modified the Common Rule?
How does the Rule help Institutional Review Boards (IRB) handle the additional responsibilities imposed by the HIPAA Privacy Rule?
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?
Does the HIPAA Privacy Rule prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing protected health information?
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?
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?
When is an authorization required from the patient before a provider or health plan engages in marketing to that individual?
What is the difference between “consent” and “authorization” under the HIPAA Privacy Rule?