![]() HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization - or with a waiver, alteration, or exception determination from an IRB or Privacy Board. ![]() Under HIPAA, “retrospective research” (a.k.a., data mining) on collections of PHI generally …Īnswer: is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.Īnswer: Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. PHI includes:Īnswer: identifiable health information that is created or held by covered entities and their business associates. HIPAA protects a category of information known as protected health information (PHI). HIPAA includes in its definition of “research,” activities related to …Īnswer: development of generalizable knowledge.Īnswer: can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity. ![]() ![]() When required, the information provided to the data subject in a HIPAA disclosure accounting …Īnswer: must be more detailed for disclosures that involve fewer than 50 subject records. ![]()
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