HIPAA's protections for health information used for research
purposes... - ANSWER -supplement those of the Common
Rule and FDA.
HIPAA protects a category of information known as protected
health information (PHI). PHI includes: - ANSWER -
identifiable health information that is created or held by covered
entities and their business associates.
When required, the information provided to the data subject in a
HIPAA disclosure accounting ... - ANSWER -must be
more detailed for disclosures that involve fewer than 50 subject
records.
HIPAA includes in its definition of "research," activities related to
... - ANSWER -development of generalizable knowledge.
Under HIPAA, a "disclosure accounting" is required: -
ANSWER -for all human subjects research that uses PHI
without an authorization from the data subject, except for limited
data sets.
A HIPAA authorization has which of the following
characteristics: - ANSWER -Uses "plain language" that
the data subject can understand, similar to the requirement for
an informed consent document.
Under HIPAA, "retrospective research" (a.k.a., data mining) on
collections of PHI generally ... - ANSWER -is research,
and so requires either an authorization or meeting one of the
criteria for a waiver of authorization.
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