Health & SafetyAnswer Key

Hipaa Includes In Its Definition Of Research

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QUESTION 1

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.

QUESTION 2

HIPAA includes in its definition of "research," activities related to ...

ANSWER

development of generalizable knowledge.

QUESTION 3

Recruiting into research ...

ANSWER

can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

QUESTION 4

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.

QUESTION 5

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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