HIPAA protects a category of information known as protected health information (PHI). PHI includes:
Identifiable health information that is created or held by covered entities and their business associates.
HIPAA includes in its definition of “research,” activities related to …
Development of generalizable knowledge.
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy officer (“Privacy Officer”), or privacy official (“Privacy Official”), depending on the issue.
Under HIPAA, a “disclosure accounting” is required:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
Under HIPAA, “retrospective research” (a.k.a., data mining) on collections of PHI generally …
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
Recruiting into research …
Can qualify as an activity “preparatory to research,” at least for the initial contact, but data should not leave the covered entity.
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy officer (“Privacy Officer”), or privacy official (“Privacy Official”), depending on the issue.
HIPAA protects a category of information known as protected health information (PHI). PHI includes:
Identifiable health information that is created or held by covered entities and their business associates.
If you’re unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy officer (“Privacy Officer”), or privacy official (“Privacy Official”), depending on the issue.
HIPAA’s protections for health information used for research purposes…
Supplement those of the Common Rule and FDA.
The HIPAA “minimum necessary” standard applies…
To all human subjects research that uses PHI without an authorization from the data subject.
Under HIPAA, “retrospective research” (a.k.a., data mining) on collections of PHI generally …
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
HIPAA protects a category of information known as protected health information (PHI). PHI includes:
Identifiable health information that is created or held by covered entities and their business associates.
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