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.
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.
When required, the information provided to the data subject in a HIPAA disclosure accounting …
must be more detailed for disclosures that involve fewer than 50 subject records.
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 official (“Privacy Officer”), or security official (“Security Officer”), depending on the issue.
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.
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
The National Research Act of 1974
Established the National Commission.
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may be used to conduct research that only benefits the larger society
Which of the following is included in the Nuremberg Code:
Voluntary consent
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