The Basics
An agreement that governs the sharing of data between research collaborators under the HIPAA privacy rule. It establishes how a limited data set may be used and how it is protected.
What is a Data Use Agreement?
What does PHI stand for?
Protected Health Information
(there are 18 elements!)
Research volunteers cannot do this if they do not sign the "Notice of Acknowledgement of Information Practice form".
What is, Participate in the Study?
This allows a covered entity to use and disclose a limited data set (LDS) for research without obtaining an authorization or a waiver of authorization when a DUA is in place.
What is the HIPAA Privacy Rule?
If there is no reasonable way data could be used to identify a person, it is considered, what?
What is a de-identified data set?
True or False:
The form is signed one time, across all protocols.
True
True or False:
A DUA is needed anytime identifiable data is shared in a manner not explicitly covered in the consent form.
True
True or False:
Sharing a de-identified data set requires a DUA.
False
Sharing a de-identified data set does not require a DUA, but limited data sets may be shared only after a DUA is in place.
The form states that information outside the LDS can be released in the event of what?
What is an emergency?