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Final Privacy Rule Affects Clinical Research Organizations

by admin on February 13, 2013 No comments

The final HITECH Act rule was published on January 25th, and it includes revisions to HIPAA.  The two things affected by the new rule are (1) compound authorizations, and (2) authorizations for future research.

Compound authorizations are basically authorizations for two separate uses of protected health information (PHI).  The new rule allows combining an authorization for a research study with any other written permission for the same study, such as authorization to participate in the research.  The core elements of a valid authorization remain in place.  The intent is just to provide some flexibility in clinical research settings.

Traditionally, authorizations had to be study specific.  The new rule allows authorizations not to be study specific, but they have to describe future uses or disclosures in a way that patients will understand that their PHI could be used in future research.

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