Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Additional Suggested Requirements

12/28/2000

Comment: One commenter recommended that the documentation of IRB or privacy board approval also be required to state that, "the health researcher has fully disclosed which of the protected health information to be collected or created would be linked to other protected health information, and that appropriate safeguards be employed to protect information against re-identification or subsequent unauthorized linkages."

Response: The proposed provision for the use or disclosure of protected health information for research purposes without authorization only pertained to individually identifiable health information. Therefore, since the information to be obtained would be individually identifiable, we concluded that it was illogical to require IRBs and privacy boards document that the researcher had "fully disclosed that...appropriate safeguards be employed to protect information against re-identification or subsequent unauthorized linkages." Therefore, we did not incorporate this recommendation into the final rule.