Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Use Versus Disclosure

12/28/2000

Comment: Many of the comments supported the proposed rule's provision that would have imposed the same requirements for both research uses and research disclosures of protected health information.

Response: We agree with these comments. In the final rule we retain identical use and disclosure requirements for research uses and disclosures of protected health information by covered entities.

Comment: In contrast, a few commenters recommended that there be fewer requirements on covered entities for internal research uses of protected health information.

Response: For the reasons discussed above in § 164.501 on the definition of "research," we disagree that an individual's privacy interest is of less concern when covered entities use protected health information for research purposes than when covered entities disclose protected health information for research purposes. Therefore, in the final rule, the research-related requirements of § 164.512(i) apply to both uses and disclosures of protected health information for research purposes without authorization.