FAQ 316 If a research subject revokes his or her authorization to have protected health information used or disclosed for research, does the HIPAA Privacy Rule permit a researcher/covered health care provider to continue using the protected health informa
This is guidance on the use of PHI if a research subject revokes PHI usage authorization.
Issued by: Office for Civil Rights (OCR)
If a research subject revokes his or her authorization to have protected health information used or disclosed for research, does the HIPAA Privacy Rule permit a researcher/covered health care provider to continue using the protected health information already obtained prior to the time the individual revoked his or her authorization?
Covered entities may continue to use and disclose protected health information that was obtained prior to the time the individual revoked his or her authorization, as necessary to maintain the integrity of the research study. An individual may not revoke an authorization to the extent the covered entity has acted in reliance on the authorization. For research uses and disclosures, this reliance exception at 45 CFR 164.508(b)(5)(i) permits the continued use and disclosure of protected health information already obtained pursuant to a valid authorization to the extent necessary to preserve the integrity of the research study. For example, the reliance exception would permit the continued use and disclosure of protected health information to account for a subject’s withdrawal from the research study, as necessary to incorporate the information as part of a marketing application submitted to the Food and Drug Administration, to conduct investigations of scientific misconduct, or to report adverse events.
However, the reliance exception would not permit a covered entity to continue disclosing additional protected health information to a researcher or to use for its own research purposes information not already gathered at the time an individual withdraws his or her authorization.
Date Created: 12/20/2002
Last Updated: 03/14/2006
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