Are there exceptions to the general rule requiring an authorization for research?
Yes, there are three exceptions to the general rule. These exceptions are: • Reviews preparatory to research. There is an exception that permits limited use or disclosure of PHI for reviews preparatory to research. This exception applies: (1) if the uses or disclosure of PHI is for the sole purpose of developing a research protocol or for similar purposes; (2) where the PHI will not leave the source; and, (3) the researcher represents to the covered entity that the access is necessary for research purposes. • Research on decedent’s information. Research on decedent’s information is permitted without an authorization if: (1) the researcher represents that the use or disclosure of the PHI is solely for research on the PHI of decedents; (2) the covered entity has the right to request documentation establishing the subjects death; and, (3) the researcher represents that access to the PHI is necessary for the research purposes. • Waiver. When an Institutional Review Board (IRB) determines t
Related Questions
- My research files contain PHI that has been authorized for use under a HIPAA Research Authorization. Does the HIPPA Privacy Rule have any other requirements for this data?
- What are the exceptions to the rule that certiorari will not lie unless a motion for reconsideration is first filed?
- What if the human research participant revokes the authorization?
