How does HIPAA affect a research study that also involves health care treatment?
HIPAA requires that research study subjects who will receive health care as part of the study authorize the use of their PHI in that research – or that a privacy board or Institutional Review Board (IRB) waive the authorization requirement – regardless of the consent for treatment. Additionally, any research-generated PHI that may be applied to treatment decisions is subject to HIPAA’s medical record requirements.
