The HIPAA Privacy Rule (the Privacy Rule) is a set of federal regulations providing protections for the confidentiality of health information used in clinical practice, research, and the operations of health care facilities. The intended purpose of the Privacy Rule is to ensure that health information confidentiality risks are minimized. The Privacy Rule gives patients new federal rights, and protects those rights by requiring new procedures of health care providers and human subjects researchers.
In addition, the Privacy Rule requires the training of employees, including researchers, in the protection of confidential health information. Please visit the Office of Compliance site for more information on human subjects research and the HIPAA Privacy Rule.
- HIPAA Processes & Documentation
This section of the Investigator Manual details HIPAA requirements.
- HIPAA Authorization (HRP-330, Worksheet)
Used by IRB staff when evaluating whether HIPAA authorization is valid.
- HIPAA Waiver of Authorization (HRP-441, Checklist)
Used by IRB staff when evaluation whether a waiver of authorization is justified.