If research will involve the use of Protected Health Information (PHI), criteria under the Health Insurance Portability and Accountability Act (HIPAA) may apply and the researcher will need to address how their research meets HIPAA requirements in the research submission.

• HIPAA Covered Entities
• Protected Health Information
• De-Identified Health Information
• HIPAA Authorization
• HIPAA Waiver

For more information about HIPAA and research, please visit the NIH HIPAA information page.