Privacy Board makes determinations regarding HIPAA compliance for Exempt human subjects research and for activities not regulated as human subjects research.
For studies subject to IRBMED review and approval, the Full Convened Board or Expedited Reviewer(s) makes applicable determinations regarding HIPAA compliance along with determinations required by other federal regulations.
Privacy Board applications
Overall process flowchart
- Waiver for studies Exempt under OHRP/FDA, but Regulated by HIPAA
- Waiver for projects Not Regulated under OHRP/FDA, but Regulated by HIPAA
- Other HIPAA provisions
- Protected Health Information
- Uses and Disclosures of Protected Health Information
- Waiver of HIPAA Authorization
Regulations, guidance and policies
The Privacy Board operates under the authority of and in accordance with HIPAA Privacy Rule and applicable University policies and procedures.
- IRBMED SOPs Part 3, III, C, 4, e, 7 "Studies Subject to HIPAA Regulations"
- UMHS Policy 01-04-360 Use of Protected Health Information (PHI) in Research
- UMHS Compliance Office
- Privacy Boards and the HIPAA Privacy Rule from NIH
- OCR Research and HIPAA Privacy Rule page
- Course Offerings
- Panel Discussion – 2011.10.18
Website Approved by IRBMED Chairs and Director: October 14, 2011
Updated January 29, 2015