Can covered entities continue to disclose protected health information to the HHS Office for Human Research Protections for purposes of determining compliance with the HHS regulations for the protection of human subjects (45 CFR Part 46)?
Answer:Yes. The Office for Human Research Protections is a health oversight agency under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to the Office for Human Research Protections for such compliance investigations either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for health oversight activities as permitted at 45 CFR 164.512(d).
Date Created: 12/20/2002
Last Updated: 03/14/2006