Can covered entities continue to disclose adverse event reports that contain protected health information to the Department of Health and Human Services (HHS) Office for Human Research Protections?

Yes. The Office for Human Research Protections is a public health authority under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to report adverse events to the Office for Human Research Protections either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for public health activities as permitted at 45 CFR 164.512(b).