Outpatient Surgical Facility Corrects Privacy Procedure in Research Recruitment
Covered Entity: Outpatient Facility
Issue: Impermissible Uses and Disclosures

An outpatient surgical facility disclosed a patient's protected health information (PHI) to a research entity for recruitment purposes without the patient's authorization or an Institutional Review Board (IRB) or privacy-board-approved waiver of authorization. The outpatient facility reportedly believed that such disclosures were permitted by the Privacy Rule. OCR provided technical assistance to the covered entity regarding the requirement that covered entities seeking to disclose PHI for research recruitment purposes must obtain either a valid patient authorization or an Institutional Review Board (IRB) or privacy-board-approved alteration to or waiver of authorization. Among other corrective actions to resolve the specific issues in the case, OCR required the outpatient facility to: revise its written policies and procedures regarding disclosures of PHI for research recruitment purposes to require valid written authorizations; retrain its entire staff on the new policies and procedures; log the disclosure of the patient's PHI for accounting purposes; and send the patient a letter apologizing for the impermissible disclosure.