Outpatient Surgical Facility Corrects Privacy Procedure in Research Recruitment
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.
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