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.
| § 164.314 Organizational requirements. (a) (1) Standard: Business associate contracts or other arrangements. The contract or other arrangement required by § 164.308(b)(3) must meet the requirements of paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section, as applicable. (2) Implementation specifications (Required) - (i) Business associate contracts. The contract must provide that the business associate will - (A) Comply with the applicable requirements of this subpart; (B) In accordance with § 164.308(b)(2), ensure that any subcontractors that create, receive, maintain, or transmit electronic protected health information on behalf of the business associate agree to comply with the applicable requirements of ...read more |
| Issued by: Office for Civil Rights (OCR) What if a HIPAA covered entity (or business associate) uses a CSP to maintain ePHI without first executing a business associate agreement with that CSP? Answer: If a covered entity (or business associate) uses a CSP to maintain (e.g., to process or store) electronic protected health information (ePHI) without entering into a BAA with the CSP, the covered entity (or business associate) is in violation of the HIPAA Rules. 45 C.F.R §§164.308(b)(1) and §164.502(e). OCR has entered into a resolution agreement and corrective action plan with a covered entity that OCR determined ...read more |
| Large Medicaid Plan Corrects Vulnerability that Resulted in Disclosure to Non-BA Vendors Covered Entity: Health Plans Issue: Impermissible Uses and Disclosures; Safeguards A municipal social service agency disclosed protected health information while processing Medicaid applications by sending consolidated data to computer vendors that were not business associates. Among other corrective actions to resolve the specific issues in the case, OCR required that the social service agency develop procedures for properly disclosing protected health information only to its valid business associates and to train its staff on the new processes. The new procedures were instituted in Medicaid offices and independent ...read more |
| State Hospital Sanctions Employees for Disclosing Patient's PHI Covered Entity: Health Care Provider / General Hospital Issue: Impermissible Disclosure A nurse and an orderly at a state hospital discussed the HIV/AIDS status of a patient and the patient's spouse within earshot of other patients without making reasonable efforts to prevent the disclosure. Upon learning of the incident, the hospital placed both employees on leave; the orderly resigned his employment shortly thereafter. Among other actions taken to satisfactorily resolve this matter, the hospital took further disciplinary action with the nurse, which included: documenting the employee record with a memo of ...read more |
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