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.



Thursday, November 10, 2022 Five Former Methodist Hospital Employees Charged with HIPAA Violations Memphis, TN – A federal grand jury has indicted five former Methodist Hospital Employees for conspiring with Roderick Harvey, 40, to unlawfully disclose patient information in violation of the Health Insurance Portability and Accountability Act of 1996, commonly known as “HIPAA.” United States Attorney Kevin G. Ritz announced the indictment today. HIPAA was enacted by Congress in 1996 to create national standards to protect sensitive patient information from being disclosed without a patient’s knowledge or consent. HIPAA’s provisions make it a crime to disclose patient information, ...read more



SCOPE OF CRIMINAL ENFORCEMENT UNDER 42 U.S.C. § 1320d-6 Covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6, and the knowingly element of the offense set forth in that provision requires only proof of knowledge of the facts that constitute the offense. MEMORANDUM OPINION FOR THE GENERAL COUNSEL DEPARTMENT OF HEALTH AND HUMAN SERVICES AND THE SENIOR COUNSEL TO THE DEPUTY ATTORNEY GENERAL You have asked jointly for our opinion concerning the scope of 42 U.S.C. § 1320d-6 (2000), the criminal enforcement provision of the ...read more



Pharmacy Chain Revises Process for Disclosures to Law Enforcement Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures A chain pharmacy disclosed protected health information to municipal law enforcement officials in a manner that did not conform to the provisions of the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required this chain to revise its national policy regarding law enforcement's access to patient protected health information to comply with the Privacy Rule requirements, including that disclosures of protected health information to law enforcement only be made in response to written requests from ...read more



Private Practice Revises Access Procedure to Provide Access Despite an Outstanding Balance Covered Entity: Private Practice Issue: Access A complainant alleged that a private practice physician denied her access to her medical records, because the complainant had an outstanding balance for services the physician had provided. During OCR’s investigation, the physician confirmed that the complainant was not given access to her medical record because of the outstanding balance. OCR provided technical assistance to the physician, explaining that, in general, the Privacy Rule requires that a covered entity provide an individual access to their medical record within 30 days of ...read more

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