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.
| Physician Revises Faxing Procedures to Safeguard PHI Covered Entity: Health Care Provider Issue: Safeguards A doctor's office disclosed a patient's HIV status when the office mistakenly faxed medical records to the patient's place of employment instead of to the patient's new health care provider. The employee responsible for the disclosure received a written disciplinary warning, and both the employee and the physician apologized to the patient. To resolve this matter, OCR also required the practice to revise the office's fax cover page to underscore a confidential communication for the intended recipient. The office informed all its employees of the ...read more |
| A Covered Entity is: A health plan. An individual or group plan that provides, or pays the cost of, medical care. Health plans include private entities (e.g., health insurers and managed care organizations) and government organizations (e.g., Medicaid, Medicare, and the Veterans Health Administration) A health care provider. A provider of health care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. Health care providers (e.g., physicians, hospitals, and clinics) are covered entities if they transmit health information in electronic form in connection with a transaction ...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 |
| Hospital Implements New Minimum Necessary Polices for Telephone Messages Covered Entity: General Hospital Issue: Minimum Necessary; Confidential Communications A hospital employee did not observe minimum necessary requirements when she left a telephone message with the daughter of a patient that detailed both her medical condition and treatment plan. An OCR investigation also indicated that the confidential communications requirements were not followed, as the employee left the message at the patient’s home telephone number, despite the patient’s instructions to contact her through her work number. To resolve the issues in this case, the hospital developed and implemented several new procedures. ...read more |
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