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Compliance and Enforcement

All Case Examples

Pharmacy Chain Institutes New Safeguards for Protected Health Information
Covered Entity: Pharmacies
Issue: Safeguards
A grocery store based pharmacy chain maintained pseudoephedrine log books containing protected health information in a manner so that individual protected health information was visible to the public at the pharmacy counter. Initially, the pharmacy chain refused to acknowledge that the log books contained protected health information. OCR issued a written analysis and a demand for compliance. Among other corrective actions to resolve the specific issues in the case, OCR required that the pharmacy chain implement national policies and procedures to safeguard the log books. Moreover, the entity was required to train of all staff on the revised policy. The chain acknowledged that log books contained protected health information and implemented the required changes.

Pharmacy Chain Changes 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 law enforcement officials, unless state law requires otherwise. The revised policy was implemented in the chains' stores nationwide.

Large Medicaid Plan Corrects Vulnerability that Had Resulted in Wrongful Disclosure
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 health care programs under the jurisdiction of the municipal social service agency.

Health Plan Corrects Computer Flaw that Caused Mailing of EOBs to Wrong Persons
Covered Entity: Health Plans
Issue: Safeguards
A national health maintenance organization sent explanation of benefits (EOB) by mail to a complainant's unauthorized family member. OCR's investigation determined that a flaw in the health plan's computer system put the protected health information of approximately 2,000 families at risk of disclosure in violation of the Rule. Among the corrective actions required to resolve this case, OCR required the insurer to correct the flaw in its computer system, review all transactions for a six month period and correct all corrupted patient information.

Large Provider Revises Process to Prevent Unauthorized Disclosures to Employers
Covered Entity: General Hospitals
Issue: Impermissible Uses and Disclosures; Authorizations
A state health sciences center disclosed protected health information to a complainant's employer without authorization. Among other corrective actions to resolve the specific issues in the case, including mitigation of harm to the complainant, OCR required the Center to revise its procedures regarding patient authorization prior to release of protected health information to an employer. All staff was trained on the revised procedures.

National Pharmacy Chain Extends Protections for Protected Health Information
Covered Entity: Pharmacies
Issue: Impermissible Uses and Disclosures; Safeguards
A pharmacy employee placed a customer's insurance card in another customer's prescription bag. The pharmacy did not consider the customer's insurance card to be protected health information (PHI). OCR clarified that an individual's health insurance card meets the statutory definition of PHI and, as such, needs to be safeguarded. Among other corrective actions to resolve the specific issues in the case, the pharmacy revised its policies regarding PHI and retrained its staff. The revised policies are applicable to all individual stores in the pharmacy chain.

Health Plan Corrects Impermissible Disclosure of Protected Health Information
Covered Entity: Health Plans
Issue: Impermissible Uses and Disclosures
An employee of a major health insurer impermissibly disclosed the protected health information of one of its members without following the insurer's authorization and verification procedures. Among other corrective actions to resolve the specific issues in the case, OCR required the health insurer to train its staff on the applicable policies and procedures and to mitigate the harm to the individual. In addition, the employee who made the disclosure was counseled and given a written warning.

Private Practice Revises Process to Provide Access to Records
Covered Entity: Private Practices
Issue: Access
A private practice failed to honor an individual's request for a complete copy of her minor son's medical record. OCR's investigation determined that the private practice had relied on state regulations that permit a covered entity to provide a summary of the record. OCR provided technical assistance to the covered entity, explaining that the Privacy Rule permits a covered entity to provide a summary of patient records rather than the full record only if the requesting individual agrees in advance to such a summary or explanation. Among other corrective actions to resolve the specific issues in the case, OCR required the covered entity to revise its policy. In addition, the covered entity forwarded the complainant a complete copy of the medical record.

Private Practice Revises Process to Provide Access to Records
Covered Entity: Private Practices
Issue: Access
At the direction of an insurance company that had requested an independent medical exam of an individual, a private medical practice denied the individual a copy of the medical records. OCR determined that the private practice denied the individual access to records to which she was entitled by the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required that the private practice revise its policies and procedures regarding access requests to reflect the individual's right of access regardless of payment source.

Public Hospital Corrects Impermissible Disclosure of Protected Health Information in Response to a Subpoena
Covered Entity: General Hospital
Issue: Impermissible Uses and Disclosures
A public hospital, in response to a subpoena (not accompanied by a court order), impermissibly disclosed the protected health information (PHI) of one of its patients. Contrary to the Privacy Rule protections for information sought for administrative or judicial proceedings, the hospital failed to determine that reasonable efforts had been made to insure that the individual whose PHI was being sought received notice of the request and/or failed to receive satisfactory assurance that the party seeking the information made reasonable efforts to secure a qualified protective order. Among other corrective actions to remedy this situation, OCR required that the hospital revise its subpoena processing procedures. Under the revised process, if a subpoena is received that does not meet the requirements of the Privacy Rule, the information is not disclosed; instead, the hospital contacts the party seeking the subpoena and the requirements of the Privacy Rule are explained. The hospital also trained relevant staff members on the new procedures.

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.

Clinic Sanctions Supervisor for Accessing Employee Medical Record
Covered Entity: Outpatient Facility
Issue: Impermissible Use and Disclosure
A hospital employee's supervisor accessed, examined, and disclosed an employee's medical record. OCR's investigation confirmed that the use and disclosure of protected health information by the supervisor was not authorized by the employee and was not otherwise permitted by the Privacy Rule. An employee's medical record is protected by the Privacy Rule, even though employment records held by a covered entity in its role as employer are not. Among other corrective actions to resolve the specific issues in the case, a letter of reprimand was placed in the supervisor's personnel file and the supervisor received additional training about the Privacy Rule. Further, the covered entity counseled the supervisor about appropriate use of the medical information of a subordinate.

Access
Covered Entity: Private Practice
Issue: Private Practice Revises Access Policy
A private practice denied an individual access to his records on the basis that a portion of the individual's record was created by a physician not associated with the practice. While the amendment provisions of the Privacy Rule permit a covered entity to deny an individual's request for an amendment when the covered entity did not create that the portion of the record subject to the request for amendment, no similar provision limits individuals' rights to access their protected health information. Among other steps to resolve the specific issue in this case, OCR required the private practice to revise its access policy and procedures to affirm that, consistent with the Privacy Rule standards, patients have access to their record regardless of whether another entity created information contained within it.

State Hospital Sanctions Employees for Disclosing Patient's PHI
Covered Entity: Hospital/Health Care Provider
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 the incident; one year probation; referral for peer review; and further training on HIPAA Privacy. In addition to corrective action taken under the Privacy Rule, the state attorney general's office entered into a monetary settlement agreement with the patient.

Dentist Changes Process to Safeguard PHI
Covered Entity: Health Care Provider
Issue: Safeguards, Minimum Necessary
An OCR investigation confirmed allegations that a dental practice flagged some of its medical records with a red sticker with the word "AIDS" on the outside cover, and that records were handled so that other patients and staff without need to know could read the sticker. When notified of the complaint filed with OCR, the dental practice immediately removed the red AIDS sticker from the complainant's file. To resolve this matter, OCR also required the practice to revise its policies and operating procedures and to move medical alert stickers to the inside cover of the records. Further, the covered entity's Privacy Officer and other representatives met with the patient and apologized, and followed the meeting with a written apology.

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 incident and counseled staff on proper faxing procedures.

Large Provider Revises Patient Contact Process
Covered Entity: General Hospital
Issue: Impermissible Disclosure; Confidential Communications
A patient alleged that a general hospital disclosed protected health information when a hospital staff person left a message on the patient’s home phone answering machine, thereby failing to accommodate the patient’s request that communications of PHI be made only through her mobile or work phones. In response, the hospital instituted a number of actions to achieve compliance with the Privacy Rule. To resolve this matter to the satisfaction of OCR, the hospital: retrained an entire Department with regard to the requirements of the Privacy Rule; provided additional specific training to staff members whose job duties included leaving messages for patients; and, revised the Department’s patient privacy policy to clarify patient rights to accommodation of reasonable requests to receive communications of PHI by alternative means or at alternative locations.

Large Health Care Provider Restricts Use of Patient Records
Covered Entity: Multi-Hospital Healthcare Provider
Issue: Impermissible Use
A nurse practitioner who has privileges at a multi-hospital health care system and who is part of the system’s organized health care arrangement impermissibly accessed the medical records of her ex-husband. In order to resolve this matter to OCR’s satisfaction and to prevent a recurrence, the covered entity: terminated the nurse practitioner’s access to its electronic records system; reported the nurse practitioner’s conduct to the appropriate licensing authority; and, provided the nurse practitioner with remedial Privacy Rule training.

Last revised: May 20, 2008

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