Pharmacy Chain Institutes New Safeguards for PHI in Pseudoephedrine Log Books

Pharmacy Chain Institutes New Safeguards for PHI in Pseudoephedrine Log Books
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.



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



Mental Health Center Provides Access and Revises Policies and Procedures Covered Entity: Mental Health Center Issue: Access, Restrictions The complainant alleged that a mental health center (the "Center") refused to provide her with a copy of her medical record, including psychotherapy notes. OCR’s investigation revealed that the Center provided the complainant with an opportunity to review her medical record, including the psychotherapy notes, with her therapist, but the Center did not provide her with a copy of her records.  The Privacy Rule requires covered entities to provide individuals with access to their medical records; however, the Privacy Rule exempts ...read more



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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

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