Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research

Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research
Covered Entity: Private Practice
Issue: Impermissible Disclosure-Research

A private practice physician who was the principal investigator of a clinical research study disclosed a list of patients and diagnostic codes to a contract research organization to telephone patients for recruitment purposes.  The disclosure was not consistent with documents approved by the Institutional Review Board (IRB). The private practice maintained that the disclosure to the contract research organization was permissible as a review preparatory to research.  Activities considered “preparatory to research” include: preparing a research protocol; developing a research hypothesis; and identifying prospective research participants.  Contacting individuals to participate in a research study is a use or disclosure of protected health information (PHI) for recruitment, as it is part of the research and is not an activity preparatory to research.  To remedy this situation, the private practice revised its policies and procedures regarding the disclosure of PHI and trained all physicians and staff members on the new policies and procedures.  Under the revised policies and procedures, the practice may use and disclose PHI for research purposes, including recruitment, only if a valid authorization is obtained from each individual or if the covered entity obtains documentation that an alteration to or a waiver of the authorization requirement has been approved by an IRB or a Privacy Board.



§ 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



HHS Issues Guidance on HIPAA and Audio-Only Telehealth Today, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), is issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth - PDF is no longer in effect. This guidance will help individuals ...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



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 ...read more

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