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.
| 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 ...read more |
| Health Sciences Center 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. ...read more |
| Can a covered entity refuse to disclose ePHI to an app chosen by an individual because of concerns about how the app will use or disclose the ePHI it receives? No. The HIPAA Privacy Rule generally prohibits a covered entity from refusing to disclose ePHI to a third-party app designated by the individual if the ePHI is readily producible in the form and format used by the app. See 45 CFR 164.524(a)(1), (c)(2)(ii), (c)(3)(ii). The HIPAA Rules do not impose any restrictions on how an individual or the individual’s designee, such as an app, may use the health information ...read more |
| Large Health System Restricts Provider's 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. ...read more |
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