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.
| State Hospital Sanctions Employees for Disclosing Patient's PHI Covered Entity: Health Care Provider / General Hospital 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 ...read more |
| Direct Liability of Business Associates In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act,1 making business associates of covered entities directly liable for compliance with certain requirements of the HIPAA Rules. Consistent with the HITECH Act, the HHS Office for Civil Rights (OCR) issued a final rule in 2013 to modify the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules.2 Among other things, the final rule identifies provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable.3 As set forth in the HITECH ...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 |
| 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 |
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