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.



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 ...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



Hospital Implements New Minimum Necessary Polices for Telephone Messages Covered Entity: General Hospital Issue: Minimum Necessary; Confidential Communications A hospital employee did not observe minimum necessary requirements when she left a telephone message with the daughter of a patient that detailed both her medical condition and treatment plan.  An OCR investigation also indicated that the confidential communications requirements were not followed, as the employee left the message at the patient’s home telephone number, despite the patient’s instructions to contact her through her work number. To resolve the issues in this case, the hospital developed and implemented several new procedures.  ...read more



Enforcement Actions Ensure Patients Receive Timely Access to their Records, at a Reasonable Cost Today, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the resolution of three investigations concerning potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule's patient right of access provision. These cases are part of a collective effort, bringing the total 41 cases, to drive compliance on right of access under the law. “These three right of access actions send an important message to dental practices of all sizes that are covered by the HIPAA ...read more

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