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.
| Hospital Issues Guidelines Regarding Disclosures to Avert Threats to Health or Safety Covered Entity: General Hospital Issue: Safeguards; Impermissible Uses and Disclosures; Disclosures to Avert a Serious Threat to Health or Safety After treating a patient injured in a rather unusual sporting accident, the hospital released to the local media, without the patient’s authorization, copies of the patient’s skull x-ray as well as a description of the complainant’s medical condition. The local newspaper then featured on its front page the individual’s x-ray and an article that included the date of the accident, the location of the accident, the patient’s ...read more |
| Hospital Issues Guidelines Regarding Disclosures to Avert Threats to Health or Safety Covered Entity: General Hospital Issue: Safeguards; Impermissible Uses and Disclosures; Disclosures to Avert a Serious Threat to Health or Safety After treating a patient injured in a rather unusual sporting accident, the hospital released to the local media, without the patient’s authorization, copies of the patient’s skull x-ray as well as a description of the complainant’s medical condition. The local newspaper then featured on its front page the individual’s x-ray and an article that included the date of the accident, the location of the accident, the patient’s ...read more |
| TYLER, Texas — U.S. Attorney John M. Bales announced today that a former employee of an East Texas hospital has pleaded guilty to criminal HIPAA charges in the Eastern District of Texas. Joshua Hippler, 30, formerly of Longview, Texas, was indicted on March 26, 2014, on charges of Wrongful Disclosure of Individually Identifiable Health Information. Hippler pleaded guilty on August 28, 2014 during a hearing before United States Magistrate Judge John D. Love. The indictment alleged that from December 1, 2012, through January 14, 2013, Hippler, who was then an employee of a covered entity under HIPAA, obtained protected ...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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