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.
| 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; ...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 |
| 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 |
| Wednesday, November 9, 2022 A federal grand jury in Newark, New Jersey, returned an indictment today charging an Indian national for fraudulently obtaining millions of dollars in Paycheck Protection Program (PPP) loans guaranteed by the Small Business Administration (SBA) under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. According to court documents, Abhishek Krishnan, 40, previously resided in Wake County, North Carolina, before returning to his home country of India. After returning to India, Krishnan allegedly submitted numerous fraudulent PPP loan applications to federally insured banks, including on behalf of purported companies that were not registered business entities. ...read more |
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