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 |
| Mental Health Center Provides Access after Denial Covered Entity: Mental Health Center Issue: Access, Authorization The complainant alleged that a mental health center (the "Center") improperly provided her records to her auto insurance company and refused to provide her with a copy of her medical records. The Center provided OCR with a valid authorization, signed by the complainant, permitting the release of information to the auto insurance company. OCR also determined that the Center denied the complainant's request for access because her therapists believed providing the records to her would likely cause her substantial harm. The Center did not, ...read more |
| Entity Rescinds Improper Charges for Medical Record Copies to Reflect Reasonable, Cost-Based Fees Covered Entity: Private Practice Issue: Access A patient alleged that a covered entity failed to provide him access to his medical records. After OCR notified the entity of the allegation, the entity released the complainant’s medical records but also billed him $100.00 for a “records review fee” as well as an administrative fee. The Privacy Rule permits the imposition of a reasonable cost-based fee that includes only the cost of copying and postage and preparing an explanation or summary if agreed to by the individual. To ...read more |
| Radiologist Revises Process for Workers Compensation Disclosures Covered Entity: Health Care Provider Issue: Impermissible Uses and Disclosures A radiology practice that interpreted a hospital patient’s imaging tests submitted a worker’s compensation claim to the patient’s employer. The claim included the patient’s test results. However, the patient was not covered by worker’s compensation and had not identified worker’s compensation as responsible for payment. OCR’s investigation revealed that the radiology practice had relied upon incorrect billing information from the treating hospital in submitting the claim. Among other corrective actions to resolve the specific issues in the case, the practice apologized to ...read more |
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