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 Process to Provide Access to Records Covered Entity: Private Practices Issue: Access A private practice failed to honor an individual's request for a complete copy of her minor son's medical record. OCR's investigation determined that the private practice had relied on state regulations that permit a covered entity to provide a summary of the record. OCR provided technical assistance to the covered entity, explaining that the Privacy Rule permits a covered entity to provide a summary of patient records rather than the full record only if the requesting individual agrees in advance to such a summary ...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 |
| 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 |
| Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI? This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. Yes. When an individual requests access to her PHI and the covered entity intends to charge the ...read more |
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