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.
| When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials? Answer: The Privacy Rule is balanced to protect an individual’s privacy while allowing important law enforcement functions to continue. The Rule permits covered entities to disclose protected health information (PHI) to law enforcement officials, without the individual’s written authorization, under specific circumstances summarized below. For a complete understanding of the conditions and requirements for these disclosures, please review the exact regulatory text at the citations provided. Disclosures for law enforcement purposes are permitted as follows: To comply with a court order or ...read more |
| Hospital Revises Email Distribution as a Result of a Disclosure to Persons Without a "Need to Know" Covered Entity: General Hospital Issue: Impermissible Use and Disclosure A complainant, who was both a patient and an employee of the hospital, alleged that her protected health information (PHI) was impermissibly disclosed to her supervisor. OCR’s investigation revealed that: the hospital distributed an Operating Room (OR) schedule to employees via email; the hospital’s OR schedule contained information about the complainant’s upcoming surgery. While the Privacy Rule may permit the disclosure of an OR schedule containing PHI, in this case, a hospital employee ...read more |
| National Pharmacy Chain Extends Protections for PHI on Insurance Cards Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures; Safeguards A pharmacy employee placed a customer's insurance card in another customer's prescription bag. The pharmacy did not consider the customer's insurance card to be protected health information (PHI). OCR clarified that an individual's health insurance card meets the statutory definition of PHI and, as such, needs to be safeguarded. Among other corrective actions to resolve the specific issues in the case, the pharmacy revised its policies regarding PHI and retrained its staff. The revised policies are applicable to all individual ...read more |
| Outpatient Surgical Facility Corrects Privacy Procedure in Research Recruitment Covered Entity: Outpatient Facility Issue: Impermissible Uses and Disclosures An outpatient surgical facility disclosed a patient's protected health information (PHI) to a research entity for recruitment purposes without the patient's authorization or an Institutional Review Board (IRB) or privacy-board-approved waiver of authorization. The outpatient facility reportedly believed that such disclosures were permitted by the Privacy Rule. OCR provided technical assistance to the covered entity regarding the requirement that covered entities seeking to disclose PHI for research recruitment purposes must obtain either a valid patient authorization or an Institutional Review Board ...read more |
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