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.
| Large Provider Revises Patient Contact Process to Reflect Requests for Confidential Communications Covered Entity: General Hospital Issue: Impermissible Disclosure; Confidential Communications A patient alleged that a general hospital disclosed protected health information when a hospital staff person left a message on the patient’s home phone answering machine, thereby failing to accommodate the patient’s request that communications of PHI be made only through her mobile or work phones. In response, the hospital instituted a number of actions to achieve compliance with the Privacy Rule. To resolve this matter to the satisfaction of OCR, the hospital: retrained an entire Department with ...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 |
| Dentist Revises Process to Safeguard Medical Alert PHI Covered Entity: Health Care Provider Issue: Safeguards, Minimum Necessary An OCR investigation confirmed allegations that a dental practice flagged some of its medical records with a red sticker with the word "AIDS" on the outside cover, and that records were handled so that other patients and staff without need to know could read the sticker. When notified of the complaint filed with OCR, the dental practice immediately removed the red AIDS sticker from the complainant's file. To resolve this matter, OCR also required the practice to revise its policies and operating ...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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