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.
| 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 Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded.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 |
| 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 |
| 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 |
| Public Hospital Corrects Impermissible Disclosure of PHI in Response to a Subpoena Covered Entity: General Hospital Issue: Impermissible Uses and Disclosures A public hospital, in response to a subpoena (not accompanied by a court order), impermissibly disclosed the protected health information (PHI) of one of its patients. Contrary to the Privacy Rule protections for information sought for administrative or judicial proceedings, the hospital failed to determine that reasonable efforts had been made to insure that the individual whose PHI was being sought received notice of the request and/or failed to receive satisfactory assurance that the party seeking the information ...read more |
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