Honest Broker

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Policy No.: 6014
Effective Date: DRAFT
Revised Date:
Reviewed Date:

Honest Broker Policy

Basis for Policy

Policy

UNMC Affiliated Covered Entity (ACE) shall implement an “honest broker” program to ensure compliance with the HIPAA Privacy rules and requirements pertaining to the use and disclosure of protected health information (PHI) and de-identification of PHI used for research and Healthcare Operations as well as any applicable related state laws that are not preempted by HIPAA.

Purpose

The purpose of the Honest Broker Policy is to establish standard operating procedures for de-identification of PHI for the purpose of safely and securely linking together or sharing clinical data to support research in compliance with HIPAA and IRB requirements.

Definitions

Affiliated Covered Entity (ACE)

Legally separate covered entities have designated themselves as a single covered entity for the purpose of HIPAA Compliance. Current UNMC ACE members are: UNMC, Nebraska Medicine, UNMC Physicians, University Dental Associates, Bellevue Medical Center, and Nebraska Pediatric Practice, Inc. ACE membership may change from time to time. The Notice of Privacy Practices lists current ACE members.

Business Associate

A person or entity, other than a member of the workforce of a covered entity, who performs functions on behalf of a covered entity per 45 CFR 160 is a business associate.

De-identification

De-identification refers to removal of all eighteen (18) of the HIPAA identifiers or any other identifiers which would allow the reasonable possibility for investigators or others to identify patients directly or indirectly to prevent re-identification of patients.

Information Custodian

All application systems must have an information custodian (IM17, Access Control to Information Technology Resources) who performs the following functions: (IM29 - Information Custodian Roles and Responsibilities)

  • Ongoing day to day administration for departmentally owned information systems
  • Coordination of system upgrades
  • End user training
  • First tier application support
  • Business process owner
  • System access and control
  • Resource table configuration and application testing
  • Business continuity coordination (downtime procedures)
  • Interface troubleshooting and error management
  • Report development
  • Research and development of emerging technologies
  • Primary vendor contact
  • Change management documentation and communication
  • Auditing requirements
  • Other duties as mutually agreed upon

Institutional Review Board (IRB)

IRB means the Institutional Review Board of record for the ACE.

Limited Data Sets

A Limited Data Set means a set of identifiable patient information, as defined by HIPAA, which has limited identifiable information which may be used solely for the purpose of research, public health, or health care operations. A Limited Data Set should be shared only upon execution of a Data Use Agreement, which is an agreement which addresses HIPAA-mandated conditions related to subsequent uses and disclosures of Limited Data Sets.

Protected Health Information (PHI)

Protected Health Information means any information whether oral or recorded in any medium created or received by a health care provider, health plan, employer or health care clearinghouse which relates to past, present or future physical or mental health or condition of an individual, or the past, present, or future payment for the provision of health care to an individual for which there is a reasonable basis to believe the information may be used to identify an individual.

IRB Requirements

Use of human biological, samples, specimens and data or the like shall be consistent with the requirements, regulations, laws for use of such information and materials.

Workforce Member

Workforce member refers to faculty, staff, volunteers, trainees, students, independent contractors and other persons whose conduct in the performance of work the ACE entities, or are under the direct control of an ACE entity.

Procedures

Honest Broker Requirements

The ACE will comply with the HIPAA Privacy Rule requirements pertaining to the use and disclosure of protected health information (PHI) and de-identification of PHI used for research and healthcare operations as well as any applicable related state laws that are not preempted by HIPAA and IRB Requirements.

  • De-identified health information must not include any of the eighteen identifiers defined by HIPAA, or any other identifiers, that would allow a reasonable possibility for any person to identify the patients directly or indirectly.
  • Limited Data Sets: If the health information provided to research investigators is based on a Limited Data Set the investigators must complete and obtain Institutional Review Board (IRB) approval of a UNMC/Nebraska Medicine If the investigator requests changes to the Data Use agreement, the Privacy Office shall review and approve the revisions.
  • Re-Identification Codes: The information provided to the investigators/others by the Honest Broker may incorporate linkage codes to permit information collation and/or subsequent inquiries (i.e., a “re-identification code”), however the information linking this re-identification code to the patient’s identity must be retained by the Honest Broker, secured and separate from research/other documents; all subsequent inquiries must be conducted through the Honest Broker and IRB approval.

Honest Broker Role

  • An Honest Broker will provide a research investigator with a de-identified listing of the health information of potential eligible research subjects. The Honest Broker will retain re-identification codes that permit only the Honest Broker to re-identify the data.
  • The Honest Broker may facilitate identification of potential research subjects by contacting patients’ personal physicians who would contact the patients to:
  • Introduce the research study;
  • Ascertain their interest in study participation; and
  • Facilitate contact with an investigator or obtain their written authorization to share their interest in study participation with the investigators and to be contacted by them. The Honest Broker would not directly contact the patient.
  • After secondary review by the Associate Vice Chancellor for Clinical Research, an Honest Broker may provide the research investigator with a list of potentially eligible patients who have agreed to be contacted for research studies they are eligible for based on their election on the Conditions of Treatment form or consistent with the Human Research Protection Program Policy #3.4 “Use of Protected Health Information in Research and Registries” for further information.

Honest Broker Certification Criteria

  • Appointment: Honest Brokers shall not be a part of the research team for which they are performing honest broker services, unless approved by the ACE Privacy Officer, the Associate Vice Chancellor for Clinical Research and the Chief, Quality/Outcomes Officer.
  • Education and Training: The proposed Honest Brokers responsible for a research data source must complete education and training, currently mandated by the IRB for all research investigators, prior to submitting an application.
  • The individual or the organization or team must submit an Application for Honest Broker Certification Form to become part of the UNMC Honest Broker System.
  • Applications should be submitted to the Privacy Officer for the ACE.
  • Attestation of Agreement: All Honest Brokers must sign a written agreement that they will abide by all relevant ACE policies including continuing adherence to the ACE Honest Broker certification criteria section of this policy.
  • Certification, Approval, and Maintenance
  • Initial Review and Approval: The ACE Privacy Officer, the Associate Vice Chancellor for Clinical Research and the Chief, Quality/Outcomes Officer will review and approve Honest Broker applications and related documentation to determine that satisfactory evidence has been presented to meet or exceed the following certification criteria:
  • Written documentation of the processes and/or systems to be used to develop both fully de-identified health information data sets and limited data sets, for both electronic and paper-based records;
  • Written documentation of policies, procedures and controls necessary for:
  • Compliance with HIPAA, and regulations for human subject protections (45 CFR 46), if applicable.
  • Security and management of all PHI in the Honest Broker’s possession during the performance of Honest Broker functions;
  • Audits and/or quality checks related to determining the efficacy of de-identification mechanisms;
  • Security and management of re-identification keys; and
  • Maintenance and retention of work-product documentation for all work performed (for whom, what was provided, IRB approval info, etc.).
  • Requests for data shall be retained for six (6) years.
  • Ongoing Review and Maintenance: Each certified Honest Broker’s individual status will be reviewed at least annually by the Privacy Office. Changes in an Honest Broker’s status should be reported immediately by the sponsoring investigator or team leader.
  • Adding and/or Removing Brokers
  • Adding Brokers:
  • New brokers must first complete the education/certification modules as noted in the Honest Broker certification section above.
  • In accordance with UNMC/Nebraska Medicine policy, applicants who are not UNMC/Nebraska Medicine employees must complete and sign a business associate agreement (BAA).
  • A complete revision of the each unit’s application must be submitted to the Privacy Office with any brokers to be added reflected in the revision. A copy of any relevant BAAs must accompany the revision documents.
  • Removing Brokers: A complete revision of the application must be submitted to the Privacy Office with any brokers to be removed and the reason for the removal reflected in the revision.
  • Duties and Other Requirements of the Honest Broker: In order for a certified Honest Broker to work on behalf of investigators to de-identify PHI that is owned/held by UNMC, the Honest Broker must perform the following UNMC/Nebraska Medicine-defined duties and adhere to the following -defined requirements:
  • Non-UNMC/Nebraska Medicine Honest Brokers must execute a Business Associate Agreement (BAA) with UNMC:
  • The terms of the BAA will specify continuing confidentiality requirements, duties and other expectations UNMC/Nebraska Medicine has of an Honest Broker service. The UNMC/Nebraska Medicine BAA can be viewed at http://www.unmc.edu/hipaa/forms/index.html.
  • All certified Honest Brokers must ensure that approval of the IRB of record has been obtained for a research study before the Honest Broker acts on a request for PHI (from an investigator that is served by the IRB of record).
  • All certified Honest Brokers must adhere to any and all terms and conditions specified by the IRB of record for any research study for which the Honest Broker will perform services.
  • If an investigator requests a Limited Data Set, rather than a fully/completely de-identified data set:
  • The IRB of record may require evidence of a completed Data Use Agreement for a Limited Data Set as part of its application process for approval of the proposed research involving the use of a Limited Data Set.
  • An individual Honest Broker for the investigator must obtain (and retain) evidence of an appropriately executed Data Use Agreement in order to be granted access to the UNMC/Nebraska Medicine-held PHI.

Additional Information


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