30 Jun Adopting the ‘Honest Broker’ System: UW Medicine Policy Changes for Identified & De-Identified Clinical Data Sets
Policy changes are ahead that will change the way clinical data sets are handled – and these new rules will impact workflow for many researchers.
What’s Changing?
All research-related data sets involving UW Medicine Identified and/or De-Identified Clinical Data must be pulled by a Neutral Intermediary or ‘Honest Broker’ to ensure the data set matches the approved IRB and the data set is accurately de-identified when applicable (see the definition of an Honest Broker below).
Honest Broker Options after 7/1:
- Research IT can pull the data set and/or review an already pulled data set to ensure compliance with the approved IRB for a small fee Request support
- Affiliated Developers or Analysts who have completed annual Honest Broker training and attested to the rules of the road can pull data sets for research
Two New Compliance Policies
- COMP.307 Honest Broker Policy
- Outlines the rules of the road for anyone acting as an Honest Broker
- Describes core principles, annual training requirements, and duties & responsibilities to assure compliant release of UW Medicine Clinia Data to researchers.
- COMP.306 Release of Clinical Data for Research Purposes
- Describes the circumstances when UW Medicine may disclose Protected Health Information (PHI) for research purposes.
- Introduces the concept of “clinical data” that is broader than the definition of PHI and describes the centralized and values-based approach for reviewing and responding to requests to use or share UW Medicine clinical data for research.
- Describes research data stewardship obligations that fall outside patient privacy and security requirements, including UW Medicine institutional standards, the requirement to execute data use agreements, and how to report unforeseen events that involve data.
Why Is This Changing?
In order to ensure UW Medicine reduces risk and protects clinical data with consistent data stewardship practices, the Honest Broker Program was developed. This measure aims to close any potential gaps in policy and process.
What is an Honest Broker?
An “Honest Broker” is an individual, software application, organization or team acting to search UW Medicine patient medical records to collect clinical data and/or review the collected clinical data to respond to a researcher’s approved request to access or use clinical data. The Honest Broker provides identified or de-identified information to the research team in accordance with applicable IRB authorization, UW Medicine policies, and core principles. The Honest Broker resides within the covered entity or is a business associate and acts as a gatekeeper between the covered entity and the research team and serves as the link between HIPAA privacy and security.
When does this take effect?
The policy takes effect July 1, 2025.
What support will be offered to assist with compliance?
Training links will be sent out to the 71 Affiliated Developers who self-identified as pulling for research. Compliance will be enforced by ERHI through our new Honest Broker auditing and compliance program. They will ensure that data pulls are being recorded, training has been completed, policies are acknowledged and will also perform auditing spot checks.
Honest Broker Toolkit for Researchers
Research IT has been working on developing an accessible repository for the research community including Data Use Agreement (DUA) templates, a how-to library with guides and checklists, registry lists (owners and data stewards), language to include in new proposals. A specialized Epic-integrated instance of REDCap is under development along with a growing tool library for a self-service option.
More details about the Honest Broker Program can be found here: UW Medicine Honest Broker Program – Home. Questions can be directed to Research Data Services: ritdatahelp@uw.edu.
