The document discusses the design of a governance framework for data sharing in a multi-stakeholder and multi-jurisdictional health informatics project in Canada. It outlines the challenges posed by different legal regimes and cultural preferences in observational research, particularly between Ontario and Quebec. Key solutions include nested governance structures, standardized committee materials, and planned sun-setting of committees to improve collaboration and trust while sharing best practices across jurisdictions.

1. Design for Governing the flow of Data in a Complex, Multi-Stakeholder and
Multi-jurisdictional Health Informatics Project across Canada
Karim Keshavjee, Frank Sullivan, Michelle Greiver and Don Willison
University of Toronto, Toronto, Canada
The Problem
Need to share data for observational research across
• Multiple jurisdictions
• Multiple cultural preferences
• Multiple stakeholders
Use case 1: Ontario and Quebec have different legal regimes to govern
data sharing and observational studies
Need to conduct human research across multiple
organizations and disease types
Use case 2: Type 1 and Type 2 diabetes studies are done by different sets
of researchers with different goals
Method
• Interviewed multiple
stakeholders
• Used the British Design
Council’s Double Diamond
Method to Design the
Solution for the Problem
Results
Nested and parallel governance structures
Governance of individual committees is standardized to the
extent possible through templates for Terms of References
(TORs) and other materials to allow for quick start-up, easy
maintenance/updating of materials, easy cross-
appointments and quick sun-setting of committees.
Benefits of Standardization
1. Easier to cross-fertilize committees when they work in similar ways.
2. Easier to share best practices with other committees.
3. Easier to share structures with other organizations and entities
(i.e., more scalable)
4. Easier to transact business with multiple governance entities.
5. Increases trust and trustworthiness of data
6. Could form the basis of interoperability in the future.
Benefits of Planned Sun-Setting
1. Poor practices end quickly with little friction
2. Best practices are disseminated faster through
updated templates
Identified need for:
1. Local control over risks and goals, yet
2. Standardization across jurisdictions & stakeholders
3. Learn from experience
4. Share best practices across teams
contemporaneously and over time
Solutions developed:
1. Nested and parallel governance structures
2. Standardized committee materials
3. Cross-appointment of individuals across committees
4. Planned sun-setting of committees
GoalsOverall
Governance
Type 1 Diabetes RCTs
Policy & Process
Workflow
Info Flow
Info Tech
Goals
Type 2 Diabetes Obs Research
Policy & Process
Workflow
Info Flow
Info Tech
Goals
Quebec Clinical Trials
Policy & Process
Workflow
Info Flow
Info Tech
Goals
Presented at European Federation for Medical
Informatics Conference 2017