1. Multilevel collaborative platforms Linking Diabetes Medical Records to other sources Mark McGilchrist Senior Research Fellow University of Dundee Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

2. Register Primary Care Clinics BMI Lifestyle Rx Lab Eye Foot Renal Hospital Community Pharmacy Rx Discharge Education & Social Care Death Certification Cancer Registry Genetic Data (Research) Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

3. Interoperability Static, long-term collaborations requiring time and resource Semantics Syntax Semantics Syntax Shared Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

4. Interoperability Updating an existing collaboration is time-consuming and costly, so use RL Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

5. Register Research Recipient Offers dynamic binding (loose coupling) of existing systems to create approximations to new systems, quickly and at low cost Record-linkage Hospital Recipient Must handle heterogeneity Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Considerations?

6. Considerations  Ethics  Data Protection Law  Contractual arrangements  Validity  Specification  Authorisation  Regulatory compliance  Confidentiality framework  Security  Shared syntax  Shared semantics  Shared linkage standards  Data flow models  Recipient facilities  Disclosure control  Provenance  Business models  Political models Local, national, international Are all different! Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

7. Ethics Single/Multi-centre RECs? Diverse data sources?  Clinical  Biobank  Local government authority  Government agency So who decides, who takes responsibility? Benefits vs risks? Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

8. Data Protection Law  EU Directive  National Laws  Border flows Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

9. Contractual arrangements Transfer agreements:  Data  Materials  Recipient obligations  Publication of results Time consuming, but necessary? How do we hold others to account? Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

10. Specification Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee  Actors  Interaction  Standards  Tools and Coding systems  Technology UMLS ®

11. Authorisation Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee  Access committee - centralised or decentralised?  Peer review  Supporting documentation (Ethics, protocol,...)  Legal persons?  How is decision made? Transparent?

12. Confidentiality Framework Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee  Purpose: primary or secondary use  Consent: implicit, explicit, informed  Anonymous data  Pseudonymous/coded data  Policy  Responsibility  Data flow  PETs  Trust  Data controllers, processors, owners  Genetic data

13. Security Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee  Data transfer routes  Payload encryption: algorithms and protocols  Certificate authorities

14. Syntax and semantics Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee  Data heterogeneity  Common Information model  Vocabulary and terminology services  Ontology-driven mapping  Healthcare data interchange standards

15. Linkage standards Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee  Local/study identifiers  Institutional identifiers  National identifiers  Mappings Probabilistic matching generates a ‘standard’

16. Recipient facilities Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Recipient facilities  Terminal access  Virtual hardware  Pre-defined software configurations  Disclosure control Data

17. Data Flow Models Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Model A – central conduit (relies on TTP) Model B – data bus (relies on Technology) Model C – multi-institutional Each model has its own unique set of issues, e.g.: Where is trust placed? Authorisation? Business obligations? Specification? Contracts?...

18. Rules Architecture System Behaviour is sensitive to:  Systems  System rules  System relationships  Relationship rules Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Recipient

19. Model A – central conduit Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee TTP (PETs, Trust, controller) DS Recipient Usually involves transfer of complete, identifiable data to a TTP. TTP releases anonymised, linked data to the recipient. The TTP may provide authorisation facilities. Resources concentrated at the TTP. Identifiable data Anonymised/anonymous data

20. Model B – data bus Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee DS Recipient Encrypted identifiers and data  Does not involve the transfer of directly identifiable data.  Encryption schemes permit SQL join type operations, but data flows are not known in advance and may move between sources.  Although field-level RBAC may be implemented, actual queries cannot be anticipated.  Authorisation is coarse grained.  All parties are trusted  Resource requirements unclear

21. Model C – Multi-institutional Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee DS Recipient Link Anonymised/ Anonymous data Mappings  Data sources only transfer anonymised data.  Data flow is well defined in advance  Actual requests are actioned  Authorisation is fine-grained.  Trust levels required are low  DS must be resourced

22. Multi-level combined models Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee DS TTPDS Recipient Link

23. Example: Local - WTCCC Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee NHSSCI-DCPheno HICGeno Analyst Link WTCCC WTCCC Access committee HIC Access committee

24. ... Example: National - SFHS Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee FamilyPhenoGeno Recipient Link Anonymised/ Anonymous data Mappings HEPAC

25. Considerations  Ethics  Data Protection Law  Contractual arrangements  Validity  Specification  Authorisation  Regulatory compliance  Confidentiality framework  Security  Shared syntax  Shared semantics  Shared linkage standards  Data flow models  Recipient facilities  Disclosure control  Provenance  Business models  Political models Local, national, international Are all different! Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee

26. Growth of Record-Linkage Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Local International Pragmatic Formal: modelling/standard National

27. Scottish Health Informatics Programme Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee An ambitious, Scotland-wide research platform for the collation, management, dissemination and analysis of Electronic Patient Records (EPRs). Partners:  University of Dundee  University of Edinburgh  University of Glasgow  University of ST. Andrews  Information Services of NHS Scotland (ISD)

28. Scottish Health Informatics Programme Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Aims:  Provide access to an exciting new national research facility, firmly embedded within and supported by NHS Scotland, providing the basis for numerous future studies using EPRs.  Create a research portal for EPRs already held by NHS Scotland that will provide rapid, secure, access to the type of data that clinical scientists require.  Develop and evaluate systems that work across institutional boundaries to allow linkage between large, federated, third party research datasets and the NHS research portal

29. Example: European - TRANSFoRm Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee Generic, European-wide research platform based in primary care and validated with two use cases:  GWAS: genetic complications of diabetes  RCT: QoL/outcomes in GORD 5-year formal approach to development and implementation:  Modelling of use cases and clinical research  Requirements analysis of data sources (clinical and genetic)  Comparability of data sources  Data access and interchange model  Ontology-driven integration and interoperability  Vocabulary services  Meta-data repository  Regulatory, security, confidentiality and provenance frameworks All standards-based.

30. Multilevel collaborative platforms Linking Diabetes Medical Records to other sources Mark McGilchrist Senior Research Fellow University of Dundee m.m.mcgilchrist@dundee.ac.uk Record-Linkage, BIRO Academy 2 Copyright 2011 M. McGilchrist, University of Dundee