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

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

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

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

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?

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

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

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

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

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

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?

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

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

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

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’

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

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?...

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

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

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

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

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

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

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

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

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

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)

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

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.

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