Melbourne Genomics Establishing data governance in clinical genomics Ian Pham Data Governance Lead
Melbourne Genomics Health Alliance 1
Melbourne Genomics Health Alliance 3
Focused on implementing genomics in practice Discovery Translational Implementation Routine Practice Research Research Research Institutes and Universities Australian Genomics Health Alliance Melbourne Genomics Health Alliance Clinical Genetics Services and Hospitals Melbourne Genomics Health Alliance 4
Approach STREAM 3: INNOVATION AND RAPID ADOPTION Develop and deploy systems to ensure patients STREAM 1: have access to cutting-edge, high quality genomic WORKFORCE DEVELOPMENT testing that is cost-effective. STREAM 5: NATIONAL AND Build the literacy, skills and INTERNATIONAL IMPACT confidence of the clinical and diagnostic workforce in Establish active relationships and participation in genomics, as relevant to each national and international initiatives with the aim professional role of disseminating, communicating and collaborating on the work of the Alliance and its implications. DISEASE FLAGSHIPS Flagships are the mechanism through which genomic sequencing is provided to patients with defined clinical conditions or indications. STREAM 2: ASSESSING THE VALUE Flagships will also be the means by which the OF GENOMICS workforce is developed, innovation is adopted, outcomes are evaluated and information systems Evaluate the place of genomics in health care trialled, and underpin the five streams. practice, by: (1) evaluating the process and outcomes of genomic tests in practice, and STREAM 4: ACCESS TO GENOMIC INFORMATION (2) establishing and applying a platform for Develop and implement a single set of standards, policies health service research, program evaluation, and procedures to support a common infrastructure for the economic evaluation and translational research management and use of genomic data by stakeholders in in the use of genomics in health care. Victoria. . . Melbourne Genomics Health Alliance 5
Flagships 2014-2015 2016-2018 2017-2019 AML Complex care Controlling superbugs Childhood syndromes Congenital deafness Bone marrow failure Focal epilepsy Dilated cardiomyopathy Complex neurological and neurodegenerative diseases Hereditary colorectal Immunology cancer Genetic kidney disease Advanced solid cancers Hereditary neuropathy Perinatal autopsy Advanced lymphoma (non-Hodgkin) Melbourne Genomics Health Alliance
Outcomes to date 465 patients tested (and growing) Prototype systems used in NATA labs Patient data available to all members Evidence of cost-effectiveness for MSAC application $25M funding from NHMRC for AGHA led from Victoria 4 peer-reviewed publications, plus 6 under review International collaborations Presentations at major conferences in Europe, North America, Asia, Australia Melbourne Genomics Health Alliance | IMG meeting slides – 12 December 2016 7
Access to Genomic Information Develop and implement a single set of standards, policies and procedures to support a common infrastructure for the management and use of genomic data by stakeholders in Victoria. Melbourne Genomics Health Alliance 8
Melbourne Genomics Health Alliance 9
GenoVic People Technology Policy & Process 7. Identity & Access Management 1. Standardised policy and 8. Clinical Tools 10. Patient Tools 9. Diagnostic Tools processes for data 5. Staff to management & access Electronic manage the Clinician Consent (data governance) Analysis Orders and data Knowledge (Pipeline) Tools Results Results Clinical Decision Support Curation Tools Education Tools 2. Standardised policy & processes for patient consent 11. Data Access Tools 6. Staff to manage the technology 12. Master 13. Genomic Data Repository 3. Standardised policy and Patient Index processes for test ordering & reporting 14. Data Integration LIMS 4. Change control process EMR Public variant (genomic (clinical data) curation data sequencing data) Melbourne Genomics Health Alliance 10
Data Governance
Vision ‘We will support improvement in patient outcomes and disease prevention for Victorians through secure, ethical use and sharing of reliable genomic information.’ Melbourne Genomics Health Alliance 12
Principles We all respect the rights of the patient and work collaboratively for better health outcomes through ensuring information is: • Secure • Used to its full extent • Fit-for-purpose • Valued Melbourne Genomics Health Alliance 13
Data Governance Framework Melbourne Genomics Health Alliance 14
Data Governance Framework – Implementation Plan GenoVic implementation Pre-implementation Foundation Release 1 • • Data Governance Framework Appointment of Data Release 2 Custodian/ Owner / Steward • Change Management • Data Sharing Agreement • • Communications Information Asset Register Release 3 • Data Access Policy • Information Asset Register • • Information Architecture Data Security Policy Procedures • Reference Group Priority data sets • New data sets • Information Architecture • Data classification • • Roles and responsibilities Procedures Accountability • Information Model • Expand metadata • Maturity Assessment • • Accountability Measurement • Data Quality Baseline • • Measurement Procedures • Data Quality Plan • Procedures • Data Quality Assessment Change Management Operationalise 15
Work to date
Melbourne Genomics Health Alliance 17
Data Governance Roles and Responsibilities DATA GOVERNANCE OWNER : The CEO (or similar) for the Alliance Member Organisation has authority and accountability. Is accountable to Delegates to DATA GOVERNANCE STEWARD , an Executive with responsibility with the organisation that has delegated authority. Provides strategic and policy direction Delegates to Is accountable to PROJECT CONTROL GROUP : Provides leadership, oversight and decision making for the management of information. ALLIANCE DATA CUSTODIAN : Defines and embraces the rules for the resource on behalf of the data steward Delegates to Provides feedback to Is accountable to DATA USER: Provides requirements and feedback Alliance Data Governance Lead : Implements the rules on behalf of Follows the rules when using the resource the custodian Melbourne Genomics Health Alliance 18
Information Architecture Reference Group • Alliance SME input • Member participation • Decision maker for information architecture • Review/endorsement of project deliverables • Monthly meetings Melbourne Genomics Health Alliance 19
Data Sharing Agreement • Supports strong ongoing collaboration • Contractually defines roles and data management processes • Ensures legal and ethical compliance • Enacts policies and procedures • Protects member IP and confidentiality Melbourne Genomics Health Alliance 20
Security Risk Assessment • Identify security risks • Risk analysis and rating • Risk treatment • Security control prioritisation Melbourne Genomics Health Alliance 21
What’s next?
• Security Information implementation architecture Data Data quality management framework (incl metadata) Melbourne Genomics Health Alliance 23
Security implementation • Security control implementation plan • Information security policy, sub-policies and procedures • Data access and release policy • Data classification Melbourne Genomics Health Alliance 24
Information Architecture • Information architecture standards and principles • Information asset register • Information architecture standard operating procedures • Information models Melbourne Genomics Health Alliance 25
Data Quality Framework • Data quality framework and policy • Data profiling assessment • Data quality plans • Baseline metrics • Data quality Standard operating procedure Melbourne Genomics Health Alliance 26
Data Management (includes metadata) • Data lifecycle requirements and framework • Identify and prioritise datasets and metadata definitions • Standard operating procedures • Metadata policy and standards • Training material developed and delivered Melbourne Genomics Health Alliance 27
Data & Technology Team Melbourne Genomics Health Alliance 28
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