Electronic Health Records for Clinical Research
BIG DATA EN SANTÈ
Professor Dipak KalraPresident of i~HD
Sources of Big Health Data
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Whi tti ngton
H ospi tal
Healthcare Record
John SmithDoB : 12.5.46
Genomic data Population registries,Clinical trials, BioBanks
Bio-sensors
Clinical applications
Care pathways, decision support, trends and alerts
Mobile devices
Environmental data
Social networks
Integrating information at scale
Creating and using knowledge
Centring services on citizens
Big Health Data: where are the opportunities?
▪ Rich and well integrated EHRs
▪ Increasing big data capability of hospitals/regions
▪ Increasing data capture by individuals & sensors▪ Genomics, proteomics, metabolomics...
▪ Advanced mathematical modellingProvide greater evidence of safety, outcomes and comparative effectiveness
Improve efficiency and reduce the cost of conducting clinical research
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Health care and clinical research both need to accelerate learning from health data
BUT: we need to better enable trustworthy access to combined health data from across Europe
Common challenges to the use of health data for person centred care, and the re-use of health data for clinical research
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InteroperabilityData security, privacy & ethics
Scalability and sustainabilityData quality
and utility
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Harmonised health information and standards
Solutions for better quality health data
Quality assessments, certification and audit
Value realisation from health data
Clinical Research needs Healthcare needs
Best practices in information governance
Best practices in learning from health data e.g. research, outcomes
Ensuring trust when reusing EHRs for research
▪ Compliance with data protection legislation, at a European level and across all European Member States
▪ Societally acceptable codes of good practice for governing many uses of health data
▪ Citizen support for public health and research uses of health data
Give confidence and reduce risk for those providing data for research use e.g. hospitals, GPs, patientsGive confidence and reduce risk for those performing the research, managing the data or sponsoring the research
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i~HD information governance (privacy assurance) enablers▪ Quality labelling criteria for big data research platforms, including components deployed
at hospitals, and in other data sources▪ Codes of Practice for feasibility studies and for remote data access and data sharing▪ Standard Operating Rules
▪ Legal requirements and their implementation through specific technical safeguards and specified duties, to ensure proper use of big data research platforms
▪ Standard Operating Procedures▪ Access Controls, Incident Management, Audit & Monitoring, Study Management, Organisation
Management
▪ Staff competence checklist and training resources about data management and privacy protection▪ for hospital staff, pharma and academic research staff, for platform service providers
▪ i~HD Information Governance Board7
Personalised health…
Personalisedcare
Personalisedmedicine
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Clinical understanding of
disease
Molecular understanding of
disease
Patient preferences,
goals, situations
Health system capability and
capacity
Evidence Based Medicine
Innovative medicines
Patient stratification
Targeted therapy
New integrated care models
New reimbursement
models
Patient empowerment
(co-production of health)
…critically dependent on big health data
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