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