Electronic Health Records for Clinical Research

THE EUROPEAN

INSTITUTE FOR

INNOVATION THR~UGH

HEALTH DATA

Dipak Kalra

President

Georges De Moor

Advisory Board Chair

Responding to a convergence of needs

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Need to remove the bottlenecks to accessing and combining

health data from diverse sources across Europe

Clinical Research needs

Optimise clinical research processes

•achieve faster and more accurate

patient identification

• identify sites that have access to the

most suitable patients

• reduce protocol amendments

Enhance access to Real World Data

•study the use of new medicines in real

populations

•conduct comparative effectiveness

studies

•monitor long term safety

•gather evidence for adaptive licensing

Healthcare needs

Improve quality and safety of care

•enhance care co-ordination

• increase adherence to clinical

evidence

• reduce medical errors and treatment

delays

Support patients in self-care and health

maintenance

Improve efficiency of care

•optimise care pathways to improve

outcomes

•collate evidence for public health

strategy and decision-making

The Learning Health System

3 Slide courtesy of Prof. Brendan Delaney

What is the Learning Health system?

The term Learning H ealth System (LH S) w as first adopted by the U S Institu t e of M edicine in 2007. It is now being

increasingly applied in the U S and around the w orld to describe cycles that include data collection , analytics to

generate clinical know ledge, and feedback of that know ledge in a form that directly influe nces the proces s of

care. Learning cycles m ay be local, nation al or global and the application of know ledge m ay take place via

decision support at the point of care, or through organization al or regional strategies.

The key difference betw een the LH S and traditio

n

al research and know ledge trans lation is that by being based

on rapid, scaleable and highly collaborative approaches to share data and know ledge in a com putable fashion,

the LH S drives m edicine to better, m ore evidence based and safer patien t care. A t the centre of the LH S is the

capacity of continu ous learning, w ith each stakeholder operating as a data provider, data consum er and in the

end as a learner enabling the pos s ibility for the continu ous im provem ent of diagnosis and treatm ent. The LH S

can increasingly autom ate currently laborious and time consum ing proces ses of data standardization , checking,

analysis, provenance, know ledge trans lation and quality imp r ovem ent.

A t present, m any highly relevant initiatives and projects are com partm entalized in initiatives such as BD 2K in the

U SA , Precision M edicine and D ecision Support. This conference aim s to bring together projects acros s Europe

and the U SA in looking at a com m onality of problem s, approaches and opportunitie

s

relevant to Learning H ealth

System s.

W e believe that by sharing these challenges internation ally w e can start to build a LH S that can achieve global

scale.

Brendan D elaney

D ipak Kalra

The Learning Health System

Research in A dvanced M edical

Inform atics and Telem atics

Common challenges to the use of health data for person-centred

care, and the reuse of health data for clinical research

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Interoperability Data security, privacy

& ethics Scalability and

sustainability Data quality

and utility

There is a need to combine and sustain the results of

European projects

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eHealth

Stakeholders Group

and to form partnerships

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i~HD is registered in Belgium

as a not-for-profit organisation

It is being financed by membership fees,

by providing services

such as certification and governance and through

specifically-funded projects and initiatives

The European Institute for Innovation through Health Data (i~HD)

has been formed as one of the key sustainable entities arising from the EHR4CR and

SemanticHealthNet projects, in collaboration with several other European projects and initiatives

supported by the European Commission

Guiding and catalysing the best, most efficient and trustworthy uses of health data and interoperability,

for optimising health and knowledge discovery

i~HD has been formed because a complementary,

neutral and not-for-profit organisation is needed

▪ to play a central role in governing and expanding a trustworthy health data-driven ecosystem including EHRs and clinical research platforms

▪ to promote the adoption of healthcare standards and of data quality, to enable more effective, safer and better integrated healthcare

▪ to act as a connector between health care and clinical research standards, that are presently developed in silos and impair the interoperability and pooling of health data for research

▪ to promote to society the importance of using health data for research, to improve efficiency through reduced duplications, delays, costs enhance speed and efficiency in clinical studies

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Harmonised health information and

standards

Solutions for better quality health

data, and legitimate uses of data

Quality assessments, certification

and audit Value Assessment programmes

Clinical Research needs Healthcare needs

Best practices in

information governance

Intelligence derived from health data

e.g. research, outcomes

Agenda

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Club des Cordeliers- French Revolution (1789-1794)

Assasinat de Marat dans son bain par

Jacques-Louis David (1793)

Couvent des Cordeliers, 1793 Localisation sur la carte de Paris

Agenda