Trustworthy Reuse of Health Data “Perspective from the EU”

Report
Georges De Moor, MD, PhD
1
Brussels, 14-15 May 2012
Trustworthy Reuse of Health Data
“Perspective from the EU”
Prof. Dr. Georges De Moor,
Ghent University, Belgium
EuroRec President
European Institute for Health Records
Georges De Moor, MD, PhD
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Brussels, 14-15 May 2012
The European Continent and the E.U.
Only “European” part of Russia and Turkey included
From Wikipedia, the free encyclopedia
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Brussels, 14-15 May 2012
Europe
Figures for the population of Europe vary according to which definition of European
boundaries is used. According to the United Nations, the population within the standard
physical geographical boundaries is about 720 million using the definition which has been
used for centuries. The European Union (E.U.) population is about 500 million.
There are 27 E.U.- Member States and each is responsible for its own National Health
System (cf. subsidiarity principle). There is no central Health Authority in Europe.
17 countries have adopted the Euro as currency: they constitute together the Eurozone.
The languages of the European Union are languages used by people within the member
states of the European Union. They include the 23 official languages of the European Union
along with a range of others.
The most widely spoken mother tongue in the EU is German, while 51% of adults can
understand English.
The eHealth market is highly fragmented (e.g. over 900 EHR system vendors).
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Brussels, 14-15 May 2012
Back to Confucius…
“… is truth best apprehended in
terms of many little things or in
terms of one big thing? …”
551 BC - 479 BC
(Ben T. Williams, Computer Aids to Clinical Decisions, CRC Press, 1982)
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Brussels, 14-15 May 2012
Accelerating and Leveraging Knowledge Discovery
“… many little things …”
Real fine-grained Patient Level Data
(from representative samples
of longitudinal EHRs)
interpretation
Information
E.B.M.
interpretation
Knowledge
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Brussels, 14-15 May 2012
E.B.M.
E. ? B. M.
Data
E xplanation Based Medicine
Patient
Information
E conomy Based Medicine
Health Authorities
(cost containment)
Knowledge
E vidence Based Medicine
Clinicians (treatment protocols,
care pathways,
clinical guidelines,
decision support systems,
¨VPH” & other models)
Georges De Moor, MD, PhD
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(personalised medicine)
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A Caricature
Data
Explanations
Patient Care
LOCAL/
REGIONAL
Information
Economy
Health Reforms
NATIONAL
Knowledge
Evidence
Science
GLOBAL
(Wisdom)
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Brussels, 14-15 May 2012
Stakeholders (cf. perceived benefits)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Patients
Clinicians (in Primary, Secondary and Tertiary Care settings)
Clinical Investigators
Contract Research Organisations (CROs)
Pharmaceutical Industry
Hospital Administrators
Academia
EHR Systems Vendors
Trusted Third Parties (TTPs) and Trusted Services Providers (TSPs)
Health Authorities
Health Care Planners
Regulators
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Brussels, 14-15 May 2012
Stakeholders and Forces in Place
Who can influence? … the one who …
pays / invests ?
regulates ?
knows?
(and many other: e.g. who owns,
who…?)
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EHRs and some examples of data Re-use
Patient
Clinicians
TRUST
(PHR)
EMR
Privacy Enhancing Techniques
Billing
Clinical Trials
Other Research
… Adverse
Event
Registries
Knowledge
Bases &
Models (VPH)
Georges De Moor, MD, PhD
Marketing
Decision
Support
Systems
11
Public
Health
Management
Brussels, 14-15 May 2012
Trustworthy Reuse of Health Data
“Perspective from the EU”
Focus of this presentation on:
the EHRs as data sources
and
the reuse of data for Research
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Brussels, 14-15 May 2012
What is an Electronic Health Record?
• “One or more repositories, physically or virtually integrated, of information in
computer processable form, relevant to the wellness, health and health care
of an individual, capable of being stored and communicated securely and of
being accessible by multiple authorised users, represented according to a
standardised or commonly agreed logical information model. Its primary
purpose is the support of life-long, effective, high quality and safe integrated
health care”
•
(Kalra D. Editor. Requirements for an electronic health record reference architecture.
ISO 18308. International Organisation for Standardisation, Geneva, 2011)
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Brussels, 14-15 May 2012
EuroRec
• The EuroRec Institute (EuroRec) is a European
independent not-for-profit organisation, whose main
purpose is promoting the use of high quality Electronic
Health Record systems (EHRs) in Europe.
• EuroRec is overarching a permanent network of national
ProRec centres and provides services to industry
(developers and vendors), healthcare systems and
providers (buyers), policy makers and patients.
• EuroRec produced and maintains a substantial resource
with ± 1700 functional quality criteria for EHR-systems,
categorised, indexed and translated in 19 European
languages. The EuroRec Use Tools help users to handle
this resource.
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Brussels, 14-15 May 2012
EHRs: Trends…
• Patient-centered (gatekeeper?) and longitudinal (life-long) records
• Multi-disciplinary / multi-professional/ participative
• Transmural, distributed and virtual (incl. cloud computing and apps)
• Structured and coded (cf. semantic interoperability)
• More metadata (tagging and coding!) in EHRs at granular level
• Intelligent (cf. decision support modules, clinical pathways, VPH models…)
• Personalised (the specific data from individual patients used in models)
• Preventive
• Predictive (use of personal genetic data in predictive models )
• More sensitive content (privacy protection!)
• Integrative
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Brussels, 14-15 May 2012
Towards Integrated Health
Biosensors
Genomic data
Environmental
Data
Phenomic data
Integrated Health Records
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Brussels, 14-15 May 2012
The growing role of EHRs in
Translational Bioinformatics
• The implementation of EHRs in inpatient and outpatient settings is
expanding rapidly, providing large patient-based longitudinal data sets.
• In parallel genotyping technology is also advancing quickly.
• There is therefore an increasing potential to bring functional genomics and
genetics data to the “bedside”.
• The potential impact is very large in terms of personalised medicine,
pharmacogenomics, redefining diseases classification and understanding
drug repositioning.
EMBL-EBI Industry Programme Workshop (28th to 29th February 2012).
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Brussels, 14-15 May 2012
A Two Way Translational Challenge
• The bio-informatics research communities need to understand better the
kinds of diverse inputs that different professionals and specialties have to
interpret, the kinds and quality and time spans of data that need to be cointerpreted, the nature and criticality of the decisions being made, and how
accurate the modeling projections would have to be in order to be useful.
• Reciprocally, clinical communities need to understand better what future
opportunities and solutions are in the pipeline, how these might impact on
care decisions, any adaptations to physical and virtual team-working that
should be anticipated and prepared for.
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Brussels, 14-15 May 2012
Significant changes in ICT to be anticipated…
• Everything driven by “BIG” data (genomics, proteomics, metabolomics…):
processes in healthcare are data intensive!
• In 2008: 1bn PCs (today: shift also from personal to personalised computing!)
• In 2020: 10 bn mobile connected devices …Mobile computing will further
encourage people to use web services more often (in Q4 2011: already more than
1 million Apps from within the group of bigger stores, incl. approx. 20000 are
health related applications)
• Will the rise of the Cloud create an explosion of consumer focused web services,
also including cloud based Personal Health Records to be directly adopted by
consumers?
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Cloud Computing
Cloud computing is no longer
a buzz term but a reality …
With the opportunity for on–
demand Software-as-aservice, migrating IT services
to the clouds is an
opportunity that is hard to
ignore…
But cloud computing on itself
will not solve the real
problems in eHealth
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Brussels, 14-15 May 2012
Recent & Ongoing Projects with
Involvement of EuroRec
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Unlocking the Data: many E.U.-Projects
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Brussels, 14-15 May 2012
The EHR4CR Project
A joint undertaking between Academia & Industry
Overview of the EHR4CR project
Electronic Health Record systems for
Clinical Research
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Brussels, 14-15 May 2012
Electronic Health Records for Clinical Research
• The IMI EHR4CR project runs over 4 years (2011-2014) with a budget of +16
million € :
– 10 Pharmaceutical Companies (members of EFPIA)
– 22 Public Partners (Academia, Hospitals and SMEs)
– 5 Subcontractors
– Mats Sundgren (EHR4CR Coordinator, AstraZeneca )
– Georges De Moor (EHR4CR Managing Entity, EuroRec)
• The EHRCR project is - to date - one of the largest public-private partnerships
aiming at providing adaptable, reusable and scalable solutions (tools and
services) for reusing data from Electronic Health Record systems for Clinical
Research.
• Europe is uniquely placed for large scale reuse of health data: the widespread
adoption of eHealth, the variety of health environments and the diversity in its
population offer the opportunity to exploit a wealth of “real world” data that
will help better understanding more complex health problems (e.g. comorbidity in ageing population etc.)
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Partners
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Brussels, 14-15 May 2012
Project Objectives
• To promote the wide scale re-use of EHRs to accelerate regulated
clinical trials, across Europe
• EHR4CR will produce:
– A requirements specification
• for EHR systems to support clinical research
• for integrating information across hospitals and countries
– The EHR4CR Technical Platform (tools and services)
– The EHR4CR Business Model, for sustainability
– Pilots for validating the solutions (i.e. the TP and the BM)
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Brussels, 14-15 May 2012
The
Scenarios
A joint undertaking between Academia & Industry
•
•
•
•
Clinical Trial Feasibility (= the year 1 focus)
Patient Recruitment (*)
Clinical Trial Execution
Drug Surveillance Reporting
• across different therapeutic areas (oncology, inflammatory diseases,
neuroscience, diabetes, cardiovascular diseases etc.)
• across several countries (under different legal frameworks)
– (*) half of all Pharma Phase III trial delays are due to recruitment problems!
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Brussels, 14-15 May 2012
The
Business Model
A joint undertaking between Academia & Industry
Specify in detail the product and service offering;
Include an impact analysis on multiple stakeholders;
Deliver a self-sustaining economic model incl. sensitivity analysis;
Define governance arrangements for the platform services;
Define operating procedures and Trusted Third Party service
requirements;
Identify the value proposition and incentives for each of the key
players and stakeholders impacted by EHR4CR;
Define accreditation and certification plans for EHR systems capable
of interfacing with the platform;
Define a roadmap for pan-European adoption and for funding future
developments.
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Brussels, 14-15 May 2012
The
Technical Platform
A joint undertaking between Academia & Industry
Support the feasibility, exploration, design and execution of
clinical studies and long-term surveillance of patient
populations;
Enable trial eligibility and recruitment criteria to be
expressed in ways that permit searching for relevant patients
across distributed EHR systems, and to confidentially initiate
participation requests via the patients’ authorised clinicians;
Provide harmonised access to multiple heterogeneous and
distributed EHR systems and integration with existing clinical
trials infrastructure products (e.g. EDC systems);
Induce improvements of data quality to enable routine
clinical data to contribute to clinical trials, and importantly
vice versa, thereby reducing redundant data capture.
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Brussels, 14-15 May 2012
The
First Year Results (1)
A joint undertaking between Academia & Industry
Platform Architecture Design
Georges De Moor, MD, PhD
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Brussels, 14-15 May 2012
The Semantic Interoperability Issue
• A Semantic Interoperability Layer is part of EHR4CR Platform Architecture
• Semantic Interoperability and Data Quality Markers:
-
in CARE: Faithfulness (cf. biases in coding, window dressing for
reimbursement)
-
in RESEARCH: Faithfulness and Consistency
• Importance/Specificity of Context (depending on the context in which data
are captured, the meaning and the value of the data may vary…)
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Brussels, 14-15 May 2012
Health Information Flows needing Interoperability
(Kalra D., UCL, UK)
Wellness
Fitness
Complementary health
rapid bench to bed translation / personalised care
Teaching
Research
Clinical trials
Citizen in the
community
Point of care
delivery
explicit consent
Social care
Occupational health
School health
real-time knowledge directed care
implied consent
Disease registries
Screening recall
systems
Continuing care
(within the institution)
Education
Research
Epidemiology
Data mining
de-identified
implied consent
+/- consent
Long-term shared
care (regional national,
global)
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Brussels, 14-15 May 2012
Public health
Health care
management
Clinical audit
Semantic Interoperability Resource Priorities
•
•
•
Widespread and dependable access to maintained collections of coherent and
quality-assured semantic resources
– clinical models, such as archetypes and templates
– rules for decision making and monitoring
– workflow logic
which are
– mapped to EHR interoperability standards
– bound to well specified multi-lingual terminology value sets
– indexed and correlated with each other via ontologies
– referenced from modular (re-usable) care pathway components
SemanticHealthNet will establish good practices in
developing such resources
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Brussels, 14-15 May 2012
ARGOS semantic interoperability
recommendations
Nine strategic actions that now need to be championed,
as a global mission
1. Establish good practice
2. Scale up semantic resource development
3. Support translations
4. Track key technologies
5. Align and harmonise standardisation efforts
6. Support Education
7. Assure quality
8. Design for sustainability
9. Strengthen leadership and governance
(10. Support Research)
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Book (IOS Press: editor Georges J.E. De Moor)
A TRANS ATLANTIC PROJECT
Foreword by Herman Van Rompuy‐ E. Council President
Memorandum of Understanding signed by:
• Neelie Kroes - Eur. Commission Vice-President
• Kathleen Sebelius – Secretary of HHS
Policy briefs for Transatlantic cooperation
• The current status of Certification of Electronic
Health Records in the US and Europe
• Semantic interoperability
• Modeling and simulation of human physiology and
diseases with a focus on the Virtual Physiological Human
• Policy Needs and Options for a Common Approach towards
Measuring Adoption, Usage and Benefits of eHealth
• eHealth Informatics Workforce challenges
A NEXT TRANS ATLANTIC PROJECT? … on reuse of Health data for Research?
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Use of the EHR4CR Platform
Global
National
Regional
Local
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Personal
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Platform: Use (and Migration?)
(within
2 years?)
Global
National
Regional
Local
Georges De Moor, MD, PhD
Personal
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On-demandsoftware as- a- service
Brussels, 14-15 May 2012
The
First Year Results (2)
A joint undertaking between Academia & Industry
Year 1 Focus: Protocol Feasibility (Scenario 1)
Through detailed engagement with protocol managers within Pharma and the
wider clinical research community, workflows were documented for
establishing the feasibility of a trial protocol (is a protocol viable? Fine tuning
the eligibility criteria to optimise trial design)
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Brussels, 14-15 May 2012
The
First Year Results (3)
A joint undertaking between Academia & Industry
A formal and validated Software Requirements Specification
Contains approx. 75 use cases, over 200 requirements, a first user
interface mock-up and a set of generic non-functional requirements.
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Brussels, 14-15 May 2012
The
First Year Results (4)
A joint undertaking between Academia & Industry
An Inventory of Pilot Site EHR data items
A top list of data elements has been identified (containing 81 EHR data elements)
resulting from comparing commonly used eligibility criteria by the EFPIA partners
with available data elements in the EHR/CDW and CDMS at the pilot sites.
- The current listing represents the first version of the data inventory.
- To validate and refine the data inventory a data export at all pilot sites has
been performed.
- This has delivered information on the availability of the data elements at
the sites.
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Brussels, 14-15 May 2012
The
First Year Results (5)
A joint undertaking between Academia & Industry
Business Modelling and Value Proposition
• Business Model Template
• SWOT Analysis Matrix
• PEST Analysis Matrix
(Dupont D. Data Mining International)
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Brussels, 14-15 May 2012
Accreditation and Certification
A joint undertaking between Academia & Industry
• Accreditation of Clinical Research Units (ECRIN) and
Certification of EHR systems (EuroRec) will accelerate the
adoption of a more harmonised approach throughout Europe
and serve as a powerful means for ensuring to the
pharmaceutical industry the reliability and trustworthiness of
the research partners (i.e. of the data providers, e.g. the
hospitals).
• Both the vendors of certified products and the accredited
hospitals (with source data) will have a competitive
advantage.
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Brussels, 14-15 May 2012
EuroRec profile for EHRs that are
compliant with Clinical Trials requirements
• Already in December 2009 EuroRec released a profile identifying the
functionalities required of an EHR system in order to be considered as a
reliable source of data for regulated clinical trials.
• Details of the profile, including information designed to support use, are
accessible from the EuroRec website. A sister profile has been endorsed by
Health Level Seven® (HL7®).
• As both the EuroRec and HL7 profiles draw upon the same standard
requirements for clinical trials, ”conforming to one” will mean, in principle
conformance to both.
• These requirements have contributed into a Work Item in ISO (TC/215), to
help shape a future International Standard.
• The EHR4CR Project will expand the set of quality criteria for EHRs to be used
for research…
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Brussels, 14-15 May 2012
The
First Year Results (7)
A joint undertaking between Academia & Industry
Other early deliverables …
• Overview of relevant IT standards
• An inventory of information and knowledge models
• An inventory of available and re-useable components meeting the
functional and non-functional requirements
• Requirements and specifications of the Security and Privacy Services
• Definition of EHR4CR Information Models
• Data acquisition specifications, concept for local interfaces
• Dissemination material
• …
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Brussels, 14-15 May 2012
The
First Year Results (6)
A joint undertaking between Academia & Industry
Publications
Business Strategy
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Brussels, 14-15 May 2012
Unlocking the Data: many E.U.-Projects
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Brussels, 14-15 May 2012
E.U.-Projects need to Converge !
Multiple Sources
EuroRec Annual Conference: “Convergence Workshop” (Basel, Nov. 8, 2012)
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Brussels, 14-15 May 2012
Privacy Enhancing Technologies
De-identification… pseudonymisation… sticky policies in EHRs…
Reconciling the concept of a “central anonymous database” with “nominative access”…
Nominative Data Realm
Doctor
(Dealing with
nominative patient
information)
On-the-fly
–Pseudonymisation
–Encryption
Pseudonymisation
server at TTP
Doctor
(Dealing with
nominative patient
information)
Pseudonymous Data Realm
Register
Pseudonymous Database
(at data warehouse)
}
Collective Records
Access
Research
Community
(Claerhout Brecht, Custodix NV, Belgium)
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Brussels, 14-15 May 2012
Privacy and Scientific Research
!!!
Restriction on access to available data is a major obstacle….
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End
THANK YOU!
Prof. Dr. Georges J.E. De Moor
[email protected]
http://www.eurorec.org
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Brussels, 14-15 May 2012

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