Trends in Electronic Health Records
(EHRs) and the importance of Quality
Labeling in the context of the use of
EHRs in Care and Research
Prof. Dr. Georges De Moor
University of Gent, Belgium
EuroRec President
European Institute for Health Records (EuroRec)
Georges De Moor, MD, PhD
Moscow– 19 April 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”
•
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(Kalra D, Editor. Requirements for an electronic health record reference architecture.
ISO 18308. International Organisation for Standardisation, Geneva, 2011)
Georges De Moor, MD, PhD
Moscow– 19 April 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 several European
languages. The EuroRec Use Tools help users to handle this
resource.
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
EHRs: Trends…
• Patient-centered (gatekeeper?) and longitudinal (life-long) records
• Multi-disciplinary / multi-professional
• Transmural, distributed and virtual
• Structured and coded (cf. semantic interoperability)
• More metadata and coding in EHRs at granular level!
• Intelligent (cf. decision support,clinical pathways, VPH…)
• Personalised (to populate models with specific data from an individual patient)
• Predictive (use of predictive models and personal genetic data)
• More sensitive content (! privacy protection)
• Integrative
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Georges De Moor, MD, PhD
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Moscow– 19 April 2012
Towards Integrated Health
Biosensors
Genomic data
Environmental
Data
Phenomic data
Integrated Health Records
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Significant changes 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 encourages
people to use web services more often (in Q2 2011: already more than 1 million
Apps within the group of bigger stores)
• Will the rise of the Cloud create an explosion of consumer focused web services,
e.g. cloud based Personal Health Records to be directly adopted by consumers?
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
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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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Integrated Electronic Health Record
Clinical trials,
functional genomics,
public health databases
EHR repositories
Decision support,
knowledge management
and analysis components
Integrating
information
Whittington
Hospital
Centring services
John Smith
DoB: 12.5.46
on citizens
Healthcare Record
Personnel registers,
security services
Clinical devices,
instruments
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Georges De Moor, MD, PhD
Creating and using
knowledge
Mobile devices
Clinical
applications
Social computing:
forums, wikis and blogs
Moscow– 19 April 2012
PHRs, EHRs and the Re-use of EHR data
Patient
Clinicians & others
TRUST
EHR (EMR, EPR…)
PHR
Privacy Enhancing Techniques
Clinical Trials
& Research
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Billing
Safety and
Adverse
Event
Registers
Georges De Moor, MD, PhD
Marketing
Knowledge
Mgmt
Platforms
Decision
Support
Systems
Healthcare
Management
Moscow– 19 April 2012
Health information flows
needing interoperability
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
Public health
Health care
management
Clinical audit
Long-term shared
care (regional
national, global)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
EHRs certification: why?
• Care Providers: assurance and trust in quality and functionality of
EHRs and other eHealth solutions
• Vendors: competitive advantage, improve market access, defragment market
• Health Care Authorities: high quality systems offer amongst other
better inter-operability which is important for the continuity in the
care.
• Patients: better quality of records thus more safety, better privacy…
in their care
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The EuroRec Repository
Current status (1)
• At present, the EuroRec Repository contains +/- 1700 Criteria/ Fine Grained
Statements with + 15000 index links. The majority of the Fine Grained
Statements are referencing one or more Source Statements (at the moment
+/- 4000 links exist) and can be grouped into Good Practice Requirements.
The current database contains +/- 200 of these Good Practice Requirements.
• A large number of these criteria have been translated into 19 European
languages (Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, French,
German, Greek, Hungarian, Italian, Polish, Portuguese, Romanian, Serbian,
Slovakian, Slovenian, Spanish and Lithuanian) and other languages (e.g.
Russian) as well.
EuroRec Seals 1 and 2
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The EuroRec Repository
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The EuroRec Use Tools
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The EHR-Q-TN (Thematic Network)
Progress:
Validation of existing quality criteria and tools
Further translation of existing quality criteria
Market analysis resulting in an updated inventory of EHR system vendors
in Europe (843) and an exhaustive contact list of Health authorities and policy makers
Expanding the harmonisation of certification via the “Seal 2” criteria
Roadmap for the future
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
EHR Quality Labelling & Certification
Current status in US and Europe (1)
US: ARRA and HITECH act and Meaningful use of Certified EHR
technology approach. Currently: 6 Authorised Testing and
Certification bodies
Europe: national certification schemes in place in 10 member states
and starting harmonisation of certification through the EuroRec
“Seals 1 and 2” now in 27 countries (cf. the EHR‐Q‐TN project).
Remark: there is an 80‐90 % commonality between the functional
certification criteria of Europe and of the US… but regulations differ!
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
EHR Quality Labelling & Certification
Current status in US and Europe (2)
• The launch of the permanent program for Certification of Electronic Health
Records was delayed in the US until mid-2012.
• ONC recently released new rules for EHR certification:
“WASHINGTON – The Office of the National Coordinator for Health IT
released Feb. 24 its proposed rule for the certification of electronic health
record systems”
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
EuroRec’s EU funded research projects (1)
Past Projects
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Project acronym
FP
Timeline
Topic
MediRec
FP3
1994-1995
Declaration (Recom. 9)
ProRec
FP4
1996-1998
Creation of first ProRec centres
Widenet
FP5
2000-2003
Creation of EuroRec
Q-Rec
FP6
2005-2008
Creation of Repository & Tools
RIDE
FP6
2006-2007
Roadmap for Interoperability
EHR-Implement
FP6
2007-2010
National Policies for EHR Implementation in the
European area: social and organisational issues
Georges De Moor, MD, PhD
Moscow– 19 April 2012
EuroRec’s EU funded research projects (2)
Other Projects
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Project acronym
FP
Timeline
Topic
EHR-QTN
FP7
2009-2012
ARGOS
FP7
2010-2011
HITCH
FP7
2010-2011
EHR4CR
IMI call 2
2011-2015
Thematic Network on Quality Labelling and Certification
of EHR Systems
Transatlantic Observatory for Meeting Global Health
Policy Challenges through ICT-Enabled Solutions
Healthcare Interoperability Testing and Conformance
Harmonisation
Electronic Health Records for Clinical Research
INBIOMEDvision
FP7
2011-2013
eHealth Innovation
FP7
2011-2013
Georges De Moor, MD, PhD
Promoting and Monitoring Biomedical Informatics in
Europe
eHealth Innovation – Scaling up eHealth facilitated
personalized health services: Developing a European
roadmap for sustained eHealth Innovation
Moscow– 19 April 2012
EuroRec’s EU funded research projects (3)
Starting Projects
Project acronym
FP
Topic
EURECA
FP7
Enabling information re-use by linking clinical research and care
SALUS
FP7
SemanticHealthNet
FP7
Scalable, standard based interoperability framework for sustainable
proactive post market safety studies
Network of Excellence on semantic interoperability and European
health infostructure
Prospects (3 in the pipeline):
…EUCLID, RD-CODE, Antilope
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Overview of the EHR4CR project
Electronic Health Record systems for
Clinical Research
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Electronic Health Records for
Clinical Research
• The IMI EHR4CR project runs over 4 years (2011-2014) with a budget
of +16 million € (EuroRec acts as Managing Entity):
– 10 Pharmaceutical Companies (members of EFPIA)
– 22 Public Partners (Academia, Hospitals and SMEs)
– 5 Subcontractors
• 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.
• Electronic Health Record (EHR) data offer large opportunities for the
advancement of medical research, the improvement of healthcare, and
the enhancement of patient safety.
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Partners
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Georges De Moor, MD, PhD
Moscow– 19 April 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)
– Pilots for validating the solutions
– The EHR4CR Business Model, for sustainability
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The EHR4CR Scenarios
•
•
•
•
Protocol feasibility
Patient recruitment
EHR-EDC integration
Pharmaco-vigilance
• across different therapeutic areas (oncology, inflammatory diseases,
neuroscience, diabetes, cardiovascular diseases etc.)
• across several countries (under different legal frameworks)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Business benefits
• 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. hospitals).
• The EHR4CR approach will thus also enable research and
clinical trials to be delivered more cost effectively.
• Both vendors of certified products and hospitals (source
data) that will be accredited will have a competitive
advantage.
• The EHR4CR business model for re-using EHR data in
research aims at offering benefits for all stakeholders and
strengthen the collaboration amongst all the partners in
research.
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Georges De Moor, MD, PhD
Moscow– 19 April 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 is continuing research on best practice for EHRs to be
used for research
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Accelerating and leveraging
knowledge discovery
• Firstly, we need to accelerate the discovery of new knowledge from large
populations of existing health records
• EHRs can provide population prevalence data and fine grained co-morbidity
data to optimise a research protocol, and help identify candidates to recruit
– almost half of all Pharma Phase III trial delays are due to recruitment
problems
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Example clinical questions
• Find the age and gender of patients who have been diagnosed with Hodgkin's
disease, where the initial diagnosis occurred between the ages 50 and 70
inclusive
• What is the percentage of patients diagnosed with primary breast cancer in
the age range 30 to 70 who were surgically treated and had post operative
haematoma/seroma?
• What percentage of patients with primary breast cancer who relapsed had the
relapse within 5 years of surgery?
• What is the average survival of patients with Chronic Myeloid Leukaemia
(CML) and both with and without splenomegaly at diagnosis?
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The two way translational challenge
• The bio-informatics research communities need to understand better the
kinds of diverse inputs that different professionals and specialities 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 modelling 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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Georges De Moor, MD, PhD
Moscow– 19 April 2012
ARGOS book: editor Georges J.E. De Moor
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
Records in the US and Europe
• Semantic interoperability
• Modelling 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
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Drivers for “semantic” interoperability
• The adoption, use and interoperability of Electronic Health Records has
become a major focus of European and US eHealth
policies, strategies and investments
• Drivers for Integrated EHRs and Semantic Interoperability are:
–
–
–
–
–
–
–
–
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Manage increasingly complex clinical (multi-professional) care
Let interact multiple locations of care delivery
Deliver evidence based health care
Need for intelligent decision support in medicine
Better exploit biomedical research
Improve safety and cost effectiveness of health care
Enrich population health management and prevention
Empower and involve citizens
Georges De Moor, MD, PhD
Moscow– 19 April 2012
Semantic Interoperability (S.I.) (ctd)
S.I. requires widespread and dependable access to published and
maintained collections of coherent and quality assured semantic
resources: “the detailed clinical models or clinical archetypes”.
Clinical archetypes are a formal, rigorous and standardised (interoperable)
specification for an agreed consensus or best practice representation of
clinical data structures (within an electronic health record). They provide a
standardised way of specifying EHR clinical data hierarchies and the kinds
of data values that may be stored within each kind of entry. An archetype
defines (or constrains) relationships between data values within an EHR
data structure, expressed as algorithms, formulae or rules.
(ISO/EN13606 Definition of Archetype)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Semantic Interoperability (S.I.) (ctd.)
New generation personalised medicine underpinned by ‘-omics sciences’
and translational research needs to integrate data from multiple EHR
systems with data from fundamental biomedical research, clinical and
public health research and clinical trials.
Clinical data that are shared, exchanged and linked to new
knowledge need to be formally represented to become machine processable.
This is more than just adopting existing standards or profiles, it is
“mapping clinical content to a commonly understood meaning”.
! Remark: one can exchange in a perfectly standardised message complete
meaningless information, hence the importance of ‘content’- related quality
criteria (clinically meaningful) and of “true” semantic interoperability.
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Semantic Interoperability
Resource priorities
•
•
•
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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
– using practical exemplars in heart failure and coronary prevention
– involving major global SDOs, industry and patients
Georges De Moor, MD, PhD
Moscow– 19 April 2012
Semantic Interoperability (S.I.) (ctd)
S.I. requires widespread and dependable access to archetypes :
Hence the need of archetypes and templates mapped to EHR‐
interoperability standards and bound to well specified multi‐lingual
value sets, indexed and associated with each other via ontologies
and referenced from modular care pathway components.
(Multilingual: not only to support cross-border care but also to
enable cross-border aggregation of research data!)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Interoperability standards relevant to the EHR
Business requirements
ISO 18308 EHR Architecture Requirements
HL7 EHR Functional Model
ISO EN 13940 Systems for Continuity of Care
ISO EN 12967-1 HISA Enterprise Viewpoint
Information models
EHR system reference model openEHR
EHR interoperability Reference Model ISO/EN 13606-1
HL7 Clinical Document Architecture
Clinical content model representation openEHR ISO/EN 13606-2
archetypes
ISO 21090 Healthcare Datatypes
ISO EN 12967-2 HISA Information Viewpoint
Computational services
EHR Communication Interface Specification ISO/EN 13606-5
ISO EN 12967-3 HISA Computational Viewpoint
HL7 SOA Retrieve, Locate, and Update Service DSTU
Security
EHR Communication Security ISO/EN 13606-4
ISO 22600 Privilege Management and Access Control
ISO 14265 Classification of Purposes of Use of Personal Health
Information
Clinical knowledge
Terminologies: SNOMED CT, etc.
Clinical data structures: Archetypes etc.
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Requirements the EHR must meet: ISO 18308
The EHR shall preserve any explicitly defined
relationships between different parts of the record,
such as links between treatments and subsequent
complications and outcomes.
The EHR shall preserve the original data values within
an EHR entry including code systems and
measurement units used at the time the data were
originally committed to an EHR system.
The EHR shall be able to include the values of
reference ranges used to interpret particular data
values.
The EHR shall be able to represent or reference the
calculations, and/or formula(e) by which data have
been derived.
The EHR architecture shall enable the retrieval of part
or all of the information in the EHR that was present
at any particular historic date and time.
The EHR shall enable the maintenance of an audit
trail of the creation of, amendment of, and access to
health record entries.
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Contextual building blocks of the EHR
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EHR Extract
Part or all of the electronic health record
for one person, being communicated
Folders
High-level organisation of the EHR
e.g. per episode, per clinical speciality
Compositions
Set of entries comprising a clinical care
session or document e.g. test result, letter
Sections
Headings reflecting the flow of information
gathering, or organising data for readability
Entries
Clinical “statements” about Observations,
Evaluations, and Instructions
Clusters
Multipart entries, tables,time series,
e.g. test batteries, blood pressure, blood count
Elements
Element entries: leaf nodes with values
e.g. reason for encounter, body weight
Data values
Date types for instance values
e.g. coded terms, measurements with units
Georges De Moor, MD, PhD
Moscow– 19 April 2012
ISO EN 13606-1 Reference Model
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
EHR and knowledge integration
Research
Epidemiology
Evidence on
treatment
effectiveness
Medical Knowledge
Pathological
processes
Bio-sciences
Diseases and
treatments
Clinical outcomes
Clinical audit
Care plans
Health Records
Descriptions,
Prompts,
findings,
reminders
intentions
Professionalism and
accountability
These areas need to be represented consistently
to deliver meaningful and safe interoperability
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Clinical data standards are needed!
• To formally model the clinical domain concepts
– e.g. “smoking history”, “discharge summary”, “fundoscopy”
• To encapsulate evidence and professional consensus on how clinical data
should be represented
– published and shared within a clinical community, or globally
– imported by vendors into EHR system data dictionaries
• To support consistent data capture, adherence to guidelines
• To enable use of longitudinal EHRs for individuals and populations
• To define a systematic EHR target for queries: for decision support and for
research
Archetypes (openEHR and ISO 13606-2)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Example archetype for adverse reaction
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
record structure
and context
architecture
identifiers for people
policy models
structural roles
functional roles
purposes of use
care settings
pseudonymisation
Consistent
representation,
Rich EHR
access
and interpretation
interoperability
clinical terminology systems
terminology sub-sets
value sets and micro-vocabularies
term selection constraints
post-co-ordination
terminology binding to archetypes
semantic context model
categorial structures
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Georges De Moor, MD, PhD
workflow
guidelines
care pathways
continuity of care
terminology
systems
privacy
EHR reference model
data types
near-patient device interoperability
archetypes
templates
Moscow– 19 April 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
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Semantic Interoperability (ctd)
Longer term:
In the longer term a governance organisation needs to be nominated
• to support, oversee and quality manage the future development
of semantic interoperability resources (clinical models) for health
• and to develop an action plan for future research and
educational investments.
A role for
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
Past, ongoing and future EU efforts
• Deployment of certification at Pan-European level (EHR-Q-TN)
• Strenghtening collaboration with others (HITCH, RD-CODE? and next CIP
Thematic Network project ?)
• Continued international cooperation with e.g. the US (ARGOS and EU-US
Stewardship event ?)
• Further development of the certification criteria for the re-use of EHR data
for clinical research (EHR4CR, EURECA and EUCLID?)
• Personalised Medicine and mobile device issues: integration of biomedical
data, PHRs and other issues (INBIOMEDvision and eHealth Innovation)
• More focus on semantics, on clinicians’ involvement and on EHR-contentrelated certification criteria (SemanticHealthNet, SALUS, Eureca)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
The Future
• EuroRec will continue to raise awareness at the pan-European level, in particular
towards Healthcare Authorities or Policy Makers (cf. the BELGRADE DECLARATION
and other initiatives…) and industry
• EuroRec will strengthen its network via further EC funded projects (and by
involving its ProRec centers through new mechanisms ) (cf. also EuroRec’s
complete market inventory and roadmap)
• Eurorec believes in new technologies and new paradigms (existing legacy
systems are often a handicap)
• Europe needs to organise in the longer run structural funding for EHR and
eHealth related Certification activities (EuroRec should play for the medical
software a role analogous to the one played by the European Medicines Agency
(EMA) for new medicines (cf. safety etc.)
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Georges De Moor, MD, PhD
Moscow– 19 April 2012
THANK YOU!
Prof. Dr. Georges J.E. De Moor
‐ georges.demoor@ugent.be
‐ http://www.eurorec.org
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Georges De Moor, MD, PhD
Moscow– 19 April 2012