EHR Certification, Semantic Interoperability and the Link to Clinical Research. Moor G. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

1. Prof. Georges De Moor
President, EuroRec
University of Gent, Belgium
georges.demoor@UGent.be
ParallelMoor, MD, PhD,25, Wednesday 17 Barcelona, 17 March 2010
G. De Session EuroRec, Belgium March, 13:30-14:45

2. Parallel Session 25
EHR-Certification, Semantic Interoperability and the
Link to Clinical Research
Georges De Moor, EuroRec, Belgium
The Role of Clinicians in Clinical Concept Modelling
Dipak Kalra, Univ. College London, U.K.
Different Interoperability Needs for Clinical Research
Mats Sundgren, Astra Zeneca, Sweden
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

3. EuroRec
The EuroRec Institute is an independent not-for-profit
organisation established in 2003.
Its main mission is to promote - as a federation of national
ProRec centres (17 member countries and 6 new applicants)
- the use of high-quality Electronic Health Record systems
(EHRs) in Europe.
It therefore also supports certification by defining quality
criteria.
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

4. Quality Criteria
EuroRec has installed a central repository of +1600 indexed,
validated and translated quality criteria and has developed
tools that can be used to harmonise certification, product
documentation and procurement specification of EHR
systems.
Existing criteria and tools are now being validated and tested
in 25 Member States through an ongoing project: EHR-Q-TN.
Harmonisation of the certification will favour harmonisation of
products.
Cf. the EuroRec seal:
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

5. New Areas of Interest
- Semantic Interoperability (EHR-content, archetypes)
- Personal Health Records (and their interactions)
- Re-use of Electronic Health Record data for Research
- EHRs and Pre-emptive care: genetic data, individual risk
- EHRs and Cloud Computing
- Accreditation of Health IT Professionals
- Collaboration at global level: e.g. with the US
-…
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

6. Re-Use of data
Patient TRUST Clinician
PHR EHR (EMR, EPR…)
Privacy Enhancing Techniques
Clinical Trials
& Research Billing
Safety and Marketing
Adverse Knowledge
Event Decision Healthcare
Mgmt Support Management
Registers Platforms Systems
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

7. EHRs can support Research:
- Reduce redundant data capture
- Provide a better understanding of real patient populations
- Hypothesis testing
- Clinical trial feasibility checking
- Population screening
- Patient recruitment!
- Early detection of safety risks
- Treatment effectiveness and outcomes
- Post-marketing monitoring and long term surveillance
- Line extensions
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

8. The EHRCR Profile: a first step
The EHRCR profile is a profile of eClinical Forum endorsed by
EuroRec and HL7 with research-specific quality criteria in
order to certify EHR systems as suitable for use in the Clinical
Research environment.
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

9. Main obstacle
The ultimate stumbling block is the problem of semantic
interoperability. For a system to adequately integrate data
between clinical care and research it is necessary to be able
to go beyond the simple coding of data in each type of system
and to enhance the capture of meaning between
communicating systems.
A further critical challenge is that clinical meaning in an EHR
is not limited to the interpretation of individual terms but also
to the context in which those terms have been entered.
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

10. Response
EuroRec has - because of the problem of semantic
interoperability - a strategic interest in:
Promoting quality criteria not only related to EHR “business-”
functions but also related to “content”;
Validating clinical archetypes;
Involving the clinicians and their representative organisations
in its future projects and activities.
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

11. Other challenges
Data quality is another important challenge when dealing with
the re-use of EHR data for research: consistency, correctness
and completeness (data integrity) are important in research.
Privacy protection (cf. use of P.E.T.s and role of T.T.P.s).
Ethical issues (e.g. data mining prior to obtaining consent).
... all these requirements need to be reflected in the functional
and content-related characteristics of an EHR system in order
to be considered as a reliable source of data for e.g. regulated
clinical trials.
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

12. Synergies (1)
Accreditation schemes for research units (e.g. by ECRIN) and
certification of EHR vendor software for the re-use of data in
research (e.g. by EuroRec) can go hand in hand.
Together they will accelerate the adoption of a more
harmonised approach throughout Europe and serve as a
powerful means for ensuring reliability and trustworthiness of
the research partners (e.g. data providers) of the
pharmaceutical industry.
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

13. Synergies (2)
Accreditation and certification will also enable research and
trials to be delivered more cost effectively.
Vendors of certified products and data sources (e.g. hospitals)
that will be accredited, will get a competitive advantage.
New business models in research will also be beneficial for
“all” stakeholders and strengthen the collaboration amongst
the partners!
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

14. Thanks for listening!
http://www.eurorec.org
georges.demoor@ugent.be
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010

15. Parallel Session 25
EHR-Certification, Semantic Interoperability and the
Link to Clinical Research
Georges De Moor, EuroRec, Belgium
The Role of Clinicians in Clinical Concept Modelling
Dipak Kalra, Univ. College London, U.K.
Different Interoperability Needs for Clinical Research
Mats Sundgren, Astra Zeneca, Sweden
G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010