EHR Certification, Semantic Interoperability and the Link to Clinical Research

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

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EHR Certification, Semantic Interoperability and the Link to Clinical Research

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 14. Thanks for listening! http://www.eurorec.org georges.demoor@ugent.be G. De Moor, MD, PhD, EuroRec, Belgium Barcelona, 17 March 2010
  15. 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

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