G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 The EuroRec Annual Conference 2010 Prof. Dr. Georges De Moor EuroRec President

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 EuroRec The EuroRec Institute is an independent not-for-profit organisation established in 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 and proposing procedures.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Quality Criteria EuroRec has installed a central repository of 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 the EHR-Q-TN. Project. Harmonisation of the certification will favour the harmonisation of EHR products. The EuroRec Seal(s):

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 “The Re-use of EHR data for Clinical Research: the Initiative (IMI and DG INFSO)” “The Trans-Atlantic Project (DG RELEX)” The EuroRec Annual Conference 2010

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 EuroRec’s Recent Areas of Interest - Semantic Interoperability (EHR-content, archetypes) - Personal Health Records (and their interactions with…) - Re-use of Electronic Health Record data for Research - EHRs and Pre-emptive care: genetic data, individual risk - EHRs and Cloud Computing - Collaboration at Global Level: e.g. with the US -…

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Re-Use of EHR data Clinician Clinical Trials & Research Safety and Adverse Event Registers EHR (EMR, EPR…) Decision Support Systems Marketing Billing Knowledge Mgmt Platforms Privacy Enhancing Techniques Patient PHR TRUST Healthcare Management

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 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 EuroRec Annual Conference Tallinn - June 18, 2010 The Partners in - 10 Pharmaceutical Companies (members of EFPIA) - 22 Public Partners (Academia, Hospitals and SMEs) - 5 Subcontractors (Advisory Board)

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Main outputs of - Specification of the Requirements and a Business Model - Technical Platform (a set of tools and services) - Different Pilots for validating the solutions: - for different scenarios (e.g. patient recruitment); - across different therapeutic areas (e.g. oncology); - across several countries (under different legal frameworks).

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Main Scenarios covered in the Pilots - Clinical protocol feasibility - Patient identification and recruitment - Clinical trial execution - Adverse event reporting

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Main Disease Areas covered in the Pilots - oncology - inflammatory diseases - neuroscience - diabetes - cardiovascular diseases - respiratory diseases

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 The Platform of - Will support the feasibility, exploration, design and execution of clinical studies and long-term surveillance of populations; - Will enable trial eligibility and recruitment criteria to be expressed in ways that permit searching for relevant patients across distributed EHR systems, and initiate confidentially participation requests via the patients’ authorised clinicians; - Will provide harmonised access to multiple heterogeneous and distributed clinical (EHR) systems and integration with existing clinical trials infrastructure products (e.g. EDC systems); - Will facilitate improvements of data quality to enable routine clinical data to contribute to clinical trials, and importantly vice versa, thereby reducing redundant data capture.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 The Business Model - Will specify the product and service offering in detail; - Will deliver a self-sustaining economic model including sensitivity analysis; - Will define appropriate governance arrangements for the platform services and for pan-European EHR4CR networks; - Will define operating procedures and third party service requirements; - Will identify the value proposition and incentives for each of the key players and stakeholders impacted by EHR4CR; - Will define accreditation and certification plans for EHR systems capable of interfacing to the platform; - Will define a roadmap for pan-European adoption and for funding future developments

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Main Obstacle The ultimate stumbling block for the re-use of EHR data 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 the 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 (e.g. care versus research) in which those terms have been entered.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 In response to the general Semantic Inter-Operability Problem EuroRec has a strategic interest and will continue to invest in: - Promoting quality criteria not only related to EHR “business- functions” but also related to “content”; - Validating clinical archetypes; - Involving more clinicians and their respective organisations in its future projects and activities.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 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 the clinical research domain. 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 regulated clinical trials and all the other types of clinical research.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Synergies The accreditation of clinical research units (e.g. by ECRIN) and the certification of EHR vendor software (e.g. by EuroRec) for the re-use of data in research will reinforce each other. Together, EuroRec and ECRIN 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).

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Benefits Accreditation and certification will enable research and trials to be delivered more cost effectively and both the vendors of certified products and the data sources that will be accredited, will get a competitive advantage. A new business model for re-using EHR data in research will aim at offering benefits for “all” stakeholders and strengthen the collaboration amongst “all” the partners in Research... !

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Objectives The overall goal of the ARGOS eHealth-Project is to to establish a “Transatlantic Observatory for Meeting Global Health Policy Challenges through ICT- Enabled Solutions” in order to develop and promote “Common Methods for responding to Global Challenges in the EU and the US”.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Rationale EU and US care about the global challenges because: - citizens travel and migrate globally and there is a wish to foster good healthcare everywhere; - the EU and US wish to refine their products to better penetrate global markets; - experiences and lessons learnt globally are useful in Europe and the US.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Rationale The Observatory will thus promote mutual understanding and learning among EU and US health policy researchers and policy makers on the following general challenges with global dimension: - Improving health and well-being of citizens through accelerating eHealth strategy development and through supporting large scale implementations; - Supporting R&D in eHealth to promote the benefits from the pursuit of consistent strategies.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 The right moment for… EU: EHR Q TN -project : New momentum for certification deployment in EU, incl. Eastern European member states… US: Incentive Programs provided through the Recovery Act: New proposed certification: 60 day comment-time-period… Common Visions emerging by recognition of the importance of: - detailed clinical models; - more involvement of clinicians; - the principle of meaningful use…

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Partners EuroRec (The EuroRec Institute for Health Records, Europe) (Lead Applicant) Empirica (Gesellschaft für Kommunikations- und Technologie- forschung, Bonn, Germany) Istituto Ortopedico Rizzoli (Bologna, Italy) AMIA (American Medical Informatics Association) (US Co- ordinator) University at Buffalo (Ontology Research Group,ORG)

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Other contributing Organisations Office of the National Co-ordinator (ONC, Washington) European Commission (DG InfSO, eHealth Unit) University of California (UCSD, San Diego) European American Business Council (EABC) Center for Information Technology Leadership (CITL) American Health Information Management Association (AHIMA)

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Target Areas Interoperability in eHealth and certification of Electronic Health Record systems (EHRs) Definition of a common, consistent approach and identification of indicators and tools for measuring the adoption, usage and benefits of eHealth Modelling and simulation of human physiology and diseases with a focus on the Virtual Physiological Human (VPH)

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Outputs A comparative analysis of current US and EU approaches; Workshops in the US and the EU involving the different stakeholder groups; Interim reports and publications: Policy Briefs; one per target area, i.e. 3 separate brochures documenting the subprojects’ findings and recommendations ; The ARGOS project “grand finale” global conference.

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Certification in EU and US Agreements on future common priorities (a roadmap) YES International Harmonisation of certification criteria and procedures? (vendors are craving for it…) NO Development and validation of common archetypes (detailed clinical models) at a global level? NO Cross recognition of certification? Common certification authority? NO General Information Exchange through a Common Platform YES

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Next Event EU-US Conference in Washington, November 12, 2010 Topics: - Semantic Interoperability - Certification for the re-use of EHR data for Clinical Research - Indicators of eHealth adoption and benefits - Training of ICT for Health Professionals (eHealth Workforce)

G. De Moor, MD, PhD, EuroRec, Belgium EuroRec Annual Conference Tallinn - June 18, 2010 Thanks for listening!