1. Creating an eHealth Infostructure for Mobile Citizens – the Interoperability Initiative for a European eHealth Area Dr. Karl A. Stroetmann, Dr. Veli N. Stroetmann with Ramin Tavakolian & Marc Lange/Stephan Schug Institute for Communications- and Technology Research Bonn / Germany karl@empirica.com Third High-level Ministerial eHealth 2005 Conference, Tromsø, Norway, May 23-24, 2005

2. Contents Why interoperability? Two examples What is interoperability? Policy drivers and policy statements EU-level projects Outlook: The European eHealth Interoperability Initiative (EU eHealth I2)

3. The need for interoperability – Full medical record Alex Solomon grew up with hydrocephalus, a rare and life- threatening condition "Whether or not a treating doctor has Alex's full medical record available can literally mean life or death“ Cynthia Solomon, his mother She had to become "a walking filing cabinet of records on allergies, pituitary gland problems, brain scans and every piece of paper a doctor ever wrote about Alex's case” Economist, April 30th 2005

4. Borderless ePrescribing Process? Primary Care Community Pharmacy Secondary Care Prescriptions Conversations Dispensing Management Healthcare Funding Agency Cost Control Claims Payments Quality Prescription Management Patient Medication Budget Management Risk Management Concordance Support Clinical DSS Quality Prescription Relay Request

5. eHealth interoperability domain "The solution is not merely to use computers, but to link the systems of doctors, hospitals, laboratories, pharmacies and insurers"

6. Interoperability definition – A human user oriented perspective In a multi-lingual context, particularly when considering cross-border health care, we should go beyond the technical level and include citizens (health professionals, patients,...) as part of the interoperable system, i.e. we need an interface between the "separate application entity on each side" as defined by CEN and others, and the person (clinician, nurse, patient,...) who inputs the information into the unit and the one who interprets and acts on the output at the other side. We may be able to capture this by a wider definition of what "semantic interoperability" means, i.e. we would have to translate, e.g., concepts and terms as defined and modelled by terminology systems like SNOMED CT not only into the respective national language but also with respect to the medical culture and understanding in a given health system context.

7. General policy drivers Mobility of citizens (demand) Single European Market (supply) Decisions of the European Court of Justice Global competition Pressure by stakeholder groups Need for improved access for all, quality of services Demographics Cost pressure on systems

8. Specific policy drivers The European Parliament "notes the importance of providing an efficient and secure method of exchanging patient records between Member States" Draft report on patient mobility and healthcare developments in the European Union, 20.12.2004 "Interoperability is the corner stone supporting citizens mobility and patient centred care" Report of the High Level Group on Health Services and Medical Care (to the Council of the EU), Dec. 2004 "Establish a platform with a mandate and the necessary resources to facilitate co-operation between European Member States with support of the European Commission to promote e-health interoperability for the mobile citizen." Report of the eHealth Standardisation Focus Group, Feb. 2005 "The high level e-Health forum... will be able to set up working groups on specific topics, one of which should obviously be interoperability." Opinion of the Committee of the Regions on the Action Plan for a European eHealth Area, 22.03.2005

9. EU Support Action: The i2-Health project Objectives identify interoperability and connectivity issues and priorities, barriers and gaps, and solution approaches focus on fundamental interoperability issues (identification of actors, organisations, adequate measures to achieve interoperability, integration tests and certification) analyse similarly key topics relating to e-prescription and messaging develop a roadmap and concrete projects involving all relevant actors - guided by an open discussion process amongst Member State Health Authorities

10. i2-health: Workplan Elements Generic elements –Conceptual framework (WP1) –Analysis of infrastructure concepts and building blocks, services and applications (WP2) Specific subjects for in-depth analysis –Identification management of actors, organisations and system components - fundamental interoperability issues (WP3) –Workflow interoperability – e-prescribing and messaging (WP4)

11. Identity management of actors, organisations and system components - fundamental interoperability issues Analyse existing and planned patterns of identity management Develop an integrated European approach for identity management Identify crucial applications based on high-priority use- cases such as cross border messaging and prescription Proposal for coordinated action to achieve minimum required interoperability

12. European pivots of identity management Pan-European digital database of insurance providers Electronic (!) European health (insurance) card with unique and reliable patient identification Physicians as priority health professionals European directives on mutual recognition of diplomas, certificates and other evidence of formal qualifications (e.g. 93/16 for physicians)

13. ePrescribing and Messaging –to critically review and discuss the state-of-the-art in respect of e-prescribing and process-related messaging (like referral and discharge letters) –to identify, collate and analyse use cases for applications with priority –to develop, based on a needs and gaps analysis, a concrete procedure and work plan towards a pan- European solution WP4: Workflow interoperability

14. Organisational interoperability –recognition of physicians authorisations (legal) –reimbursement claims; etc. Semantic interoperability –pharmaceutical nomenclature & classification –drug composition; branding etc. –instructions/quantity (10-10-10 vs. qid; tid) Technical interoperability –access to digital information –access to authorisation information; etc. WP4: Interoperability Focus

15. ePrescribing: Implied Processes Primary Care Community Pharmacy Secondary Care Prescriptions Conversations Dispensing Management Healthcare Funding Agency Cost Control Claims Payments Quality Prescription Management Drug Wholesale Pharmaceutical Industry Stock Control Stock Patient Medication Budget Management Risk Management Concordance Support Clinical DSS Quality Cost Negotiation Research Enrolment & Trial Management Prescription Relay Request Quality

16. 9 Towards the Establishment of a European e-Health Research Area - eHealth ERA project Strategic goals: to coordinate national innovation-oriented eHealth RTD planning and roadmapping, stimulate bilateral and multilateral joint activities and take steps towards further integration of RTD planning and results implementation across all Member States, thereby establishing an effective European Research Area for eHealth, supporting the development of interoperable regional, national and trans-European eHealth infrastructures (Action Plan support).

17. The European eHealth Interoperability Initiative EU eHealth I2 (Preparatory Discussions on an initiative of the Member State Ministries of Health supported by the European Commission) Goals will be to assure pan-European interoperability at all levels amongst eHealth infrastructures, services and applications developing at national and regional level, thereby to further the development of a European market in borderless health services facilitated by eHealth applications

18. EU eHealth I2

20. Thank you very much for your attention! karl@empirica.com Third High-level Ministerial eHealth 2005 Conference, Tromsø, Norway, May 23-24, 2005