Mats Sundgren & Petra Wilson

1. Building high level statement Workshop onTowards integration of clinical care & clinical research for better health & high quality healthcare Mats Sundgren & Petra Wilson EuroRec/Efpia/CDIR - Brussles March 10-11, 2008

2. Rationale • The Key Issues • Health care costs • Health care quality • EU innovation • Drug development cost • Pharma research model ”EHR integration” is one common denominator WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

3. Today’s Objectives • Use the outcomes of the three workstreams, (technical, interaction model, and legal), • to develope a joint consolidated and integrated recommendation on which all can agree – a High Level Statement • ”High level statement” will not only be reflected in the white paper but also, • be used to enhance the ”political will” to promote the more engagement to understand and support integration of EHR to support medical research among EU member states WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

4. How • Introduction • Overview of arguments, assumptions and outcomes of the EHR task force • Breakout sessions • Discuss & Identify how we are going to achieve this • Key barriers • Momentum, key stakeholders, etc. • Consolidation • Build shared recommendations WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

5. Building - High level statement Arguments & building blocks EuroRec/Efpia/CDIR - Brussles March 10-11, 2008

6. Today’s situation in EU • In the case of EHR implementation & interoperability aspects, Health Care, Life Science industry and other actors are living in separate worlds • Lack of transparency & cooperation across EU member states to support harmonization on interpretation of data protection in respect to EHR implementations • Need for further guidance on current legal framework on EHRs • There is a need for enhanced political engagement to support integration and a wider use of EHR information for other medical purposes WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

7. The transitional environment • EHR technology is becoming more mature • Pace of standardisations & nomenclature models are moving forward • Adoption of EHR in both hospitals & private practice is on a steady incline • Increasing engagement (in EU & US) to leverage eHealth issues • Integration of EHR have a large potential to create a win-win-win situation for health care, patients & industry Trends have created a transitional environment (Health care, Governmental, Patients, Vendors, and Bio-pharma), which bring different opportunities & challenges WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

8. Assumptions x 3 • Build on three assumptions • Time is ripe to lay the platform in EU • for enable large benefits to Patients, Health care & Industry • Technology & standardisation • Becoming mature • Implementation and usage • Is in steady incline WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

9. Benefits x 3 • Build on three benefits • Support mobility of EU citizens • (EHR utilisation across member states) • Strengthen innovation capability in EU • by providing an improved interaction and utilisation of patient information in the life science industry • Safer & efficient Health care in EU WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

10. Needs x 3 • Build on three needs • Create the political will in EU member states • Awareness, governance, funding and key application areas (e.g. drug safety monitoring, medical research) • Develop a sustainable interaction model for interoperability of EHRs in EU • Information broker (third party), Need of accreditation, standards, Sustainable business models, accreditation mechanisms, and for clinical care & clinical research • Secure legal guidance that encompasses medical research aiming for harmonized interpretation across EU • Establish certification mechanisms and “model contract terms” for interoperability of EHRs to meet secrecy obligations across EU member states • Inclusive with consistent interpretations across EU WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

11. EHR levels x 3 • Primary care • Identifiable EHRs • Patient & drug safety monitoring • Pseudonomyisation of EHRs • Medical research purposes • Anonymisation of EHRs NB: requires different levels and methods of data protection WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

12. Reflections x 3 • Banking industry • E.g the S.W.I.F.T project (1995) • Society for Worldwide Interbank Financial Telecommunication • Supplying secure messaging services and interface software to more than 5,500 financial institutions in 150 countries • S.W.I.F.T.'s wide range of products and services help customers reduce costs, raise productivity, control risk, and strengthen the security of global financial communications WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

13. Reflections x 3 • Airline industry • E.g. EDS and Amadeus systems (1995-2000) • Keeping an airline operating during a migration involves moving millions of electronic passenger name records (PNRs) and electronic tickets, while continuing to process passengers and move airplanes • It also involves aligning those migrated PNRs with travel agencies and industry partners, such as hotel booking alliance code share partners, and coordinating countless details WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

14. Reflections x 3 • ICH (the case of Good Clinical Practice) • International Conference on Harmonization (1990) • Process to harmonize the technical requirements for registration of pharmaceuticals in human use • Involves regulatory authorities and industry experts from: Europe, US, and Japan • Make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

15. Comment - interoperability? • Interoperability & health information (e.g. EHR) exchange are best understood as business concepts rather than technical concepts • Like in the banking industry, the technical feat of creating ATM networks and point-of-service credit cards improved its interoperability and the enivironment was right • Similarly, in healthcare it is easy to be overwhelmed by the technical complexity of healthcare standards, security, architecture, and other technical advances, • Healthcare is seen as next on the list of industries that canbecome interoperable and consumer-centric • Solving these issues can have an impressive effect on the structure and functioning of the healthcare marketplace WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

16. Breakout sessions • Expectations • Go from a high level to a more practical level • Legal aspects are inbuilt to each breakout session • How can interoperability be achieved, • Identify barriers & opportunities • Ranking– primary and secondary • What are the principal recommendations for action! WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008

17. Backup and redundant slides EuroRec/Efpia/CDIR - Brussles March 10-11, 2008

18. EHR integration in EU – “one liner 1” • The transitional environment in the area of EHRs bring opportunities to support mobility, enhance safe & efficient health care for EU citizens, but also to strengthen and regain the innovation capability in EU • Time is ripe to secure synergies that will enable innovation in life science industry in EU WS - Towards integration of Clinical Care & Clincal research – Brussles March 10-11, 2008