1. EuroRec/Efpia/CDIR - Brussles March 10-11, 20081 Workshop on Towards integration of clinical care & clinical research for better health & high quality healthcare Mats Sundgren & Petra Wilson Building high level statement

2. WS - Towards integration of Clinical Care & Clincal research – 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

3. 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

4. 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

5. EuroRec/Efpia/CDIR - Brussles March 10-11, 20085 Building - High level statement Arguments & building blocks

6. WS - Towards integration of Clinical Care & Clincal research – 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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!

17. EuroRec/Efpia/CDIR - Brussles March 10-11, 200817 Backup and redundant slides

18. WS - Towards integration of Clinical Care & Clincal research – 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