1. Topic 3A SEMANTIC INTEROPERABILITY: REUSE OF EHR DATA Mats Sundgren

2. Challenges - from an end user/health care point of view –Health care costs –Health care quality –Complexity of medicine –EU innovation –Drug development cost –Pharma research model Healthcare, has to adapt – NEED to change the way we work together

3. 3 The informatics approaches Current situation of fragmented sources of EHRs, although increasing transparency in CIT and standardization. –There is not a enough progress to create enough socio-economic impact to major stakeholders – There is a need to create paradigm shift in research and collaboration Important factors to consider: –Legal and privacy requirements that differ from country to country –Acceptable to the general public, patients, and medical professionals –Provide a platform that functions across many EHR systems –Secure political engagement –Need not only to engage Patients and Health care, but also Life Science Industry –Doing R&D within a Private-Public Partnership framework Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010

4. 4 The informatics approaches - bridging one important gap A sustainable business model for using EHR data for research purposes in Europe is required –to realise the potential of enhanced research, development, and safety through the expanded use of health information technology There is a gap between: –technology solutions, –regional diversity, individual approaches and –the lack of a common viable business model across Europe Overall, EHR data offers large opportunities for the advancement of medical research, the improvement of healthcare, and the enhancement of patient safety. Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010

5. 5 Some initiatives the ARGOS observatory should consider EHR4CR project, as part of the Innovative Medicine Initiative (IMI, will move beyond the current state-of-the-art by combining previously isolated informatics progress (e.g. semantic interoperability, privacy enhancing techniques, and standards) with an entirely new approach to reusing EHR data for supporting medical research, underpinned by a comprehensive business model for governance, acceptance, adoption and sustainability. The project will demonstrate the viability and scalability of the EHR4CR business model through pilots (e.g. platform services designed for protocol feasibility, patient recruitment, and clinical trial data capture). The IMI EHR4CR project will run over 4 years and involve 33 recognised European academic and industrial partners and will be the largest public-private partnership to date with the goal to tie interoperability aspects together to provide adaptable, reusable and scalable solutions and be the first step to a pan-EU capability for clinical research with integrated interoperability for clinics across countries in Europe. Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010

6. EXTRA SLIDES

7. 7 Benefits Accreditation and certification will enable research and clinical trials to be delivered more cost effectively. Both vendors of certified products and hospitals (source data) that will be accredited will have 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... ! Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010

8. 8 Bridging the gap What it means for your business? “Industry stakeholders are calling for a framework to define public and private sector roles in secondary data use” This is exactly what EHR4CR is all about In Price Waterhouse Cooper report on “Transforming Healthcare through Secondary Use of Health Data” (October, 2009) one of the key messages is: Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010