THE EUROPEAN INSTITUTE FOR INNOVATION THR~UGH HEALTH DATA Dipak Kalra Georges De Moor President Advisory Board Chair Electronic Health Records for Clinical Research
Responding to a convergence of needs Clinical Research needs Healthcare needs Optimise clinical research processes Improve quality and safety of care • achieve faster and more accurate • enhance care co-ordination patient identification • increase adherence to clinical • identify sites that have access to the evidence most suitable patients • reduce medical errors and treatment • reduce protocol amendments delays Enhance access to Real World Data Support patients in self-care and health • study the use of new medicines in real maintenance populations Improve efficiency of care • conduct comparative effectiveness • optimise care pathways to improve studies outcomes • monitor long term safety • collate evidence for public health • gather evidence for adaptive licensing strategy and decision-making Need to remove the bottlenecks to accessing and combining health data from diverse sources across Europe 2
Res ea r c h i n A dva nc ed M edi c a l nf or m a s t i c a nd Tel em a s t i c The ter m Lea r ni ng H ea l th Sy stem ( LH S) w a s f i r st a dopted by the U S I nst u t e i t of M edi c i ne i n 20 0 7 . I t i s now bei ng i nc r ea s i ng l y a ppl i ed i n the U S a nd a r ound the w or l d to des c r i be c y c l es tha t i nc l ude da n t a c ol l ec t i o , a na l s y t i c to g ener a te c l i ni c a l k now l edg e, a nd f eedba c k of tha t k now l edg e i n a f or m tha t di r ec tl e y i nf l u nce s the pr oc es s of c a r e. Lea r ni ng c y c l es m a y be l oc a l , n na t i o al or g l oba l a nd the a ppl n i c a t i o of k now l edg e m a y ta k e pl a c e vi a dec i s i on s uppor t a t the poi nt of c a r e, or thr oug h or g a ni z n a t i o a l o r reg i ona l str a teg i es . n The k ey di f f er enc e betw een the LH S a nd tr a di t i o al r es ea r c h a nd k now l edg e tr a ns l n a t i o i s tha t by bei ng ba s ed on r a pi d, s c a l ea bl e a nd hi g hl y c ol l a bor a t i ve a ppr oa c hes to s ha r e da ta a nd k now l edg e i n a c om puta bl e f a s hi on, the LH S dr i ves m edi c i ne to bet t er , m or e evi denc e ba s ed a nd s a f er n pa t i e t c a r e. A t the c entr e of the LH S i s the c a pa c i ty of u c ont i n ous l ea r ni ng , w i th ea c h sta k ehol der oper g a t i n a s a da ta pr ovi der , da t a c ons um er a nd i n the end a s a l ea r ner ena bl i ng the pos s i bi l i ty f or the u c ont i n ous i m pr ovem ent of di a g nos i s a nd tr ea tm ent. The LH S c a n i nc r ea s i ng l y a utom a te c ur r entl y l a bor i ous a nd e t i m c ons um i ng pr oc es s es of da ta sta nda r di z a n t i o , c hec k i ng , a na l y s i s , pr ovena nc e, k now l edg e tr a ns l n a t i o a nd q ua s li t y i m p r ovem ent. A t pr es ent, m a ny hi g hl y r el eva nt i ni t i a t i ves a nd pr oj ec ts a r e c om pa r tm enta l i z ed i n i ni t i a t i ves s uc h a s BD 2K i n the U SA , P r ec i s i on M edi c i ne a nd D ec i s i on Suppor t. Thi s c onf er enc e a i m s to br i ng tog ether pr oj ec ts a c r os s Eur ope a nd the U SA i n l ook i ng a t a c om m ona l i ty of pr obl em s , a ppr oa c hes a nd oppor tuni t i e r el eva nt to Lea r ni ng H ea l th Sy stem s . W e bel i eve tha t by s ha r i ng thes e c ha l l eng es i nter na n t i o all y w e c a n sta r t to bui l d a LH S tha t c a n a c hi eve g l oba l s c a l e. Br enda n D el a ney D i pa k Ka l r a The Learning Health System Slide courtesy of Prof. Brendan Delaney 3
Common challenges to the use of health data for person-centred care, and the reuse of health data for clinical research Data security, privacy Scalability and Interoperability Data quality & ethics sustainability and utility 4
There is a need to combine and sustain the results of European projects and to form partnerships eHealth Stakeholders Group 5
i ~ HD is registered in Belgium The European Institute for Innovation through Health Data (i~HD) Guiding and catalysing the best, most efficient and trustworthy uses of as a not-for-profit organisation It is being financed by membership fees, has been formed as one of the key sustainable entities arising from the EHR4CR and health data and interoperability, by providing services SemanticHealthNet projects, in collaboration with several other European projects and initiatives for optimising health and knowledge discovery such as certification and governance and through supported by the European Commission specifically-funded projects and initiatives 6
i~HD has been formed because a complementary, neutral and not-for-profit organisation is needed ▪ to play a central role in governing and expanding a trustworthy health data-driven ecosystem including EHRs and clinical research platforms ▪ to promote the adoption of healthcare standards and of data quality , to enable more effective, safer and better integrated healthcare ▪ to act as a connector between health care and clinical research standards , that are presently developed in silos and impair the interoperability and pooling of health data for research ▪ to promote to society the importance of using health data for research , to improve efficiency through reduced duplications, delays, costs enhance speed and efficiency in clinical studies 7
Clinical Research needs Healthcare needs Best practices in Harmonised health information and information governance standards Solutions for better quality health Intelligence derived from health data data, and legitimate uses of data e.g. research, outcomes Quality assessments, certification Value Assessment programmes and audit 8
Agenda
Club des Cordeliers- French Revolution (1789-1794) Assasinat de Marat Couvent des Cordeliers, 1793 Localisation sur la carte de Paris dans son bain par Jacques-Louis David (1793) 10
Agenda
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