D4.7 - Operational plans for the pan-European umbrella ecosystem

1 A new, in e disciplina y, mul i-s akeholde Eu opean ne wo k o imp o e heal hca e se ices, esea ch and ou comes o Adolescen s and Young Adul s wi h cance . STRONG-AYA – No. 101057482 – D4.7 2 Deli e able Repo WP4 – Ope a ion o STRONG-AYA ecosys em, s akeholde and pa ien in ol emen , dissemina ion, exploi a ion, communica ion Deli e able D4.7 Ope a ional plans o he pan-Eu opean umb ella ecosys em Due da e o deli e able: 30/09/2023 Ac ual submission da e: 22/03/2024 Re ised om Consolida ed Repo o 25-07-2024, esubmi ed 30-09-2024 P ojec : STRONG-AYA Lead Con ibu o Oana Lindne (UOL) Email d.p.s a [email protected] O he Con ibu o s Dan S a k, Oana Lindne , Emily Connea n, Richa d Fel bowe , Nicola Hughes (UOL); Nicole Collaco (UOS); Leona d Wee, Ma ine Jacquemin, Joshi Hogenboom, Flo a Lysen, Da ian Meacham (UNIMAAS); Simone Hanebaum (NKI); U ska Kosi (PAB). Emails o.c.lindne @leeds.ac.uk; [email p o ec ed]; .g. el bowe @leeds.ac.uk; n. [email protected]; n.b.collaco@so on.ac.uk; [email p o ec ed]; ma ine[email p o ec ed]; joshi.hogenboom@maas o.nl; .lysen@maas ich uni e si y.nl; d.meacham@maas ich uni e si y.nl; [email protected]; u ska.kosi [email protected]. Due da e 30/09/2023 Deli e y da e 22/03/2024 Deli e able ype R Dissemina ion le el PU STRONG-AYA – No. 101057482 – D4.7 3 Desc ip ion o Wo k Ve sion Da e Fi s d a o e iew V1.0 22/03/2024 Red a om e iew V2.0 27/09/2024 Desc ip ion: Ope a ional plan con aining desc ip ion o main ac ions equi ed o he deploymen and unc ioning o he pan-Eu opean ecosys em 5. Publishable summa y (max ½ page) This deli e able de ines he con ex and a ionale o he exis ence o he pan-Eu opean ecosys em, i s go e nance model (s uc u e, guiding p inciples, incen i es o pa ne s), speci ic ope a ions, and ules o i s ope a ional ac i i ies as a pan-Eu opean ede a ed lea ning ecosys em ( o ongoing and new membe s, o he submission o use cases and use o ede a ed analysis in as uc u es). These aspec s de ine he pa h o gene a ing alue, insigh s, impac , and sus ainabili y h ough collabo a ion and ede a ed lea ning, wi h i e a i e ailo ing o he s akeholde s wi hin he STRONG-AYA Conso ium. This deli e able is pa o WP4, de ining he ac ions ha all ins i u ions need o ul il o he ope a ion o a sus ainable pan-Eu opean STRONG-AYA ecosys em. I builds upon he exis ing na ional/local ecosys ems wi hin STRONG-AYA and p e ious documen s p oduced wi hin he Conso ium ela ed o he a chi ec u e o he ecosys em (D2.1), code o conduc o membe s (D2.2), da a managemen (D3.1), echnical bluep in (D3.3), p e iously-de ined local ope a ional plans (D4.4, D4.6) and de ini ion o use cases (D4.8), and key pe o mance indica o s (D5.2). Apa om hese documen s, which all pa ne s a e awa e o , he cu en epo should be ead in conjunc ion wi h he ROPA/DPIA and G an ag eemen o any addi ional de ails. De ails encompassed by he ac ions de ined wi hin he o e a ching na ional ecosys em ope a ional plan (D4.4) and ope a ional plans o na ional ecosys ems (D4.6) eed di ec ly in o his documen , which b ings oge he he ac ions and ope a ions o he de elopmen o na ional in as uc u es eeding in o ou pan- Eu opean umb ella ecosys em. D4.4 and D.4.6 bo h ely on in e iews and discussions wi h each na ional pa ne , e alua ing he s a e o p epa edness o build om local o na ional ecosys ems. The pan-Eu opean ecosys em desc ibed he e is elian on each local cen e wo king na ionally, o c ea e capaci y o build owa ds a popula ion-based na ional S TRONG-AYA ecosys em, which can communica e wi h o he na ions. Consis en wi h he o he deli e ables o which his epo is linked, i aims o be a li ing documen , de eloped i e a i ely h oughou he p ojec and beyond. I will e ol e as new pa ne s and in e es ed s akeholde s may join he Conso ium, may con ibu e da a, and he landscape o go e nance, e hics, and secu i y changes in ime a in e na ional le els. STRONG-AYA – No. 101057482 – D4.7 4 6. Table o Con en s PUBLISHABLE SUMMARY (MAX ½ PAGE) .................................................................................................................... 3 TABLE OF CONTENTS .................................................................................................................................................. 4 DEFINITIONS ............................................................................................................................................................... 6 ABBREVIATIONS ......................................................................................................................................................... 7 4. EXECUTIVE SUMMARY ............................................................................................................................................ 8 5. INTRODUCTION ...................................................................................................................................................... 8 5.1. PROJECT BACKGROUND ........................................................................................................................................... 8 5.2. DEFINITION OF THE PAN-EUROPEAN ECOSYSTEM ........................................................................................................ 10 5.3. IMPLEMENTATION OF FEDERATED LEARNING ............................................................................................................. 11 6. GOVERNANCE MODEL .......................................................................................................................................13 6.1. STRUCTURE OF THE CONSORTIUM ........................................................................................................................... 14 6.1.1. Exis ing Conso ium pa ne s.................................................................................................................. 14 6.1.2. Commi ee o Coo dina ion ................................................................................................................... 14 6.2. FOUNDING PRINCIPLES .......................................................................................................................................... 14 6.2.1. Value-based heal hca e .......................................................................................................................... 14 6.2.2. FAIR p inciples ........................................................................................................................................ 15 6.2.3. Open science p inciples ........................................................................................................................... 15 6.2.4. T anspa ency .......................................................................................................................................... 15 6.2.5. S anda disa ion ...................................................................................................................................... 17 6.2.6. Inclusi e and ocused on pa ien bene i ................................................................................................ 17 6.2.7. P i acy and con iden iali y-p ese ing ................................................................................................... 18 6.2.8. Scalable and sus ainable ........................................................................................................................ 19 6.3. ALIGNING INCENTIVES AND MOTIVES ACROSS CONSORTIUM MEMBERS ........................................................................... 20 6.4. MANAGING NATIONAL AND INSTITUTIONAL DIFFERENCES ............................................................................................. 21 7. STANDARDS AND RULES FOR THE FEDERATED LEARNING ECOSYSTEM .............................................................26 7.1. RULES FOR ONGOING AND NEW PARTNERS ................................................................................................................ 27 7.2. APPLICATION REQUIREMENTS ................................................................................................................................. 27 7.3. DECISION PROCESS ............................................................................................................................................... 28 7.4. MANAGEMENT OF USER ACCESS AND USAGE .............................................................................................................. 28 7.5. RESOLUTION OF DISPUTES AND AMBIGUOUS SITUATIONS .............................................................................................. 32 7.6. SUBMISSION OF USE CASES ..................................................................................................................................... 33 8. RULES ON USING THE ECOSYSTEM FOR FEDERATED LEARNING AND ANALYTICS ..............................................34 8.1. ACTIVE CONTRIBUTION TO THE DATA ECOSYSTEM ........................................................................................................ 34 8.2. ABIDING BY THE TECHNICAL STANDARDS ................................................................................................................... 35 8.3. PRIVACY PRESERVATION ......................................................................................................................................... 35 8.4. SUPPORTING INTERPRETABILITY AND INTEROPERABILITY ............................................................................................... 35 8.5. TRACKING SUCCESS WITH KPIS ................................................................................................................................ 36 8.6. USING THE INFRASTRUCTURE .................................................................................................................................. 37 8.7. INTELLECTUAL PROPERTY GUIDELINES ....................................................................................................................... 41 8.8. SHARING OF BENEFITS - COMMUNICATION AND DISSEMINATION OF OUTPUTS .................................................................. 41 STRONG-AYA – No. 101057482 – D4.7 5 9. RE-AUDITING OF RULES AND STANDARDS ......................................................................................... 44 10. COMMITMENTS OF CONSORTIUM AND PARTNERS ......................................................................................44 11. CONCLUSION .................................................................................................................................................45 STRONG-AYA – No. 101057482 – D4.7 6 7. De ini ions STRONG AYA conso ium membe s a e e e ed o as ollowing wi hin his ex : 1. NKI-AVL – S ich ing he Nede lands Kanke Ins i uu – An oni an Leeuwenhoek Ziekenhuis (NL) 2. YCE – You h Cance Eu ope (RO) 3. INT – Fondazione IRCCS Ins i u o Nazionale dei Tumo i (IT) 4. FFUND – FFUND BV (NL) 5. CLB – Cen e de Lu e Con e le Cance Leon Be a d (FR) 6. ECO – Eu opean Cance O ganisa ion (BE) 7. UNIMAAS – Uni e si ei Maas ich (NL) 8. IKNL – S ich ing In eg aal Kanke cen um Nede land (NL) 9. EORTC – Eu opean O ganisa ion o Resea ch and T ea men o Cance AISBL (BE) 10. IGR – Ins i u Gus a e Roussy (FR) 11. MSCNRIO – Na odowy Ins y u Onkologii im. Ma ii Sklodowskiej-Cu ie – Pans wowy Ins y u Badawczy (Ma ie Sklodowska-Cu ie Na ional Resea ch Ins i u e o Oncology) (PL) 12. UOM – Uni e si y o Manches e (UK) 13. UOL – Uni e si y o Leeds (UK) 14. LTHT – Leeds Teaching Hospi als Na ional Heal h Se ice T us (UL) 15. SOUTHAMPTON – Uni e si y o Sou hamp on (UK)  G an Ag eemen (including i s annexes and amendmen s): he ag eemen signed be ween he bene icia ies o he HORIZON Resea ch and Inno a ions Ac ions (he ea e e e ed o as Ho izon) and he Eu opean Heal h and Digi al Execu i e Agency (he ea e e e ed o as HADEA) o he unde aking o he STRONG AYA p ojec (G an Ag eemen no. 101057482).  Bene icia y: Signa o ies o he G an Ag eemen  Associa ed Pa ne : En i ies which pa icipa e in he ac ion bu wi hou he igh o cha ge cos s o claim con ibu ions.  P ojec : he sum o all ac i i ies ca ied ou in he amewo k o he G an Ag eemen .  Conso ium: he STRONG AYA conso ium, including all he a o emen ioned pa ne s.  Conso ium Ag eemen : The ag eemen made be ween STRONG AYA membe s o he implemen a ion and execu ion o he ac ion ou lined in he G an Ag eemen . The ag eemen shall no a ec he pa ies’ obliga ions o HADEA on behal o he Eu opean Union, and/o o one ano he a ising om he G an Ag eemen . STRONG-AYA – No. 101057482 – D4.7 7 8. Abb e ia ions Ac onym/Abb e ia ion Meaning API Applica ion P og amming In e ace AYA Adolescen and Young Adul HCP Heal h Ca e P o ide PRO Pa ien Repo ed Ou come PROM Pa ien Repo ed Ou come Measu e C C Commi ee o Coo dina ion COS Co e Ou come Se FAIR Findable, Accessible, In e ope able, Reusable FL Fede a ed lea ning GDPR Gene al Da a P o ec ion Regula ion MDW Medical Da a Wo ks PHT Pe sonal Heal h T ain PI P incipal In es iga o PLUTO Public Value Assessmen Tool WP Wo k Package WPL Wo k Package Lead(s) WP1 Wo k Package 1 (De elopmen Co e Ou come Se AYA wi h cance & da a collec ion) WP2 Wo k Package 2 (Go e nance, Da a Secu i y and E hics) WP3 Wo k Package 3 (In as uc u e and In e ope abili y) WP4 Wo k Package 4 (Ope a ion o STRONG AYA ecosys ems, s akeholde and pa ien in ol emen , dissemina ion, exploi a ion, communica ion) WP5 Wo k Package 5 (Scien i ic coo dina ion and p ojec managemen ) KPI Key Pe o mance Indica o OA Open Access PAB Pa ien Ad iso y Boa d EC Eu opean Commission HADEA Eu opean Heal h and Digi al Execu i e Agency STRONG-AYA – No. 101057482 – D4.7 8 9. 4. Execu i e summa y 1. AYA cance s a e a e bu can be disabling o a la ge p opo ion o su i ing young people; mo eo e , clinical and psychosocial esea ch and ca e o AYA is no e enly dis ibu ed and de eloped ac oss Eu ope. 2. Because hey a e a e, conduc ing adequa ely powe ed esea ch ha imp o es clinical and psychosocial ca e, and implemen ing esea ch indings, while mee ing young people whe e hey a e (i.e. in case hey mo e geog aphically), equi es a collabo a i e e o ac oss Eu ope. 3. Da a sha ing o make in o med decisions and conclusions abou he ca e o AYA is no possible due o a numbe o challenges – including isks o da a p i acy and p o ec ion and di e en ways o applying e hical p inciples o da a collec ion, managemen and sha ing o e ime and be ween coun ies. 4. The STRONG-AYA Conso ium aims o build a sus ainable pan-Eu opean ecosys em ha add esses some o hese challenges h ough a de ined se o p inciples, ules o joining he ecosys em and making da a a ailable o p i acy-p ese ing ede a ed lea ning, o he bene i o AYA ca e ac oss Eu ope. 5. This documen ou lines he go e ning p inciples o he pan-Eu opean ecosys em o be adhe ed o by cu en and new membe s, he p ocess o becoming a membe , and he ules o con ibu ing o, bene i ing om, and ensu ing he sus ainabili y o a g owing ede a ed lea ning in as uc u e. I also lays ou he limi a ions, acili a o s, isks and mi iga ions o each elemen o ou pan- Eu opean ecosys em, and he nex me hods and me ics equi ed o u he p og ess 10. 5. In oduc ion 10.1. P ojec backg ound Adolescen s and young adul s (AYAs) wi h cance o m a unique g oup; hey ace age-speci ic issues and dec eased quali y o li e. Cance in AYAs aged 15-39 is a e, al hough 4-6 imes mo e equen han paedia ic cance (i.e. p epubescen pe iod). Howe e , his a i y does no e lec he signi ican pe sonal and socie al cos s o cance in his popula ion, as e lec ed in he po en ial yea s o li e los o sa ed, he dec eased p oduc i i y and quali y o li e and he li e-long complica ions o disabili ies1. Imp o ing su i al in AYA is mo e challenging han o child en and olde cance su i o s. This is pa ly due o he excess isk o second p ima y malignan neoplasms iden i ied in his g oup compa ed o coho s o younge and olde pa ien s2. Mo eo e , AYAs ace some dis inc challenges compa ed o olde and younge coun e pa s in he ea men o hei p ima y o seconda y malignancies - a unique spec um o cance ypes, di e en umou biology, unique complex psychological needs, dis inc la e sequelae, including impai ed e ili y, and pallia i e ca e3,4. 1 S oneham SJ. AYA su i o ship: The nex challenge. Cance 2020; 126: 2116-2119. 2 Keegan THM, Bleye A, Rosenbe g AS e al. Second P ima y Malignan Neoplasms and Su i al in Adolescen and Young Adul Cance Su i o s. JAMA Oncol 2017; 3: 1554-1557. 3 Bleye A, Ba R, Hayes-La in B e al. The dis inc i e biology o cance in adolescen s and young adul s. Na Re Cance 2008; 8: 288-98. 4 Fe a i A, S a k D, Pecca o i FA e al. Adolescen s and young adul s (AYA) wi h cance : a posi ion pape om he AYA Wo king G oup o he Eu opean Socie y o Medical Oncology (ESMO) and he Eu opean Socie y o Paedia ic Oncology (SIOPE). ESMO Open 2021; 6: 100096. STRONG-AYA – No. 101057482 – D4.7 9 These consequences imply ha he clinical managemen , ea men , diagnosis, and psychosocial suppo need o be designed and de eloped o he speci ic needs o AYA. Fo example, AYAs diagnosed wi h b eas and p os a e ca cinomas ha e wo se su i al han olde pa ien s because o he biological di e ences, highligh ing he need o a ge sc eening me hodologies, ea men s, and policies o hei needs. AYAs wi h cance also ace signi ican psychological challenges, including subs ance abuse, men al heal h issues, suicidal idea ions, and inc eased emo ional bu den om cance and cance - ela ed mo bidi y. Finally, ailo ing cance ca e o AYAs’ needs is also made di icul by he low a e o pa icipa ion by AYAs in clinical ials and cance esea ch5. Despi e he inc easing awa eness and a g owing body o he scien i ic li e a u e, Eu opean heal h sys ems ha e no ully ecognised and add essed he unique issues aced by AYAs wi h cance , and he e o e hese indi iduals o en do no ecei e he igh ype o suppo . In pa , his may ha e esul ed om he adi ional dicho omy be ween he in eg a ed paedia ic (“pa ien / amily-cen ed”) ca e se ices e sus dispe sed (“disease-cen ed”) adul oncology se ices4,6,7. As a esul , up o hal o AYAs wi h cance epo unme in o ma ional and se ice needs, impac ing bo h hei di ec (su i al a es) and indi ec (long- e m e ec s and men al heal h) eco e y and social in eg a ion8. Fu he mo e, aligned wi h his ba ie is he low a e o heal h ca e u ilisa ion by AYAs, especially p ima y ca e, in pa due o low awa eness o AYA malignancy among p ima y ca e s and, depending on he na ion, due o challenges o sus ain heal h insu ance co e age5. Acco ding o a su ey conduc ed h ough he ne wo ks o he AYA Wo king G oup o he Eu opean Socie y o Medical Oncology (ESMO) and he Eu opean Socie y o Paedia ic Oncology (SIOP Eu ope), 67% o p ac i ione s do no ha e access o specialised cen es o AYA wi h cance , 67% had no access o a specialis cance se ice o la e e ec s managemen and 38% had no access o e ili y specialis s. Unde -p o ision and inequali y o AYA cance ca e is common ac oss Eu ope and especially in he Eas e n and Sou he n-Eas e n a eas. Fu he mo e, he Wo king G oup also epo ed an absence o ou come measu es o moni o ing and e alua ing AYA cance ca e p og ams9. Among he ecommended u u e s eps, one o he mos impo an con ibu ions o AYA esea ch would be o pool da a (e.g. pa ien - epo ed ou comes, clinical and ea men da a) ac oss ins i u ions and coun ies and c ea e la ge coho s o esea che s o add ess he bu den o cance in AYA10. Howe e , he e a e challenges due o a lack o da a s anda disa ion, da a in e ope abili y, uni a y (p ospec i e) collec ion o ou comes o ele ance o AYAs wi h cance , da a p i acy and secu i y conce ns, as well as egional di e ences in he applica ion o e hical p inciples go e ning da a collec ion and sha ing. The STRONG-AYA p ojec aims o ackle he unde ep esen a ion o AYA’s expe iences and ou comes when na iga ing he heal hca e sys em and in clinical ca e by de eloping na ional in as uc u es o ou come da a managemen and clinical decision-making wi hin a pan-Eu opean ecosys em and es ablishing communica ion eedback o AYAs wi h cance and hei heal hca e sys ems. This will be key o imp o ing heal hca e se ices, esea ch, ou comes and policies o AYAs and o ul ima ely imp o ed cance ca e o his pa ien g oup. 5 Hayashi RJ. Adolescen and young adul cance su i o ship: The new on ie o in es iga ion. Cance 2019; 125: 1976-1978. 6 Osbo n M, Johnson R, Thompson K e al. Models o ca e o adolescen and young adul cance p og ams. Pedia Blood Cance 2019; 66: e27991. 7 Fa dell JE, Pa e son P, Wake ield CE e al. A Na a i e Re iew o Models o Ca e o Adolescen s and Young Adul s wi h Cance : Ba ie s and Recommenda ions. J Adolesc Young Adul Oncol 2018; 7: 148-152. 8 Keegan TH, Lich ensz ajn DY, Ka o I e al. Unme adolescen and young adul cance su i o s in o ma ion and se ice needs: a popula ion-based cance egis y s udy. J Cance Su i 2012; 6: 239-250. 9 Salous os E, S a k D, Michailidou K e al. Repo on ESMO/SIOPE Eu opean Landscape p ojec key esul s: Mapping he s a us and needs in AYA cance ca e. La e-b eaking and de e ed publica ion abs ac s public heal h 2017; 28, 5: V643. 10 Smi h AW, Seibel NL, Lewis DR e al. Nex s eps o adolescen and young adul oncology wo kshop: An upda e on p og ess and ecommenda ions o he u u e. Cance 2016; 122: 988-999. STRONG-AYA – No. 101057482 – D4.7 16 agains a single Conso ium membe being he majo i y da a owne which would c ea e s uc u al inequi y and powe con lic s a he decision making le el. Fo he pu pose o equi y in da a p o ision and da a que ies and hence o educe misalignmen esul ing om powe democ acy, he STRONG-AYA pan-Eu opean ecosys em will ensu e:  Da a s ewa dship and con ol will be join ly held by P incipal in es iga o s (PIs) and hei eams o in es iga o s. Tha is because ocusing powe only on he PI would emo e he ins i u ional in es iga o s om he powe s uc u e and he da a go e nance loop. Th ough join powe o e da a we ensu e he con ex and sub le y ela ed o da a is main ained, and i da a needs o be en iched, enhanced o equi es addi ional managemen , his can be done in pa ne ship wi hin he local ecosys ems, a he han i being he esponsibili y o a single pe son.  The ac ions he ein a e no a new opology o ‘da a con ol exe cise’ by a single pa ne . Tha is, i is impo an ha all pa ne s a e equal in e ms o sugges ing a use case (as long as i is cong uen wi h he ounda ional da a usage p inciples and incen i es o he conso ium) and all pa ne s mus ha e he same “powe ” in e ms o being able o un an analysis and es hei hypo heses. The conso ium will ensu e no one pa ne makes all he ules and no pa ne becomes a me e da a- eeding s a ion. “Join con olle ship” acco ding o GDPR – in e ms o he da a con ibu ions by each pa ne and he analyses being un on each o he s da ase s - becomes a cen al ene o he legal basis o da a usage and i is speci ied as pa o he da a p o ec ion ag eemen signed by conso ium membe s.  The ede a ion mus s ill be able o unc ion (albei in such cases on a educed da a sample) i one pa ne conscionably op s ou o a pa icula analysis o use case. The ac ions and ope a ions wi hin he ecosys em a e no ‘all-in o all-ou ’. Fo ins ance, i may be ha a heal hca e p o ide wan s o be pa o sa coma s udies bu wan s o op ou o b eas cance s udies. F om he STRONG-AYA conso ium pe spec i e, his complies wi h he p inciple o ensh ined au onomy o each in es iga o in he conso ium. This also espec s local p ocesses and obliga ions and egula ions; o example sociodemog aphic da a collec ion and analysis is pe mi ed in he UK, bu is illegal in F ance. The op -ou o F ench cen es om such analyses is hus impe a i e and so main aining a mo e lexible app oach is an inclusi e, a he han exclusi e, s uc u e. In he case o p ospec i e (no el) da a collec ion (such as PROs based on he COS), each local pa ne needs o ensu e ha anspa ency is p esen in communica ion wi h pa icipan s. This means ha all pa icipan s ha e p o ided and documen ed in o med consen , which con ains he ele an in o ma ion abou da a p ocessing and da a p o ec ion aligned o a icle 13 o he GDPR, including any local ins i u ional guidelines and bes p ac ices. In he case o e ospec i e (his o ical) da a a ailable and p o ided by pa ne s, a icle 4 o GDPR applies, he eby he da a collec ed by a pa ne mus mee all h ee g ounds allowing he p ocessing o such da a. Namely, he da a can be p ocessed i a) he pa icipan o e ed eely gi en, speci ic, and in o med consen (A icle 6 (1) (a)); b) p ocessing is a legi ima e in e es excep ion such as he e is a legi ima e in e es o con olle s AND he legi ima e in e es canno easonably be achie ed by using al e na i e means AND he in e es s and undamen al igh s and eedom o he pa icipan do no ake p ecedence o e he legi ima e in e es s o he con olle (s); c) he da a is anonymised and he e o e alls ou side GDPR. As an example, a legi ima e in e es excep ion would be ha o es ing hypo heses o he pu pose o public heal h. Finally, hono ing his p inciple means ha pa icipan s should ind i easy o unde s and how speci ic in o ma ion abou hei heal h is used o accessed. Pa icipan s should easily and eliably ha e con ol and be able o access hei heal h da a and hey should be able o exe cise hese igh s. Exac ly wha ype o da a STRONG-AYA – No. 101057482 – D4.7 17 pa ien s e sus heal hca e p o essionals will be able o see is decided by he C C in collabo a ion wi h he en i e conso ium and he Pa ien Ad iso y Boa d o a oid undue dis ess o ha m ul decision making. 11.2.5. S anda disa ion o da a One o he limi a ions iden i ied in summa ising and making aluable conclusions o clinical decisions in AYA’s clinical ca e in e na ionally is he lack o da a s anda disa ion. This ela es o he changing landscape o heal hca e p o essional- and pa ien - epo ed ou comes ha a e conside ed ele an o he ea men , ca e, and esea ch in AYA cance s. As AYAs a e an unde - esea ched demog aphic and s addle he adi ional di isions be ween paedia ic and adul oncology, he ype o ca e an AYA expe iences a ies signi ican ly be ween paedia ic and adul oncological ins i u ions, be ween egions, and be ween coun ies. Wi hin he STRONG-AYA ecosys em we acknowledge ha he e will be some misalignmen o da a ields collec ed wi hin an ins i u ion ac oss ime, and also be ween ins i u ions a any gi en ime. Da ase s collec ed in he pas will no ha e been s uc u ed he same way as newe ones as o ganisa ions lea ned and de eloped. As a esul , ac oss he Conso ium, he e will be a high he e ogenei y in he collec ion o some domains, pa icula ly hose elian on PROs, and only some will ha e been eco ded sys ema ically. As PROs will, alongside clinical da a, d i e insigh s ela ed o ailo ed ea men and ca e, STRONG-AYA is commi ed o s anda dising he ype and me hod o PRO da a collec ed ac oss he Conso ium o he pu poses o in e ope abili y and sus ainabili y. Wi hin STRONG-AYA we will s i e o a s anda disa ion o an op imum minimal le el o da a. To ensu e he da a ecosys em is used as e ec i ely and e icien ly o analyses and insigh s, he Conso ium elies on he wo k in WP1 ela ed o he COS, WP2 in ela ion o da a minimisa ion, WP3 in ela ion o join con olle ship ag eemen s ela ed o da a and isualisa ion me hods, and impo an ly local e hical e iews o he app op ia e collec ion and use o local da a. Going o wa d, by es ablishing a COS o AYA ca e and using da a-d i en insigh s ga he ed ia ou pan-Eu opean ecosys em, STRONG-AYA will sha e insigh s wi h policy-make s o add ess and educe inequali ies ac oss he en i e disease pa hway o di e en cance s in AYAs in di e en egions in Eu ope, owa ds ou aim o es ablishing a Eu opean-wide s anda d o ca e. STRONG-AYA will enable AYA heal hca e quali y ou comes moni o ing by acking access, such as by AYA nu se specialis s, e ili y consul an s, and social wo ke s o discussion abou wo k and es ablish benchma king be ween he di e en coun ies on key pe o mance indica o s. 11.2.6. Inclusion, ocused upon pa ien bene i STRONG-AYA ools and ac i i ies a e pa ien -cen ed and based on he Eu opean E hical P inciples o Digi al Heal h, ollowing he p inciple o ‘no hing abou me wi hou me’. These e hical p inciples, cen ed on he in e es s and alues o pa ien s, a e he ounda ion he Conso ium builds upon, a e ei e a ed and e lec ed in he de elopmen o he FL ecosys em, and buil h ough s akeholde engagemen and e lec ions om he Pa ien Ad iso y Boa d. Impo an ly, any ools and ac ions wi hin STRONG-AYA a e mean o complemen and op imise ace- o- ace heal hca e, pa ien s a e in o med bo h o he bene i s and limi s o ools de eloped by he Conso ium, and hey can cus omise hei in e ac ions wi h hese ools. Fu he mo e, h ough wo k cu en ly unde way in WP4 by engaging pa ien s in he de elopmen o he esea ch and ools, STRONG-AYA aims o ensu e pa ien - acing ools and esul ing conclusions a e accessible. Namely, STRONG-AYA will ensu e pa ien s:  A e able o easily and eliably access/ e ie e hei own STRONG-AYA heal h da a ( h ough hei own hospi al sys ems)  See hei own heal h da a in he con ex o o he AYA simila o hem STRONG-AYA – No. 101057482 – D4.7 18  Easily access in o ma ion on how hei heal h da a has been accessed o used and o wha pu pose, such ha hey should be able o easily enhance, g an o emo e access o hei heal h da a depending upon hei pe spec i e on each ‘case o use’ o hei da a, and exe cise his igh eely  Any ools de eloped by STRONG-AYA need o be inclusi e and accessible o all (including by people wi h disabili ies o low le els o digi al li e acy). They should be in ui i e and easy o use, pa ien s should ha e access o aining o help hem unde s and digi al heal h ools, which in u n should be implemen ed in ca e ou ines ha also include human communica ion.  Pa ien ep esen a ion on he C C will ensu e ha a pa ien oice is embedded in he ecosys em’s go e ning s uc u e Clinical ials and medical esea ch, his o ically, ha e been d i en by he ques ions and conce ns clinicians and esea che s wished o in es iga e. Howe e , i is pa ien s who a e di ec ly impac ed by he ou comes o esea ch. Thei ques ions and conce ns should be placed on equal oo ing wi h clinical esea ch a eas o in e es . By in ol ing pa ien s in he p ocess o co-c ea ion, STRONG-AYA will c ea e a pla o m ha se es pa ien s and empowe s hem by u he inc easing hei heal h li e acy. Following upon he abo e, STRONG-AYA will equip AYAs wi h cance wi h he da a o be e op imise hei heal hca e, and suppo sha ed and pe sonalised decision-making be ween AYA and heal h ca e p o ide s. This also ex ends o he con ol o , access o, and use o AYA’s da a in he con ex o esea ch and heal hca e. Impo an ly, by in ol ing pa ien g oups in he con e sa ions a ound he ac ions and ope a ions wi hin he ecosys em and he co-c ea ion o he pa ien pla o m and me hods o da a isualisa ion, he Conso ium is commi ed o ‘meaning ul’ pa ien pa icipa ion leading o ac ionable pa ien -cen ed and pa ien -in o med insigh s. The e o o co-c ea ion is expec ed o esul bo h ia he local/na ional-le el go e nance and e hical sys ems which a e dedica ed o inco po a ing pa ien s’ iews, bu also h ough he guiding p inciples o he conso ium. 11.2.7. P i acy, and con iden iali y-p ese ing By adop ing a FL and ede a ed analysis app oach, he p i acy and con iden iali y o he pa icipan is p o ec ed. De ails o how his is pe o med can be ound in D3.3 Technical Bluep in 11. He e we simply o e a gene al o e iew o how STRONG-AYA will mee his ounda ional p inciple. Speci ically, we will adhe e o bo h GDPR a an in e na ional le el and local da a p o ec ion egula ions in wha conce ns he le els o da a anonymiza ion o pseudonymisa ion o ede a ed lea ning. Wi hin STRONG-AYA we make a dis inc ion be ween: 1. ede a ed analyses ha do no exchange ANY indi idual pa ien in o ma ion, ONLY g oup-le el s a is ical summa ies (e.g. a e ages, con idence in e als, eg ession coe icien s) and 2. analyses ha du ing he compu a ion p ocess will una oidably exchange ou come labels o indi iduals (e.g. ali e/deceased), bu hese would need addi ional da a in o de o iden i y he indi idual. The i s poin encompasses one o he echnological co ne s ones o he p ojec - ede a ed analy ics. S a is ical analyses and desc ip i e s a is ical isualisa ions on g oups o pa icipan s will be pe o med wi hou ansmi ing any indi idual pa ien -le el da a ou side o he da a owning ins i u ion. The second poin ela es o STRONG-AYA suppo ing ede a ed lea ning – a me hod o de eloping epidemiological s a is ical models on a g oup o pa icipan s, wi hou ansmi ing iden i iable pa ien -le el da a be ween ins i u ions. Some epidemiological models will equi e he exchange o he equencies o ce ain ou comes o answe esea ch ques ions – such as ‘ali e (o deceased)’, ‘diagnosis posi i e (o nega i e) o a ime in e al (such as ’90 days since a ce ain e en ’). In some ci cums ances, such an ou come may be STRONG-AYA – No. 101057482 – D4.7 19 cha ac e is ic o only 1 pa icipan . Howe e , wi hou indi idual addi ional da a he indi idual canno be e-iden i ied, bu such speci ic indi idual da a will no be accessible ia he ecosys em and ede a ed lea ning in as uc u e. The e o e, p i acy p o ec ion in ede a ed lea ning and analy ics is based on he un easibili y o e e se-enginee ing a pa icula pa icipan s’ iden i y on he basis o summa ies, s a is ical models o o he such combined da a analyses esul s based on g oups o pa icipan s (which a e also ypically p esen ed in epo s and publica ions)11. Finally, he de elopmen o he COS is based on he idea o da a minimiza ion – s uc u ed da a o he COS is ex ac ed by in es iga o s wi hin each ins i u ion and placed in hei espec i e STRONG-AYA secu e en i onmen con olled by hei own ins i u ion and go e ned by hei own da a p o ec ion egula ions. All da a placed in hese a eas will be checked o ensu e i is pseudonymised o anonymised (as necessa y) consis en wi h he STRONG-AYA Da a P o ec ion Ag eemen o a oid he e-iden i ica ion o indi iduals and in acco dance bo h wi h GDPR and local egula ions. Fo ins ance, iden i iable in o ma ion which is no necessa y o analyses such as bi h da es and pos codes is no allowed. No da es will be s o ed in he STRONG-AYA eposi o y, only ime anges. Simila ly, o a oid e-iden i ica ion, no analyses will be un i he coun o pa icipan s a he in e sec ion o he c i e ia que y alls below 10. 11.2.8. Scalabili y and sus ainabili y As ou lined in he Business a chi ec u e (D2.119), he STRONG-AYA Conso ium is commi ed o he p inciple o scalabili y o i s esul ing ac i i ies, ools, and pan-Eu opean ecosys em – namely, ansla able o o he con ex s - and hei sus ainabili y – namely, o las beyond he li e ime o he esea ch p ojec . This will be done h ough he ope a ions o he ecosys em ou lined he e, h ough he deli e y o he COS, h ough ede a ed lea ning mechanisms, he deli e y o usable and inclusi e ools, and adap abili y o changing e hics and go e nance landscapes. The de elopmen he COS o AYAs wi h cance enables STRONG-AYA o o e new oppo uni ies o he collec ion o homogeneous p ospec i e da a, which will suppo new esea ch and heal hca e inno a ion. The agile and adap able app oach o FL allows lexibili y in inco po a ing exis ing sys ems and p ac ices in la ge ecosys ems, allowing o he accommoda ion o new local con ex s and ecosys ems. Tools which will enable and mo i a e s akeholde s o join and wo k oge he a e he websi es, speci ic ways o se -up o local da abases, po als o s akeholde s o en e and access desi ed in o ma ion, and inally he access o he expe ise equi ed o ope a e ecosys ems a local and Eu opean le els. Finally, STRONG-AYA will emain esponsi e o eme ging and unan icipa ed e hical issues by adhe ing o i e a i ely de eloped e hical guidance h oughou he du a ion o he p ojec , including pa ien -cen e ed and pa ien -in o med e hical guidance. The sus ainabili y o hese aspec s will be ensu ed ia he C C. Con inuous e hical moni o ing is impo an because no all e hical issues can be o eseen – some conce ns and implica ions o building a new esea ch da a in as uc u e and con igu ing new alliances will ha e unan icipa ed consequences. By using an i e a i e e hical guidance me hod, STRONG-AYA aims o espond o ele an e hical and go e nance issues wi h a e lexi e app oach, a ending o conce ns as hey a ise om he de eloping esea ch in as uc u e and collabo a i e esea ch ac ions. To do so, STRONG- AYA d aws on expe ise wi hin he Conso ium o o ganize sui able pla o ms and o ma s o pa ien 11D3.3_TECHNICALBLUEPRINT_STRONGAYA_ 2.pd 19D2.1_ECOSYSTEM_BUSINESS_ARCHITECTURE_STRONGAYA_2023_FINAL1.pd STRONG-AYA – No. 101057482 – D4.7 20 consul a ion ha esul in meaning ul pa ien pa icipa ion and leads o ac ionable pa ien - cen e ed and pa ien -in o med insigh s20. Th ough hese, STRONG-AYA aims o gene a e a s ong cul u e o success ul and sus ainable means o wo king oge he as well as he in eg a ion be ween clinical epidemiological and da a science p ocesses wi h he iews o s akeholde s. The e is an expec a ion ha he ecosys em will speed up analyses on cance in AYA which should lead o as e decision-making in e ms o ea men and ca e. 11.3. Aligned incen i es and mo i es, ac oss Conso ium membe s All Conso ium membe s a e expec ed o be anspa en in communica ing hei incen i es and mo i es o joining a FL Conso ium. This will help he unc ioning o he pan-Eu opean ecosys em by o e ing a gene al iew o he expec a ions and esponsibili ies o di e en use s a local, na ional, and ul ima ely pan-Eu opean le els. The STRONG-AYA Conso ium is commi ed o sa is ying he goals o each pa ne , lexibly, hence anspa ency and speci ici y in incen i es is needed o a pu pose ul collabo a ion. The alignmen o incen i es and mo i es elies on a keen unde s anding o each ins i u ion’s capaci y o achie e i s goals h ough he joining o a FL ecosys em. This ansla es in o ha ing he means and ma u e enough p ocesses o da a collec ion and s o age, o p ocesses which can be op imised wi h some suppo - o ins ance ensu ing alignmen wi h he echnical equi emen s ou lined in he Technical Bluep in (D3.3)11. This also pe ains o he desc ip ion o goals, objec i es and key pe o mance indica o s leading o hese (see D5.2)21. This will mean an alignmen (wi h suppo om he Conso ium expe ise and expe ience) on capaci y o clinical leade ship, adminis a i e powe , scien i ic, echnical, and e hical go e nance knowledge. The ongoing incen i es and mo i es o he exis ence o he STRONG-AYA Conso ium and pan-Eu opean ecosys em a e e lec ed in he p inciples ou lined abo e. In sho , hey can be summa ised as ( o de ails, see D2.2 Code o Conduc 18): 1. Imp o emen in he p o ision o heal hca e se ices:  The de elopmen o alue-based clinical p ac ice, ha becomes esponsi e o new knowledge in eal ime  Imp o ing and accele a ing he implemen a ion o eal-wo ld insigh s in o clinical p ac ice. 2. Pe o ming e hical esea ch on la ge da ase s:  Encou aging in e na ional collabo a ion o esea ch and clinical expe ise  Imp o ing and expanding on he applica ions o a ailable da a in esea ch  Unde s anding and le e aging ins i u ional capaci y. 3. Imp o ing he quali y o pa ien ou comes:  De ining and iden i ying pa ien needs – o esea ch and clinical pu poses  Imp o ing he each o esea ch and unde s anding o pa ien ou comes o pa ien s om di e se backg ounds  Imp o ing pa ien ou comes h ough he use o eal wo ld da a. I is expec ed ha di e en membe s will ha e di e ing p io i ies among hese incen i es o wan ing o pa icipa e in he Conso ium and his is accep able. Fu he mo e, i is acknowledged ha ins i u ional incen i es and mo i a ions o join a Conso ium can go beyond pa ien bene i in e ms o he que ies hey 11D3.3_TECHNICALBLUEPRINT_STRONGAYA_ 2.pd 18 D2.2_ETHICALGUIDELINES_CODEOFCONDUCT_STRONGAYA_ 1.pd 20 D4.6 _OPERATIONALPLANSNATIONALECOSYSTEMS_STRONGAYA_ .1.pd 21 D5.2_KPISandSUCCESSMETRICS_STRONGAYA_ .1.pd STRONG-AYA – No. 101057482 – D4.7 21 may wan o un. These can ange om disco e y (i.e. inc easing olume o da a o help manage a e diseases), imp o ing and expanding on implemen a ions o pas ini ia i es (i.e. sha ing wo kload on di e se da ase s), o encou aging sus ainable in e na ional collabo a ion (i.e. angible ou comes can os e collabo a i e p ac ices). Whiche e he mo i es o a po en ial new membe , he main cha ac e is ic needs o be clinical ac ionabili y ela ed o decisions on wha que ies can be un on he ede a ed da a. This also applies o how da a is collec ed and moni o ed, wha analyses can be pu sued and which analyses can be sha ed o no wi h pa ien s o heal hca e p o ide s. Hence, he pu pose o da a being collec ed, con ibu ed o he da a ecosys em and analysed will ha e a clea ly de ined clinical pu pose o pa ien bene i , in line wi h he de ini ion o ‘bona ide’ esea ch as ou lined in he Code o Conduc (D2.2) and egula ed by local e hics boa ds. This will be a equi emen o all p o essional s akeholde s (i.e. new membe s o he Conso ium) including heal hca e, academic ins i u ions, cha i ies, policy make s, indus y pa ne s, e c. The incen i es guide he ype o ou comes which a e accep able o ou ecosys em, which ou comes a e moni o ed, and he e o e he design o use cases and da a que ies, how he local ecosys ems a e o ganised and he o ganisa ional capaci y alloca ed o due o be de eloped o an ac i e membe ship in he ecosys em. The C C and exis ing Conso ium membe s will p omo e he alignmen o he di e en na ional ecosys ems wi h hese incen i es and o e all mission o he p ojec o he p omo ion o scalabili y and sus ainabili y. 11.4. Managing na ional and ins i u ional di e ences Wi hin he de ini ion o he go e nance model wi h i s s uc u e, p inciples and alignmen o incen i es and mo i es, he Conso ium acknowledges he di e ences be ween ins i u ions and coun ies in hei capaci y, capabili ies, and limi a ions in wha da a can o canno used o ede a ed lea ning o analyses. The e is an expec a ion ha no all coun ies and ins i u ions will be able o ully mee all equi emen s ( echnical, adminis a i e e c) and he e will be gaps in policies. The e hos o a collabo a i e pan-Eu opean ecosys em is ha hese gaps can be b idged as pa o he wo king p ac ices. A ask wi hin he ecosys em needs o be he anspa en communica ion and discussion o hese po en ial di e ences and gaps o allow oom o hei oubleshoo ing and seconda y plans o achie e explici goals. Be o e joining he Conso ium, he e is an expec a ion o local discussions wi h leade ship, echnical and legal eams akin o hose pu sued in D4.4. and D4.6 o iden i y local capaci y. Local e alua ion o da a a ailabili y and me ada a s uc u ing, o iden i y s eng hs and oppo uni ies o de elopmen a each na ional ecosys em le el may be necessa y. These in e iews can be had wi h a hi d, impa ial o ganisa ion bu he esul ing insigh s need o be sha ed wi h he C C as pa o he new membe applica ion p ocess. In e nal in e iews and audi s o insigh s in o po en ial knowledge gaps should p omp local discussions (as exempli ied by D4.4 and D4.6) and should inco po a e a minimum he ollowing ca ego ies: A. P o ision and a ailabili y o e ospec i e da a: Is da a a ailable and can i be analysed? *The ques ions below apply o e ospec i e da a. App o als in line wi h GDPR and local legal/e hical guidelines a e expec ed o be a anged by conso ium membe s.  Wha da a is cu en ly a ailable, om p e ious s udies o clinical p ac ice?  Did pa ien s consen o hei da a being p ocessed o public heal h esea ch?  Can he exis ing da a be FAIR-i ied?  Wha is he local complain s p ocedu e (i.e. immediacy o ac ion, ime ames o eply e c)? B. Da a collec ion and consen no ms o p ospec i e da a: How is da a collec ed? STRONG-AYA – No. 101057482 – D4.7 22 *The ques ions below apply o p ospec i e s udies. App op ia e E hics Boa d app o als in line wi h GDPR and local legal and e hical guidelines will be expec ed o be in place in each loca ion.  Do pa ien s know why he da a is being collec ed?  Do pa ien s ag ee o sha e he da a?  Do pa ien s know why he da a is being sha ed?  Do pa ien s unde s and how i is being sha ed?  Wha is he local ins i u ional p ocess o communica ing esul s back o pa ien s (i necessa y)?  Does da a collec ion ollow p e-exis ing egula ions and ules?  Wha is he local complain s p ocedu e (i.e. immediacy o ac ion, ime ames o eply e c)? C. Ope a ional no ms and s anda ds: How does each ins i u ion ope a ionalise he Conso ium in e nally? *Please ead he cu en Gene al Conso ium Ag eemen o an example o how hese ques ions can be answe ed by an applying membe .  F om whom will you accep a da a que y?  Fo wha pu pose will you use (o allow use) o he da a?  Wha esul s will you allow o be e u ned?  Who adjudica es dispu es o ambiguous si ua ions locally, in ega ds o da a collec ion and analyses (ei he om pa icipan s o esea che s)?  Wha is he h eshold o en y o a new membe o he ede a ions? D. Technical s anda ds: Wha a e he echnical s anda ds (i.e. How a e he da ase s managed o gua an ee da a secu i y, da a in eg i y, and pa ien p i acy)? *Please ead he cu en D3.3. Technical Bluep in and FAIR p inciple abo e, o an example o how hese ques ions can be answe ed by an applying membe . Wi hin STRONG-AYA hese a e managed wi hin WP3 wi h sui able so wa e wi h clea sus ainabili y plans a ailable om IKNL.  How do you ensu e secu i y o que ies wi hin he ans e p ocess?  How is pa ien p i acy p o ec ed?  Do you make you build s anda ds anspa en ?  Wha is he change managemen p ocess?  Wha le el o in e ope abili y needs o be eached (in e ms o so wa e, APIs, and da ase s)?  Wha a e you mechanisms o ensu ing da a in eg i y?  How is da a s anda disa ion cu en ly achie ed? E. Legal and e hical go e nance s anda ds: Wha a e he legal bases o consen ing, collec ing, and using pa ien da a in esea ch in each coun y and ins i u ion?  Does a joining ins i u ion ha e consen and esea ch p ocess p o ocols and p ac ices in place?  Do hese allow (and o wha ex en ) o insigh sha ing as pa o a ede a ed lea ning ecosys em? As an example, we expec a minimum o iden i y he ollowing lis o po en ial (no exhaus i e) di e ences and gaps, which can hen be le e aged and managed wi hin he Conso ium: 1. A ailabili y o e ospec i e (his o ical) clinical and PROs da a wi hin cen es 2. E hical and go e nance ules owa ds he e-use o p e iously collec ed da a o addi ional analyses o insigh s STRONG-AYA – No. 101057482 – D4.7 23 3. Limi a ions in pa ien in o ma ion and consen p ocedu es a na ional le els o e ospec i e and p ospec i e s udies 4. Na ional es ic ions in collec ing speci ic p ospec i e da a (e.g. in F ance collec ion o da a pe aining o e hnici y is no pe mi ed) 5. E hical limi a ions in conduc ing pa icula analyses (i.e. cance incidence by e hnici y) 6. Gaps in echnical o adminis a i e expe ise in handling la ge da a eposi o ies 7. Po en ial di e ences o gaps in implemen ing so wa e solu ions, APIs, and managing da a sys em upg ades o imp o emen s in echnical componen s 8. Time limi a ions in he s o age and use o exis ing o new da a. 12. Ope a ions o he ede a ed lea ning pan-Eu opean ecosys em 12.1. Summa y As desc ibed in sec ion 5.2 and pa icula ly in Figu e 1, ou pan-Eu opean ecosys em elies on he app op ia e unc ioning o i s pa s – each local, and o e ime na ional, ecosys em wi h i s own ope a ional en i onmen (desc ibed in de ail in D4.4 and D4.6). Se e al in e iews and ocus g oups wi h ep esen a i es o each na ional ecosys em e alua ed he local and na ional ‘P epa edness’ o he human esou ces, echnological, and da a managemen and secu i y in as uc u es. The Ope a ional plan below acknowledges ha ou pan-Eu opean ecosys em can only e ol e as as as i s pa s (see Figu e 1); we inco po a e knowledge ga he ed h ough indi idual na ional in e iews ela ed o he heal hca e and echnological sys em eadiness o a c oss-coun y (and la e c oss-Eu opean) de elopmen o an ecosys em. While his may no be possible a a na ional le el in each locale as ye , in ce ain pa s o Eu ope ou ini ia i e has opened he doo s o he de elopmen o he app op ia e in as uc u e o enable his beyond a local le el in each na ion. Ou ini ia i e highligh ed he cu en h ea s and oppo uni ies owa ds he goal o c ea ing na ional ecosys ems ha can hen be in eg a ed wi h an in e na ional ecosys em. The s a us o ecosys em p epa edness in each locale o de elop owa ds a na ional and hen Eu opean ecosys em is desc ibed in D4.4 and D4.6. D4.4 o e s a de ailed plan o he ac ions and issues all ins i u ions wi hin he STRONG-AYA conso ium need o ul ill o ope a e hei local ecosys ems and build na ional AYA cance ecosys ems, including desc ip ions o people/human esou ces, p io i ies o ac ions, and p agma ics o implemen ing he ede a ed ecosys em. D4.6 se ou o numbe o indi idual ac ions om each pa ne ha need o be me o ope a e hei own local and na ional, and he e o e unde pin ou pan-Eu opean ecosys em. These ac ions o med he indi idual oadmaps o each cen e whose da a will con ibu e o he Eu opean ede a ed da a. The upda e on na ional sys em p epa edness is a ailable in D4.9, which includes an upda e on sys em p epa edness one yea la e ollowing he ini ial e alua ions desc ibed in D4.4. He e we summa ize he ac ions s ill needed ac oss na ions o each he ambi ious goal o a pan-Eu opean eco-sys em wi h mul iple s akeholde s a a ious le els o p epa edness. Ou plan below ou lines he de elopmen and in eg a ion o na ional ecosys ems in o a pan-Eu opean da a-sha ing and esea ch-d i en ecosys em o AYAs wi h cance . I includes c i ical ac ions a ound human esou ces, echnology, da a managemen , and secu i y, and aligns wi h he o e a ching p inciples o da a ede a ion, e hical compliance, and s akeholde collabo a ion, ensu ing sus ainable g ow h ac oss na ional and Eu opean amewo ks. STRONG-AYA – No. 101057482 – D4.7 24 12.2. Ope a ional objec i es  Es ablish a collabo a i e da a ecosys em o AYAs wi h cance , including in each pa icipa ing loca ion and ac oss na ions.  Ensu e secu e, scalable da a managemen and moni o ing ac oss local and na ional ecosys ems.  D i e pa ien -cen e ed ca e and ou come-based analysis h ough he in eg a ion o COS and clinical da a associa ed wi h he COS a local and na ional le els.  P omo e sus ainable collabo a ion ac oss all pa icipa ing na ions. 12.3. Scope o Wo k  Suppo he de elopmen o indi idual local and na ional ecosys ems, each ailo ed o local con ex s, egula ions, and heal hca e needs.  Implemen a ede a ed da a in as uc u e ha allows secu e sha ing ac oss local, na ional, and in e na ional ecosys ems.  Es ablish go e nance, da a secu i y, and e hical amewo ks consis en wi h na ional and EU s anda ds.  De ine local ac ions, miles ones, and esou ces needed o a unc ional ecosys em. 12.4. Wo k S uc u e: 1. Ecosys em Se up  De ine na ional ecosys em leade s and eams.  Es ablish local in as uc u e o da a collec ion and s o age (e.g., Secu e Resea ch En i onmen s). 2. Technology and Da a In eg a ion  Implemen ede a ed da a sys ems o secu e c oss-bo de da a access.  Ins all po als o da a submission and moni o ing in each ecosys em. 3. Go e nance and Compliance  Align local ecosys ems wi h GDPR and ele an e hical amewo ks.  Ob ain legal app o als and consen o ms o da a sha ing. 4. S akeholde In ol emen  Engage pa ien s, heal hca e p o ide s, and local go e nmen s.  Implemen cul u al and language adap a ions in pa ien po als. 5. Con inuous Moni o ing and Con ol  Regula secu i y audi s.  Ongoing isk managemen o add ess po en ial cybe -a acks and esou ce cons ain s. 12.5. Na ional Ecosys ems The s a us o his wo k as o 30/09/2024 is de ailed in D4.4 and 4.6, ollowing de ailed in e iews wi h ecosys em leade s in each loca ion and na ion. STRONG-AYA – No. 101057482 – D4.7 25 S akeholde engagemen in collabo a i e communi ies is s ong in each na ion, excep o na ional da a policy-make s. Da a access, cu en ly based upon da a al uism and mu ual us , is delayed, due o some academic delays (in de ining he Co e Ou come da ase o be collec ed), in o ma ion echnology sys em limi a ions and upg ades, and esea ch cul u e ba ie s o AYA esea ch, each in some loca ions. Da a managemen expe ise and capaci y is in place o imminen in each pa ne cen e, o ensu e me ada a and da a quali y. Recen esea ch g an awa ds a e acili a ing widening ou da a access in F ance. O he esea ch g an applica ions can con ibu e o he b ead h o ou pan-Eu opean ecosys em, i unded. The e a e successes and ongoing p og ess plans in each na ion  The Ne he lands: Secu e da a s o age is in place in local hospi als co e ing he whole na ion. Da a ans e ag eemen s and p o ocols o exis ing da a om exis ing s udies (e.g. COMPRAYA) a e ongoing.  UK: Aspi a ions o ob ain exis ing na ional da a om NCRAS ha e been slowed by educed go e nmen al unding. Clinical leade s o AYA cance in NCRAS a e add essing his o achie e a speci ic limi ed na ional da ase , h ough key s akeholde s (TYAC, Ch is ie NHS T us ).  F ance: New esea ch g an awa e will enable wide da a access. Regula o y app o al o COS da a collec ion is delayed by he inaliza ion o he COS.  I aly: Local esea ch da ase in place, om p e ious p ojec s. A secu e in as uc u e o da a is in de elopmen .  Poland: S akeholde s in Wa saw a e building a local esea ch en i onmen . 12.6. Technology and Da a Managemen  Fede a ed Da a In as uc u e: Each na ion e ains local con ol o e i s da a, con ibu ing agg ega e da a summa ies o c oss-Eu opean analysis.  Da a Go e nance: Ensu e ha he da a collec ion and ans e adhe e o he FAIR p inciples (Findable, Accessible, In e ope able, and Reusable).  Tools: Web-based applica ions and po als will allow eal- ime and on-demand analysis o he collec ed da a. These ools will in eg a e pa ien and p o ide eedback loops o enhance decision- making. 12.7. Human Resou ces Managemen  Each cen e is ec ui ing and aining local da a manage s and suppo s a o ensu e compliance wi h da a collec ion and analysis p o ocols.  O ganize wo kshops o ain local heal hca e p o ide s on da a collec ion and in e p e a ion o AYAs. 12.8. Da a collec ion (COS and clinical in o ma ion) Moni o ing and Up ake  Implemen aining o bo h clinicians and pa ien s o inc ease he usage o COS.  Regula e alua ions o COS in eg a ion in o ou ine clinical p ac ices in coun ies unning he implemen a ion s udy. STRONG-AYA – No. 101057482 – D4.7 32 conce ns wi hin he Conso ium o be epo ed and esol ed in a imely manne wi h app op ia e eplies o s akeholde s.  Pa ne s mus ag ee upon a balance be ween da a u iliza ion, da a secu i y, and p e e ences o he da a p o ide s. Howe e , wo k o make he da a analyses use ul o o he s beyond he ini ial Conso ium is i al o sus ainabili y, so his needs o be subjec o u he wo k ac oss he STRONG- AYA ecosys em as i g ows and his documen will be upda ed acco dingly.  In o de o ensu e he sus ainabili y o he ecosys em in as uc u e, h ough use access managemen and moni o ing, Conso ium membe s will be equi ed o con ibu e and collabo a e on ongoing unding ini ia i es o he ongoing use and main enance o he sys em.  While cu en ly access o hese se ices is ee o cha ge, in he u u e, as he conso ium g ows and expands access o he eco-sys em in as uc u e may de elop in o a subsc ip ion- ype model. 13.5. Resolu ion o dispu es and ambiguous si ua ions Dispu es, complain s o ambiguous si ua ions a local le els a e expec ed o be esol ed using he policies and p ocesses speci ic o each ins i u ion as iden i ied h ough PLUTO. A he Conso ium le el, STRONG-AYA, whe e easonable, will employ a bo om-up app oach o adjudica e dispu es o ambiguous si ua ions (Figu e 3). These may ela e o decisions a ound he joining and membe ship o he da a ecosys em and Conso ium, conce ns ela ed o a new use case o esea ch me hods om any s akeholde (p o essional o pa ien ). Any dispu es a ising be ween STRONG-AYA Conso ium pa ne s should be sol ed amicably and espec ully. Ambigui ies on any gi en c i e ia o es ablish h esholds o access o how ules and s anda ds o ope a ion a e applied, will be discussed a he le el o speci ic WP wi h he help o he wo k package leads and he P ojec Coo dina o . I un esol ed, he P ojec Coo dina o will escala e he issue o he C C (speci ically he Coo dina o and he Scien i ic Coo dina o ) who will use media ion, expe and e e en powe s o objec i ely aim o esol e he issue. I he ambiguous si ua ions o dispu es canno be esol ed a his le el, he Coo dina o may appoin a dispu e esolu ion panel o op o e e he issue o he Gene al Assembly o wide consul a ion i needed. I a pa ne wishes o complain abou o he pa ne s in he Conso ium, he complain should be documen ed in w i ing. Such a complain will be add essed o he C C (Coo dina o and he Scien i ic Coo dina o ) and he P ojec Coo dina o in he i s ins ance. I a complain esolu ion panel canno esol e he issue, he Gene al Assembly will be con ened and will o e on a esolu ion o each a binding solu ion. Figu e 4: P ocess o dispu e and complain esolu ion wi hin he STRONG-AYA Conso ium STRONG-AYA – No. 101057482 – D4.7 33 13.6. Submission o use cases The STRONG-AYA Conso ium has de eloped an ini ial p io i y lis o how he da a wi hin he ecosys em in as uc u e can be used by s akeholde s o esea ch and educa ion pu poses. This p io i y lis can be seen as ‘ esea ch ques ions’ o ‘da abase que ies’ o , as hey will be e e ed o hence o h, ‘use cases’. These can only be submi ed by Conso ium membe s wi h ull o pa ial use le el access (see Figu e 4 o a depic ion o he p ocess). Figu e 5: P ocess o submi ing and app o ing new Use cases by Conso ium membe s The cu en lis o use cases has been de eloped as a lis o key ques ions, which could be answe ed by analysing da a wi hin each ins i u ion, aligned o he mo i es, goals, and pe o mance indica o s o he STRONG-AYA pan-Eu opean ecosys em as a whole and hose o each o i s membe s (local and na ional ecosys ems). Consis en wi h he p inciples o s anda disa ion and pa ien bene i , he use cases a e aligned o he COS de ined in WP1 (see D1.2) and hey ha e been u he de ined and p io i ised in collabo a ion wi h se ice use s (pa ien s and ca e s), heal hca e p o essionals, esea che s, heal h se ice manage s, and policy make s (see D4.8). I is en isaged ha his lis o use cases is dynamic and will e ol e o e ime. Consequen ly, he e we se he ules o he de elopmen and submission o new use cases o he Conso ium. An app o ed membe o he Conso ium can choose o submi a use case o be e iewed by he C C ( o an example o how he ini ial use cases ha e been de ined, see D4.8). The c i e ia hese will be e alua ed agains a e:  Demons able clinical bene i : he use cases need o lead di ec ly o imminen ly (wi hin maximum 5 yea s) o imp o emen in clinical o psychosocial ca e.  Demons able co-design wi h ele an s akeholde s: membe s need o desc ibe he p ocess h ough which he use cases we e iden i ied, o mula ed, and p io i ised wi h all s akeholde s in ol ed (pa ien g oups, leads o membe s o o he wo k packages, esea che s, policy make s e c.).  Desc ip ion o legal and e hical conside a ions: use cases submi ed o e iew should include an assessmen o legal and e hical isks and mi iga ions p ocedu es om local e hics/go e nance bodies and consis en wi h GDPR.  Desc ip ion o adminis a i e, echnical, esea ch, and clinical capabili y: once a use case is submi ed and app o ed i will p oduce an ou pu which can be used by he membe (s) o he Conso ium. The implica ions o a gi en insigh need o be assessed and eassu ance o e ed ha STRONG-AYA – No. 101057482 – D4.7 34 he Conso ium membe (s) ha e he capaci y o use he insigh o pa ien bene i and p e en any unin ended ha m.  Plans o g ow h: as pa o he p ocess o submi ing a use case o e iew, Conso ium membe s need o demons a e he p ac ical s eps o how he use case will lead logically and in a imely manne o pa ien bene i , o hemsel es and/o o he Conso ium membe s, wi h associa ed KPIs. 14. Rules on using he ecosys em o ede a ed lea ning and analy ics Once a Conso ium pa ne has de ined hei local go e nance model, se up o upg aded hei capabili ies ( echnical, adminis a i e, e c) o mee he s anda ds o he Conso ium, ha e had hei use cases app o ed, and ha e implemen ed he API, hey a e eady o use he ecosys em o FL and analy ics. This ac ion is led by i s own speci ica ions and ules de ined below. 14.1. Ac i e con ibu ion o he da a ecosys em New and exis ing pa ne s a e expec ed o con ibu e o he da a ecosys em wi h hei own da ase s, which will suppo he sus ainabili y and con inuous de elopmen o he ecosys em. Hono ing he p inciple o S anda disa ion de ined ea lie means ha pa ne s will need o iden i y ways o imp o e he s uc u ing o hei exis ing da a and implemen hese imp o emen s in new da a collec ed. To achie e his, pa ne s and hei local in es iga o s may wan o use me ada a (in o ma ion abou da a such as i s o igin, meaning, measu ing scales, loca ion, iming o collec ion, limi s on s o age du a ion, e c.) which will suppo he use o algo i hms o ede a ed analy ics. While he STRONG-AYA commi s o o e ing he ools and da a science suppo o de elop his, he up ake o local in es iga o s is c ucial o he unde s anding o da a coding and labelling sub le ies. The e is an expec a ion o di e ences in he labelling and o ma ing o da ase s be ween local and na ional ecosys ems. The Conso ium welcomes di e ing da a s uc u es, as long as i can be joined up by me ada a making i possible o pu sue ede a ed lea ning and analy ics ac oss he ecosys em. To assess in e nally whe he ac i e con ibu ion is possible, each Conso ium membe needs o sel -e alua e whe he hey can mee ce ain expec a ions ( o mo e de ails, see D3.1. Da a managemen plan and D3.3. Technical Bluep in ), namely:  Each Conso ium membe is expec ed o ha e a ange o exis ing da a al eady collec ed o being collec ed, co e ing PROs, clinical and se ice use da a wi h ele ance o AYAs wi h cance . Capaci y o p o ide me ada a on hese is necessa y.  The exis ing da a will be associa ed wi h hei own da a collec ion wo k lows and da a managemen p ac ices cha ac e is ic o each ins i u ion, independen om STRONG-AYA, which can be anspa en ly desc ibed.  I can be expec ed ha any new joining pa ne s as well as exis ing ones will ha e a sui able local elec onic pa ien eco d and a de i ed clinical da abase.  Each cen e has an exis ing (o a minimum in ad anced de elopmen ) da abase held in a secu e esea ch en i onmen sui able o special ca ego y STRONG-AYA da a. This will be used o he hos ing o da a locally, unning local compu a ions, and o he s o age o pa ial summa ies o in eg a e in o he Conso ium-wide s a is ical model as pa o he ede a ed lea ning p ocess;  Each joining pa ne needs o p o ide he me ada a o he da a hey will be p o iding o he ede a ed lea ning ecosys em o ensu e and main ain he in e p e abili y and in e ope abili y o he sys em. STRONG-AYA – No. 101057482 – D4.7 35 14.2. Abiding by he echnical s anda ds The Technical Bluep in (D3.3.) de ails he echnical equi emen s, he plan o le e age exis ing expe ise, and hen p o ide suppo o ex end and imp o e local sys ems. The Conso ium will p o ide suppo o pa ne s o ollow s anda ds o he managemen o da ase s o ensu e da a secu i y, in eg i y and p i acy p ese a ion. STRONG-AYA p omo es, encou ages and empowe s au onomy, lexibili y and sus ainabili y a he pa ne le el. Each ins i u ion’s con ibu ion o he COS da ase in STRONG-AYA will emain ully con olled, and managed locally, by he leading in es iga o ep esen ing ha ins i u ion. The echnical eams o each pa ne ins i u ion in he Conso ium mus s i e o imp o e hei own da ase s and hei managemen wi h ag eed, consis en sys em upg ades. The sys em needs o be able o use he APIs o ede a ing da a which will be p og ammed cen ally ( ollowing use case app o al) by membe s o he C C ollowing he p inciples and s anda ds o he Conso ium’s go e nance model (Sec ion 3). As he goals and objec i es o he Conso ium g ow o addi ional pa ne s join he Conso ium, changes will need o be made and a clea change-managemen p ocess will be u he ou lined wi hin his dynamic epo . 14.3. P i acy p ese a ion The STRONG-AYA Conso ium is dedica ed o he concep o ‘p i acy-by-design’. No da a will be expo ed locally om whe e i has pe missions o be held. Only au ho ised s a o a gi en ins i u ion a e allowed access o he line-by-line da a inside hei da a s a ion. No one ou side o ha ins i u ion will be gi en access o his. Any emo e access o he in o ma ion (anonymised o pseudonymised) s o ed in a speci ic ins i u ion is comple ely o bidden. Howe e , each pa ne will be able o see he ou pu o analyses ha includes he da a hey ha e con ibu ed, i hey had been g an ed access o he laye o he ecosys em websi e holding hose ou pu s. Fo example, pa ien s may be able o see hei own pe sonal line-by-line S ong-AYA da a ( h ough a po al in o hei local Elec onic Heal h Ca e eco ds), bu no he line-by-line da a o o he s. Howe e , hey may be able o see compa a i e summa ies o hei own da a agains summa ies o simila da a o o he simila pa ien s (e.g. hey may be able o see hei epo ed PROs da a e sus a e age esponses o o he people wi h he same diagnosis). Da a ele an o he ede a ed sys em will no be accessed by hi d pa ies wi hou explici , unanimous app o al by all membe s o he Conso ium and wi hou explici consen om pa ien s con ibu ing da a o he Conso ium. P o ec ion om da a b eaches is ensu ed h ough a se o obus pene a ion es s – a epo is a ailable om he C C upon eques . P o ec ion om da a leakages is ensu ed h ough he local cybe secu i y s anda ds each ins i u ion has o ollow, commensu a e wi h he equi emen s se ou in he Technical Bluep in and Da a managemen plan. STRONG-AYA encou ages pa ne s o ensu e he a ailabili y o a compensa ion und, in he unlikely e en hey become a ic im o cybe secu i y a acks. Da a will no be used o he pu poses o iden i ying pa ien s o a emp ing o iden i y pa ien s in any ci cums ances. Failu e o ollow his ule will esul in immedia e and pe manen emo al om access o he Conso ium. Any da a b eaches will be in es iga ed using local da a p o ec ion p ocesses and by he C C commensu a e wi h he Da a p o ec ion ag eemen . 14.4. Suppo ing in e p e abili y and in e ope abili y A la ge pa o wo k pu sued by he STRONG-AYA pan-Eu opean ecosys em ocused on ensu ing he in e p e abili y and in e ope abili y o da a a c oss-na ional le el h ough adhe ence o FAIR p inciples. This STRONG-AYA – No. 101057482 – D4.7 36 was done h ough he de elopmen o he WP1 COS and use o me ada a. The COS is an example o alignmen o he da a collec ed unde he same de ini ions in a ious na ions and ins i u ions. This way, a common language is ensu ed as s anda dised, mo e homogeneous in o ma ion can be collec ed and p o ided a local le els, which insu es in e ope abili y – any pa ne will be able o use he da a collec ed wi h a clea knowledge o wha i ep esen s. The use o me ada a locally and ac oss he conso ium also ensu es he in e ope abili y o he da a in as uc u es. Fo example, haemoglobin may be measu ed ac oss all pa icipa ing coun ies. Me ada a ela ed o his da a poin in each ins i u ion will con ain in o ma ion o he measu ing uni s in which i is ep esen ed (e.g. g ams pe decili e o blood o g ams pe li e). While all hese uni s o measu emen a e eligible and accep able o be sha ed wi hou a need o addi ional ans o ma ions, me ada a associa ed wi h he a iable is necessa y o ensu e algo i hms (APIs) can be p og ammed o un ans o ma ions au oma ically and ha he ou pu can be easily in e p e ed by he use . Ano he example is ha o speci ic in e p e a ions o less known a iables – such as nico ine exposu e. This can be encoded as ‘smoking ciga e es’ o ‘chewing obacco’ as lowe le el sub-classes o nico ine exposu e bu i can also be accompanied by quan i y speci ica ions such as numbe o pack/yea s o consump ion. Simila ly, one may de ine a highe le el class o ‘T4’ o umou s aging, wi h T4a and T4b as sub-classes. In his case, sea ching o ‘T4’ will e u n all pa icipan s wi h T4, T4a, and T4b, whe eas sea ching o T4a will only e u n hese speci ic pa icipan s wi h a T4a. The p og amming wi hin he API will be based on he embedded hie a chical ela ionships be ween a iables. To enhance he e-usabili y o local da ase s he ede a ed que ies (de eloped on he basis o use cases) will con e speci ic da a labels p o ided ia me ada a in o gene ic (i.e. schema-independen RDF objec s) and hen adding s udy-speci ic anno a ions. Thus, consis ency in he me ada a sha ed by each pa ne is necessa y o ensu e he sys em is in e ope able and a co ec in e p e a ion o he COS da a and insigh s. While he COS has al eady been de ined, he e is some lexibili y whe eby new ou comes o in e es may be added i associa ed wi h a clea a ionale and p o ided hei measu emen does no aise e hical conce ns such as disc imina ion. These aspec s will be e alua ed by C C in collabo a ion wi h WP2. In he e en ha a p ospec i e pa ne is only collec ing a speci ic, niche ype o da a wi hou plans o expanding his in olume o scope, his will in luence hei abili y o make he Conso ium success ul. Consequen ly, when he ype o exis ing o planned o be collec ed da a is limi ed in a ailabili y (e.g. e y a e umou ypes) pa ne s will need o p o ide in o ma ion on u u e da a collec ion plans and/o g ow h ajec o ies o da a se s as a way o helping hemsel es and C C de e mine ins i u ional capaci y. The Conso ium app ecia es he ime and e o necessa y o hese exe cises i his wo k is no al eady in place as pa o he local da a managemen sys em, and is commi ed o p o iding suppo when necessa y and easible. Di e ing p ecise ypes o da a should no be a oadblock o a success ul da a ecosys em and Conso ium, bu he e needs o be a ecogni ion ha he absence o such in o ma ion may limi he long- e m ope a ion o he Conso ium and will limi he abili y o de i e new insigh s ia ede a ed lea ning and ul ima ely deli e on sha ed goals and incen i es. 14.5. T acking success wi h KPIs As pa o he applica ion p ocess, po en ial new membe s will need o de ine and p o ide a b eakdown o key pe o mance indica o s (KPIs) associa ed wi h hei incen i es and goals (see D5.2 as an example). This is also a equi emen o ongoing membe s, hence KPIs will be cha ac e is ic o each new p ojec a pa ne de elops and will ela ed di ec ly o he exis ing and new use cases submi ed o C C e iew. The da a insigh s accessed ia he ede a ed sys em and subsequen clinical o esea ch indings will be acked in line STRONG-AYA – No. 101057482 – D4.7 37 wi h ag eed KPIs, which will be dependen on he build o he API (i.e. he algo i hms sen h ough he ede a ed ecosys em o p oduce summa y s a is ics). 14.6. Using he in as uc u e Fo he use o he STRONG-AYA in as uc u e membe s need o:  Abide by a pu pose ha is wi hin he lis o accep able au ho ized pu poses o use (e.g. educa ion o esea ch) and consis en wi h he limi a ions o local egis e s. Any pu pose no app o ed ini ially should be discussed and app o ed wi h he Conso ium and da a p o ide s.  A disclaime will be a ailable on all isible pa o he STRONG-AYA in as uc u e s a ing ha he a ailable ools should be used only o esea ch o educa ion pu poses. Conc e e examples will be made a ailable.  Follow he ecommenda ions and aining p o ided on how we a e legally pe mi ed and ha e ag eemen o use he sys em o he di e en pu poses such o pa ien in o ma ion, esea ch, e c.  Use s will be made awa e o he limi a ions o using AI solu ion and he challenges o inco po a e AI in he pa ien -doc o in e ac ions.  All Conso ium membe s need o aise use awa eness abou he isk o o e eliance on he sys em. Use s should ake he ime o unde s and and o challenge he ou comes om he sys em be o e implemen ing hem especially in clinical se ing. Clinicians should make i s hei own diagnosis and hen compa e i wi h he ou pu om he sys em. T aining ma e ials, disclaime s, and ou pu desc ip ions on he STRONG-AYA web in e ace will be adap ed o he ype o use s – heal hca e p o essionals o pa ien s – in conjunc ion wi h o he deli e ables. Below (Table 2) we iden i ied a lis o po en ial isks associa ed wi h he use o a special ca ego y da a ecosys em and some o he ways in which hese isks will be mi iga ed by STRONG-AYA. This lis is no exhaus i e and addi ional isks will be added as hey a e iden i ied. Impo an ly, while some he le els o isks will be di e en o pa ien s e sus p o essional use s, he e we o e a gene ic o e iew. Fo addi ional in o ma ion please e e o he Code o Conduc (D2.2) and G an ag eemen . Risks Mi iga ion ules Risks ela ed o pa ien pa icipan s Pa ien e-iden i ica ion Many people li ing wi h a a e disease may be easie o e-iden i y due o he low numbe o o he indi iduals in he wo ld wi h he same a ian s o a speci ic a e disease. In he case o ex eme a e e en s e- iden i ica ion can ake place h ough he c ossing o da a om he same pa ien s om di e en bu accessible sou ces. A emp ing da a que ies o a e e en s wi h mino changes in se ings/ ules o da a sea ches can lead o he a ibu es o pa icipan s being in e ed. The e will be an ongoing e o o seek da a o achi e e g ea e olumes o diagnoses o people wi h a e diseases. The so wa e au oma ically excludes any compu a ions on 10 o ewe subjec s in any gi en da a s a ion. No analyses will be pe mi ed in e na ionally i da a cells all unde he ag eed da a supp ession h esholds (such as 10 cases pe cell). These es ic ions will apply bo h o absolu e da a quan i y bu also o he amoun o new da a added STRONG-AYA – No. 101057482 – D4.7 38 o he ecosys em since he las analysis by any one API. This p e en s analyses and e-analyses inad e en ly p o iding iden i iable in o ma ion o pa icipan a ibu es o be in e ed. Risks Mi iga ion ules Pa ien wi hd awal om s udy Pa ien s may wish o wi hd aw hei con ibu ion o STRONG-AYA ollowing he pseudonymisa ion o da a. Bein g able o wi hd aw consen is a igh con e ed by GDPR. As he ini ial pseudonymisa ion o da a is done locally by each ins i u ion, and he eques o wi hd awal will be di ec ed a ha ins i u ion, such cases will be deal wi h locally. Conso ium membe s managing local da a s a ion a e expec ed o ha e he means (wi hin he limi s o hei own go e nance sys ems) o manage changes in consen s a us and e-iden i y pa icipan s, i necessa y, by accessing hei own da a s o e sepa a e om he pseudonymised da ase used o ede a ed lea ning. Pa ien pa icipan s do no engage o do no adhe e o su ey comple ions Lack o pa ien engagemen and adhe ence o su ey comple ion is common in PRO esea ch s udies. To mi iga e his, pa ien ad ice will b e sough in he de elopmen o ools and ou comes o be collec ed h ough he STRONG-AYA Pa ien Ad iso y Boa d. They will ensu e ma e ials a e isually engaging, su icien ly in o ma i e and aligned o pa ien needs o mo i a e he comple ion o he ques ionnai e and o ensu e e en ion. Pe sonalized eedback is en isaged o mo i a e pa ien s o con inue pa icipa ion. Guidance and helpdesks will be a ailable. Disc imina ion o o he uses no in he in e es o he pa ien s (ha m ul use) Po en ial que ies in he API may lead o disc imina o y conclusions, which could endange pa ien sa e y. The use and in eg a ion o AI/big da a solu ion in o medical p ac ice b ings he challenge o p ese ing pa ien igh s and in e es s, while s ill making ull use o inno a ion. Po en ial que ies o a iables wi hin he ecosys em which migh lead o biased disc imina o y conclusions will be limi ed h ough he design o he sys em. Howe e , i is di icul o en isage all he ways in which a que y migh lead o disc imina ion wi hou limi ing he use o psychosocial a iables. Use s o he sys em will be able o lag pa icula que ies o a iables as po en ially disc imina o y and o e a desc ip ion o his conce n. This will enable STRONG- AYA o imp o e he sys em o e ime. Use s o he STRONG-AYA esea ch in as uc u e should employ i only o he bene i o he pa ien (on he basis o bona ide esea ch o he imp o emen o pa ien su i al and quali y o li e). This is ensu ed h ough he acking o API usage and STRONG-AYA – No. 101057482 – D4.7 39 i s alignmen wi h p e - de ined KPIs, use cases, and goals. Use s should no use he in as uc u e o po en ially ha m ul use ha could lead o any ype o disc imina ion o endange pa ien ’s wellbeing. Any such ac ions will lead o he emo al o he pa ne om he Conso ium. Risks Mi iga ion ules Dis essing conclusions Da a gene a ed by he STRONG-AYA in as uc u e may equi e s eng h in he pa ien - doc o ela ionship, such as di e en cance ou comes be ween na ions and cen es. The in as uc u e could p o ide in o ma ion o a heal h ca e p o essional o a pa ien which equi es discussion and explanai on o manage any dis ess. App op ia e aining and guidance will be p o ided o all use s o he sys em o how insigh s gene a ed should be in e p e ed o be communica ed o a pa ien (i no he use ). The STRONG-AYA in as uc u e will no be a ou e o speci ic clinical ad ice. Howe e , o hose who may ha e pa icula ques ions, heal hca e p o essional con ac in o ma ion will be made a ailable o pa ien s o discuss po en ially dis essing indings. Technical eedback can be p o ided by IKNL and UNIMAAS as membe s o a C C. The in e p e a ion o analyses comple ed by he APIs will be joined by hei pu pose, app op ia e FAQs, in o ma ion on he limi a ions o common misconcep ions abou he indings. App op ia e disclaime s will be pu in place whe e esul ing insigh s migh be dis essing o a use , especially in he case o pa ien /ca e s. Howe e , a bespoke se o aining, ou pu desc ip ions and disclaime s will be designed o p o essional e sus pa ien use s. Risks o p o essional membe s o he Conso ium Di e ences in legal, e hical, o echnical s anda ds in local ecosys ems o Conso ium membe s Di icul ies in c ea ing he legal en i y and in de eloping a iable ope a ing plan o he pan-EU ecosys em due o lack o alignmen o na ional ecosys ems ope a ing models. This will be mi iga ed acco ding o he sec ion on Managing ins i u ional gaps and di e ences. The e will be an expec a ion o alignmen o local go e nance/e hical s anda ds and p ocesses as well as GDPR om each conso ium membe . STRONG-AYA – No. 101057482 – D4.7 40 Risks Mi iga ion Rules Sys em o e eliance o clinical decision making I may be di icul o p e en clin icians om using he sys em o suppo hei clinical decision-making. This in oduces is a isk o o e eliance on he sys em. All inal clinical decisions will emain wi h he clinician, bu hey may be in luenced by he ou pu s om he sys em (e.g. quali y o li e da a being used in clinical p ac ice). The STRONG-AYA esea ch in as uc u e is de o ed o esea ch and educa ional uses and his ule needs o be ollowed by all pa ne s. The Conso ium will assess, on a case-by-case basis, how he esul s could be used o clinical decision-making (wi hin he po als o STRONG-AYA and da a in local Elec onic Heal h Reco ds) and which limi a ions a e he e o e applicable. The pu pose o making a speci ic que y in he API will need o be decla ed by each use a poin o use. App op ia e aining and guidance will be p o ided o new use s o he sys em and a eedback p ocedu e om use s be made a ailable so ha use s can challenge ou pu s i needed. Ou pu s will include app op ia e desc ip ions and disclaime s commensu a e wi h he ype o use ha may iew hem. Use s will also be able o con ac he STRONG-AYA helpdesk o he local in es iga o s o addi ional ques ions and cla i ica ions. Que ies ou side scope This ela es o que ies, algo i hms, o use cases placed wi hin he API o p ocessing, bu ou side o he scope o he Conso ium and i s goals. Da a ha is collec ed and a ailable o be que ied will always be wi hin he disease a ea o ocus. New que ies and use cases a e pe mi ed only a e due p ocess, conside ing e hical, mo i a ion-based and wide scien i ic condi ions. Any que y, algo i hm, o use case submi ed ia he API which is no aligned o a p e-de ined KPI, goal, and app o ed by he C C will e u n an e o message. Inconclusi e esul s The use asks w ongly o mula ed ques ions which esul s in inconclusi e indings, which could s ill be applied in clinical p ac ice, hence pu ing pa ien sa e y a isk. The e is need o use educa ion and awa eness on how o o mula e use cases and how o use a iables wi hin he sys em o answe hese. App op ia e aining and guidance will be p o ided o new use s o he sys em and a eedback p ocedu e om use s be made a ailable so ha use s can challenge ou pu s i needed. App op ia e disclaime s will be a ailable o he a ious ou pu s, ailo ed o he ype o use s. T aining, guidance and disclaime s a e de eloped by Conso ium membe s as pa o o he deli e ables. Failu e o he echnical sys em due o ex e nal a acks on in as uc u e STRONG-AYA – No. 101057482 – D4.7 41 Gi en he echnical na u e o FL ecosys ems cybe -a acks on in as uc u e a e a isk in he o m o da a poisoning; ea esd opping; model poisoning; decommissioning o he se e ; decommissioning o he ins i u ional da a poin ; pene a ion o he cen al se ice; p i acy e e sion. These aspec s ha e been conside ed in de ail by he STRONG-AYA echnical leads and sa egua ds a e in place as de ailed ac oss mul iple documen s including ROPA/DPIA, Technical Bluep in , e c. App op ia e and obus sys em pene a ion es ing has been pu sued and he epo , which iden i ied minimal such isks, is a ailable upon eques . O e and abo e sa egua ding a he umb ella ecosys em le el, local in es iga o s mus ollow ins i u ional access and da a con ol policies (mul i- ac o au hen ica ion, s ong passwo ds, no sha ing passwo ds, no gi ing access o unwan ed pe sons; people in e ac ing wi h STRONG AYA mus be s a who a e epo ing hei ac ions o he PI). The e a e measu es in place o es ic access o he cen al se e o he minimum numbe o necessa y pe sonnel. Mi iga ion is by design and enc yp ion – by exchanging only summa ies o models and by enc yp ing elecommunica ions i ’s un easible o e-iden i y a pe son. Table 3. Risks and mi iga ion ules 14.7. In ellec ual p ope y guidelines All membe s o he Conso ium ag ee o sha e in ellec ual p ope ly and gi e c edi o he Conso ium as a whole. I an ins i u ion has a p e-exis ing in e nal in ellec ual p ope ly policy, ha policy needs o be communica ed i di e en om he s a emen abo e. The local ins i u ional policies o he Conso ium membe will be applied o any disco e ies made using da a ou side o he Conso ium’s da ase (i.e. PRO o clinical da a a ailable in an ins i u ion ha is no made a ailable/sha ed wi h he Conso ium). 14.8. Sha ing o bene i s - Communica ion and dissemina ion o ou pu s All pa s o he wo k conduc ed by he Conso ium is expec ed o be e iewed by he C C and P ojec Coo dina o . They a e expec ed o e ine wo k (such as he COS, Da a managemen plan o his p esen epo ), upda e i , ensu e ha he e is a clea channel o communica e i o pa ne s (i.e. he p ojec Mic oso Teams sha ed d i e and email communica ions) and o o e see how his wo k is implemen ed. O he communica ion me hods will include in e nal in o ma ion exchange in p e-de ined p ojec mee ings, newsle e s, and summa ies o newly deli e ed epo s o all pa ne s. All and any ou pu s connec ed o he da a and in o ma ion (i.e. including images, new ways o wo king, policy ou each ac i i ies e c.) p oduced wi hin he STRONG-AYA ecosys em should c edi he Conso ium as a whole.