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

Lindner, Oana; Stark, Dan; Connearn, Emily; Feltbower, Richard; Hughes, Nicola; Collaco, Nicole; Wee, Leonard; Jacquemin, Marine; Hogenboom, Joshi; Lysen, Flora; Meacham, Darian; Hanebaum, Simone; Košir, Urska

Abstract

This deliverable defines the context and rationale for the existence of the pan-European ecosystem, its governance model (structure, guiding principles, incentives of partners), specific operations, and rules of its operational activities as a pan-European federated learning ecosystem (for ongoing and new members, for the submission of use cases and use of federated analysis infrastructures). These aspects define the path to generating value, insights, impact, and sustainability through collaboration and federated learning, with iterative tailoring to the stakeholders within the STRONG-AYA Consortium.

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

Author: Lindner, Oana; Stark, Dan; Connearn, Emily; Feltbower, Richard; Hughes, Nicola; Collaco, Nicole; Wee, Leonard; Jacquemin, Marine; Hogenboom, Joshi; Lysen, Flora; Meacham, Darian; Hanebaum, Simone; Košir, Urska
Publisher: Zenodo
DOI: 10.5281/zenodo.17232800
Source: https://zenodo.org/records/17232800/files/D4.7_Operational_plan_pan_European_ecosystem_STRONGAYA_v2.0_30092024.pdf
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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
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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
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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
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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
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9. RE-AUDITING OF RULES AND STANDARDS ......................................................................................... 44
10. COMMITMENTS OF CONSORTIUM AND PARTNERS ......................................................................................44
11. CONCLUSION .................................................................................................................................................45

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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
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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
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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
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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
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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
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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
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 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
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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
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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
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STRONG-AYA – No. 101057482 – D4.7
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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
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*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
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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.
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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.
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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.
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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

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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
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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.
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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
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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.