D5.3 – X-bundle open-source community of the doers

XpanDH G an Ag eemen No. 101095594
D5.3 – X-bundle open-sou ce communi y o he doe s
WP5 – G owing Digi al Heal h ecosys ems
31.12.2024
Au ho s:
Name
O ganisa ion
Name
O ganisa ion
Alexande Be le
Gnomon
Ande son Ca mo
Isc e
Simon Lewe enz
Isc e
Apos olia Ka aba ea
Gnomon
Hen ique Ma ins
Isc e
A gi is Gkogkidis
Gnomon
Ca ola Schul z
empi ica
Funded by he Eu opean Union. Views and opinions exp essed a e howe e hose
o he au ho (s) only and do no necessa ily e lec hose o he Eu opean Union o
HaDEA. Nei he he Eu opean Union no he g an ing au ho i y can be held
esponsible o hem.
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XpanDH G an Ag eemen No. 101095594
Documen con ol
S a us
Final
Ve sion
1.0
Type o Documen
R: Documen , epo ;
Dissemina ion Le el
PU – Public
Wo k Package
WP5- G owing Digi al Heal h ecosys ems
Full documen name
D5.3 - X-Bundle open-sou ce communi y o he doe s
Link o access documen
(i applicable)
Pa ne lead(s)
Gnomon
O he pa ne s in ol ed
Isc e, EMP, CHUP, KETEKNY, TechFo Li e, EDHA, UiO
Wha did his documen aim
o achie e?
[In NO MORE han 5-7 lines]
P esen he main
me hodological app oaches in
bulle poin o ma
The scope o his ask is o b ing oge he implemen e s and end-use s o new and exis ing
solu ions: IT de elope s and endo s/supplie s on one hand; pa ien s and heal hca e
p o essionals on he o he , unde he concep o he 3C-3P communi y (Co-c ea ion
Communi y o Pa ien s, P o essionals and P og amme s).
Wha we e he main indings
o ake-away messages?
Wha implica ions does i
ha e o he XpanDH p ojec ?
See sec ion 6 abou he ecommenda ions and esul s
Which p ojec s akeholde
g oup would bene i he mos
om he documen and why?
Heal hca e P o essional
X
In e na ional Adhe ence
Ne wo k/Ini ia i e
In es o s and Funding
Pa ien O ganiza ion
X
Pa ien /Ca egi e
Pha ma
(Ma ke ing&Sales/Medical
Dep ./R&D)
Public Au ho i y o
Policymake
X
Regula o y body
S anda diza ion Body/ Open-
Sou ce Ne wo k
Resea che /Academic
S a u o y Heal h Insu ance
Company
Technology & Se ice P o ide
X
O he
Lis any ele an
o ganiza ions o social media
accoun s o wide isibili y
h ps://xpandh-p ojec .isc e-iul.p /shape- he- u u e-o -heal hca e-join-xpandhs-
communi y-o -doe s-and-co-c ea o s/
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XpanDH G an Ag eemen No. 101095594
Re ision His o y
Ve sion
Da e
Au ho
Desc ip ion
0.1
18/11/2024
Hen ique Ma ins (Isc e)
Simon Lewe enz (Isc e)
Alexande Be le (Gnomon)
S uc u e o he deli e able
0.2
25/11/2024
Simon Lewe enz (Isc e)
Alexande Be le (Gnomon)
A gi is Gkogkidis (Gnomon)
Fi s d a
0.3
10/12/2024
Ca ola Schul z (empi ica)
In e nal e iew
0.4
19/12/2024
Simon Lewe enz (Isc e)
Alexande Be le (Gnomon)
In eg a ion o eedback om
s akeholde s in wo kshop a he
Eu opean Digi al Heal h
In e ope abili y Days @Isc e)
0.5
24/12/2024
Simon Lewe enz (Isc e)
Re iew be o e submission
0.6
27/12/2024
Alexande Be le (Gnomon)
Re iew be o e submission
0.7
30/12/2024
Hen ique Ma ins (Isc e)
Simon Lewe enz (Isc e)
Re iew be o e submission
1.0
31/12/2024
Alexande Be le (Gnomon)
Ande son Ca mo (Isc e)
Final Re iew
DISCLAIMERS
Disclaime o o iginali y
This deli e able con ains o iginal unpublished wo k excep whe e clea ly indica ed
o he wise. Acknowledgemen o p e iously published ma e ial and o he wo k o
o he s has been made h ough app op ia e ci a ion, quo a ion, o bo h.
Disclaime o con iden iali y
This documen con ains in o ma ion ma e ial om au ho p op ie y (iden i iable,
whe he w i en, eco ded (audio/ ideo), compu e ized, o in e e ence o XpanDH
bene icia ies). This s a emen highligh s he in ellec ual p op ie y o he XpanDH
au ho s, and may no be used (copied/ ep oduced) wi hou a clea au ho isa ion o
he membe s.
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Table o Con en s
Lis o abb e ia ions ................................................................................................................................................ 6
Execu i e summa y ................................................................................................................................................... 7
1 In oduc ion ......................................................................................................................................................... 9
1.1 Backg ound ..................................................................................................................................................... 9
1.2 Scope and objec i es ......................................................................................................................... 9
2 De ini ion o he Communi y o Doe s ............................................................................................ 10
3 Ra ionale and me hodological app oach ...................................................................................... 10
4 Plena y Communi y o Doe s ................................................................................................................. 13
5 Wo king g oups ................................................................................................................................................ 14
5.1 Wo king g oup on Mul idisciplina y umou boa ds o cance pa ien s (3C-
3P-MDT) ..................................................................................................................................................................... 15
5.2 Wo king g oup on elec onic p esc ip ion, elec onic dispensa ion and
elec onic p oduc in o ma ion (3C-3P-EPD) ................................................................................. 17
5.3 Mul i-Coun y wo king g oup on imaging – CoD (3C-3P-MIM) ........................... 18
5.4 Wo king g oup on Teleheal h—Teleconsul a ion Encoun e Repo (3C-3P-
TER) 19
6 Lessons lea ned and Key Recommenda ions ........................................................................... 20
6.1 Lessons Lea ned ................................................................................................................................. 20
6.2 Key Recommenda ions om WGs ..........................................................................................24
6.2.1 Key Recommenda ions om 3C-3P-MDT ....................................................................24
6.2.2 Key Recommenda ions om 3C-3P-EPD ............................................................... 26
6.2.3 Key Recommenda ions om 3C-3P-MIM ............................................................... 26
6.2.4 Key Recommenda ions om 3C-3P-TER ................................................................. 27
7 Con inua ion and nex s eps .................................................................................................................28
8 Re e ences ........................................................................................................................................................ 30
Annexes .......................................................................................................................................................................... 32
Annex 1 ....................................................................................................................................................................... 32
Annex 2 ..................................................................................................................................................................... 45
Annex 3 ..................................................................................................................................................................... 83
Annex 4 ..................................................................................................................................................................... 114
Annex 5 .................................................................................................................................................................... 132
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Table o Figu es
Figu e 1 Pho os o he i s ga he ing o he Communi y o Doe s in A hens .................. 13
Figu e 2 Sc eensho s om he i s online webina o he Communi y o Doe s. ........ 14
Figu e 4 Pho o o i s mee ing o wo king g oup on umou boa ds a G eek Cance
Fo um in A hens, G eece ..................................................................................................................................... 16
Figu e 5 Pho os o he wo king g oup on eP/eD/ePI wo kshop 27 June a Madei a
Digi al T ans o ma ion Week in Funchal, Po ugal .............................................................................. 18
Figu e 6 Pho o o XpanDH a he IHE-Eu ope Connec a hon in Rennes, F ance .......... 19
Figu e 6 Pho o o he 3C-3P-TER wo king g oup’s p esen a ion a he Eu opean
Digi al Heal h In e ope abili y Days @Isc e in Lisbon, Po ugal.............................................. 20
Table o Tables
Table 1 Communi y o Doe s Wo king G oups wi h sho desc ip ion ................................. 14
Table 2 Possible hando e o XpanDH's Communi y o Doe s wo king g oups ...........28

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Lis o abb e ia ions
Ac onym
Desc ip ion
3C-3P
Co-c ea ion Communi y o Pa ien s, P o essionals and
P og amme s
COD
Communi y o Doe s
EEHRxF
Eu opean Elec onic Heal h Reco d Exchange Fo ma
EHDS
Eu opean Heal h Da a Space
WG
Wo king g oup
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Execu i e summa y
This deli e able p o ides a comp ehensi e o e iew o he philosophy, s uc u e,
and key ou comes o he X-Bundle open-sou ce communi y ini ia i e, known as he
3C-3P Communi y (Co-C ea ion Communi y o Pa ien s, P o essionals, and
P og amme s), as de eloped wi hin he XpanDH p ojec . The deli e able explo es
how his collabo a i e amewo k was designed and ope a ionalised o suppo he
adop ion o he Eu opean Elec onic Heal h Reco d Exchange Fo ma (EEHRxF) and
ad ance he Eu opean Heal h Da a Space (EHDS).
The documen begins by in oducing he backg ound, scope, and objec i es o he
X-Bundle ini ia i e, which aims o engage di e se s akeholde s—IT de elope s,
heal hca e p o essionals, and pa ien s—in a anspa en and sus ainable co-c ea ion
en i onmen . The communi y's s uc u e is de ined in e ms o i s co e objec i es,
go e nance, and ope a ional me hodologies, which d aw on success ul models such
as openNCP and openHIE.
The a ionale and me hodological app oach ou line he guiding p inciples and
s a egies o communi y o ma ion, ocusing on inclusi i y, collabo a ion, and he
euse o asse s de eloped in p e ious wo k packages. Pa icula emphasis is placed
on he es ablishmen o a Plena y Communi y o Doe s and se e al specialised
wo king g oups.
Fou wo king g oups we e es ablished du ing he cou se o he p ojec :
1. Mul idisciplina y umou boa ds o cance pa ien s (3C-3P-MDT)
2. Elec onic p esc ip ion, elec onic dispensa ion and elec onic p oduc
in o ma ion (3C-3P-EPD)
3. Mul i-Coun y wo king g oup on imaging – CoD (3C-3P-MIM)
4. Teleheal h— Teleconsul a ion Encoun e Repo (3C-3P-TER)
These g oups acili a ed a ge ed discussions and wo kshops, including a highly
a ended on-si e mee ing o he 3C-3P-MDT g oup du ing he 1s G eek Fo um on
Cance : Policy, Resea ch & Funding S a egies on July 2nd, 2024, and a no able se ies
o 3 in ense plena y sessions om he 3C-3P-EPD g oup held in he las imes e o
2024. Such wo kshops se ed as pla o ms o knowledge-sha ing, co-c ea ion, and
e ining ools o suppo EEHRxF adop ion.
Key lessons lea ned and ecommenda ions highligh he challenges and enable s
encoun e ed du ing he p ocess, p o iding ac ionable insigh s o sus aining and
scaling he communi y. Finally, he deli e able ou lines he con inua ion and nex
s eps, ensu ing he momen um o he X-Bundle ini ia i e is main ained and i s
con ibu ions o he EHDS a e expanded.
This deli e able no only cap u es he ounda ional e o s behind he 3C-3P
Communi y bu also se es as a oadmap o os e ing collabo a i e inno a ion and
sus ainable go e nance in digi al heal h in e ope abili y ini ia i es.
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Following he plena y Communi y o Doe s wo kshop du ing he Eu opean Digi al
Heal h In e ope abili y Days held a Isc e in Lisbon, Po ugal in Decembe 2024, a se
o o he possible WGs ha e been iden i ied, and while he syne gies be ween his
bo om-up pa icipa ed and co-c ea ed manne and he op-down “ o ma
Implemen ing Ac s” app oach will be di icul a imes, i seems essen ial o ROOT
he o ma in conc e e alue-adding p ocesses o ca e.
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1 In oduc ion
1.1 Backg ound
The scope o his deli e able is o documen he me hodology, go e nance, and
ope a ional s a egies employed by XpanDH o es ablish and suppo he 3C-3P
Communi y o Doe s. I cap u es he collabo a i e e o s unde aken o co-c ea e
ools, e ine wo k lows, and align p ac ices wi h he equi emen s o he EEHRxF and
EHDS. The deli e able also syn hesises key lessons lea ned and p o ides ac ionable
ecommenda ions o os e ing a sus ainable and scalable communi y o
s akeholde s.
The objec i es o Deli e able 5.3 include:
1. Desc ibing he ounda ional p inciples and go e nance s uc u e o he X-
Bundle open-sou ce communi y.
2. Highligh ing he pa icipa o y me hods and s akeholde engagemen
s a egies employed in he co-c ea ion o digi al heal h ools and se ices.
3. Repo ing on he key ou comes and insigh s om wo king g oups and
communi y ac i i ies, such as wo kshops and plena y sessions.
4. P oposing ecommenda ions o he con inua ion and scalabili y o he X-
Bundle communi y, ensu ing i s alignmen wi h he e ol ing digi al heal h
landscape in Eu ope.
By add essing hese objec i es, his deli e able aims o p o ide a comp ehensi e
esou ce o s akeholde s in e es ed in os e ing co-c ea ion and in e ope abili y
wi hin he Eu opean heal h da a ecosys em.
1.2 Scope and objec i es
Deli e able 5.3 ocuses on desc ibing he philosophy and s uc u e o he app oach
aken o es ablish he X-Bundle open-sou ce communi y, known as he 3C-3P
Communi y, wi hin he XpanDH p ojec . I p o ides an accoun o he collabo a i e
amewo k designed o engage IT de elope s, heal hca e p o essionals, and pa ien s
in co-c ea ing ools aligned wi h he EEHRxF and he EHDS. This deli e able epo s
on he go e nance model, communi y dynamics, ope a ional p ocesses and esul s
o he Communi y o Doe s and i s wo king g oups.
Addi ionally, i cap u es key insigh s and ou comes om he a ious wo king g oups
o med as pa o he ini ia i e, showcasing hei con ibu ions o he co-c ea ion
p ocess. By documen ing hese ac i i ies, along wi h annexed ma e ials om wo king
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unde sco ed he impo ance o p e en ion, ea ly de ec ion, accina ion access, and
he p o ision o high-quali y heal hca e se ices in enhancing pa ien ou comes and
sa ing li es. Wi h leade ship om WHO Eu ope’s Regional Di ec o D . Hans Kluge,
discussions os e ed collec i e s a egies o enhance cance ca e, pa ing he way
o mul idisciplina y collabo a ion. The o um’s emphasis on inno a i e, pa ien -
cen ed ca e, models inspi ed he XpanDH wo king g oup’s commi men o
ad ancing he ole o digi al ools and in e disciplina y coope a ion in op imising
umou boa d p ac ices o cance managemen .
Figu e 3 Pho o o i s mee ing o wo king g oup on umou boa ds a G eek Cance Fo um in
A hens, G eece
2
This i s in-pe son ga he ing was used as a pla o m o launch he wo king g oup.
Following his, he g oup con ened o se en mee ings, al e na ing be ween in-
pe son and online o ma s. These sessions ocused on co-c ea ing solu ions o
enhance he ope a ion o mul idisciplina y umou boa ds.
Key ac i i ies included e iewing in e ope abili y gaps in pa ien da a sha ing,
explo ing he in eg a ion o digi al ools o suppo decision-making, and add essing
challenges in aligning mul idisciplina y collabo a ion wi h EHDS egula ions.
S akeholde engagemen was cen al, in ol ing oncologis s, IT p o essionals, pa ien
ep esen a i es, and policymake s o ensu e a well- ounded app oach.
2
Sou ce: LinkedIn o he Hellenic Cance Fede a ion - ELLOK

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MDT was de ined as a key use case o he adop ion o he EEHRxF as depic ed in
he pic u e below
The ou comes o hese discussions a e consolida ed in a comp ehensi e epo (see
Annex 2), which ou lines ac ionable ecommenda ions o imp o ing umou boa d
p ocesses h ough inno a i e digi al solu ions and mul idisciplina y coope a ion.
5.2 Wo king g oup on elec onic p esc ip ion,
elec onic dispensa ion and elec onic p oduc
in o ma ion (3C-3P-EPD)
The idea ion o he XpanDH Communi y o Doe s' wo king g oup on elec onic
p esc ip ion (eP), elec onic dispensa ion (eD), and elec onic p oduc in o ma ion
(ePI) eme ged du ing a dedica ed wo kshop held on 27 June 2024 a Madei a Digi al
T ans o ma ion Week in Funchal, Po ugal. This e en , mode a ed by expe s
including Hen ique Ma ins (ISCTE), Alexande Be le (Gnomon), and Anne Moen
(Uni e si y o Oslo), engaged o e 20 pa icipan s om academia, indus y, and
esea ch communi ies. The discussions highligh ed he in eg a ion o use
pe spec i es o design in e ope able solu ions ha align wi h he p ac ical needs o
pa ien s and heal hca e p o essionals, b idging he digi al di ide. B eakou sessions
explo ed added alue, se ice domain scope, and echnical asse s o enhance
eP/eD/ePI se ices. Con ibu ions om ela ed p ojec s like UNICOM and G a i a e-
Heal h en iched he discou se, ocusing on c oss-bo de digi al heal h inno a ion
and alue-adding pa ien -cen ic in o ma ion sys ems.
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Figu e 4 Pho os o he wo king g oup on eP/eD/ePI wo kshop 27 June a Madei a Digi al
T ans o ma ion Week in Funchal, Po ugal
A e his i s on-si e mee ing, he wo king g oup c ea ed a co e eam o 7
indi iduals o mee weekly and ocus on p oducing he epo annexed in his
deli e able (See Annex 3). Th ee online mee ings wi h he plena y CoD we e held o
e iew and in eg a e b oade con ibu ions in o he discussion and o di ec ly in o m
he inal epo .
5.3 Mul i-Coun y wo king g oup on imaging –
CoD (3C-3P-MIM)
The Mul i-Coun y Wo king G oup on Imaging – CoD (hos ed by IHE-Eu ope
3
) was
concei ed du ing he IHE Eu ope Connec a hon e en held in Rennes in Sep embe
2023. This g oup ocuses on ad ancing imaging p ac ices by in eg a ing new
s anda ds and echnologies o managing images in bo h p ima y and seconda y use
cases. The ini ia i e builds on p io wo k ca ied ou in F ance unde he Segu
p og amme and inco po a es ecommenda ions om IHE Eu ope's mul i-coun y
wo king g oup. Wi h ac i e pa ien in ol emen , his wo king g oup is also aligned
3
See: h ps://www.ihe-eu ope.ne /mul i-coun y-wo king-g oup-Imaging-In o ma ion-
Sha ing
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wi h he eHeal h Ne wo k, X-eHeal h, and XpanDH p ojec s. I aims o ha monise
imaging p ac ices ac oss bo de s, ensu ing in e ope abili y and inno a ion in he use
and exchange o medical imaging da a unde he Eu opean Heal h Da a Space
amewo k.
Figu e 5 Pho o o XpanDH a he IHE-Eu ope Connec a hon in Rennes, F ance
The MCWG on Imaging b ings oge he a di e se ne wo k o s akeholde s, such as
na ional eHeal h agencies, minis ies, compe ence cen es, and ep esen a i es om
XpanDH's o he Communi ies o Doe s. By aligning imaging p ac ices and s anda ds,
he g oup os e s in e ope abili y and le e ages eedback om i s pa icipan s o
de elop ac ionable ecommenda ions. The ini ia i e is suppo ed by a co-c ea ion
amewo k, in eg a ing pa ien s, p o essionals, and p og amme s o ensu e ha end-
use needs emain cen al. This wo king g oup plays a pi o al ole in shaping
Eu opean heal hca e policies and s anda ds, u he ein o cing he EHDS goals. See
Annex 4 o a ull e iew o he ecommenda ions o his wo king g oup.
5.4 Wo king g oup on Teleheal h—
Teleconsul a ion Encoun e Repo (3C-3P-TER)
The Teleheal h—Teleconsul a ion Encoun e Repo wo king g oup was es ablished
h ough a se ies o online wo kshops and esea ch ac i i ies ca ied ou unde WP6,
pa icula ly Task 6.2. Ini ially d awing hea ily on he No dic expe ience, especially
Denma k, he g oup is now expanding i s scope o inco po a e insigh s om o he
pionee ing coun ies like Po ugal, an ea ly de elope o eleheal h se ices.
The p ima y objec i e o he g oup is o design se ices ha suppo
eleconsul a ions wi hin he amewo k o he EEHRxF. I s inspi a ions and ocuses
include ad ancing da a collec ion me hodologies om elemoni o ing, pa icula ly
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ensu ing he au oma ic s o age o collec ed measu emen da a in na ional
eposi o ies. Fu he mo e, key echnical challenges include explo ing he use o AI o
suppo da a collec ion and he p epa a ion o encoun e epo s, add essing access
igh s o sha ing, iewing, and o wa ding pa ien heal h da a, and de e mining
op imal me hods o da a s o age—all while ensu ing ull alignmen wi h he EEHRxF.
See annex 5 o he ull ecommenda ions o his wo king g oup.
Figu e 6 Pho o o he 3C-3P-TER wo king g oup’s p esen a ion a he Eu opean Digi al Heal h
In e ope abili y Days @Isc e in Lisbon, Po ugal
6 Lessons lea ned and Key
Recommenda ions
Lessons lea ned om idea ing, igni ing and p opelling he Communi y o Doe s and
i s di e en wo king g oups a e sha ed, be o e dwelling in o he key
ecommenda ions om each wo king g oup. The ecommenda ions a e mo e o less
de ailed depending on he g oups’ le el o ma u i y.
The ull ecommenda ions can be ound in he annexed epo s om he espec i e
wo king g oups. They encompass legal, egula o y, policy, ca e p ocess, in o ma ion,
applica ions and IT in as uc u e laye s o in e ope abili y o each ocus.
6.1 Lessons Lea ned
This p ocess o in ol ing expe s and olun ee s om he h ee main communi ies
p o ed ha bo om-up app oach engaging he eal end use s can p ope ly de ine
speci ic use cases aking in o accoun all he p oblems and challenges ha end use s
ace in eal li e. The in oduc ion o he EEHRxF in hei daily p ocesses need o be
bene icial o all namely.
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1. Fo he p og amme s communi y (so wa e enginee s, in o ma ion a chi ec s,
e c) his p ocess was enligh ening as echnical people had access o he end
use s hey a e building in o ma ion sys ems.
2. Fo he p o ide ’s communi y, he p ocess allowed hem o eely desc ibe
hei daily challenges, ocus on he pa s ha could be imp o ed and educe
hei wo kload. They unde s ood be e why he use o s uc u ed documen s
such as hose p oposed by he EEHRxF could acili a e hei wo k. In some
cases, hey had he oppo uni y o p opose ou o he box ideas and new
clinical documen s o new heal h in o ma ion domains o be conside ed o
he EEHRxF and he EHDS egula ion in he u u e.
3. Fo he pa ien ’s communi y, a g ea pa o hei wo k ocused on ensu ing
ha pa ien s can be included as an impo an s akeholde , ensu ing digi al
li e acy o pa ien s as well as secu ing hei igh s and access o hei da a.
We summa ize he lessons lea ned om ou XpanDH Communi y o Doe s, below:
The Powe o Mul is akeholde Engagemen
The inclusion o di e se s akeholde s—heal hca e p o essionals, IT expe s, legal
au ho i ies, go e nmen al bodies, pa ien associa ions —p o ed essen ial o
unde s anding he complexi ies o da a exchange in speci ic use cases. Thei a ied
pe spec i es en iched he discussions and highligh ed he need o a collabo a i e
app oach in add essing sha ed challenges.
Fu he mo e, his p ocess was p o en bene icial o all s akeholde s engaged as hey
had he possibili y o clea ly s a e hei needs and challenges.
The 7-laye me hodological app oach p oposed by XpanDH COD guided he
s akeholde s in o di ing s ep by s ep in he desc ip ion o a use case whe e EEHRxF
use could be bene icial. The p ocess enabled open discussions and consensus
building allowing all oices o be hea d.
Pa ien -Cen ic App oaches A e Key
A ecu ing heme was he need o empowe pa ien s wi h g ea e in ol emen in
heal h ca e p ocesses. Ensu ing ha pa ien s a e well-in o med abou hei
condi ion and ea men op ions os e s us and imp o es decision-making. The
consen p ocess also eme ged as a c i ical a ea o enhancemen , emphasizing
anspa ency and simplici y. F om he p ocess and discussions du ing he WG
mee ings i was clea ha no all s akeholde s had he same iew abou impo an
issues ela ed o pa ien igh s, such as access o da a, igh o objec in he use o
hei da a, da a po abili y, seconda y use o hei da a and many mo e.
Du ing he mee ings pa ien s and p o ide s managed o ind he igh way o de ine
he p ocesses and wo k low so ha heal hca e p o essionals can do hei wo k
p ope ly wi h no delay and impedimen s bu aking in o accoun he need o keep

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hei pa ien s in o med du ing hei ea men . This in ol es unde s anding how o
use medica ion documen a ion, be in o med abou c i ical challenges and decisions
ha need o be made du ing he he apeu ic ea men . This was especially ue
du ing he discussions o o he Tumou Boa d p ocesses.
Dealing wi h ba ie s and challenges oge he
Fo example, in he Mul idisciplina y umou boa d WG, while he ocus was on
cance , se e al challenges—such as he need o be e communica ion be ween
doc o s and pa ien s, smoo he wo k lows, and he adop ion o digi al echnologies
like emo e moni o ing—we e iden i ied as sys emic issues ac oss heal hca e
domains. Add essing hese could yield b oade bene i s beyond he scope o cance
ca e.
Each wo king g oup ocused on de ining he challenges and ba ie s cu en ly
exis ing and ied o ocus on how he EHDS egula ion and he applica ion o EEHRxF
could emo e ba ie s and acili a e he p ocess o ca e. Discussing challenges and
open issues a he le el o he wo king g oups enabled o simpli y he discussions
and ind ways o p opose possible solu ions o he u u e. I was no ed in many
cases ha mos o he ba ie s we e no echnical, bu mos ly legal o p ocedu al.
EHDS egula ion will po en ially enable discussions in membe s a es o al e he
cu en legal amewo k and enhance he use o digi al ools o bo h pa ien and
heal hca e p o ide s.
In e ope abili y and In eg a ion A e Non-Nego iable
Seamless in o ma ion exchange be ween sys ems emains a co ne s one o
achie ing be e ou comes. Technical ba ie s, such as sys em incompa ibili ies, and
he lack o s anda dized o ma s o da a sha ing, need u gen esolu ion o suppo
he goals o he upcoming Eu opean Heal h Da a Space (EHDS). The use o EEHRxF
complian clinical documen will enable o educe his p oblem in mos cases. I is
impo an hough o ensu e he implemen a ion o an in e ope abili y amewo k
go e nance in all EU membe s a es o enable bo om-up discussions o each
in e ope abili y use case sepa a ely. Coun ies such as F ance and G eece ha e
bene i ed o his p ocess and enabled he possibili y o co-c ea e he design and
echnical speci ica ions o sol e speci ic in e ope abili y use cases aking in o
accoun he opinion and expe ise o all s akeholde s. In e ope abili y F amewo ks
a e a key elemen o success o he u u e adop ion o he EEHRxF speci ica ions a
he MS le el. The exis ing Re ined eHeal h In e ope abili y F amewo k is a good
example a he Eu opean le el.
Adminis a i e and Wo kload Challenges o Heal hca e P o essionals
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Bu eauc a ic hu dles and hea y wo kloads we e iden i ied as signi ican ba ie s o
heal hca e p o essionals. These issues no only hinde e icien ca e deli e y bu also
a ec he adop ion o new digi al solu ions. S eamlined p ocesses and a ge ed
suppo could alle ia e hese challenges. The c ea ion o WG eusing he app oach
o he 3C-3P me hodology p oposed by XpanDH has p o en ha his co-c ea ion
p ocess managed o iden i y a he ea ly s ages such issues, ying o ind
echnological p oposal, new inno a i e business se ices ha could educe hose
challenges and empowe he ole o he heal hca e p o essionals.
Value o a S uc u ed "As-Is" o "To-Be" App oach
Mapping he cu en s a e (“as-is”) and en isioning he u u e s a e (“ o-be”)
p o ided a s uc u ed way o analyse gaps and p opose ac ionable solu ions. This
amewo k was ins umen al in o mula ing p ac ical ecommenda ions ailo ed o
ca e p ocesses, IT in as uc u e, and egula o y en i onmen s. Some wo king g oups
used collabo a ion ools o analyse s ep by s ep how o mo e om he cu en
s a us quo o a u u e be e designed, echnology enabled use case. In se e al cases
he o-be app oach p oposed new clinical documen s o p oposed o use clinical
modelling o c ea e new clinical documen s ha can be eused o he con inui y o
ca e p ocess as well as o seconda y use o da a.
The Impo ance o Legal and Regula o y Alignmen
Regula o y amewo ks o en lag echnological ad ancemen s, c ea ing ic ion in
adop ion. Discussions highligh ed he impo ance o aligning legal equi emen s wi h
he EHDS egula ion o ensu e secu e, e hical, and e icien da a use ac oss Eu ope.
The wo k o he 3C-3P WG de ined in mos cases ecommenda ions o al e , e iew
and adap he cu en legal amewo k o allow he use o s uc u ed da a, ind ways
o allow he use o digi al heal hca e ools especially in he collabo a ion o pa ien s
and heal hca e p o essionals o bo h he ea men and p e en ions cycles.
Recommenda ions Need o Be Holis ic and Ac ionable
Di iding ecommenda ions in o clea ca ego ies—ca e p ocesses, IT in as uc u e,
applica ions, and legal amewo ks—helped in p o iding a ge ed and ac ionable
insigh s o s akeholde s. This app oach ensu es ha p oposed solu ions add ess
he speci ic needs o each domain while aligning wi h he o e all p ojec goals.
Digi al T ans o ma ion Mus Be Comp ehensi e
Digi al echnology’s ole in heal h ca e, including emo e moni o ing and ad anced
da a managemen , was ecognized as c ucial. Howe e , i s success ul
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implemen a ion depends on bo h echnical eadiness and cul u al accep ance
wi hin heal hca e sys ems.
Communica ion Is he Glue
E ec i e communica ion and collabo a ion be ween pa ien s, ca egi e s, and
heal hca e p o ide s eme ged as an o e a ching heme. Wi hou s ong
communica ion channels, e en he mos ad anced sys ems and p ocesses isk
ailing o deli e op imal ca e.
6.2 Key Recommenda ions om WGs
Below a e lis ed he key ecommenda ions s emming om he ou wo king g oups:
Mul idisciplina y umou boa ds o cance pa ien s (3C-3P-MDT), Elec onic
p esc ip ion, elec onic dispensa ion and elec onic p oduc in o ma ion (3C-3P-
EPD), Mul i-Coun y wo king g oup on Imaging (3C-3P-MIM), Teleheal h—
Teleconsul a ion Encoun e Repo (3C-3P-TER). Mo e de ails o each espec i e
ocus can be ound in he annexed epo s.
6.2.1 Key Recommenda ions om 3C-3P-MDT
The ollowing ecommenda ions we e iden i ied in he p ocess o he wo king
g oup on Mul idisciplina y umou boa ds o cance pa ien s (3C-3P-MDT):
1. Legal and P ocedu al F amewo ks:
• De elop comp ehensi e legal amewo ks o ensu e GDPR compliance and
alignmen wi h he Eu opean Heal h Da a Space (EHDS).
• Add ess challenges such as consen e oca ion, pa ien p i acy, and sha ed
liabili y wi hin Mul idisciplina y Teams (MDTs).
• Implemen p o ocols o anonymisa ion and s uc u ed communica ion o
enhance anspa ency and mi iga e isks in decision-making.
2. S akeholde Collabo a ion:
• Fos e collabo a ion among heal hca e p o ide s, esea ch ins i u ions,
echnology i ms, and pa ien ad ocacy g oups.
• Es ablish clea go e nance s uc u es, oles, and communica ion channels o
ensu e alignmen wi h pa ien -cen ed ca e p inciples.
• P omo e inno a ion and e idence-based p ac ices by in eg a ing
s anda dised wo k lows and bes p ac ices.
3. Ca e P ocess Op imisa ion:
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• Implemen In eg a ed Ca e Pa hways (ICPs) o align ca e p ocesses and
s anda dise miles ones.
• Use Sha ed Wo k lows o assign oles, s eamline ope a ions, and inco po a e
bes p ac ices, he eby enhancing accoun abili y and e iciency.
• Le e age s uc u ed da a o ma s and eal- ime communica ion ools o
educe delays and imp o e coo dina ion.
4. IT In as uc u e S anda ds:
• Build scalable, secu e, and in e ope able sys ems adhe ing o HL7 FHIR, o he
HL7 s anda ds, and IHE p o iles.
• Ensu e compliance wi h in e na ional e minology s anda ds like SNOMED CT,
ICD-10/11, and ICD-O-3.
• Inco po a e obus enc yp ion, modula a chi ec u es, a ibu e-based
access con ols, and audi logs o secu e da a managemen .
5. In eg a ion o Ad anced Tools:
• Enable he use o wea ables and IoT de ices o en iched da a collec ion and
eal- ime heal h moni o ing.
• In es in s o age, backup solu ions, and edundancy o ensu e sys em
esilience and minimise dis up ions.
6. Use -Cen ic Applica ions:
• De elop applica ions wi h in ui i e in e aces, da a isualisa ion capabili ies,
and in eg a ion wi h exis ing sys ems such as EHRs.
• Ensu e pa ien empowe men by p o iding anspa en , eal- ime access o
pe sonal heal h da a while adhe ing o eme ging s anda ds.
7. C oss-En e p ise Da a Sha ing:
• Le e age he Eu opean Elec onic Heal h Reco d Exchange Fo ma (EEHRxF)
o collec and p esen dispa a e da a o MDT umou boa ds.
• U ilise c oss-en e p ise documen sha ing a chi ec u es o acili a e
e ec i e MDT ope a ions, suppo ing p ecision medicine and inno a i e
ea men s.
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Annexes
Annex 1
Templa e documen o Wo king g oups
No e: This empla e was le amendable o a ce ain ex en o i each g oup’s ocus
and needs.
Double click o open
Communi y o Doe s Wo king
G oup Repo and
Recommenda ions
Fo Teleconsul a ion Encoun e Repo
Scope
This documen se es he pu pose o collec all con ibu ions om he Communi y
o Doe s (CoD)
4
ega ding he idealisa ion, discussion, and ecommenda ions o he
o malisa ion o an e olu ion o an exis ing se ice in o a new adop ion domain,
inco po a ing o he EC- unded p ojec s’ knowledge and o he expe s’ iews
h ough a p ocess o coc ea ion wi h pa ien s, p o essionals, and IT de elope s
(p og amme s) ollowing he logic o he CoD se o h by XpanDH.
Goal o Wo king G oups
Th ough a de ined me hodology o mul i-s akeholde s balanced coc ea ion as se
o h by he CoD de ini ion, he CoD is o ganised in o Wo king G oups ha aim o
ansla e in o eams o eHeal h ac o s wi h one main objec i e: explo ing and
4
The Communi y o Doe s and Co-c ea o s b ings oge he implemen e s and end-use s o
new and exis ing solu ions, IT de elope s and endo s/supplie s; pa ien s and heal hca e
p o essionals, in a 3C-3P communi y (co-c ea ion communi y o Pa ien s, P o essionals and
P og amme s). The scope o his open communi y is o ind use cases and business needs
ha would be eused in p ac ice domains o he Eu opean EHR (Elec onic Heal h Reco d)
Exchange Fo ma in a bo om-up co-c ea ion app oach.

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deli e ing ha d ecommenda ions o o malising an e olu ion o he exis ing se ices
in EHDS con ex in o new adop ion domains o new app oaches o exis ing da a
ca ego ies speci ica ion.
This newly es ablished wo king g oup ocuses on eleconsul a ion encoun e
epo s suppo ed by he Eu opean Elec onic Heal h Reco ds Exchange Fo ma
(EEHRxF) o acili a e c oss-bo de and na ional eleheal h se ices in he EU.
Ha ing me in 4 online wo kshops o da e, his g oup aims o u he iden i y and
add ess echnical, egula o y, socio-cul u al and clinical aspec s equi ed o
eleconsul a ion epo s o be in e ope able ac oss and wi hin bo de s.
De elopmen s will build on lessons lea n om success s o ies o pa icipa ing
coun ies wi h ela ed eleheal h use cases.
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Table o Con en s
1 Backg ound ....................................................................................................................................................... 35
1.1 Rele an exis ing ma e ial ............................................................................................................. 50
1.2 Heal hca e challenge........................................................................................................................ 35
1.3 Rele an scien i ic knowledge ................................................................................................... 35
1.4 Ou pu s om ele an EC- unded p ojec s .................................................................... 35
2 In e ope abili y gap desc ip ion ........................................................................................................ 55
2.1 O e iew ................................................................................................................................................... 55
2.2 E olu ion p ocess ............................................................................................................................... 56
2.3 In e -domain dependencies ....................................................................................................... 63
2.3.1 Pa ien s ........................................................................................................................................... 63
2.3.2 P o essionals................................................................................................................................ 64
2.3.3 P og amme s ............................................................................................................................... 65
3 Vision o he EEHRxF-suppo ed se ice ..................................................................................... 68
4 Recommenda ions o ele an asse bundle ............................................................................42
4.1 Legal and egula o y ......................................................................................................................... 43
4.2 Policy ........................................................................................................................................................... 43
4.3 Ca e p ocess ......................................................................................................................................... 43
4.4 In o ma ion .............................................................................................................................................. 43
4.5 Applica ions ........................................................................................................................................... 44
4.6 IT in as uc u e ................................................................................................................................... 44
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1 Backg ound
1.1 Con ex and heal hca e challenge
[Expand on he con ex and iden i y hen explain he p oblem which he o ma
should sol e.]
1.2 Rele an scien i ic knowledge
[De elop a gumen s based on scien i ic li e a u e ha a e ele an o he
challenge a s ake. Use knowledge ha desc ibe he challenge, suppo he
app oach aken, e c.]
1.3 Ou pu s om ele an EC- unded p ojec s
and o he ini ia i es
[Rela e o ele an knowledge and wo k om o he EC- unded p ojec s; examples
and se ices om Denma k?]
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2 In e ope abili y challenges desc ip ion
2.1 O e iew
[Fill in he amewo k below o cha ac e ise he in e ope abili y challenges a s ake.
This amewo k is inspi ed by ha o desc ip ion o a use case in he eHeal h
Ne wo k’s Re ined eHeal h Eu opean In e ope abili y F amewo k (ReEIF).
2.1.1 Ti le
Teleheal h use case: Teleconsul a ion Encoun e Repo
2.1.2 Pu pose
[ he main unc ionali y o he se ice – wha is i , wha does i do?]
The new se ice aims o
2.1.3 Rele ance
[ he “why”, he a ionale o he se ice: bo h medical (wha p oblem does i sol e?)
and economical (business case, cos s and bene i s)]
2.1.4 P io i y ca ego ies add essed
[ om he 2024 EHDS egula ion:
(a) pa ien summa ies;
(b) elec onic p esc ip ions;
(c) elec onic dispensa ions;
(d) medical imaging s udies and ela ed imaging epo s;
(e) medical es esul s, including labo a o y and o he diagnos ic esul s and ela ed
epo s;
( ) discha ge epo s.]
2.1.5 Scale
[- C oss-bo de
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- Na ional
- Regional
- In a-o ganisa ional
- Ci izens a home and on he mo e]
2.2 E olu ion p ocess
[Fill in he amewo k below o desc ibe he p ocess o e ol ing om he cu en
‘AS-IS’ si ua ion o he a ge ‘TO-BE’ si ua ion. This amewo k is a simpli ied
adap a ion o ha which has been de eloped by he XpanDH X-Bubbles.]
2.2.1 Ta ge g oup
[ a ge g oup o he new se ice]
2.2.2 S akeholde s
[s akeholde s in ol ed in o impac ed o some ex en by he new se ice]
2.2.3 Con ex o use
[con ex a ound he use case desc ibing he end use o he new se ice]
2.2.4 AS-IS si ua ion
[cu en si ua ion in one sen ence]
[abou echnical speci ica ions]
[abou seman ic elemen s]
[ abou mas e da ase s and alues se s]
2.2.5 TO-BE si ua ion
[ he ideal si ua ion which his e o aims a achie ing]

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2.2.6 Desc ip ion o Necessa y S eps o Mo e om AS-IS
o TO-BE Si ua ion:
[Necessa y s eps o mo e om he AS-IS o he TO-BE si ua ion
1. …
2. …
3. … ]
2.2.7 Objec i es
[ he aim(s) o he new se ice, ela ing o he eason(s) why i needs o be
de eloped]
2.2.8 Ac o s and Roles
Ac o
Role
[e.g. physician,
pa ien ,
labo a o y
in o ma ion
sys em]
[e.g. Documen c ea o and use ]
2.2.9 P econdi ions
[ he condi ions equi ed o he new se ice o be implemen ed and ope a i e]
2.2.10 T igge
[ he ac ion igge ing he use o he new se ice]
2.2.11 Flow
[desc ibe he pa h o in o ma ion/da a low wi hin he new se ice and he ole o
each ac o ]
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2.2.12 Pos condi ions
[ he condi ions equi ed o deeming he igge ed se ice success ul]
2.2.13 Requi emen s
Use equi emen s
Technical equi emen s
Ope a ional equi emen s
E hics equi emen s
2.2.14 Majo challenges o eseen
[main ba ie s o eseen o pose a isk o he new se ice’s implemen a ion, use, and
success]
2.2.15 A chi ec u e
[bes p esen ed as diag am e.g. o deploymen nodes]
2.3 In e -domain dependencies
[Analyse and highligh in e -domain dependencies: om exis ing domains, wha is
eusable o his new se ice? The aim o his exe cise is o a oid he mul iplica ion
o ideas, making he de elopmen o new se ices mo e s eamlined. ]
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3 Consul a ion p ocess
[Desc ibe he p ocess o eedback collec ion and co-c ea ion e.g. n° mee ings,
s uc u e and go e nance i any]
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D Ch is os
Emanouilidis
C oss Balkan Ongology Cen e
Elias Pessah
A hens Medical Cen e
Geo ge Da oulas
Uni e si y o Thessaly
Dimi is Ka ehakis
FORTH, HL7 Hellas
Aineias Spilio is
Lawye
Ei ini Ka od i ou
Theageneio Oncology Hospi al

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Table o Con en s
1 Backg ound ....................................................................................................................................................... 35
1.1 Rele an exis ing ma e ial ............................................................................................................. 50
1.2 Heal hca e challenge........................................................................................................................ 35
1.3 Rele an scien i ic knowledge ................................................................................................... 35
1.4 Ou pu s om ele an EC- unded p ojec s .................................................................... 35
2 In e ope abili y gap desc ip ion ........................................................................................................ 55
2.1 O e iew ................................................................................................................................................... 55
2.2 E olu ion p ocess ............................................................................................................................... 56
2.3 In e -domain dependencies ....................................................................................................... 63
2.3.1 Pa ien s ........................................................................................................................................... 63
2.3.2 P o essionals................................................................................................................................ 64
2.3.3 P og amme s ............................................................................................................................... 65
3 Vision o he EEHRxF-suppo ed se ice ..................................................................................... 68
4 Recommenda ions o ele an asse bundle ............................................................................42
4.1 Legal and egula o y ......................................................................................................................... 43
4.2 Policy ........................................................................................................................................................... 43
4.3 Ca e p ocess ......................................................................................................................................... 43
4.4 In o ma ion .............................................................................................................................................. 43
4.5 Applica ions ........................................................................................................................................... 44
4.6 IT in as uc u e ................................................................................................................................... 44
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1 Backg ound
1.1 Rele an exis ing ma e ial
Rele an ma e ial a e he eHeal h Ne wo k’s (eHN) guidelines.
They include speci ic guidelines o i e di e en se ices: eP esc ip ion and
eDispensa ion, Pa ien Summa y, Labo a o y esul s, Medical imaging s udies and
epo s, and Hospi al discha ge epo s.
They a e based on he Commission Recommenda ion on a Eu opean Elec onic
Heal h Reco d exchange o ma ’s o iginal ‘heal h in o ma ion domains’.
- eHeal h Ne wo k Gene al guidelines
- eHN guidelines on eP esc ip ion and eDispensa ion
- eHN guidelines on Pa ien Summa y
- eHN guidelines on labo a o y esul s
- eHN guidelines on Medical imaging s udies and epo s
- eHN guidelines on Hospi al discha ge epo s
The o iginal ‘heal h in o ma ion domains’ ha e e ol ed wi h he Ap il 2024 EHDS
egula ion, o be eca ego ized in o six ‘p io i y ca ego ies o pe sonal elec onic
heal h da a’:
(a) pa ien summa ies;
(b) elec onic p esc ip ions;
(c) elec onic dispensa ions;
(d) medical imaging s udies and ela ed imaging epo s;
(e) medical es esul s, including labo a o y and o he diagnos ic esul s and
ela ed epo s;
( ) discha ge epo s.
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1.2 Heal hca e challenge
The heal hca e sec o aces a ange o c i ical challenges ha demand inno a i e
solu ions. In pa icula , he apid e olu ion o echnology, combined wi h he
inc easing complexi y o pa ien needs, has highligh ed gaps in he cu en
heal hca e se ice. While he exis ing se ice has success ully add essed ce ain
needs wi hin i s o iginal domain, i is inc easingly e iden ha i canno ully
espond o he challenges o [new adop ion domain] wi hou signi ican e olu ion.
One o he p ima y issues is he lack o accessibili y o unde se ed popula ions,
pa icula ly hose in emo e o u al a eas. The cu en se ice is limi ed in i s each,
lea ing many pa ien s wi hou imely access o c i ical ca e. This dispa i y is
u he exace ba ed by he agmen a ion o pa ien ca e, whe e communica ion
be ween heal hca e p o essionals and sys ems is disjoin ed, leading o delays in
ea men and po en ial gaps in pa ien ca e con inui y.
Mo eo e , ine icien p ocesses emain a signi ican hu dle. The cu en se ice
elies hea ily on ou da ed manual wo k lows, causing delays in se ice deli e y and
unnecessa y adminis a i e bu dens o heal hca e p o essionals. These
ine iciencies ul ima ely impac he quali y o pa ien ca e, as heal hca e
p o essionals a e o ced o spend mo e ime on adminis a i e asks a he han
pa ien in e ac ion. Ano he c i ical challenge lies in he lack o in eg a ion o
heal hca e da a. In he cu en se ice model, da a silos exis ac oss a ious
sys ems, p e en ing a comp ehensi e, eal- ime iew o pa ien heal h
in o ma ion. This limi s he abili y o p o essionals o make da a-d i en decisions,
which could o he wise imp o e pa ien ou comes and s eamline ca e deli e y.
F om he pa ien pe spec i e, he e is a g owing demand o mo e pe sonalized
and engaging heal hca e expe iences. Many pa ien s eel ha hei ole in
managing hei own heal h is unde alued, and hey lack he ools and esou ces
o ac i ely pa icipa e in hei ca e. This lack o engagemen con ibu es o lowe
adhe ence o ea men plans and poo e heal h ou comes.
To add ess hese p essing challenges, he exis ing se ice mus e ol e o be e
in eg a e ad anced echnologies, os e mo e obus communica ion be ween
s akeholde s, and ensu e pa ien s a e a he cen e o ca e. This e olu ion mus be
co-c ea ed wi h inpu om pa ien s, heal hca e p o essionals, and IT de elope s,
o ensu e ha he new se ice is bo h i o pu pose and adap able o u u e
heal hca e needs. Wi hou his e olu ion, he heal hca e sec o isks u he
en enching inequali ies and ine iciencies, unde mining he quali y o ca e
deli e ed o pa ien s.
1.3 Rele an scien i ic knowledge
An oncological council ypically e e s o a g oup o medical p o essionals who
come oge he ei he physically o emo ely, in o de o discuss and decide on
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ea men plans o cance pa ien s. This mul idisciplina y eam may include,
among o he s, oncologis s, su geons, adiologis s, pa hologis s, adia ion
he apis s and nu ses. Thei goal is o ensu e ha pa ien s ecei e mos sui able
ca e ia comp ehensi e app oach, which is ailo ed o hei speci ic condi ion,
conside ing he la es esea ch and ea men op ions.
Medical p o essionals in an oncological council need a di e se se o knowledge
and skills o e ec i ely discuss and decide on cou se o ea men o pa ien s
wi h cance . Key a eas o expe ise may include:
1. Oncology: In-dep h unde s anding o a ious ypes o cance , hei biology,
s aging, and p og ession.
2. T ea men Modali ies: Knowledge o di e en ea men op ions, including
su ge y, chemo he apy, adia ion he apy, immuno he apy, and o he
a ge ed he apies.
3. Clinical Guidelines: Familia i y wi h cu en clinical guidelines and
p o ocols o cance ea men .
4. Pa hology: Unde s anding umo biology, his opa hology, and molecula
diagnos ics o assess umo cha ac e is ics.
5. Radiology: Abili y o in e p e imaging s udies o de e mine umo loca ion,
size, and me as asis.
6. Pa ien Ca e: Skills in managing side e ec s, suppo i e ca e, and pallia i e
ca e op ions.
7. Mul idisciplina y Collabo a ion: Expe ience wo king in a eam
en i onmen , acili a ing communica ion among a ious special ies.
8. E hics and Pa ien Ad ocacy: Knowledge o e hical conside a ions in
cance ca e and he impo ance o conside ing pa ien p e e ences and
alues.
9. Resea ch and Clinical T ials: Awa eness o ongoing esea ch, clinical ials,
and eme ging he apies ha may bene i pa ien s.
10. Psycho-Social Aspec s: Unde s anding he psychological and social
impac s o cance on pa ien s and hei amilies.
By combining hei expe ise, membe s o he oncological council aim o c ea e
pe sonalized and e ec i e ea men plans ha conside all aspec s o a pa ien ’s
heal h and well-being.
Challenges
Mul idisciplina y Teams (MDT) pe o ming Mul idisciplina y Tumou Boa ds
(MDTB) a e a aluable ool in cance ca e, aiming o acili a e ea men decisions
o ecommenda ion and p o ide a comp ehensi e app oach by in eg a ing
insigh s om mul iple specialis s. Howe e , he achie emen o op imal ou comes
equi es add essing he ollowing challenges.
1. Da a agmen a ion: A signi ican ba ie o e ec i e MDT discussions is da a
agmen a ion, gi en ha impo an pa ien da a migh be sca e ed ac oss
a ious hospi als and clinics, making i di icul o eam membe s o ha e a
holis ic iew o he medical his o y, diagnos ic esul s, and ea men
esponses. Also, he e is a lack o s anda disa ion ac oss pla o ms and da a
sou ces, which u he bu dens in e ope abili y be ween di e en
in as uc u es.
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2. In o ma ion o e load: MDT o en depends on mul iple diagnos ic da a,
including adiology, pa hology, genomic sequencing, and pa ien his o y, which
can o e whelm clinicians, unde sco ing he impo ance o de eloping da a
syn hesis and summa isa ion ools.
3. Coo dina ion ac oss speciali ies: E ec i e MDT depends on e ec i e
communica ion and collabo a ion be ween di e se specialis s. This is
challenging, pa icula ly due o he lack o in e ope abili y wi hin exis ing
elec onic heal h eco d (EHR) sys ems. Addi ionally, he absence o
s anda dised communica ion pla o ms can lead o agmen ed discussions
and incomple e in o ma ion sha ing.
4. Resou ce a ailabili y and ep esen a ion gaps: In some MDTs, some
speciali ies ha e unequal ep esen a ion, leading o biased decisions. Also,
MDT held a non-academic cen es o in emo e egions o en lack access o
he ull spec um o oncological expe ise and bes p ac ices, he eby limi ing
he e ec i eness o mul idisciplina y inpu .
5. S uc u al a iabili y and non-s anda disa ion: A non-s anda dized
s uc u e wi hin MDT poses ano he ba ie , as inconsis encies in he o ma ,
epo ing s anda ds, and eedback mechanisms can lead o a iabili y in he
quali y o ca e ac oss ins i u ions.
6. Time and esou ce cons ain s: The p epa a ion and conduc ion o MDT
demand subs an ial ime, di e ing heal hca e p o essionals om di ec
pa ien ca e. Physicians o en ace a ade-o be ween dedica ing ime o
MDT mee ings and a ending o hei clinical du ies, pa icula ly in se ings
whe e esou ces a e limi ed. Time managemen solu ions, such as s eamlined
mee ing s uc u es and ocused case selec ions, a e c ucial o maximising he
e iciency o MDT discussions wi hou de ac ing om pa ien ca e.
7. Limi ed access in emo e a eas: Access o MDT migh be limi ed in emo e
egions, and pa ien s may no ecei e he same le el o mul idisciplina y inpu
as hose in u ban cen es o academic hospi als. Telemedicine and emo e
collabo a ion echnologies could play an essen ial ole in mi iga ing his gap.
8. Conside a ion o sociodemog aphic ac o s: MDT should aim o in eg a e a
b oade ange o pa ien in o ma ion, encompassing medical his o y and
ele an social de e minan s o heal h, which a e o en o e looked.
Inco po a ing social ac o s and demog aphic da a in o MDT delibe a ions is
essen ial o pe sonalised cance ca e. Socioeconomic s a us, amily suppo ,
and cul u al ac o s can signi ican ly impac ea men adhe ence and
ou comes.
Re e ences
h ps://pubmed.ncbi.nlm.nih.go /23613417/
h ps://doi.o g/10.1007/s44178-024-00107-7
h ps://doi.o g/10.14694/EdBook_AM.2014.34.e461
h p://dx.doi.o g/10.2217/ on-2021-0471

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1.4 Ou pu s om ele an EC- unded p ojec s
The e olu ion o Mul idisciplina y Tumou Boa ds (MDTs) in Eu ope has been
signi ican ly suppo ed by a ious EU- unded p ojec s ha add ess
in e ope abili y, pa ien -cen ic ca e, and collabo a i e decision-making. These
ou pu s o m he ounda ion o ad ancing MDTs owa ds mo e in eg a ed and
e ec i e cance ca e.
1. iManageCance : This p ojec de eloped digi al ools o empowe cance
pa ien s, ocusing on sel -managemen and enhancing hei ole wi hin
MDTs. By p o iding applica ions ha allow pa ien s o access and sha e
hei heal h da a seamlessly, iManageCance p omo es pa ien
engagemen and in o med decision-making du ing MDT discussions.
2. CanCon (Cance Con ol Join Ac ion): A pi o al ini ia i e in ha monizing
cance con ol s a egies ac oss Eu ope, CanCon emphasized he
in eg a ion o MDTs as a c i ical componen o e ec i e cance ca e. I s
ou pu s include bes p ac ices and policy ecommenda ions o imp o ing
collabo a ion ac oss special ies.
3. UNICOM: While p ima ily ocusing on medicinal p oduc iden i ica ion,
UNICOM con ibu es o MDTs by s anda dizing da a exchange ela ed o
oncology ea men s, ensu ing ha he apeu ic p o ocols a e consis en
and in e ope able ac oss heal hca e sys ems.
4. ASCAPE: Le e aging a i icial in elligence o pe sonalize cance ca e,
ASCAPE p o ides decision-suppo ools ha MDTs can use o p edic
ou comes and ailo in e en ions, enhancing he quali y o
mul idisciplina y decisions.
Re e ences:
iManageCance : h ps://co dis.eu opa.eu/p ojec /id/643529/ epo ing
CanCon: h ps://cance con ol.eu/a chi ed/
UNICOM: h ps://unicom-p ojec .eu/
ASCAPE: h ps://www.ascape-p ojec .eu/
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2 In e ope abili y gap desc ip ion
2.1 O e iew
Ti le
Mul idisciplina y Tumo Boa ds
Documen a ion and Ope a ion
Pu pose
The se ice acili a es he ope a ion and
documen a ion o Mul idisciplina y
Tumou Boa ds (MDTBs) by enabling
collabo a ion among specialis s o
make e idence-based decisions o
cance pa ien s. I suppo s seamless
coo dina ion and da a exchange ac oss
di e en hospi als and wi hin indi idual
hospi al sys ems. Th ough he
in eg a ion o ad anced digi al ools, he
se ice enables emo e managemen
and pa icipa ion o MDTBs, ensu ing
comp ehensi e accessibili y o all
s akeholde s ega dless o loca ion. This
s eamlined app oach enhances case
managemen , ensu ing da a accu acy,
accessibili y, compliance wi h
egula o y s anda ds, and imp o ed
pa ien ou comes.
Rele ance
Medical: MDTBs add ess he
complexi y o cance ea men by
p o iding a s uc u ed pla o m o
coo dina ed decision-making. This
collabo a i e app oach enhances
diagnos ic p ecision and enables he
de elopmen o comp ehensi e,
e idence-based ea men plans,
leading o imp o ed pa ien ou comes.
Economical: By enabling enhanced and
mo e e ec i e ea men plans, MDTBs
con ibu e o be e ea men
ou comes and imp o ed pa ien heal h.
This esul s in indi ec bene i s, such as
lowe ing he socie al cos s associa ed
wi h p olonged o ine ec i e
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ea men s. Addi ionally, he op imized
use o heal hca e esou ces educes
unnecessa y s ain on he sys em,
imp o ing o e all e iciency.
P io i y ca ego y
(a) pa ien summa ies;
(b) elec onic p esc ip ions;
(c) elec onic dispensa ions;
(d) medical imaging s udies and
ela ed imaging epo s;
(e) medical es esul s, including
labo a o y and o he diagnos ic esul s
and ela ed epo s;
( ) discha ge epo s.]
Scale
- C oss-bo de : Ensu es MDTs can
collabo a e on complex cases in ol ing
specialis s om mul iple coun ies. -
Na ional: Facili a es consis en MDT
ope a ions wi hin a na ional heal hca e
sys em. - Regional: Enhances
coo dina ion ac oss egional cance
ca e cen e s. - In a-o ganisa ional:
S eamlines wo k lows wi hin a single
ins i u ion.
2.2 E olu ion p ocess
Ta ge g oup
[ a ge g oup o he new se ice]
The new se ice is designed o p ima ily empowe and se e
pa ien s, pa icula ly hose in unde se ed egions who cu en ly
ace challenges in accessing imely and coo dina ed heal hca e.
Addi ionally, i will bene i heal hca e p o essionals, including
doc o s, nu ses, and adminis a i e s a , by p o iding hem wi h
mo e e icien ools o deli e ca e. IT de elope s will also be a
key use g oup, as hey will be in ol ed in main aining and
enhancing he echnical in as uc u e needed o his se ice.
Ul ima ely, he goal is o c ea e a holis ic ecosys em ha se es
all s akeholde s engaged in he heal hca e p ocess.
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S akeholde s
Pa ien s: The pa ien as an ul ima e bene icia y who will
expe ience imp o ed ca e access and g ea e engagemen in
managing hei own heal h.
Heal hca e P o essionals: Doc o s, nu ses, and adminis a i e
s a who will in e ac wi h he se ice daily, bene i ing om
s eamlined wo k lows, be e access o pa ien da a, and
imp o ed decision-making ools.
IT De elope s: Technical expe s esponsible o building,
main aining, and upda ing he pla o m o ensu e i s e iciency,
secu i y, and adap abili y.
Heal hca e P o ide s: Key decision-make s who will o e see he
se ice's implemen a ion and ensu e i s alignmen wi h b oade
heal hca e goals.
Policy Make s: Au ho i ies who egula e heal hca e p ac ices
and da a p i acy and ensu e ha he se ice adhe es o legal
and e hical guidelines.
Con ex o
use
The new se ice will be implemen ed wi hin he b oade con ex
o digi al heal h in eg a ion, ocusing on enhancing ca e
deli e y o pa ien s wi h ch onic diseases and hose equi ing
long- e m moni o ing and ea men . The se ice aims o
s eamline he in e ac ion be ween heal hca e p o ide s and
pa ien s h ough a uni ied pla o m ha allows Real ime
access o da a h ough da a sha ing and da a agg ega ion,
communica ion, and collabo a ion. This will be especially
aluable in u al o unde se ed a eas whe e heal hca e
se ices a e sca ce, and access o expe s is limi ed. The new
sys em will acili a e op imal heal hca e se ices, be e
coo dina ion, Remo e heal hca e/ ele-heal hca e, also ia
emo e pa ien moni o ing, and inc eased pa ien engagemen ,
he eby imp o ing o e all heal h ou comes.
AS-IS
si ua ion
Cu en Si ua ion (in one sen ence):
The cu en se ice ope a es in silos, o e ing agmen ed
heal hca e deli e y wi h ine icien p ocesses o pa ien -
p o essional in e ac ion and limi ed da a sha ing capabili ies.
Abou Technical Speci ica ions:
The cu en se ice elies on ou da ed legacy sys ems, which
lack in e ope abili y wi h newe echnologies, leading o
ine iciencies in da a sha ing be ween heal hca e ins i u ions.
Manual p ocesses domina e, causing delays and inaccu acies in
pa ien in o ma ion exchange.
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comp ehensi e de ails om hei a ending physician o any membe o he
umou boa d.
2.3.2 P o essionals
Es ablishing a digi al o m o he oncological council may in ol e se e al in e -
domain dependencies. Add essing some o hem is judged as c i ical, in o de o
enhance communica ion, s eamline p ocesses, and ul ima ely imp o e pa ien
ou comes by means o a digi al oncological council.
1. Heal h IT Sys ems: In eg a ion and b idging wi h elec onic heal h eco ds
(EHR) and/o oncology-speci ic so wa e, in o de o ensu e seamless access
o pa ien da a, ea men his o y, and clinical no es.
2. Collabo a ion Tools / Telemedicine Pla o ms: De elopmen o secu e,
use - iendly pla o ms o secu e messaging, i ual consul a ions, enabling
eal- ime discussions among p o essionals and wi h pa ien s, in o de o
acili a e discussions and decision-making among he mul idisciplina y eam.
3. Da a Secu i y and Compliance: Ensu ing adhe ence o heal hca e EU
policies (e.g. GDPR) o p o ec pa ien p i acy and da a in eg i y ac oss all
digi al in e ac ions.
4. In e ope abili y S anda ds: Adop ing common da a s anda ds and ans e
p o ocols o allow di e en sys ems and pla o ms o communica e
e ec i ely.
5. T aining and Suppo : P o iding ongoing aining o all s akeholde s o
ensu e e ec i e use o digi al ools and os e a collabo a i e cul u e.
Add essing some o he in e -domain dependencies is p obably op ional, bu , i
easible, i is judged as e y help ul in u he enhancing he apeu ic e ec i eness
and o e all quali y o ca e ia a digi al oncological council.
6. Clinical Decision Suppo Sys ems: Implemen ing machine lea ning ools o
assis in analyzing pa ien da a and sugges ing e idence-based ea men
op ions.
7. Pa ien Engagemen Tools: C ea ing digi al esou ces o pa ien educa ion
and suppo , ensu ing hey can pa icipa e in discussions and decision-
making ega ding hei ca e.
8. Resea ch and Analy ics: In eg a ing da a analy ics ools o eal- ime
e alua ion o anonymized ea men ou comes and ends, suppo ing
con inuous imp o emen in pa ien ca e.

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2.3.3 P og amme s
In e ope abili y and S anda diza ion
P o ide ic ionless da a exchange among a ious heal h in o ma ion sys ems o
acili a e i al pa ien da a access ac oss all pla o ms o MDTs.
• The clinical implemen a ion shall u ilize in e na ionally ecognized da a and
anspo s anda ds such as HL7 FHIR and HL7 CDA, LOINC, ICD-10, ICD-O-3,
ATC and EMA’s EDQM. Such s anda ds enable he MDT pla o m o in e ace
wi h o he sys ems, such a e EHRs o oncology-speci ic sys ems (sou ces o
da a), using a cen alized in e ope abili y hub.
• The hub u ilizes s anda ds, s anda d APIs (da a and p o ocol) and a ious
connec o s o manage secu e exchange and lows o s uc u ed and
uns uc u ed clinical da a, equi ed o he op imal MDT p ocesses, enabling
MDTB p ocesses such a e assessmen s, consul a ions and hei ou comes.
S uc u ed Da a o Oncology
To s anda dize sys ems da a poin s and ensu e high- alue, s anda dized oncology
in o ma ion o discussion a he MDT.
• To ensu e s uc u ed da a o oncology, de elope s can le e age HL7 FHIR
Implemen a ion Guides (FHIR IG) ailo ed o oncology use cases. These
guides p o ide de ailed amewo ks o s uc u ing clinical da a, such as
pa ien demog aphics, diagnosis, ea men s, and ou comes, in a
s anda dized o ma . By de ining p o iles, speci ic o oncology, FHIR IG
suppo s consis en da a ep esen a ion while ensu ing in e ope abili y
ac oss sys ems. This app oach enables seamless in eg a ion wi h exis ing
heal hca e in as uc u e and aligns wi h EU equi emen s/speci ica ions, and
global bes p ac ices o managing oncology in o ma ion.
• De elope s can ensu e MDTB membe s ope a e om he same ounda ion
by educing edundancy and enhancing o e all quali y in cance ca e
in o ma ion.
Au oma ed Da a and Wo k low Managemen
S eamlining wo k lows be ween MDT membe s o go ahead, wi hou a gli ch om
one s age o pa ien ca e in o he nex .
• Au oma e clinical wo k lows. S eps in managing a case om sc eening and
diagnosis o ollow-up a e a ew o he key wo k lows. T ea men egimen ,
diagnos ic checkups, ea men planning, and measu ed ou comes a e
among he common wo k lows.
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• Suppo ing in as uc u e should au oma ically no i y MDTB membe s abou
he change in he pa ien eco d and any an icipa ed ou come o clinical
pa hway. The unc ionali y is suppo i e o imely upda es aimed a ensu ing
ha all membe s a e well-in o med and p epa ed o e e y MDTB session.
Clinical Decision Suppo (CDS)
Suppo da a-d i en ea men ecommenda ions o MDT membe s o make
in o med decisions on complica ed cases.
In eg a ion o a CDS ool, such is openCDS
6
, which can p ocess (s uc u ed) da a and
assis he ea ing physician wi h choices o ea men gi en cu en s a es o
pa ien heal h and clinical guidelines. Mos CDS solu ions can inges such
in o ma ion as diagnosis, s aging, and p io ea men s o a gi en pa ien and
p opose an indi idualized he apy plan.
CDS enables s anda diza ion o ea men pa hways and ensu es accu acy in
decision-making by o e ing e idence-based ecommenda ions. This module will be
e en mo e use ul when MDT membe s conside a ious op ions in ea men s o a e
conce ned wi h in equen complex cases. Mo e p ecisely, CDS ool may help decide
on app op ia e ea men pa hways h ough clinical da a analysis and sugges ion o
e idence-based p o ocols ha can be e iewed by he MDT membe s.
Pa ien Consen and Da a P i acy
To p o ec he da a o pa ien s and adhe e o a ious egula ions such is GDPR.
• S ong da a p o ec ion policies enabled wi h secu e au hen ica ion h ough
OAu h and RBAC/ABAC (Role-Based Access Con ol/A ibu e-Based Access
Con ol) and consen managemen shall be p o ided o pa ien s. Since mos
o he sha ing will be ac oss sys ems, o e en ac oss bo de s, consen shall
be managed explici ly.
• The sys em shall audi in e ac ions and p oduce log, acing e e y access and
modi ica ion o he da a, p o iding ull accoun abili y; i shall ensu e ha
sensi i e pa ien in o ma ion is accessible only o au ho ized MDTB membe s.
Te minology Se ices and Da a Coding
To ensu e clinical e minology is s anda dized among MDT membe s o clea e
unde s anding, he eby b inging consis ency in da a in e p e a ion. •
Implemen a ion: I shall implemen a e minology se e ha will in eg a e he coding
s anda ds in he o m o ICD and ICD-O3 o diagnoses and ETIP (G ekk clinical
p ac ice p ocedu es) he G eek DRG (Diagnosis- ela ed g oup). Such a se e
6
h ps://www.opencds.o g/
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au oma es coding consis ency and minimizes manual en y e o s, he eby
s anda dizing he clinical language ac oss he pla o m.
Te minology se ices ensu e ha MDT in e p e and eac consis en ly o da a. This
allows mo e accu a e and apid decision making on a pa ien 's diagnosis du ing MDT
mee ings.
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3 Vision o he EEHRxF-suppo ed se ice
MDTs a e essen ial o cance ca e since hey p o ide a mul idisciplina y se ing
o comp ehensi e case assessmen s. Thei goal is o o e e idence-based,
indi idualised ea men p og ams o cance pa ien s by conside ing he complex
na u e o hei illness. Tumou boa ds should be ope a ionally e ec i e, pa ien -
cen ed, and scien i ically sound o op imise pa ien ad an ages. To achie e he
g ea es bene i o pa ien s, umou boa ds mus adop he ollowing p inciples:
Mul idisciplina y Collabo a ion:
• Di e se Expe ise: Include specialis s ac oss all ele an ields, such as
medical and adia ion oncology, su ge y, pa hology, adiology, gene ics, and
psychosocial ca e.
• De ined Roles: Assign clea esponsibili ies o each membe o ensu e
comp ehensi e e alua ion and e icien use o ime.
Pa ien -Cen ed Decision-Making:
• Indi idualised Plans: Tailo ecommenda ions o he pa ien 's unique clinical
and pe sonal ci cums ances.
E idence-Based App oach:
• U ilise he la es clinical guidelines, esea ch indings, and diagnos ic ools
o in o m decisions.
• Le e age molecula and gene ic insigh s o pe sonalise ea men .
In eg a ion o Ad anced Technology:
• Da a Sha ing Pla o ms: Use in e ope able elec onic heal h eco ds (EHRs)
o ensu e seamless access o pa ien in o ma ion.
• AI and Analy ics: Employ p edic i e ools o analyse da a and suppo
decision-making.
• Telemedicine: Facili a e i ual umou boa ds o pa ien s in emo e a eas
o ensu e equi able access o expe ise.
No e on Vi ual Tumou Boa ds: Vi ual boa ds b ing lowe cos (ha ing many
people in he same oom assessing pa ien da a o he i s ime is expensi e.
Vi ual allows hem o asses da a be o e he mee ing when hey ha e ime and
use mee ing o con i m ha all a e in ag eemen ), easie planning (i ’s ha de o
ind ee oom o all and ee ime o e e y membe . Vi ual enables hem o
ha e mee ing anywhe e and a any ime), as e decision (case assessmen is
asynch onous. Ins ead o spending ~30 minu es pe case combined in he
mee ing, doc o s a e spending 30 minu es when hey can and on hei own and
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spend 5~7 minu es o con i m and ag ee du ing he mee ing. Such app oach
enables hem o assess mo e cases pe mee ing and p e en pa ien o
unnecessa y wai o he nex boa d mee ing jus because mee ing alloca ed
ime an ou ).
S anda dised Go e nance and Ope a ions:
• Clea F amewo ks: Es ablish ope a ional guidelines, including mee ing
schedules, documen a ion s anda ds, and decision-making p o ocols.
• Consensus Building: Employ s uc u ed p ocedu es o esol e di e ing
opinions and ensu e uni ied ecommenda ions.
T anspa ency and Communica ion:
• Communica e he ou comes o umou boa d discussions in a clea ,
accessible manne , including he easoning behind ecommenda ions.
• P o ide oppo uni ies o pa ien s and amilies o ask ques ions and seek
cla i ica ions.
Capaci y Building and Con inuous Imp o emen :
• Educa ion and T aining: Regula ly upda e umou boa d membe s on
ad ancemen s in cance ca e.
• Ou come Moni o ing: E alua e he impac o umou boa d decisions on
pa ien ou comes o e ine p ocesses.
The ollowing high-le el schema depic s en isioned MDT se ice and i s ole and
in e ac ion wi hin heal hca e.

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I is highly desi ed ha sys ems a e in e ope able and in eg a ed enabling secu e
and immedia e access o da a, ei he o MDT o p opose o decide on ea men , o
o ea ing physician and pa ien o access MDT decision.
Cance is a complex condi ion and almos all a ailable da a is bene icial o he MDT
assessmen and decision.
This means ha MDT sys em shall be in eg a ed wi h:
- p ima y ca e sys ems o e ie e EHR da a
- seconda y and e ia y ca e sys ems o e ie e EHR and diagnos ics da a
- p i a e se ice p o ide s o e ie ing diagnos ics da a
- pa ien sys ems o e ie e PHR da a
Da a om hose sys ems should con ex ual, as wi hou con ex da a alue is lowe
and he e is isk o misin e p e a ion.
Almos all da a equi ed o he MDT p ocesses can be mapped o Eu opean EHRxF.
Deciding o implemen EEHRxF in he MDT will also enable MDT o u ilize EHDS. Such
decision will also lowe he e o o heal hca e p o ide s, as implemen a ion o he
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EEHRxF is also bene icial o hei own easons such is p epa a ion o he EHDS
compliancy.
EHR and PHR da a
Eu opean Pa ien Summa y con ains all in o ma ion ha MDT needs om elec onic
heal h eco d. I p o ides impo an heal h in o ma ion abou pa ien , cu en and
his o ical s a us. Thus, i is su icien and sui able o he MDT in eg a ion wi h
p ima y, seconda y and e ia y elec onic heal h eco ds and sys ems shall u ilize i
o his pu pose.
HIS da a
A e hospi aliza ion pa ien is discha ged om he hospi al and hospi al p o ides
discha ge in o ma ion. This in o ma ion is use ul and needed o he MDT
assessmen as i con ains he eason o hospi aliza ion, pe o med p ocedu es, and
p o ided ea men . Addi ionally, i con ains pa ien condi ion and s a us
(disposi ion) a discha ge, as well as ollow-up ca e guidelines.
EEHRxF de ines Eu opean Hospi al discha ge epo s which is sui able o ma o
sha e in o ma ion wi h MDT, and his o ma shall be used o e ie e da a om he
hospi al in o ma ion sys em.
Diagnos ics da a
The MDT decision is la gely d i en by esul s o a ious diagnos ics p ocedu es. Such
p ocedu es a e a ious labo a o y examina ions, adiology examina ions, and clinical
assessmen s. Again, he EEHRxF is su icien and sui able.
The MDT shall u ilize
- he Eu opean Labo a o y esul s and epo s o ma o e ie ing da a om
hospi als labo a o y diagnos ics and om p i a e diagnos ic cen e s.
- The Eu opean Medical imaging s udies and epo s o ma o adiology
diagnos ics om hospi als adiology diagnos ics and om p i a e
diagnos ic cen e s
MDT ou come
The esul o an MDT assessmen is decision o ecommenda ion o ea men . The
esul shall con ain assessmen epo and plan o ca e in o ma ion.
The EEHRxF does no p o ide any sui able da ase and/o speci ica ion.
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The u u e wo k will look a and assess he HL7 C-CDA speci ica ions o Ca ePlan
documen and Consul a ion No e documen . Those will be used as s a ing
discussion poin wi h s akeholde s. The p ocess will collec equi ed da ase and
p opose addi ional EEHRxF based on HL7 FHIR documen pa adigm o documen ing
and sha ing he MDT decision. As MDT can be seen as a consul a ion wi h an expe ,
he p oposed o ma will be sui able also o o he ypes o clinical consul a ions as
well as o 2nd opinion.
Cance eco d
The MDT needs o main ain hei own eco d o a ious easons which include legal
equi emen s and analy ics.
The cance eco d con ains da a assessed du ing decision making. Such da a is
in oduced o he sys em ia in eg a ions as EEHRxF documen s – pa ien summa y,
labo a o y/ adiology epo s and clinical images, so cance eco d is a documen
eposi o y main aining eco d as a se o documen s ha belongs oge he .
Due o use o he EEHRxF, which a e s uc u ed and p ope ly clinically coded
documen s, he cance eco d shall also enable da a ope a ions on ine g ained le el,
ul illing a ious equi emen s o analy ics and p ecise que ies o e da a and
smalles da a poin s.
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4 Recommenda ions o ele an asse
bundle
[P o ide ecommenda ions o s eps o ollow, p ecau ions o be aken, ma e ial o
be p oduced, o else, in he 6 in e ope abili y le els ou lined by he eHeal h
Ne wo k’s e ined eEIF (ReEIF).
Below we display wo models ha display how hese 6 in e ope abili y le els can be
applied o (i) alignmen ac i i ies be ween o ganisa ions, and (ii) s akeholde s.]
Figu e 9 Re ined eEIF (ReEIF) model – alignmen ac i i ies be ween o ganisa ions
Figu e 10 Re ined eEIF (ReEIF) model – s akeholde s
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• Da a Secu i y and P i acy P o ocols (GDPR Compliance):
Ensu ing compliance wi h GDPR and o he ele an da a p o ec ion egula ions is
essen ial when handling he impo and expo o sensi i e medical da a. This
includes implemen ing enc yp ion p o ocols o da a in ansi and a es , as well
as ensu ing ha pa ien s ha e con ol o e who can access hei in o ma ion.
Technical Speci ica ions o In o ma ion T anspo :
The echnical speci ica ions a his le el should ensu e ha he low o medical
in o ma ion be ween sys ems is bo h secu e and e icien . This can be achie ed
by adop ing he ollowing echnical app oaches:
• REST ul APIs o eal- ime da a e ie al and in e ac ion. These APIs should
be designed o allow hi d-pa y applica ions (e.g., Elec onic Heal h
Reco ds, emo e pa ien moni o ing ools) o in e ac wi h he heal hca e
sys em seamlessly.
• OAu h 2.0 and OpenID Connec : These a e ecommended o
au hen ica ion and au ho iza ion, ensu ing ha only au ho ized use s and
sys ems can access sensi i e heal h in o ma ion du ing he impo /expo
p ocess.
In eg a ion o Exchanged In o ma ion in Use -F iendly Applica ions:
A c ucial aspec o his p ocess is no only ensu ing ha in o ma ion is exchanged
be ween sys ems bu also ha i is in eg a ed in o use - iendly applica ions. Fo
his pu pose, he ollowing s a egies should be adop ed:
• In ui i e Use In e aces (UI) and Use Expe ience (UX) Design: The
applica ions buil a ound he se ice mus ocus on ease o use o all
s akeholde s—pa ien s, heal hca e p o essionals, and adminis a o s. This
includes designing dashboa d iews o heal hca e p o essionals ha
summa ize pa ien da a and p o ide ac ionable insigh s. Fo pa ien s,
applica ions should o e easy access o hei medical eco ds, eal- ime
communica ion wi h heal hca e p o ide s, and clea acking o heal h da a
(e.g., moni o ing ch onic condi ions).
• Da a Visualiza ion Tools: To help heal hca e p o essionals and pa ien s
make sense o he impo ed da a, applica ions should include ad anced
da a isualiza ion ools, such as g aphs, cha s, and end analysis,
pa icula ly o pa ien heal h eco ds and ea men p og ess. This will
imp o e decision-making and pa ien engagemen .
• Seamless In eg a ion wi h Exis ing Sys ems: The new se ice mus be
capable o in eg a ing wi h exis ing Elec onic Heal h Reco ds (EHRs),
Pe sonal Heal h Reco ds (PHRs), and Clinical Decision Suppo Sys ems
(CDSS), wi hou equi ing a comple e o e haul o legacy sys ems. This will
make adop ion smoo he o heal hca e ins i u ions and educe he need
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• In e ope abili y wi h Wea able and IoT De ices: To ensu e ha pa ien s
can con ibu e eal- ime heal h da a (such as i al signs, ac i i y le els, o
glucose eadings), he se ice should suppo in eg a ion wi h wea ables
and In e ne o Things (IoT) de ices. This da a should be secu ely
impo ed in o he sys em, p ocessed, and displayed in a way ha is bo h
meaning ul and ac ionable o heal hca e p o ide s.
Recommenda ions o Implemen a ion:
• Pilo Tes ing o Communica ion S anda ds: Be o e ull implemen a ion,
conduc pilo es s o ensu e ha s anda ds wo k as expec ed in he eal-
wo ld heal hca e en i onmen , add essing any compa ibili y issues wi h
exis ing sys ems. I is ecommended o o ganise MDT p ojec a hons o
enable es ing and o mal es ing p io o implemen a ion.
• Use -Cen e ed Design App oach: Engage use s (pa ien s, p o essionals,
and de elope s) in he design and es ing p ocess o ensu e ha he
applica ions mee hei needs and expec a ions in e ms o usabili y,
accessibili y, and unc ionali y. This is he co-c ea ion app oach p oposed
by XpanDH COD me hodology.
• Con inuous Upda es: Gi en he apid pace o echnological ad ances, i is
c i ical o implemen a sys em ha can e ol e and scale easily. Regula
upda es should be scheduled o ensu e con inued alignmen wi h
eme ging s anda ds and echnologies.
4.6 IT in as uc u e
1. Communica ion and Ne wo k P o ocols:
The in as uc u e should suppo a ange o ne wo k and communica ion
p o ocols ha ensu e secu e and consis en da a low be ween sys ems. This
includes:
• REST ul APIs o e icien eal- ime da a exchange and in e ac ion ac oss
sys ems, pa icula ly o pa ien eco ds and clinical da a.
• Au hen ica ion and Au ho iza ion S anda ds such as OAu h 2.0 o ensu e
ha only au ho ized use s can access sensi i e heal h da a.
2. Da a S o age and Backup Solu ions:
The pla o m equi es eliable s o age solu ions o handle la ge olumes o medical
da a, including imaging, es esul s, and pa ien his o ies. P og amme s should
ocus on:
• Scalable Da abase Engines: Da abases like Pos g eSQL o MongoDB can
suppo s uc u ed and uns uc u ed da a o ma s, allowing o lexible
da a handling.
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• Regula Backup and Reco e y Sys ems: Au oma ed backups and disas e
eco e y solu ions a e c i ical o ensu ing da a a ailabili y and esilience
agains po en ial da a loss.
3. Compliance wi h In e ope abili y S anda ds:
In e ope abili y s anda ds mus be implemen ed a e e y le el o he IT
in as uc u e. This includes:
• HL7 s anda ds (FHIR and o CDA) o s uc u ing and exchanging heal hca e
in o ma ion.
• LOINC, ICD-10, ICD-O-3, SNOMED CT and ATC coding s anda ds o
main ain consis ency in medical e minology, enabling eliable da a
exchange ac oss di e en heal hca e sys ems.
4. Scalabili y and Flexibili y:
The in as uc u e should be designed o adap o u u e needs, suppo ing bo h
ho izon al (adding mo e se e s) and e ical scaling (inc easing he capaci y o
exis ing se e s) as da a olumes g ow. Cloud-based solu ions, hyb id sys ems, o
on-p emises op ions can be e alua ed based on he heal hca e o ganiza ion’s
equi emen s.
5. Da a P i acy and Secu i y Measu es:
Compliance wi h p i acy egula ions such as GDPR is non-nego iable. This
equi es:
• Enc yp ion o da a bo h a es and in ansi .
• A ibu e-based access con ol (ABAC) o es ic access o pa ien da a
based on use oles, ensu ing ha only necessa y pe sonnel can access
sensi i e in o ma ion.
• Audi Logs o acking da a access and modi ica ions, which help main ain
accoun abili y wi hin he sys em.
6. Ne wo k Redundancy and Load Balancing:
Fo a eliable MDT pla o m, he ne wo k in as uc u e should inco po a e
edundancy and load balancing o handle high a ic olumes wi hou dis up ion.
Load balancing dis ibu es eques s ac oss mul iple se e s, ensu ing ha no
single se e is o e whelmed, hus main aining pe o mance and up ime.
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Annex 3
Repo and ecommenda ions documen p epa ed by Wo king g oup: Elec onic
p esc ip ion, elec onic dispensa ion and elec onic p oduc in o ma ion (3C-3P-
EPD).
Double click o open
Communi y o Doe s Wo king
G oup Repo and
Recommenda ions
eP esc ip ion/ eDispensa ion/ eP oduc In o ma ion o pa ien s
[eD – eP] + ePI
06 Decembe 2024
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Scope
This documen p esen s all collec ed con ibu ions om he Communi y o Doe s
(CoD)
7
ega ding he idealisa ion, discussion, and ecommenda ions o o malisa ion
o augmen a ion and e olu ion o he exis ing se ice o eP esc ip ion /
eDispensa ion [eP-eD] in o a iche adop ion domain p o isionally called [eP-eD] +
ePI (elec onic P oduc In o ma ion: “ePI”) as de ined by EMA–HMA-EC
8
). This
augmen ed se ice inco po a es con ibu ions om UNICOM p ojec , G a i a e-
Heal h p ojec , and o he expe s’ iews h ough a p ocess o co-c ea ion wi h
pa ien s, p o essionals, and IT de elope s (p og amme s) ollowing he logic o he
CoD se o h by XpanDH. This epo cap u es in a snapsho he ongoing discussions
o he pu pose o enabling hei con inua ion in legacy ini ia i es, p o iding
desc ip ion and ecommenda ions o ul ima ely pe mi ing he pilo ing, es ing and
deploymen o he p oposed augmen ed [eP-eD] + ePI se ice.
Goal o Wo king G oup
The XpanDH Communi y o Doe s employs a me hodology o balanced co-c ea ion
among mul iple s akeholde s, as ou lined in i s ounda ional p inciples. To acili a e
his collabo a i e app oach, he CoD is o ganized in o opical Wo king G oups (WGs).
These WGs b ing oge he eams o eHeal h ac o s wi h a p ima y objec i e: o
explo e and deli e ecommenda ions o e ol ing exis ing se ices wi hin he
con ex o he Eu opean Heal h Da a Space (EHDS). This includes iden i ying new
da a ca ego ies o adop ion o p oposing new app oaches o speci ying exis ing
p io i y da a ca ego ies.
Con ibu o s:
Bi gi Baue (DSL DE)
Lapo Be ini (Dedalus)
Ande son Ca mo (Isc e)
Sascha Ma schang (HOPE)
Hen ique Ma ins (Isc e)
Anne Moen (UiO)
Simon Lewe enz (Isc e)
Ma iam Shok alla (HIMSS)
Elsa Sil a (LPCDR)
Eleono a Va n oumian (EHMA)
Albe o Zanini (ARiA Spa)
Isabelle de Zeghe (b!loba)
7
The Communi y o Doe s and Co-c ea o s b ings oge he implemen e s and end-use s o
new and exis ing solu ions, IT de elope s and endo s/supplie s; pa ien s and heal hca e
p o essionals, in a 3C-3P communi y (co-c ea ion communi y o Pa ien s, P o essionals and
P og amme s). The scope o his open communi y is o ind use cases and business needs
ha would be eused in p ac ice domains o he Eu opean EHR (Elec onic Heal h Reco d)
Exchange Fo ma in a bo om-up co-c ea ion app oach.
8
See Elec onic p oduc in o ma ion o human medicines in he EU: key p inciples
h ps://www.ema.eu opa.eu/en/documen s/ egula o y-p ocedu al-guideline/elec onic-
p oduc -in o ma ion-human-medicines-eu opean-union-key-p inciples_en.pd
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1 Backg ound ........................................................................................................................................................ 87
1.1 Con ex and heal hca e challenge ................................................................................................ 87
1.2 Rele an scien i ic knowledge ................................................................................................. 89
1.3 Ou pu s om ele an EC- unded p ojec s and o he ini ia i es .................. 92
2 In e ope abili y challenge desc ip ion ........................................................................................... 95
2.1 O e iew ................................................................................................................................................. 95
Ti le ......................................................................................................................................................................... 95
Pu pose ................................................................................................................................................................ 95
Rele ance ........................................................................................................................................................... 95
Scale ...................................................................................................................................................................... 96
2.2 E olu ion p ocess ............................................................................................................................. 96
Ta ge g oup ..................................................................................................................................................... 96
S akeholde s ..................................................................................................................................................... 97
Con ex o use ................................................................................................................................................. 97
AS-IS si ua ion ................................................................................................................................................ 98
TO-BE si ua ion .............................................................................................................................................. 98
Desc ip ion o Necessa y S eps o Mo e om AS-IS o TO-BE Si ua ion: ........... 99
Objec i es ....................................................................................................................................................... 100
Ac o s and Roles ........................................................................................................................................... 101
P econdi ions .................................................................................................................................................102
T igge ................................................................................................................................................................. 103
Flow ...................................................................................................................................................................... 103
Gene al wo k low.......................................................................................................................................................... 103
Wo k low wi h Digi al Walle ................................................................................................................................ 105
Pos condi ions ............................................................................................................................................ 106
Requi emen s ................................................................................................................................................ 106
Majo challenges o eseen .................................................................................................................... 107
A chi ec u e ................................................................................................................................................... 108
3 Recommenda ions ......................................................................................................................................... 111
3.1 Se ice ecommenda ions ........................................................................................................... 111
3.2 Legal, egula o y and Policy ......................................................................................................... 111
3.3 In o ma ion .............................................................................................................................................112
3.4 IT in as uc u e ..................................................................................................................................112

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Table o abb e ia ions
eD
eDispensa ion
EMA
Eu opean Medicines Agency
eP
eP esc ip ion
ePI
Elec onic Medicinal P oduc In o ma ion ( equi ed o
p o ide o pa ien s)
EU
Eu opean Union
EUDI Walle
Eu opean Digi al Iden i y Walle
FHIR
Fas Heal hca e In e ope abili y Resou ces
HCP
Heal hca e p o essional
IDMP
Iden i ica ion o Medicinal P oduc s
IPS
In e na ional Pa ien Summa y
IT
In o ma ion echnology
LLM
La ge Language Model
OTC
O e - he-Coun e
POM
P esc ip ion-Only-Medicines
PS
Pa ien Summa y
NCA
Na ional Compe en Au ho i ies
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1 Backg ound
1.1 Con ex and heal hca e challenge
The Eu opean heal hca e landscape is inc easingly cha ac e ised by he
mo emen o ci izens and c oss-bo de in e ac ions, necessi a ing obus and
in e ope able eHeal h se ices. Cen al o his e olu ion a e elec onic
P esc ip ion (eP esc ip ion - eP) and Dispensa ion whe e he use is
(eDispensa ion - eD). Unde EHDS p ima y use eP esc ip ion – eDispensa ion [eP
– eD], can acili a e seamless issuance and ul ilmen o medical p esc ip ions
ac oss membe s a es. Despi e he es ablishmen o hese se ices, signi ican
challenges pe sis , pa icula ly conce ning sa e use o medicines and he p o ision
o comp ehensi e d ug in o ma ion o pa ien s in hei chosen language du ing
c oss-bo de dispensa ions.
Cu en eP esc ip ion and eDispensa ion [eP - eD] se ices p ima ily ocus on
he elec onic ans e and e i ica ion o p esc ip ion da a o dispensa ion a
he ecipien p e e ed place. Howe e , [eP-eD] o en all sho in deli e ing
essen ial d ug- ela ed in o ma ion, such as usage ins uc ions, measu ing
dosage, obse a ion o po en ial side e ec s, and in e ac ion wa nings, in a
manne ha is bo h accessible and unde s andable o pa ien s when na iga ing
heal hca e sys ems in di e en linguis ic, cul u al and heal h li e acy con ex s.
These challenges no only hampe pa ien unde s anding and adhe ence bu also
ele a e he isk o medica ion e o s, unde mining pa ien sa e y and he o e all
e ec i eness o c oss-bo de heal hca e p o ision.
The p oposed augmen ed se ice, e med [eP-eD] +ePI (eP esc ip ion-
eDispensa ion + eP oduc In o ma ion o pa ien s)9, aims o b idge his
in e ope abili y challenge by in eg a ing mul ilingual d ug in o ma ion, i.e., ePI in o
he exis ing [eP-eD] amewo k. This enhancemen is pa icula ly c i ical o
ansla ions, mee ing mobile and displaced popula ions’ needs such as
indi iduals eloca ing due o geopoli ical con lic s (e.g., e ugees ), who equi e
access o accu a e and comp ehensible medica ion in o ma ion in ano he (EU)
language o choice complemen ing language o ju isdic ion whe e dispensa ion
akes place . By p o iding egula o y in o ma ion and ansla ed medicinal
p oduc in o ma ion (digi al o lea le ) a he poin o dispensa ion, he se ice
ensu es ha pa ien s ecei e necessa y in o ma ion o manage hei
medica ions sa ely and e ec i ely, i espec i e o hei loca ion wi hin he EU.
Key assump ions unde pinning his ini ia i e include he p io esolu ion o
coun y-speci ic peculia i ies, he balanced dis ibu ion o na ional and c oss-
9
The e m ePI “elec onic p oduc in o ma ion o medicines” is used in alignmen wi h he
key p inciples on elec onic p oduc in o ma ion o human medicines in he EU, p oduced
join ly by he Eu opean Medicines Agency (EMA), Heads o Medicines Agencies (HMA) and
he Eu opean Commission in 2020.
Re ie ed om: h ps://www.ema.eu opa.eu/en/news/key-p inciples-use-elec onic-
p oduc -in o ma ion-eu-medicines
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bo de esponsibili ies, and he es ablishmen o essen ial in as uc u es such
as In e na ional Pa ien Summa y (IPS), pa ien iden i ica ion and heal hca e
p o essional (p esc ibe ) iden i ica ion. Addi ionally, he p ojec ope a es wi hin
he amewo k o he Eu opean Heal h Da a Space (EHDS), adhe ing o i s
s anda ds and o ma speci ica ions o ensu e seamless in eg a ion and
in e ope abili y ac oss membe s a es. Finally, o he pu pose o he i s e sion
o his documen , he ocus is on adding alue o he use o medicines, and
dispensa ion o eP esc ip ions mainly ia o pha macies se ing he public.
Fu he expansion can add ess wo dis inc aspec s: hospi al p esc ip ions
dispensed in pha macies se ing pa ien s—such as communi y pha macies
ope a ed by hospi als—and online pha macies, which p ima ily ocus on
medica ion dispensa ion and in oduce di e en conside a ions o P esc ip ion-
Only Medicines (POM) and p esc ip ion e i ica ion.
The scope o he augmen ed se ice “[eP - eD] +ePI” excludes online pha macies
and non-physical dispensa ions, ocusing ins ead on augmen ing he adi ional,
in-pe son medica ion dispensa ion o main ain cla i y and manageabili y o he
p ojec . Fu he mo e, da a secu i y ma e s a e seen as ounda ional o EHDS
and excluded om his scope, allowing he wo king g oup o concen a e on he
unc ional and in o ma ional aspec s o he se ice wi hou del ing in o he
complexi ies o da a p o ec ion p o ocols.
Augmen ing he [eP- eD] se ices wi h ePI (elec onic medicinal p oduc
In o ma ion ) o pa ien s en ails se e al c i ical conside a ions:
• Regula o y Compliance in Mul iple Languages: Ensu ing ha all
egula o y in o ma ion is a ailable in a pa ien ’s p e e ed / chosen (EU)
language, which is essen ial o mobile and displaced pe sons o sa e use
o medicines.
• P i acy-P ese ing Mechanisms: Implemen ing s a egies ha sa egua d
pa ien p i acy while p o iding necessa y medica ion in o ma ion.
• Pa ien Sa e y and T anscul u al Conside a ions: Add essing pa ien
sa e y by conside ing ansla ion o key ins uc ions, anscul u al ac o s
and a ia ions in p ac ice ha may a ec he unde s anding and use o
medica ions.
Addi ional ac o s o be mind ul o may include:
• P esc ip ion Label S anda disa ion: Conside ing he po en ial bene i s o
s anda dising ce ain elemen s o he ex on p esc ip ion labels— he
s icky labels added by pha macies du ing dispensing. S anda dised
exp essions can acili a e p og ammed ansla ions and enable he
p o ision o p in ed, pe sonalised ins uc ions in he pa ien 's language o
ju isdic ion o choice. This app oach may con ibu e o dec easing
medica ion e o s. Howe e , i is impo an o acknowledge ha he
c ea ion and o ma o p esc ip ion labels a e o en pa o na ional
dispensing p ac ices. The e o e, any ecommenda ions should be
sensi i e o he accep abili y o EU-wide s anda disa ion in his a ea. A
hyb id app oach, combining s anda dised ex whe e easible wi h
necessa y ee ex , could be sugges ed o balance consis ency and
lexibili y.
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• Language Suppo : Assessing he need o he inclusion o addi ional
languages, including ex a-Eu opean ones, o accommoda e he di e se
linguis ic needs o popula ions wi hin he Eu opean egion. Ad anced
echnologies, such as us ed and sa e a i icial in elligence, may play a
ole in acili a ing accu a e ansla ions, he eby enhancing unde s anding
and compliance.
• C oss-bo de P esc ip ion Condi ions: Managing he leng h, ype, and
in o ma ional equi emen s o p esc ip ions issued ab oad, ensu ing ha
w i en in o ma ion and elec onic medicinal p oduc in o ma ion (d ug e-
Lea le s) a e a ailable in language o ju isdic ion whe e dispensed (local)
and he pa ien ’s chosen language, and main aining adequa e medica ion
s ock le els.
• Secu i y Conce ns: P o ec ing he sys em agains cybe a acks o
main ain he in eg i y and con iden iali y o pa ien da a.
• IPS S anda d Inclusion: In eg a ing IPS s anda ds o c i ical pa ien
in o ma ion, such as alle gies, while allowing pha macies o manage
dispensa ion esponsibili ies based on a ailable da a and pa ien consen
h ough op -in/ou mechanisms.
• Eu opean Digi al Iden i y Walle (EUDI) in eg a ion: Accoun o possible
in e sec ion wi h he upcoming EUDI Walle , and mo e b oadly he
inc easing a ailabili y o mobile solu ions empowe ing pa ien s.
• Inc easing a ailabili y o AI echnologies and digi al solu ions– and mo e
speci ically La ge Language Models (LLM) – o p o ide explana ion on
ea men o pa ien s and suppo o heal hca e p o essionals (HCP).
By add essing hese challenges, he [eP-eD] +ePI se ice aims o enhance he
in e ope abili y and unc ionali y o exis ing eHeal h sys ems, and suppo a
h i ing EHDS, ul ima ely con ibu ing o sa e and mo e e icien use o
medicines, imp o ed pa ien ou comes, inc eased medica ion adhe ence, and a
mo e cohesi e Eu opean heal hca e ecosys em.
1.2 Rele an scien i ic knowledge
WHO epo s ha mo e han 50% o all medicines a e p esc ibed, dispensed, o
sold inapp op ia ely wo ldwide10, and OECD es ima es ha a ound 200,000
p ema u e dea hs annually in Eu ope ela e o poo medica ion adhe ence11. The
p ima y sou ce o p oduc in o ma ion in ended o pa ien s is he pape lea le 12
in he language o he ju isdic ion whe e he medicinal p oduc is dispensed.
Dis ibu ion, p oduc ion and dissemina ion o new/ e ised in o ma ion is ime-
10
h ps://apps.who.in /i is/bi s eam/handle/10665/67438/WHO_EDM_2002.3.pd
11
h ps://www.oecd-ilib a y.o g/docse e /heal h_glance_eu -2018-en.pd
12
h ps://www.ema.eu opa.eu/en/human- egula o y-o e iew/ma ke ing-
au ho isa ion/p oduc -in o ma ion- equi emen s
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Addi ionally, s anda dised ePI, al eady a ailable in language o ju isdic ion and
complemen ed by he e sions in a pe son’s language o choice can s eamline he
dispensa ion p ocess ac oss bo de s, educing adminis a i e bu dens and
enhancing he e iciency o c oss-bo de heal hca e se ices. Imp o ed pa ien
adhe ence and sa e y can also con ibu e o be e heal h ou comes, po en ially
lowe ing long- e m heal hca e cos s.
O e all. The in eg a ion o ePI in o he exis ing amewo k as “[eP - eD] +ePI” aligns
wi h he Eu opean Heal h Da a Space (EHDS) objec i es o enhance in e ope abili y,
pa ien empowe men , and c oss-bo de heal hca e deli e y. This augmen a ion
suppo s a mo e holis ic app oach o pa ien ca e, ensu ing ha indi iduals ecei e
no only hei medica ions bu also he necessa y in o ma ion o use hem sa ely and
e ec i ely, ega dless o whe e he dispensa ion occu s wi hin he EU.
The se ice acili a es he seamless p o ision o ePa ien In o ma ion ac oss
di e en EU membe s a es, enabling pa ien s o ecei e s anda dised d ug
in o ma ion i espec i e o whe e he p esc ip ion is illed.
EHDS p io i y ca ego ies add essed
(a) pa ien summa ies (i applicable);
(b) elec onic p esc ip ions;
(c) elec onic dispensa ions.
2.1.4 Scale
- C oss-bo de . The se ice acili a es he seamless p o ision o ePI ac oss di e en
EU membe s a es, enabling pa ien s o ecei e s anda dised d ug in o ma ion
i espec i e o whe e he p esc ip ion is illed.
- Ci izens a home and on he mo e. Ca e s o bo h esiden s and a elle s wi hin
he EU, ensu ing ha all ci izens ha e access o essen ial medica ion in o ma ion
whe he hey a e a home o ab oad.
2.2 E olu ion p ocess
2.2.1 Ta ge g oup
Pa ien s who ecei e p esc ip ions and/o wish o ha e hei medica ion dispensed
ac oss di e en EU membe s a es, pa icula ly hose who equi e d ug in o ma ion

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in hei chosen language ha is di e en om he local language o he ju isdic ion
whe e dispensa ion akes place.
2.2.2 S akeholde s
• Pa ien s: End-use s who will bene i om he augmen ed [eP - eD] + ePI
se ices.
• In o mal Ca egi e s: Suppo ne wo k indi iduals who a end o he needs o a
pe son wi h empo a y o pe manen limi a ions due o illness, inju y, o disabili y.
• Heal hca e P o essionals and Heal h Manage s: Physicians, pha macis s, and
o he heal hca e s a in ol ed in p esc ibing and dispensing medica ions.
• Heal h Ca e Sys ems: En i ies esponsible o he a ailabili y o medicines,
managing cos s, and ensu ing consis en supply o mee pa ien needs.
• Supply Chain and Access S akeholde s: Manu ac u e s, wholesale s,
dis ibu o s, and logis ics p o ide s in ol ed in he p oduc ion, anspo a ion,
s o age, and dis ibu ion o medica ions. Thei ole is c ucial in ensu ing imely
access o medicines and p e en ing sho ages.
• IT De elope s/P og amme s: Responsible o de eloping and main aining he
echnical aspec s o he se ice, ensu ing seamless in eg a ion and use - iendly
in e aces.
• Regula o y Bodies: O ganiza ions ha ensu e compliance wi h EU egula ions
and na ional laws, sa egua ding pa ien sa e y and da a p i acy.
• Pha maceu ical Companies: Responsible o p o iding accu a e d ug
in o ma ion, upda ing ePI con en , and ensu ing easy access o any upda es.
• Heal h Insu ance Paye s: En i ies ha may ha e an in e es in imp o ing
medica ion adhe ence, educing cos s, and op imizing heal hca e ou comes.
• Da a S anda disa ion O ganisa ions: Bodies ha ensu e consis en da a
o ma s, in e ope abili y, and adhe ence o in e na ional s anda ds, enhancing
he e iciency and eliabili y o heal h in o ma ion exchange.
2.2.3 Con ex o use
Pa ien s a eling o esiding in di e en membe s a es will ecei e hei
p esc ip ions wi h accompanying elec onic medicinal P oduc In o ma ion (ePI) in
hei chosen language. This ensu es ha pa ien s access unde s andable
in o ma ion abou hei medica ions, including usage ins uc ions, po en ial side
e ec s, and in e ac ions, ega dless o whe e he dispensa ion occu s. Heal hca e
p o essionals ac oss membe s a es will use he sys em o issue and dispense
p esc ip ions ha sys ema ically include mul ilingual d ug in o ma ion, enhancing
pa ien sa e y and adhe ence in c oss-bo de scena ios, as well as HCP’s wo k in
si ua ions ha equi e ansla ion.
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2.2.4 AS-IS si ua ion
The cu en eP esc ip ion/eDispensa ion [eP - eD] se ices in Eu ope does no
consis en ly p o ide medicinal p oduc in o ma ion in he pa ien ’s chosen language
a he poin o dispensa ion, leading o misunde s andings and po en ial medica ion
e o s, especially in c oss-bo de con ex s.
2.2.5 TO-BE si ua ion
The augmen ed [eP-eD]+ePI se ice p o ides comp ehensi e d ug in o ma ion
elec onically a he poin o dispensa ion, in he pa ien 's language o choice. This
ensu es cla i y, unde s anding, and sa e medica ion use ac oss all EU membe
s a es du ing c oss-bo de heal hca e in e ac ions.
By in eg a ing ePI in o he eP-eD amewo k, pa ien s ecei e immedia e access o
up- o-da e, au ho ized medicinal p oduc in o ma ion di ec ly linked o hei
p esc ibed and dispensed medica ion. This includes de ailed in o ma ion on:
• Dosage Ins uc ions (Posology): Clea guidance on he amoun o
medica ion o ake, he equency, and he du a ion o ea men .
• Me hod o Adminis a ion: Ins uc ions on how o co ec ly adminis e he
medica ion (e.g., o ally, in a enously, opically).
• Po en ial Side E ec s: Comp ehensi e lis s o common and se ious ad e se
e ec s, along wi h ad ice on wha ac ions o ake i hey occu .
• Con aindica ions and P ecau ions: In o ma ion on condi ions o si ua ions
whe e he medica ion should no be used o used wi h cau ion.
• D ug In e ac ions: De ails abou o he medica ions, oods, o subs ances
ha could in e ac nega i ely wi h he p esc ibed d ug.
• S o age Condi ions: Guidelines on how o s o e he medica ion p ope ly o
main ain i s e ec i eness.
• Addi ional Pa ien Suppo : Links o mul imedia esou ces such as
ins uc ional ideos, diag ams, o pa ien suppo p og ams ha enhance
unde s anding.
Addi ionally, he augmen ed se ice includes a dispensa ion con i ma ion o
ollow-up message in elec onic o m, which is sen o he pa ien h ough hei
p e e ed communica ion channel (e.g., email, SMS, secu e pa ien po al). This
message ein o ces key medica ion ins uc ions and may p o ide:
• Pe sonalized Medica ion Schedules: Tailo ed calenda s o eminde s o
assis pa ien s in adhe ing o hei medica ion egimen.
• ePI – he e sion o egula o app o ed in o ma ion in a chosen language,
complemen ing language o ju isdic ion, whe e dispensa ion akes place
• Sa e y Ale s: No i ica ions abou impo an sa e y in o ma ion, such as
ecalls o new con aindica ions.
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• Feedback Mechanisms: Op ions o pa ien s o epo side e ec s o ask
ques ions di ec ly o heal hca e p o ide s.
• Educa ional Ma e ials: Access o b ochu es, FAQs, o suppo g oups
ele an o hei heal h condi ion o ea men .
By le e aging hese digi al ools, he augmen ed [eP - eD] + ePI se ice enhances
pa ien empowe men and engagemen . I suppo s medica ion adhe ence by
making essen ial in o ma ion eadily accessible and unde s andable, ailo ed o
indi idual needs and language p e e ences. This holis ic app oach p omo es be e
heal h ou comes by educing he isk o medica ion e o s, imp o ing pa ien
sa is ac ion, and os e ing a mo e in o med pa ien popula ion.
Key Bene i s o he Augmen ed Se ice:
• Sa e use o medicines: egula o app o ed in o ma ion abou he speci ic,
dispensed medica ion is made a ailable o he use a poin o dispensa ion,
complemen ing exis ing in o ma ion in language o he ju isdic ion.
• Consis ency Ac oss Bo de s: S anda dized in o ma ion ensu es ha
pa ien s ecei e he same high-quali y in o ma ion ega dless o whe e hey
ecei e ca e wi hin he EU.
• Imp o ed Communica ion: Enhanced channels o pa ien -p o ide
communica ion acili a e imely in e en ions and suppo .
• Accessibili y: Digi al o ma s o e come ba ie s associa ed wi h los o
damaged pape lea le s, ensu ing in o ma ion is always a ailable when
needed.
• En i onmen al Impac : Reducing eliance on p in ed ma e ials suppo s
sus ainabili y e o s.
This en isioned sys em ep esen s a signi ican ad ancemen in how medicinal
p oduc in o ma ion is deli e ed and u ilized, p io i izing pa ien needs and
le e aging echnology o imp o e heal hca e deli e y ac oss Eu ope.
2.2.6 Desc ip ion o Necessa y S eps o Mo e om AS-IS
o TO-BE Si ua ion:
1. Requi emen Analysis and S akeholde Engagemen :
- Conduc wo kshops wi h s akeholde s o ga he de ailed equi emen s
cap u ing c oss-bo de needs.
- Iden i y language p e e ences, ansla ion needs, and o he c oss-bo de -
speci ic ac o s such as local egula o y equi emen s, a ailabili y o gene ic
d ugs, p oduc a ailabili y, OTC s. POM, and cul u al a ia ions in pha macy
p ac ices.
- T ansla ion o key in o ma ion on he p esc ip ion label wi h ins uc ions /e.g.
ake wi h ood, no milk o in he mo ning.
2. S anda disa ion and Da a In eg a ion:
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- Align s anda dised da a o ma s o d ug in o ma ion ha suppo
mul ilingual da a aking ad an age o FHIR ePI Implemen a ion Guide, and
ISO-IDMP s anda d).
- In eg a e mul ilingual capabili ies in o he exis ing [eP - eD] sys ems o
suppo he c oss-bo de p o ision o medicinal p oduc in o ma ion and
sa e use o medicines.
3. De elopmen and Implemen a ion:
- Collabo a e wi h IT de elope s o build he ePI module wi h obus
mul ilingual suppo , explo ing po en ial o LLM models.
- Ensu e ha he de elopmen p ocess accoun s o egional egula o y
di e ences, medica ion a ailabili y, and cul u al nuances in d ug in o ma ion
p esen a ion.
- Implemen ansla ion se ices and ensu e accu acy and cul u al
app op ia eness o ansla ions.
4. Tes ing and Valida ion:
- Pe o m igo ous es ing ac oss di e en languages and c oss-bo de
scena ios.
- Valida e he sys em wi h eal-wo ld c oss-bo de use cases and ga he
eedback.
5. T aining and Deploymen :
- T ain heal hca e p o essionals on he new sys em ea u es wi h an emphasis
on c oss-bo de usage.
- Roll ou he se ice ac oss membe s a es in phases, p io i ising high c oss-
bo de a ic a eas.
6. Moni o ing and Con inuous Imp o emen :
- Moni o usage and ga he c oss-bo de -speci ic eedback o ongoing
enhancemen s.
- Regula ly e iew compliance wi h local egula ions, medica ion a ailabili y
upda es, and cul u al e ec i eness o he ePI con en .
- Regula ly upda e d ug in o ma ion and ansla ions o main ain accu acy
and ele ance.
2.2.7 Objec i es
- Enhance Pa ien Unde s anding: Ensu e ha pa ien s ha e access o
in o ma ion hey can comp ehend, o ully unde s and hei medica ions by
p o iding d ug in o ma ion and ela ed egimen in hei chosen language
du ing c oss-bo de in e ac ions.
- Imp o e Medica ion Adhe ence and Sa e y: Reduce he isk o medica ion
e o s and imp o e adhe ence by making in o ma ion accessible and
comp ehensible ac oss bo de s.
- Facili a e Seamless C oss-Bo de Heal hca e: Enable seamless heal hca e
expe iences o pa ien s a eling o esiding in di e en EU membe s a es.
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- Align wi h EHDS Objec i es: Suppo he Eu opean Heal h Da a Space’s
goals o in e ope abili y, pa ien empowe men , and in eg a ed heal hca e
deli e y, speci ically wi hin c oss-bo de con ex s.
2.2.8 Ac o s and Roles
Ac o
Role
Physician
Physicians, as he c ea o s o elec onic p esc ip ions, play a
c i ical ole in ensu ing ha p esc ip ion in o ma ion is
documen ed clea ly wi hin he heal h eco d. E en wi hou
ha monised e minology being in use, physicians can acili a e
he ansla ion o p esc ip ion in o ma ion by using clea and
unambiguous language.
Pha macis
Pha macis s a e esponsible o dispensing he co ec
medica ions (o iginally p esc ibed p oduc o a biosimila
app o ed in he coun y) and acili a ing pa ien access o he
ansla ed elec onic P oduc In o ma ion (ePI). Thei ole
ensu es ha pa ien s ecei e clea and unde s andable
in o ma ion abou hei medica ions—in hei own language and
na ional con ex —which is c ucial o adhe ence and sa e y,
especially in c oss-bo de con ex s. While p in ing he ePI a he
poin o dispensa ion may no be an in eg al pa o hei se ice,
pha macis s can p o ide access h ough al e na i e means. This
could include o e ing a lye wi h a QR code o digi al access o
he ePI o sending a link ia an au oma ed digi al dispensing
con i ma ion message, p o ided he pa ien 's con ac de ails a e
sha ed wi h and consen ed o use by he dispensing pha macy.
Nu se
Nu ses, when adminis e ing medica ions, p o ide essen ial
in o ma ion abou he medicines hey gi e o pa ien s. They
ein o ce medica ion ins uc ions, moni o pa ien esponses,
and se e as a poin o con ac o any ques ions o conce ns he
pa ien may ha e ega ding hei medica ion egimen. Nu ses
ensu e ha pa ien s unde s and how o ake hei medica ions
co ec ly and sa ely.
Pa ien
Pa ien s a e he end-use s who bene i di ec ly om he se ice.
By ecei ing ePI in hei chosen language, hey can be e
unde s and in o ma ion abou hei medica ions, leading o
imp o ed adhe ence and educed isk o e o s.
Suppo
Ne wo k /
In o mal
Ca egi e
Suppo ne wo k indi iduals, such as amily membe s o iends
who, a he pa ien 's disc e ion and wi h consen , need o know
and con ibu e o obse ing medicine use. They assis pa ien s
wi h medica ion adhe ence, help moni o o side e ec s o
ad e se eac ions, and communica e wi h heal hca e
p o essionals as needed o suppo he pa ien 's heal h and well-
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IT De elope
IT De elope IT de elope s ensu e ha he [eP-eD] +ePI sys em
is echnically obus , suppo ing mul iple languages and enabling
seamless da a in eg a ion ac oss di e en heal hca e sys ems
and membe s a es. Addi ionally, hey a e esponsible o
implemen ing a dispensa ion documen a ion componen o
con i m he dispensa ion e en , which cu en ly does no exis .
This componen should aim a wo ecei e s:
1. Pa ien Communica ion: P o ide con i ma ion o dispensa ion
o he pa ien , including any elec onic P oduc In o ma ion (ePI)
o p esc ip ion ins uc ions. This enhances pa ien awa eness
and suppo s adhe ence.
2. P esc ibe Au ho i y No i ica ion: No i y he p esc ibe o
ele an au ho i y o a oid duplica ion o dispensing, ensu ing
pa ien sa e y and egula o y compliance.
This aligns wi h ini ia i es such as MyHeal h@EU, aiming o
imp o e c oss-bo de heal hca e se ices wi hin he EU.
Regula o y
Body
Regula o y bodies ensu e ha he se ice complies wi h all
ele an EU and na ional egula ions. Thei o e sigh is c ucial o
main aining legal s anda ds and p o ec ing pa ien da a ac oss
bo de s.
Pha maceu ical
Company
Pha maceu ical companies supply he necessa y d ug
in o ma ion ha is included in he ePI as pa o ma ke
au ho isa ion o a p oduc . Thei ole ensu es ha he
in o ma ion is accu a e, up- o-da e, and consis en ac oss
di e en languages and egions.
S anda ds
De eloping
O ganisa ion
These o ganisa ions wo k o s anda dise da a o ma s, ensu ing
in e ope abili y be ween di e en heal hca e sys ems. This
s anda disa ion is essen ial o he seamless exchange o
in o ma ion ac oss bo de s.
2.2.9 P econdi ions
S anda dised Da a Fo ma s: Adop ion o uni ied o ma s o d ug in o ma ion and
pa ien da a ac oss EU membe s a es o suppo c oss-bo de in e ope abili y,
such as he Eu opean Elec onic Heal h Reco d Exchange Fo ma (EEHRxF). Unique
ID (ISO-IDMP) s anda disa ion can help « e ch» he exisi ing ePI in chosen language.
Mul ilingual T ansla ion Se ices: A ailabili y o eliable and accu a e ansla ion
capabili ies o mul iple languages. This includes le e aging manu ac u e -p o ided
d ug in o ma ion in local languages whe e he p oduc is ma ke ed o dispensed, as
hese esou ces a e eliable and con inuously main ained.
Regula o y Compliance: Adhe ence o EU egula ions and na ional laws ela ed o
c oss-bo de eHeal h se ices and da a p o ec ion, including GDPR and ele an
heal h da a di ec i es.
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Technical In as uc u e: Implemen a ion o obus IT in as uc u e o suppo
secu e c oss-bo de da a in eg a ion, s o age, and e ie al. This goes beyond jus
ha ing digi al iden i ies and digi al walle s (DW). While Digi al Iden i y solu ions
and Digi al Walle s (such as he EUDI Walle ) a e c ucial o au hen ica ing use s
and managing consen , addi ional componen s a e necessa y:
• Secu e Da a Exchange P o ocols: U ilize s anda dized p o ocols (e.g., HL7
FHIR) o he secu e ansmission o heal h da a be ween sys ems.
• In e ope abili y S anda ds: Ensu e sys ems can communica e e ec i ely
by adhe ing o in e ope abili y s anda ds ac oss di e en heal hca e IT
sys ems in membe s a es.
• Pa ien Po als and Access Pla o ms: P o ide pa ien s wi h pla o ms
whe e hey can secu ely access hei heal h in o ma ion, eP esc ip ions, and
ePI.
• Da a Secu i y Measu es: Implemen enc yp ion, anonymiza ion, and o he
secu i y measu es o p o ec pa ien da a du ing ansmission and s o age.
In summa y, while digi al iden i y and digi al walle s a e essen ial componen s, a
comp ehensi e IT in as uc u e is equi ed o acili a e seamless and secu e da a
sha ing ac oss bo de s.
Digi al Con ac In o ma ion: Ensu e he a ailabili y and accu acy o pa ien s'
digi al con ac in o ma ion (e.g., email add esses, mobile numbe s) o enable di ec
sha ing o da a, such as ePI and dispensa ion con i ma ions, wi h he pa ien .
Cul u al and Linguis ic Adap abili y: Ensu e ha ansla ions a e no only
linguis ically accu a e bu also cul u ally app op ia e and con ex ually ele an o
di e en membe s a es. This enhances pa ien unde s anding and engagemen by
espec ing cul u al nuances and heal h li e acy le els.
2.2.10 T igge
Ac ion T igge ing he Use o he New Se ice:
A pa ien wi h a p esc ip ion ecei ed in one EU membe s a e seeks o ha e i
dispensed in ano he membe s a e, ac i a ing he p o ision o eP oduc pa ien
In o ma ion (ePI) in he pa ien 's selec ed language a he poin o dispensa ion.
2.2.11 Flow
Gene al wo k low
1. P esc ip ion Issuance:
• Physician c ea es an eP esc ip ion wi hin he [eP - eD] sys em, ensu ing
he accu acy and legali y o he p esc ip ion.
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• Key in o ma ion om he pape p oduc lea le (PIL) is included o
maximize compliance.
• Pa ien Engagemen : The physician p o ides o al guidance, discussing he
medica ion's pu pose, usage ins uc ions, po en ial side e ec s, and
add essing any pa ien ques ions. This ea ly in e ac ion ensu es he pa ien
unde s ands he ea men plan and eels com o able wi h hei medica ion
egimen.
• Feedback Oppo uni y: A his s age, he pa ien can p o ide immedia e
eedback o exp ess conce ns, allowing he physician o cla i y any
misunde s andings.
2. Da a T ansmission:
• The p esc ip ion da a, including medica ion de ails and language
p e e ence, is secu ely ansmi ed o he dispensing pha macy in a
di e en membe s a e.
• Pha macis ecei es he eP esc ip ion and assesses he alidi y o he
documen .
3. Pa ien In e ac ion a Dispensing:
• Upon a i al, he pha macis con i ms he pa ien 's chosen language o
ecei ing he ePI and any ansla ed ins uc ions.
• Pha macis inds he medica ion and he co esponding elec onic
P oduc In o ma ion (ePI) in he pa ien 's chosen language.
• Gene a es a s anda dised p esc ip ion label ("s icky label") wi h usage
ins uc ions, ansla ed as necessa y in o he pa ien 's chosen language.
• P o ides addi ional guidance as needed, possibly o e ing a lye wi h a QR
code o digi al access o he ePI o sending a link ia an au oma ed digi al
con i ma ion message.
• Feedback Oppo uni y: The pha macis engages wi h he pa ien ,
add essing any addi ional ques ions o conce ns, and collec s immedia e
eedback on he cla i y o he in o ma ion p o ided.
4. eDispensa ion:
• Pha macis dispenses he medica ion along wi h he ePI, ensu ing he
pa ien ully unde s ands he usage ins uc ions and o he ele an
in o ma ion.
• Ensu es comp ehension, possibly by asking he pa ien o epea key
ins uc ions o by p o iding supplemen al educa ional ma e ials.
5. Con inuous Imp o emen Feedback Loop:
• Feedback Collec ion: Pa ien eedback on he cla i y and use ulness o he
ePI, as well as he in o ma ion p o ided by bo h he physician and
pha macis , is ga he ed du ing bo h he issuance and dispensing s ages.
• Da a U ilisa ion: This eedback is used o e ine and imp o e he se ice,
including upda ing s anda dized ins uc ions and enhancing communica ion
s a egies.
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• S akeholde Collabo a ion: Insigh s a e sha ed among heal hca e
p o essionals, IT de elope s, and egula o y bodies o acili a e ongoing
imp o emen s in he sys em.
Wo k low wi h Digi al Walle
1. P esc ip ion Issuance:
o Physician In e ac ion:
▪ The physician c ea es an eP esc ip ion using hei sys em
and, wi h pa ien consen , sends i di ec ly o he pa ien 's
Digi al Heal h Walle .
▪ P o ides clea and unambiguous medica ion ins uc ions,
acili a ing unde s anding and u u e ansla ion.
▪ Engages wi h he pa ien o discuss medica ion de ails and
add ess any ques ions.
2. Da a Access and Consen :
o Pa ien Con ol:
▪ The pa ien e iews he eP esc ip ion in hei Digi al Walle .
▪ G an s access pe missions o pha macis s when seeking
dispensa ion.
3. Dispensa ion:
o Pha macis In e ac ion:
▪ The pa ien p esen s hei Digi al Walle (e.g., ia QR code o
secu e digi al oken) a he pha macy.
▪ The pha macis e ie es he eP esc ip ion om he pa ien 's
walle wi h consen .
▪ Ve i ies p esc ip ion alidi y and accesses he ePI in he
pa ien 's chosen language.
▪ Gene a es s anda dized p esc ip ion labels wi h ansla ed
ins uc ions, which a e added o he pa ien 's Digi al Walle .
4. Medica ion Dispensing and In o ma ion Sha ing:
o Dispensa ion Reco d:
▪ The pha macis upda es he eDispensa ion eco d in he
pa ien 's Digi al Walle .
▪ Con i ms ha he pa ien unde s ands usage ins uc ions and
p o ides addi ional guidance i needed.
▪ O e s digi al o p in ed ma e ials (e.g., QR codes, links) o
accessing he ePI.
5. Pa ien Engagemen :
o Access o In o ma ion:
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aining—aligned wi h EU legal s anda ds and guidance om bodies such as he
EMA—o ganisa ions can p o ide clea e idence o compliance du ing audi s o
inspec ions.
3.3 In o ma ion
1. Conside he exis ing in o ma ion asse s, such as:
• Exis ing [eP - eD] guidelines
• EU PS guidelines
• Conside he IPS as u u e con e gence is o eseen
- EU ePI common s anda d; ISO IDMP, FHIR ePI IG
2. P o ide in o ma ion and aining possibili ies o end-use s, om heal h
p o essionals o ci izens as ways o os e awa eness, unde s anding and
ul ima ely accep ance and use o he se ice.
3.4 IT in as uc u e
1. Vendo selec ion. Choosing a endo wi h a s ong ack eco d o success ul
in eg a ions is essen ial, as hei expe ience can signi ican ly impac he o e all
e ec i eness o he p ojec . A endo ha specialises in heal hca e solu ions
unde s ands he unique challenges aced by he indus y, including
compliance equi emen s and da a p i acy conce ns. Fu he mo e, obus
suppo se ices a e c ucial du ing and a e implemen a ion. Vendo s ha
o e ongoing echnical assis ance can help o ganisa ions oubleshoo issues
as hey a ise. This suppo may include aining o s a , egula sys em
upda es, and access o a dedica ed help desk, which enhances use
expe ience and sys em eliabili y.
2. Conduc ing pilo es ing is ano he e ec i e s a egy o add essing po en ial
echnical challenges. By olling ou he new sys em in a con olled en i onmen ,
o ganisa ions can iden i y and esol e issues be o e ull-scale implemen a ion.
Pilo es ing allows o ho ough examina ion o he sys em's unc ionali y,
enabling o de ec bugs, compa ibili y issues, o use in e ace challenges.
Ga he ing eedback om end-use s du ing his phase is in aluable.
Adjus men s made du ing pilo es ing can lead o a smoo he ansi ion when
he sys em is inally launched o ganisa ion-wide, minimising dis up ion o daily
ope a ions.
3. Ne wo k and Secu i y P o ocols: Recommend adop ing secu e p o ocols (e.g.,
TLS/SSL) o all eP esc ip ion- ela ed da a exchanges ac oss ne wo ks,
ensu ing compliance wi h EHDS da a secu i y s anda ds and EU cybe secu i y
equi emen s. Can be based on exis ing used p o ocols such as he TESTA
ne wo k.

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Annex 4
Repo and ecommenda ions documen p epa ed by Wo king g oup: Mul i-Coun y
wo king g oup on Imaging (3C-3P-MIM).
Double click o open
Communi y o Doe s Wo king
G oup Repo and
Recommenda ions
Mul i-Coun y wo king g oup on Imaging (3C-3P-MIM).
Scope
This documen p esen s all collec ed con ibu ions om he Communi y o Doe s
(CoD)
24
ega ding he idealisa ion, discussion, and ecommenda ions o he
o malisa ion o an e olu ion o exis ing eleconsul a ion se ices in o a new
adop ion domain, inco po a ing o he Eu opean knowledge and expe s’ iews
h ough a p ocess o coc ea ion wi h pa ien s, p o essionals, and IT de elope s
(p og amme s) ollowing he logic o he CoD se o h by XpanDH. This epo
cap u es in a snapsho he ongoing discussions o he pu pose o enabling hei
con inua ion in legacy ini ia i es, p o iding desc ip ion and ecommenda ions o
24
The Communi y o Doe s and Co-c ea o s b ings oge he implemen e s and end-use s o
new and exis ing solu ions, IT de elope s and endo s/supplie s; pa ien s and heal hca e
p o essionals, in a 3C-3P communi y (co-c ea ion communi y o Pa ien s, P o essionals and
P og amme s). The scope o his open communi y is o ind use cases and business needs
ha would be eused in p ac ice domains o he Eu opean EHR (Elec onic Heal h Reco d)
Exchange Fo ma in a bo om-up co-c ea ion app oach.
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ul ima ely pe mi ing he pilo ing, es ing and deploymen o he p oposed
augmen ed eleconsul a ion encoun e epo se ice.
Goal o Wo king G oups
The XpanDH Communi y o Doe s employs a me hodology o balanced co-c ea ion
among mul iple s akeholde s, as ou lined in i s ounda ional p inciples. To acili a e
his collabo a i e app oach, he CoD is o ganized in o opical Wo king G oups (WGs).
These WGs b ing oge he eams o eHeal h ac o s wi h a p ima y objec i e: o
explo e and deli e ecommenda ions o e ol ing exis ing se ices wi hin he
con ex o he Eu opean Heal h Da a Space (EHDS). This includes iden i ying new
da a ca ego ies o adop ion o p oposing new app oaches o speci ying exis ing
p io i y da a ca ego ies.
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Table o Con en s
Execu i e Summa y................................................................................................................................................ 117
1 Backg ound ...................................................................................................................................................... 118
1.1 Rele an exis ing ma e ial .................................................................................................................. 118
1.2 Desc ip ion o he MCWG and XpanDH pa ne ship ...................................................... 118
1.3 Heal hca e challenges in imaging app oached by MCWG ......................................... 119
1.4 Rele an scien i ic ecommenda ions ...................................................................................... 119
1.5 Inpu s om ele an EC- unded p ojec s and o he ini ia i es ............................ 120
1.6 Cha ac e is ics ........................................................................................................................................ 120
1.7 In e -domain dependencies ........................................................................................................... 123
2 Vision o he EEHRxF-suppo ed se ice ................................................................................... 125
3 Ta ge ed Recommenda ions De eloped by MCWG .......................................................... 126
3.1 Sha ing he in o ma ion abou Signi ican Images along wi h a sha ed imaging
s udy .......................................................................................................................................................................... 126
3.2 A Quick Use Guide o clinicians o bes use sea ch me ada a o il e ing
ele an imaging s udies .............................................................................................................................. 127
4 Recommenda ions o ele an asse bundle ......................................................................... 128
4.1 Legal and egula o y ............................................................................................................................. 129
4.2 Policy ............................................................................................................................................................... 129
4.3 Ca e p ocess ............................................................................................................................................. 129
4.4 In o ma ion ................................................................................................................................................. 130
4.5 Applica ions .............................................................................................................................................. 130
4.6 IT in as uc u e ........................................................................................................................................ 131
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Execu i e Summa y
The Mul i-Coun y Wo king G oup (MCWG) Communi y o Doe s (CoD), o mally
ecognized by he XpanDH p ojec and suppo ed by IHE-Eu ope, aims o enhance
medical imaging da a sha ing and in e ope abili y ac oss Eu ope unde he
Eu opean Heal h Da a Space (EHDS). This ini ia i e add esses challenges such as
agmen ed s anda ds, inconsis en me ada a de ini ions, and un eliable wo k lows
ha hinde c oss-bo de and na ional da a exchange. Th ough collabo a ion wi h
na ional ep esen a i es, eHeal h agencies, and echnical expe s, he MCWG CoD
has de eloped key ecommenda ions o align imaging p ac ices wi h he EHDS and
he Eu opean Elec onic Heal h Reco d Exchange Fo ma (EEHRxF).
The MCWG has p oduced i e key epo s:
1. Posi ioning Imaging S anda ds and P o iles, which shows how IHE P o iles
and eHeal h Ne wo k (eHN) guidelines can enable secu e, s anda dized
c oss-bo de in e ope abili y.
2. Imaging Sha ing Me ada a and Linkages, which emphasizes he impo ance
o s anda dized me ada a o e ec i e imaging s udy disco e y and sha ing.
3. KOS Imaging S udy Mani es , which p o ides echnical guidance on c ea ing
and sha ing imaging mani es s o consis en wo k lows and eliable da a
sha ing.
4. Flagging Signi ican Images in sha ed Imaging S udies which adds he
in e ope able capabili y o a sou ce lagging o signi ican images ha is
ully and easily accessible o he imaging consuming heal h p o essional.
5. A quick use guide o help clinicians be e unde s and he que y
pa ame e s o sea ch me ada a associa ed wi h “sea ch ca ds” o clinical
documen s o objec s ha need o be sha ed such as medical imaging
s udies and medical imaging epo s.
These epo s a e essen ial esou ces o aligning imaging p ac ices wi h EHDS
objec i es. The documen also highligh s he balanced co-c ea ion me hodology
used by he MCWG, in ol ing pa ien s, heal hca e p o essionals, IT de elope s, and
policymake s o ensu e p ac ical and comp ehensi e ecommenda ions. I also
d aws on insigh s om Eu opean Commission- unded p ojec s, such as XpanDH
and X -EHR, o align wi h exis ing eHeal h Ne wo k guidelines.
The MCWG aims o add ess he challenges o c oss-bo de and na ional
in e ope abili y, agmen ed wo k lows, and me ada a inconsis encies, p oposing
solu ions ha suppo clinicians in accessing accu a e and ele an imaging
in o ma ion e icien ly. The epo s p o ide ecommenda ions ac oss a ious le els
o he Re ined eHeal h Eu opean In e ope abili y F amewo k (ReEIF), including legal,

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egula o y, policy, and echnical aspec s, guiding coun ies and o ganiza ions
owa d imp o ed imaging da a in e ope abili y.
1 Backg ound
1.1 Rele an exis ing ma e ial
Rele an ma e ial a e he eHeal h Ne wo k’s (eHN) guidelines.
They include speci ic guidelines o i e di e en se ices: eP esc ip ion and
eDispensa ion, Pa ien Summa y, Labo a o y esul s, Medical imaging s udies and
epo s, and Hospi al discha ge epo s.
They a e based on he Commission Recommenda ion on a Eu opean Elec onic
Heal h Reco d exchange o ma ’s o iginal ‘heal h in o ma ion domains’.
- eHeal h Ne wo k Gene al guidelines
- eHN guidelines on eP esc ip ion and eDispensa ion
- eHN guidelines on Pa ien Summa y
- eHN guidelines on labo a o y esul s
- eHN guidelines on Medical imaging s udies and epo s
- eHN guidelines on Hospi al discha ge epo s
The o iginal ‘heal h in o ma ion domains’ ha e e ol ed wi h he Ap il 2024 EHDS
egula ion, o be eca ego ized in o i e ‘p io i y ca ego ies o pe sonal elec onic
heal h da a’:
(a) pa ien summa ies;
(b) elec onic p esc ip ions; elec onic dispensa ions;
(c) medical imaging s udies and ela ed imaging epo s;
(d) medical es esul s, including labo a o y and o he diagnos ic esul s and
ela ed epo s;
(e) discha ge epo s.
1.2 Desc ip ion o he MCWG and XpanDH
pa ne ship
The Mul i-Coun y Wo king G oup (MCWG), wi h pa icipa ion om mo e han 10
coun ies (including F ance, Aus ia, Ne he lands, Spain, and Belgium, e c...) is hos ed
by IHE-Eu ope and plays a c i ical ole in ad ancing heal hca e in e ope abili y by
p o iding ecommenda ions based on eHeal h Ne wo k
(eHN) guidelines and es ablished implemen able speci ica ions based on
in e na ional s anda ds and p o iles. These ecommenda ions, ha a e app o ed by
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he pa icipa ing coun ies, ensu e secu e, s anda dized imaging da a exchange
eady o be deployed a a na ional and egional le el. These ecommenda ions a e
designed o be ex endable o he C oss-bo de . This makes MCWG a obus
consensus essen ial o he EEHRxF and Eu opean Heal h
Da a Space. MCWG main ains an ac i e ela ionship wi h X -EHR WP7.2 h ough
se e al common coun y ep esen a i es.
To suppo his, he Mul i-Coun y Wo king G oup on Imaging - Communi y o
Doe s (MCWG-Imaging CoD) has been es ablished. This g oup uni es a wide ange
o s akeholde s, including o he XpanDH Communi ies o Doe s ac oss Eu ope.
Wi hin i , he MCWG-Imaging Co e subg oup b ings a necessa y leade ship wi h
na ional ep esen a i es om eHeal h Agencies, Minis ies, and Compe ence
Cen e s, wi h a ocus o deli e ecommenda ions on aligning imaging p ac ices and
s anda ds a he na ional le el o imp o ed in e ope abili y. Inpu and eedback
om he MCWG on Imaging – CoD S akeholde s is been le e aged in a cons uc i e
and e icien manne .
XpanDH o mally ecognizes he MCWG on Imaging as a Communi y o Doe s,
p omo ing collabo a ion, esou ce sha ing, and a s onge pla o m o shaping
Eu opean heal hca e in e ope abili y policies and s anda ds.
1.3 Heal hca e challenges in imaging app oached
by MCWG
• Lack o c oss-bo de in e ope abili y o imaging da a due o agmen ed
adop ion o s anda ds and inconsis encies in implemen a ion.
• Inconsis en me ada a de ini ions and managemen , which hinde
disco e abili y and usabili y o imaging da a ac oss mul iple sys ems and
coun ies.
• F agmen ed imaging wo k lows and un eliable da a consis ency ac oss
sys ems.
1.4 Rele an scien i ic ecommenda ions
MCWG add esses hese issues by p o iding ecommenda ions and de eloping
in e ope abili y speci ica ions o align imaging p ac ices wi h he Eu opean
Heal h Da a Space (EHDS) and EEHRxF goals wi h he ollowing deli e ables:
• Posi ioning imaging s anda ds and p o iles: Ou lines he applica ion o
IHE P o iles and eHeal h Ne wo k (eHN) guidelines o suppo c oss-bo de
in e ope abili y.
Read he ull epo he e.
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• Imaging Sha ing Me ada a and Linkages: Focuses on he impo ance o
me ada a managemen o disco e abili y and e ec i e imaging s udy
sha ing, including p ac ical ecommenda ions o implemen a ion.
Read he ull epo he e.
• KOS (Key Objec Selec ion) Imaging S udy Mani es : P o ides echnical
ecommenda ions o c ea ing and sha ing KOS mani es s o imaging
S udies, which enhance da a eliabili y and acili a e consis en imaging
wo k lows.
Read he ull epo he e.
1.5 Inpu s om ele an EC- unded p ojec s and
o he ini ia i es
XpanDH P ojec : MCWG builds on XpanDH's amewo k o c ea ing in e ope able
solu ions ac oss he EU. The XpanDH app oach emphasizes s akeholde co-
c ea ion and he adop ion o consensus-based ecommenda ions, ensu ing
p ac ical alignmen wi h he Eu opean Elec onic Heal h Reco d Exchange Fo ma
(EEHRxF).
X -EHR Join Ac ion : Con ibu ions om X -EHR, pa icula ly in WP7 (Task 7.2),
a e in eg a ed in o MCWG’s e o s. Se e al MCWG membe s a e also pa o his
Join Ac ion, ensu ing knowledge ans e and alignmen wi h EU c oss-bo de
in e ope abili y goals.
eHeal h Ne wo k : The MCWG d aws hea ily on he guidelines de eloped by he
eHN, such as hose o imaging s udies and imaging epo s sha ing. These
guidelines a e used as a basis o e ining use cases and p oposing me ada a
speci ica ions.
Link o eHN Guidelines
Eu opean eHeal h Digi al Se ice In as uc u e (eHDSI) and MyHeal h@EU:
eHDSI's c oss-bo de da a-sha ing amewo k and echnical s anda ds p o ide
ounda ional inpu s o MCWG’s ecommenda ions, pa icula ly in ensu ing GDPR
compliance and secu e da a exchange.
1.6 Cha ac e is ics
[Fill in he amewo k below o desc ibe he use s o y a s ake. This amewo k is
inspi ed by ha o desc ip ion o a use case in he eHeal h Ne wo k’s Re ined
eHeal h Eu opean In e ope abili y F amewo k (ReEIF).]
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Ti le
Enhancing c oss-bo de in e ope abili y o Medical
Imaging
Pu pose
Enable seamless sha ing and accessibili y o medical imaging
da a ac oss EU Membe S a es o imp o e pa ien ca e,
op imize wo k lows, and align wi h he Eu opean Heal h Da a
Space (EHDS) and EEHRxF objec i es.
Rele ance
Medical a ionale: Reduces edundan imaging exams and
adia ion exposu e, imp o es access o clinicians wi hou
imaging acili ies, and acili a es imely specialis e iew wi h
inc ease clinical quali y by compa ing wi h p io s udies.
P omo es luid pa ien pa hways by add essing delays
caused by in e ope abili y gaps.
Economic a ionale: Elimina es duplica ion o imaging
s udies, educing cos s o pa ien s and heal hca e sys ems.
Enhances e iciency by s eamlining wo k lows and
suppo ing seconda y use o imaging da a.
P io i y ca ego y
[ om he 2024 EHDS egula ion:
(a) pa ien summa ies;
(b) elec onic p esc ip ions;
(c) elec onic dispensa ions;
(d) medical imaging s udies and ela ed imaging epo s;
(e) medical es esul s, including labo a o y and o he
diagnos ic esul s and ela ed epo s;
( ) discha ge epo s.]
Scale
C oss-bo de , na ional, egional, and in a-o ganiza ion
in e ope abili y, wi h po en ial o empowe pa ien s h ough
con olled da a sha ing (e.g., ia EEHRxF)
Ta ge g oup
Heal hca e p o essionals, including adiologis s, gene al
p ac i ione s, and specialis s, alongside pa ien s needing
accessible imaging se ices ac oss egions.
S akeholde s
Pa ien s, adiologis s, sys em a chi ec s, heal hca e IT
implemen e s, egula o y bodies, and policymake s in ol ed
in he EHDS amewo k.
Con ex o use
Challenges:
• F agmen ed adop ion o s anda ds
• Me ada a inconsis encies a ec ing disco e abili y
and usabili y.
• Limi ed awa eness among clinicians and pa ien s
abou imaging ools.
• C oss-bo de GDPR compliance and da a secu i y
conce ns.
• Technological and wo k low in eg a ion ba ie s due
o egional dispa i ies.
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4 Recommenda ions o ele an asse
bundle
[P o ide ecommenda ions o s eps o ollow, p ecau ions o be aken, ma e ial o
be p oduced, o else, in he 6 in e ope abili y le els ou lined by he eHeal h
Ne wo k’s e ined eEIF (ReEIF).
Below we display wo models ha display how hese 6 in e ope abili y le els can be
applied o (i) alignmen ac i i ies be ween o ganisa ions, and (ii) s akeholde s.]
Figu e 11 Re ined eEIF (ReEIF) model – alignmen ac i i ies be ween o ganisa ions
Figu e 12 Re ined eEIF (ReEIF) model – s akeholde s

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4.1 Legal and egula o y
S eps:
• Ha monize legal amewo ks, including compliance wi h GDPR and pa ien
consen ac oss bo de s.
• Add ess da a so e eign y issues o ensu e consis en c oss-bo de
exchange o medical da a, pa icula ly o imaging.
P ecau ions:
• Ensu e na ional egula ions a e ha monized, pa icula ly wi h espec o
c oss-bo de da a sha ing and pa ien p i acy.
• Main ain cla i y on consen managemen and legal liabili y.
Ma e ials o P oduce:
• Legal and egula o y guidelines documen o c oss-bo de da a
exchange in imaging.
• Da a p i acy and secu i y amewo ks ensu ing GDPR compliance.
4.2 Policy
S eps:
• Fo malize collabo a ion ag eemen s be ween heal hca e o ganiza ions,
ocusing on da a sha ing in imaging.
• De ine mu ual esponsibili ies and he us -building p ocesses be ween
coun ies o o ganiza ions o c oss-bo de da a exchange.
P ecau ions:
• Ensu e all pa ies a e aligned on da a sha ing pu poses, secu i y measu es,
and compliance esponsibili ies.
• P e en ambigui y in oles and esponsibili ies du ing c oss-bo de
collabo a ions.
Ma e ials o P oduce:
• Collabo a ion ag eemen s o da a sha ing and c oss-bo de medical
imaging.
• Go e nance amewo k de ining oles, policies, and secu i y p o ocols.
4.3 Ca e p ocess
S eps:
• Align clinical wo k lows o he exchange o imaging da a ac oss bo de s.
• S anda dize ca e pa hways o c oss-bo de in e ope abili y, ensu ing
seamless in eg a ion o medical imaging da a in he clinical wo k low.
P ecau ions:
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• Adap wo k lows o di e en heal hca e se ings while main aining
consis ency in he da a needed o ea men .
• P e en clinical e o s due o inconsis en wo k lows o missing da a.
Ma e ials o P oduce:
• Clinical wo k low documen a ion wi h s anda dized imaging da a
in eg a ion.
• Guidelines on aligning ca e p ocesses o in e ope able c oss-bo de
heal hca e se ices.
4.4 In o ma ion
S eps:
• De ine s anda dized da a models, e minologies, and me ada a schemas
o c oss-bo de imaging da a sha ing.
• Ensu e in e ope abili y by linking imaging da a elemen s wi h common
e minologies and me ada a o enhance disco e abili y.
P ecau ions:
• Ensu e consis ency in me ada a de ini ions o educe e o s and
ambigui ies.
• U ilize exis ing s anda ds (e.g., IHE, HL7, DICOM) o suppo c oss-bo de
da a exchange.
Ma e ials o P oduce:
• Me ada a o imaging da a exchange.
• Te minology and da a model guidelines o in e ope able heal hca e
sys ems.
4.5 Applica ions
S eps:
• Es ablish echnical speci ica ions o da a ans e p o ocols (e.g., HL7, IHE
XDS-I, DICOM) o ensu e smoo h impo and expo o imaging da a.
• Implemen secu e and use - iendly applica ions ha enable easy access
o imaging da a o clinicians and pa ien s.
P ecau ions:
• Ensu e seamless in eg a ion o in e ope able sys ems in o exis ing clinical
applica ions.
• P io i ize secu i y in he da a exchange p o ocols, especially in c oss-
bo de scena ios.
Ma e ials o P oduce:
• Communica ion and applica ion in eg a ion s anda ds o medical imaging.
• Technical documen a ion and use manuals o clinicians on new
in e ope able sys ems.
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4.6 IT in as uc u e
S eps:
• Implemen s anda dized ne wo k p o ocols (e.g., IHE, DICOM, HL7) o
eliable communica ion ac oss bo de s.
• Ensu e secu e s o age and backup o imaging da a, wi h a en ion o
scalabili y o accommoda e u u e demands.
P ecau ions:
• Ensu e obus da a p o ec ion and enc yp ion measu es o pa ien da a
secu i y.
• Minimize sys em down ime o a oid in e up ions in c oss-bo de da a
sha ing.
Ma e ials o P oduce:
• Technical speci ica ions o communica ion s anda ds and p o ocols.
• Secu i y and in as uc u e guidelines o implemen ing c oss-bo de da a
exchange.
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Annex 5
Repo and ecommenda ions documen p epa ed by Wo king g oup: Teleheal h—
Teleconsul a ion Encoun e Repo (3C-3P-TER).
Double click o open
Communi y o Doe s Wo king
G oup Repo and
Recommenda ions
Teleheal h: Teleconsul a ion encoun e epo
TER
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Scope
This documen p esen s all collec ed con ibu ions om he Communi y o Doe s
(CoD)
25
ega ding he idealisa ion, discussion, and ecommenda ions o he
o malisa ion o an e olu ion o exis ing eleconsul a ion se ices in o a new da a
ca ego y, inco po a ing o he Eu opean knowledge and expe s’ iews h ough a
p ocess o coc ea ion wi h pa ien s, p o essionals, and IT de elope s (p og amme s)
ollowing he logic o he CoD se o h by XpanDH. This epo cap u es in a snapsho
he ongoing discussions o he pu pose o enabling hei con inua ion in legacy
ini ia i es, p o iding desc ip ion and ecommenda ions o ul ima ely pe mi ing he
pilo ing, es ing and deploymen o he p oposed augmen ed eleconsul a ion
encoun e epo se ice.
Goal o Wo king G oups
The XpanDH Communi y o Doe s employs a me hodology o balanced co-c ea ion
among mul iple s akeholde s, as ou lined in i s ounda ional p inciples. To acili a e
his collabo a i e app oach, he CoD is o ganised in o opical Wo king G oups (WGs).
These WGs b ing oge he eams o eHeal h ac o s wi h a p ima y objec i e: o
explo e and deli e ecommenda ions o e ol ing exis ing se ices wi hin he
con ex o he Eu opean Heal h Da a Space (EHDS). This includes iden i ying new
da a ca ego ies o adop ion o p oposing new app oaches o speci ying exis ing
p io i y da a ca ego ies.
25
The Communi y o Doe s and Co-c ea o s b ings oge he implemen e s and end-use s o new and
exis ing solu ions, IT de elope s and endo s/supplie s; pa ien s and heal hca e p o essionals, in a 3C-
3P communi y (co-c ea ion communi y o Pa ien s, P o essionals and P og amme s). The scope o his
open communi y is o ind use cases and business needs ha would be eused in p ac ice domains o
he Eu opean EHR (Elec onic Heal h Reco d) Exchange Fo ma in a bo om-up co-c ea ion app oach.

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Table o Con en s
1 Backg ound ...................................................................................................................................................... 135
1.1 Rele an exis ing ma e ial ............................................................................................................ 135
1.2 Heal hca e challenge....................................................................................................................... 136
1.3 Rele an scien i ic knowledge .................................................................................................. 136
1.4 Inpu s om ele an p ojec s and na ional scena ios ............................................. 137
2 In e ope abili y challenge desc ip ion .......................................................................................... 139
2.1 O e iew .................................................................................................................................................. 139
Ti le ........................................................................................................................................................................ 139
Pu pose ............................................................................................................................................................... 139
Rele ance .......................................................................................................................................................... 139
P io i y ca ego y ........................................................................................................................................... 139
Scale .................................................................................................................................................................... 140
2.2 E olu ion p ocess ............................................................................................................................. 140
2.3 In e -domain dependencies ...................................................................................................... 143
3 Example: he case o Denma k ........................................................................................................... 143
3.1 In as uc u e........................................................................................................................................ 143
3.2 Teleconsul a ion: ypes and use ............................................................................................. 145
4 Nex s eps and open ques ions ........................................................................................................ 148
4.1 Recommenda ions o nex s eps ......................................................................................... 148
4.1.1 Legal, egula o y and policy ............................................................................................. 148
4.1.2 Ca e p ocess .............................................................................................................................. 148
4.1.3 In o ma ion .................................................................................................................................. 149
4.1.4 Applica ions ............................................................................................................................... 150
4.1.5 IT in as uc u e ....................................................................................................................... 150
4.2 Open ques ions ................................................................................................................................. 150
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1 Backg ound
1.1 Rele an exis ing ma e ial
Rele an ma e ial a e he eHeal h Ne wo k’s (eHN) guidelines.
They include speci ic guidelines o i e di e en se ices: eP esc ip ion and
eDispensa ion, Pa ien Summa y, Labo a o y esul s, Medical imaging s udies and
epo s, and Hospi al discha ge epo s.
They a e based on he Commission Recommenda ion on a Eu opean Elec onic
Heal h Reco d exchange o ma ’s o iginal ‘heal h in o ma ion domains’.
- eHeal h Ne wo k Gene al guidelines
- eHN guidelines on eP esc ip ion and eDispensa ion
- eHN guidelines on Pa ien Summa y
- eHN guidelines on labo a o y esul s
- eHN guidelines on Medical imaging s udies and epo s
- eHN guidelines on Hospi al discha ge epo s
The o iginal ‘heal h in o ma ion domains’ ha e e ol ed wi h he 2024 EHDS
egula ion, o be eca ego ized in o six ‘p io i y ca ego ies o pe sonal elec onic
heal h da a’:
(a) pa ien summa ies;
(b) elec onic p esc ip ions;
(c) elec onic dispensa ions;
(d) medical imaging s udies and ela ed imaging epo s;
(e) medical es esul s, including labo a o y and o he diagnos ic esul s and
ela ed epo s;
( ) discha ge epo s.
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1.2 Heal hca e challenge
When pa ien s a e hospi alised, sha ing o discha ge le e s a e aking place in
se e al EU Membe S a es, bu besides he encoun e s du ing he hospi al
admission, u he encoun e s can ake place ou side he hospi al, and
documen a ion o hese encoun e s holds impo an clinical in o ma ion o he
o e all holis ic iew o he pa ien s’ condi ion.
When clinical no es a e documen ed in public EHR sys ems, se e al encoun e
ypes a e egis e ed he same way and can be uploaded o a na ional eposi o y
o indexed in a na ional egis y. Some se ices in he p i a e ma ke pe o m
eleconsul a ion and he e is need o a eleconsul a ion encoun e epo o
sha ing in o ma ion o hese encoun e s.
1.3 Rele an scien i ic knowledge
Teleconsul a ion has been ex ensi ely e alua ed ac oss a ious se ings in
Denma k, o e ing aluable insigh s in o i s implemen a ion, e ec i eness, and
challenges. Key e alua ions highligh i s impac on gene al p ac ice, municipal
heal hca e, c oss-sec o collabo a ion, and public sec o digi isa ion.
1. E alua ion o Teleconsul a ion in Gene al P ac ice (CIMT, 2020)26
This s udy assessed he use o ideo consul a ions in gene al p ac ice,
ocusing on he sui abili y o eleconsul a ion o speci ic pa ien g oups and
condi ions. The indings indica ed ha eleconsul a ion can enhance pa ien
access and con enience, pa icula ly o ollow-up isi s and non-u gen
consul a ions. Howe e , he s udy also emphasised he need o physicians
o assess pa ien sui abili y, as eleconsul a ion may no be app op ia e o
complex o sensi i e cases. The e alua ion highligh ed he impo ance o
in eg a ing eleconsul a ion seamlessly in o gene al p ac ice wo k lows o
maximise i s po en ial.
2. E alua ion o Teleconsul a ion in Municipali ies (MedCom, 2023)27
This e alua ion explo ed he use o ideo consul a ions in municipal
heal hca e se ices, pa icula ly in he con ex o home nu sing and elde ly
ca e. The indings demons a ed ha eleconsul a ion imp o es e iciency,
enabling heal hca e p o essionals o deli e imely ca e while educing a el
ime. Howe e , challenges we e iden i ied in ensu ing adequa e echnical
in as uc u e and in aining s a o use eleconsul a ion pla o ms
26
E alua ion o eleconsul a ion in gene al p ac ice (CIMT 2020). A ailable a :
h ps://cim .dk/p ojek e / o sknings-og-e alue ingsp ojek e /e alue ing-a - ideo-i-almen-p aksis
27
E alua ion o eleconsul a ion in municipali ies (MedCom 2023). A ailable a :
h ps://medcom.dk/wp-con en /uploads/2023/07/6-1-kon ak -laege-e alue ings appo - eb-23.pd
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e ec i ely. The epo ecommended a ge ed in e en ions o add ess
hese ba ie s and imp o e he up ake o eleconsul a ion ac oss
municipali ies.
3. E alua ion o C oss-Sec o Teleconsul a ions (VIVE, 2022-2025)28
This ongoing e alua ion ocuses on eleconsul a ions in c oss-sec o se ings,
pa icula ly o complex pa ien pa hways in ol ing mul iple s akeholde s.
P elimina y esul s sugges ha eleconsul a ions acili a e imp o ed
communica ion and coo dina ion be ween sec o s, enhancing con inui y o
ca e o pa ien s wi h ch onic o mul i ace ed condi ions. Howe e , he s udy
iden i ied challenges in es ablishing clea wo k lows and sha ed
esponsibili ies among s akeholde s, unde sco ing he need o obus
go e nance and in e ope abili y s anda ds.
4. E alua ion o Teleconsul a ions by he Danish Digi isa ion Au ho i y
(2023)29
The Danish Digi isa ion Au ho i y’s e alua ion in es iga ed he b oade use o
ideo mee ings ac oss he public sec o , including heal hca e. The s udy
highligh ed he e iciency gains o eleconsul a ion, such as educed a el
and wai ing imes, while also add essing ba ie s such as use accep ance
and echnical s abili y. The epo s essed he impo ance o ensu ing da a
secu i y and compliance wi h GDPR o build us in eleconsul a ion
solu ions. Fu he mo e, i emphasised he po en ial o eleconsul a ion o
imp o e se ice deli e y in unde se ed a eas, p o ided ha in as uc u e
in es men s and aining a e p io i ised.
These e alua ions collec i ely demons a e he ans o ma i e po en ial o
eleconsul a ion in enhancing heal hca e deli e y, while also highligh ing he need
o ailo ed app oaches o add ess con ex ual challenges in di e en heal hca e
se ings. The indings p o ide a s ong ounda ion o he u he de elopmen o
eleconsul a ion se ices unde amewo ks such as he Eu opean Heal h Da a
Space (EHDS).
1.4 Inpu s om ele an p ojec s and na ional
scena ios
Denma k:
28
E alua ion o c oss-sec o eleconsul a ions (VIVE 2022-2025). A ailable a :
h ps://www. i e.dk/da/unde soegelse -i-gang/ i e-e alue e - ae sek o ielle- ideomoede -om-
de -komplekse-pa ien o loeb-0dx4nk o/
29
E alua ion o eleconsul a ions by he Danish Digi iza ion Au ho i y (2023). A ailable a :
h ps://digs .dk/media/bmcn2c5d/digi alise ingss y elsen- ideomoede -i-den-o en lige-sek o -
ap il-2023.pd
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lookups, bu has he disad an age o each use in e ace is in di e en design,
e minology and use. Rele an in o ma ion ha needs documen ed mus be
manually e- yped.
3. MedCom is esponsible o he Danish backbone se ice based
in as uc u e, used o publish se ices and make se ice eques om
sys ems, and also hos ing websi e based solu ion ope a ing on his secu e
ne wo k ins ead o he open in e ne . The Danish heal h da a au ho i ies
publish a na ional se ice pla o m (NSP), wi h se ices o secu i y, consen ,
logging e c. Use o he ne wo k is ee o cha ge, bu he e is a small ee o
onboa ding he ne wo k.
4. The na ional se ice pla o m con ains IHE XDS documen sha ing, and ha e
a numbe o egis ies and eposi o ies in a ede a ed ecosys em. The egis y
con ains he me ada a, and he eposi o ies con ains uploaded documen s.
Fo some documen ypes, he documen s a e gene a ed a he ime o
eques , and Denma k has a mix o hese wo s o age o ms, ei he in a
na ional eposi o y, and gene a ed om cen al o local sys ems.
5. Videocall in as uc u e (VDX) is ee o cha ge, since MedCom has acqui ed
a la ge numbe o licenses o use in egions, municipali ies and p ima y
sec o . This ideocall solu ions is es ablished in 2009 and in eg a ed in o EHR
sys ems and o he sys ems, po al and Apps.
Denma k es ablished sha ing o discha ge le e om hospi al many yea s ago,
be o e implemen ing IHE XDS documen sha ing, so discha ge le e s and clinical
no es is uploaded wi h a na ional EHR exchange o ma “SUP”, and s o ed in a na ional
da abase on he backbone se ice based ne wo k using webse ice echnology. The

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Danish s a egy is o subs i u e his old “SUP” o ma wi h he Eu opean EHR
exchange o ma EEHRxF, possibly added ex ensions o local need.
The na ional se ice pla o m has a eposi o y o eleheal h, con aining documen s
wi h measu emen s and ques ionnai e esponses om he ci izens homes. The
s a egy is o add new eposi o y ha can s o e eleconsul a ion encoun e epo s,
and hese h ee ypes o eleheal h da a is he Danish unde s anding o
elemedicine. I uses wo in as uc u es, one o ideocalls and he o he one o
documen sha ing.
3.2 Teleconsul a ion: ypes and use
EHR sys ems has de eloped in eg a ions o he na ional ideocall in as uc u e, so
ega dless om whe e a eleconsul a ion encoun e is pe o med, he ci izen is
mee ing he same use in e ace, which makes i easie o he ci izens o use.
Du ing co id19 pandemic, his al eady implemen ed in as uc u e made in easy o
up-scale na ionally use o eleconsul a ions, and a e he pandemic he up ake
seems o s ay a he same le el o s eadily g ow.
Abo e is shown numbe o eleconsul a ions each mon h by gene al p ac i ione s
Up ake by gene al p ac i ione s is 86%
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Abo e shows numbe o clinics pe o ming a numbe o eleconsul a ions.
Fo con ac o gene al p ac i ione s, he e was de eloped a i ual wai ing oom,
whe e he ci izens om hei App “MyDoc o ” can eques a eleconsul a ion wi h
hei usual physician. A he gene al p ac i ione s clinic, he pa ien s could be in i ed
o he eleconsul a ion wi h use o a link send in a SMS, o popup in he App.
Alongside eleconsul a ions he e is also pe o med encoun e s as elephone
consul a ions o e-consul a ions (secu e cha be ween MyDoc o App and he
gene al p ac i ione s EHR. The eleconsul a ions encoun e epo is expec ed o be
ollowed by epo ypes o he wo o he encoun e ypes.
The ideocall in as uc u e is also used o con e ences be ween heal hca e
p o essionals, and in hese use cases, he ou come o he con e ence is s o ed in
bo h EHR sys ems. Heal hca e p o essionals in he municipali ies use he same
queue sys em in he gene al p ac i ione EHR sys em. As shown below he
heal hca e p o essionals is wai ing as numbe wo in he queue sys em.
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A c i ical c i e ia o up ake and use, is he ideocall pla o m s abili y and easy use.
Busy heal hca e p o essionals expe ience e o s o bad usabili y s op using he
solu ion, and acco ding o e alua ion hey a e highly esis an o come back.
Abo e is shown o e all numbe o eleconsul a ion and elecon e ences du ing a
ou yea s
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4 Nex s eps and open ques ions
4.1 Recommenda ions o nex s eps
To e ec i ely ad ance he da a ca ego y o eleconsul a ion encoun e epo s, i
is ecommended o ollow he s uc u ed app oach used in de eloping p io i y
domains such as Labo a o y Repo s and Hospi al Discha ge Repo s. This en ails
es ablishing clea in e ope abili y s anda ds, engaging mul i-s akeholde g oups o
co-c ea ion, and ensu ing alignmen wi h he EHDS amewo k. Le e aging lessons
lea ned om hese p io i y domains will enable a sys ema ic, scalable, and eplicable
model o eleconsul a ion. Such a s a egy can suppo consis ency, p omo e us ,
and acili a e subsequen c oss-bo de in eg a ion o TER se ices.
4.1.1 Legal, egula o y and policy
To ensu e c oss-bo de in e ope abili y o eleconsul a ion encoun e epo s,
membe s a es mus es ablish egula o y guidelines ha espec di e se consen
models while p omo ing ha monisa ion unde he EHDS. Consen mechanisms
should align wi h GDPR equi emen s, allowing secu e and e hical da a sha ing
ac oss bo de s. Addi ionally, clea policies mus add ess he use o AI models,
speci ying anspa en aining me hodologies and da ase s o uphold da a
p o ec ion, inclusi i y, and bias mi iga ion, in alignmen wi h he AI Ac . This dual
ocus on consen and AI egula ion is c i ical o os e ing us and compliance
ac oss di e se heal hca e sys ems.
A he policy le el, o mal con ac s and ag eemen s mus de ine he pu pose,
alue, and go e nance o collabo a ions be ween o ganisa ions o enable
seamless in e ope abili y o eleconsul a ion se ices. T us and esponsibili ies
should be explici ly ou lined o ancho he go e nance o hese pa ne ships.
Recognising he cul u al challenges in al e ing heal hca e p o essionals’ wo k lows,
a ge ed legisla ion may be equi ed o s anda dise eleconsul a ion p ac ices and
ensu e consis en adop ion by physicians. Clea go e nance amewo ks and
legisla i e suppo will acili a e sus ainable and us ed collabo a ions wi hin and
ac oss bo de s.
4.1.2 Ca e p ocess
Despi e yea s o eleconsul a ion use, he e emains ongoing deba e abou which
pa ien s a e bes sui ed o use his mode o heal hca e deli e y. Findings om he
Danish e alua ion sugges ha his decision should es wi h he physician, as hey
a e bes posi ioned o assess he pa ien ’s li e acy, heal h s a us, and social
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condi ions. Physicians can de e mine whe he eleconsul a ion will p o ide
adequa e ca e o i al e na i e encoun e ypes a e mo e app op ia e.
To enhance he e iciency o eleconsul a ion wo k lows, AI ools should be
employed o gene a e clinical documen a ion seamlessly. Du ing o immedia ely
a e he eleconsul a ion, hese ools can p oduce bo h a ansc ip and a
s uc u ed clinical no e. This documen a ion should be expo able om he
eleconsul a ion pla o m di ec ly in o he EHR sys em, ensu ing ha he same
clinical no e is a ailable locally o con inui y o ca e.
Howe e , i is c i ical o allow physicians ull edi o ial con ol o e AI-gene a ed
ex . This lexibili y enables hem o make necessa y adjus men s o e lec he
nuances o he pa ien ’s si ua ion accu a ely. By inco po a ing hese e inemen s,
eleconsul a ion wo k lows can main ain high s anda ds o clinical p ecision while
s eamlining documen a ion p ocesses.
4.1.3 In o ma ion
A he in o ma ion le el, eleconsul a ion documen a ion mus accoun o di e se
da a equi emen s ac oss membe s a es. While some encoun e s may only
equi e plain ex documen a ion, o he s may necessi a e mo e s uc u ed da a
based on he pa ien 's disease o he speci ic episode o ca e. Fo example, in
cases like diabe es managemen , some membe s a es link all consul a ions and
ela ed da a o a single episode o ca e, enabling con inui y and holis ic ca e
managemen . To suppo his a iabili y, he eleconsul a ion amewo k should
include an op ional unc ionali y ha allows encoun e s o be linked o an episode
o ca e, ensu ing lexibili y and in e ope abili y ac oss heal hca e sys ems.

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4.1.4 Applica ions
A he applica ions le el, ag eemen s mus s anda dise how medical in o ma ion
is impo ed and expo ed ac oss di e se heal hca e in o ma ion sys ems while
accommoda ing he di e ing in as uc u es implemen ed by membe s a es. Fo
ins ance, some membe s a es may use a na ional egis y wi h me ada a o
documen sea ches, while o he s may s o e documen s locally in EHR sys ems o
upload hem o a na ional XDS eposi o y. Rega dless o hese in as uc u e
a ia ions, i is essen ial ha he eleconsul a ion encoun e documen emains
in e ope able and usable ac oss all sys ems. Adop ing uni e sal communica ion
s anda ds and ensu ing seamless in eg a ion in o use - iendly applica ions will
acili a e consis en handling and p ocessing o sha ed in o ma ion.
4.1.5 IT in as uc u e
A he IT in as uc u e le el, gene ic in e ope abili y s anda ds and p o ocols
mus ensu e seamless communica ion, s o age, and backup o eleconsul a ion
encoun e epo s. Membe s a es ha lack IHE XDS-based documen sha ing in
hei na ional in as uc u e will need o es ablish his capabili y o implemen an
al e na i e in as uc u e ha suppo s secu e and e icien exchange o hese
epo s. Rega dless o he chosen solu ion, compliance wi h s anda dised
p o ocols is c i ical o enable in e ope abili y and ensu e eliable access o
eleconsul a ion da a ac oss di e en heal hca e sys ems.
4.2 Open ques ions
To guide u he discussions and acili a e in o med decision-making, se e al open
ques ions emain o be add essed wi hin he con ex o eleconsul a ion encoun e
epo s:
1. Scope:
o Wha speci ic aspec s o eleconsul a ion should be p io i ised o
s anda disa ion unde he EHDS amewo k?
o How can he amewo k balance lexibili y o membe s a es while
main aining consis ency ac oss bo de s?
o Should he eleconsul a ion scope ex end o all clinical speciali ies o
ocus on selec domains whe e i s alue is mos e iden ?
2. AI Suppo o Summa ising Tele-encoun e s:
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o Wha le el o au oma ion is app op ia e o AI ools in summa ising
eleconsul a ion encoun e s, and how should hese ools balance
au oma ion wi h human o e sigh ?
o Wha da a p i acy and bias mi iga ion measu es a e equi ed o
ensu e hese AI ools align wi h he GDPR and AI Ac ?
o How can accu acy and us wo hiness o AI-gene a ed summa ies be
alida ed and con inuously imp o ed?
3. Access Righ s:
o Wha should he access con ol amewo k look like o
eleconsul a ion da a?
o Should dis inc igh s be de ined o "sha e- o- iew" ( ead-only
access) and "sha e- o-sha e" (allowing u he dissemina ion), and
how should hese igh s be en o ced?
o Wha p o ocols should go e n access be ween pa ien s and doc o s,
as well as be ween doc o s, o ensu e bo h usabili y and da a
secu i y?
4. Da a Reposi o y and Exchange:
o How can duplica ion o eleconsul a ion encoun e da a wi h exis ing
s o ed clinical no es be a oided?
o Should na ional eposi o ies (as seen in Denma k) o p i a e company
in as uc u es be a ou ed, and wha c i e ia should go e n his
choice?
o How can he EEHRxF amewo k suppo seamless linking be ween
public and p i a e s o age solu ions o p omo e in e ope abili y and
con inui y o ca e?
Add essing hese ques ions is c ucial o ad ancing he implemen a ion and
in eg a ion o eleconsul a ion encoun e epo s ac oss membe s a es. They
highligh key challenges a he in e sec ion o echnology, policy, and pa ien -cen ic
ca e, equi ing collabo a i e inpu om all s akeholde s.