11/26/25
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B idging AI in e na ional
policy and p ac ice
AIDV WG
F ancis C awley, Na alie Meye s, Rod igo Roa, Seonyoung
Kim, Pa icia Buendia, Madha a Jay
Oc 15, 25 h RDA Plena y Mee ing
B isbane, 2025
h ps://www. d-alliance.o g/g oups/a i icial-in elligence-and-da a- isi a ion-aid -wg/ac i i y/
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Acknowledgemen
o Coun y
We acknowledge and celeb a e
he Fi s Aus alians on whose
adi ional lands we mee , and
we pay ou espec o hei
elde s pas and p esen .
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Welcome o new RDA membe s!
OPENNESS COMMUNITY-
DRIVEN
CONSENSUS
NON-PROFIT AND
TECHNOLOGY-
NEUTRAL
HARMONISATION INCLUSIVITY
6 Guiding P inciples a e a he hea o he RDA communi y.
JOIN THE RDA
www. d-alliance.o g/ egis e /
All RDA membe s a e expec ed o adhe e by he RDA Code
o Conduc o os e a welcoming and inclusi e en i onmen .
h ps://www. d-alliance.o g/g oups/a i icial-in elligence-and-da a- isi a ion-aid -wg/ac i i y/
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EOSC-Fu u e/RDA AIDV
Wo king G oup and i s co e
ou pu s
Co-Chai s: Na alie Meye s & F ancis C awley
h ps://www. d-alliance.o g/g oups/a i icial-in elligence-and-da a- isi a ion-aid -wg/ac i i y/
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Fou Recommenda ions om he AIDV
Wo king G oup:
Shaping Responsible AI
h ps://www. d-alliance.o g/news/shaping- esponsible-ai- ou -new- ecommenda ions- om- he-aid -wo king-g oup
Ou pu s
•Guidance o E hics commi ees & IRBs e iewing
AI and DV p ojec s
•Guidance o In o med Consen in con ex o AI
and DV
•Secu e P ocessing En i onmen s o Open
Science: P oposing Legal Founda ions
•AI Bill o Righ s Recommenda ion
Suppo ing/O he Ou pu s
• Geog aphies o T us : AI, Biomedicine,
and he Nex E a o Fede a ed and
Visi ing Da a Models whi epape
•AIDV-WG Sha ed Ci a ion Lib a y
11:35
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The Shi ing Pa adigm: F om Da a T ans e o Da a
Visi a ion
•Inc easing olume and sensi i i y o da a
(e.g., heal h, genomics).
•Challenges o adi ional da a ans e
(secu i y, go e nance, duplica ion).
•Da a isi a ion: Enabling analysis in si u
wi hou physical mo emen .
•Po en ial bene i s: Collabo a ion, secu i y,
educed bu den on da a owne s.
11:40
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DV4RDA TIGER P ojec :
Pu ing RDA P inciples in o
P ac ice
Na alie Meye s
11:45
This DV4RDA p ojec has ecei ed unding h ough RDA TIGER om he Eu opean Union’s Ho izon Eu ope
amewo k p og amme unde g an ag eemen No. 101094406. 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 ins i u ions
ep esen ed he e. Nei he he Eu opean Union no he ins i u ions can be held esponsible o hem.
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B idging Da a Silos and P i acy
•The Challenge: Biomedical da a holds p o ound po en ial, bu
is o en apped in silos due o complex secu i y and p i acy
conce ns (e.g., HIPAA, GDPR).
•The Solu ion: The DV4RDA p ojec di ec ly aligns wi h RDA's
mission o champion in e ope abili y, ep oducibili y, and
accessibili y by p o iding a p ac ical amewo k o add ess
hese hu dles.
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DV4RDA: Embodimen o RDA Co e
P inciples
•Communi y-D i en: Global RDA Membe s collabo a ed o
implemen policies and e alua e eal-wo ld da a echnology.
•Deli e ing Value: The p ojec champions p oducing angible,
implemen able ou pu s h ough a p ac ical da a pla o m.
•Ha moniza ion: The p ojec ’s "compu a ion- o-da a" model
aligns wi h da a secu i y and heal h da a RDA wo king g oups
like:
•T us ed Resea ch En i onmen s o Sensi i e o Con iden ial Da a
•Heal h Da a Commons GORC P o ile
•Building Immune Digi al Twins
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Goals o he DV4RDA p ojec
•F amewo k o Implemen ing Da a Visi a ion echnologies
•Demons a e and E alua e Da a Visi a ion in P ac ice
•Enhance Da a Secu i y and P i acy
•P omo e FAIR Da a P inciples
•Accele a e Resea ch
•Fos e Global Collabo a ion
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Pa icipan s' Rec ui men
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DV4RDA Pa icipan s
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Ac ionable RDA Ou pu s
•Policy Language: P oposed expansion o language o IRB
P o ocols and In o med Consen Fo ms (ICFs) o explici ly
include "Da a Visi a ion" as a p o ec ion me hod.
•Secu i y F amewo k: De eloped a comp ehensi e "RDA AIDV
Templa e -Sys em Secu i y Assessmen Plan" o u u e Da a
Visi ing Technologies.
•Technical Tool: Implemen ed pe -subjec consen checking
du ing he da a quali y con ol (QC) p ocess o DV4RDA.
•Bill o Righ s: Expanded online documen a ion wi h AIDV
policy in o ma ion.
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4 Sho Talks
P esen e s: Rod igo Roa, Seonyoung Kim, Pa icia Buendia, Madha a Jay
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Policy in o P ac ice & he Da a
Obse a o y Expe ience
Rod igo Roa, Execu i e Di ec o
Da a Obse a o y
San iago, Chile
11:50
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Who we a e?
Da a Obse a o y (DO) is a non-p o i public–
p i a e–academic ins i u ion c ea ed by he
Go e nmen o Chile, Amazon Web Se ices
(AWS), and Adol o Ibáñez Uni e si y.
I s mission is o acqui e, p ocess, and make
a ailable la ge olumes o da a wi h scien i ic,
echnological, and social impac .
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As onomy Ea h
Obse a ion
Na u al
Resou ces
Socie y
Resea ch & Wo k A eas
Open da a pla o ms and in as uc u es
wi h a FAIR app oach (Findable,
Accessible, In e ope able, Reusable),
de eloped in collabo a ion and
pa ne ship wi h public and p i a e
ins i u ions.
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Pe -Subjec In o med Consen
Ve i ica ion Du ing QC
●Buil on he dbGaP model
●S anda dized using he In o med
Consen On ology (ICO)
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Implemen a ion and Call o Ac ion
•IRB and ICF language now p o ide a clea amewo k o complian Da a
Visi a ion
•Ins i u ions can adop his language o demons a e p i acy-by-design p ac ices
•Aligns wi h NIH DMS & GDS policies, HIPAA secu i y s anda ds, and GDPR
p inciples
•Enables e hical AI applica ions while p ese ing pa icipan au onomy
•Call o Ac ion: We in i e RDA membe s and ins i u ions o adop and e e ence
his guidance in hei own policies and p o ocol empla es
“A econside a ion o he classic o m o in o med consen is necessa y in ligh o AI. We need
o suppo au onomy h ough p ac ical, lexible consen mechanisms.”
–D . K is y Hacke , Ins i ue on E hics & Policy o Inno a ion, McMas e Uni e si y
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Ques ions o
Seonyoung
Kim
abou In o med
Consen in DV?
h ps://www. d-alliance.o g/g oups/a i icial-in elligence-and-da a- isi a ion-aid -wg/ou pu s/
12:20
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Use Case: FAIRlyz
Implemen a ion o AIDV
Policies
Pa icia Buendia
12:25
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2. FAIRlyz Demo o
New Fea u es
3:25 minu es ideo
1. Video Slide Deck
P esen a ion
2.49 minu es ideo
Video P esen a ions
Also in YouTube
Also in YouTube
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FAIRlyz: An In as uc u e o Secu e Da a Visi a ion
*FAIR da a is Findable, Accessible, In e ope able, Reusable
*FAIRLYZ adds anaLYZable as a 5 h p inciple o he FAIR p inciples
*Da a isi a ion e e s o mo ing he analysis o he da a
Manage
Da a
simply and secu ely
+
Valida e
Da a
wi h semi-au oma ed QC
h ough da a isi a ion
+
Sha e
Da a
based on FAIR
p inciples
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FAIRLYZ:Re hinking he Da a Wo k low
•EHRs
•Omics
•Public Reposi o ies
•Resea che s
Da a Consume
ia Da a Visi a ion
QC Repo s
S udy Da a Regis y
On ology and Omics
models
•Resea ch Ins i u ions
•Funding Agencies
•Collabo a o s
•AI
Access he egis y
o e iew
Public o P i a e
Da a Cu a ion
P o ide QC Sco e
Da a Con ibu o
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Value P oposi ion: QC Be o e Commi men
•The Pain Poin : Resea che s in es ime and esou ces na iga ing
DUA, IRB, and downloads only o disco e unusable da a.
Meanwhile, eposi o ies bea he cos o s o ing and main aining
access po als o da ase s ha ne e ge used.
•Ou Solu ion: FAIRlyz QC allows da a sha e s o un in-place QC
and sha e esul s be o e legal s eps o eposi o y uploads, aiding
hem wi h da a cu a ion.
•The Resul : T anspa ency ensu es QC a he sou ce, sa ing ime
and speeding scien i ic disco e y. Reposi o ies wai and accep
only QC-ed da a.
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Fu u e Focus
AI-Powe ed QC
New UI will in eg a e
an AI agen cha bo o
guide esea che s
h ough complex QC
asks in ui i ely.
Enhanced Secu i y
T ansi ioning o a
locally ained AI
model o elimina e
eliance on ex e nal
APIs, ensu ing da a
emains isola ed and
secu e.
Ecosys em G ow h
Release o open-
sou ce plugins and
in eg a ion wi h
ede a ed lea ning
ne wo ks o encou age
communi y con ibu ion
and maximum
ex ensibili y.
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Call o Ac ion
Seeking Ins i u ional Da a Owne s Wo ldwide:
•Valida ion: Help us ensu e FAIRlyz mee s eal-wo ld ins i u ional
needs
•Cus omiza ion Funding: Suppo ailo ed enhancemen s ha e lec
you unique da a challenges.
Seeking De elope s:
•De elope collabo a o s o ou upcoming open-sou ce plugin
de elopmen
Seeking Resea che s:
•Pa ne s o es ou new AI-powe ed QC ea u es.
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Ques ions abou FAIRlyz
Implemen a ion abou DV
Policies?
h ps://www. d-alliance.o g/g oups/a i icial-in elligence-and-da a- isi a ion-aid -wg/ou pu s/
12:35
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Ligh ning Talk
Sy Box: a Gene al Pu pose Solu ion o
Da a Visi a ion and Equi able Da a Sha ing
Madha a Jay
12:40
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Madha a Jay
🧬Ra e Disease Pa ien
So wa e Enginee @ OpenMined
🚀Help sol e da a access wi h open sou ce
🌏B isbane, Aus alia
📧madha [email protected] g
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Mission
Building he public ne wo k
o non-public in o ma ion
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-Founded in 2017
-Tech Nonp o i and 501(c)(3)
-We build open-sou ce p i acy-p ese ing echnologies
-> 30 Team Membe s
-> 230 Gi Hub Repos
-~ 20k Slack Communi y
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This ligh ning alk
1. P oblems wi h da a sha ing
2. A gene al pu pose solu ion
3. A use-case o equi able genomics
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Da a’s ue powe comes om collabo a ion.
Bu many da a owne s a e o ced o choose be ween gi ing
up da a owne ship h ough copying and cen aliza ion, o
simply no pa icipa ing.
Due o legal and e hical cons ain s, copying da a ac oss
bo de s is o en unaccep able; esul ing in no ac ion.
We need a new way o collabo a e ai ly and secu ely.
The Mo i a ing P oblem
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Remo ely s udy da a
on a compu e a
ano he o ganisa ion
Da a Scien is Da asi e
Can answe a “speci ic” ques ion
…and only ha ques ion
Re ains go e nance o e he
in o ma ion hey s ewa d
…and ne e sha es a copy o he da a
Da a Visi a ion
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