Luxembourg Ministry of the EconomyHead of Digital Health Technologies
May 14, 2024
1:30 PM1:40 PM
Opening speech
LD
LexDelles
Minister of the Economy, SME, Energy and TourismLuxembourg
May 14, 2024
1:40 PM2:00 PM
Opening remarks
MK
MennoKok
European Institute of Innovation and Technology (EIT) HealthManaging Director EIT Health Belgium-Netherlands
Data collection and access: national and European challenges
Fair and easy access to patient data for all stakeholders is an integral component of digital health innovation. This segment addresses challenges inherent to the generation, storage, access, re-use, and quality of patient data. It specifically considers:
· European and national level initiatives
· Cross-country projects in digital health
· Engagement of healthcare providers and patients
· Primary and secondary use of patient data
· Interoperability in healthcare
May 14, 2024
2:00 PM2:15 PM
The European Health Data Space
MM
MarcoMarsella
European CommissionDirector for Digital, EU4Health and Health Systems Modernisation, DG SANTE
May 14, 2024
2:15 PM2:25 PM
Digitalisation and access to health data – Initiatives at national level
IZ
IsabelleZablit
Europe & International director for digital healthFrench Health Ministry
May 14, 2024
2:25 PM2:35 PM
Transnational collaboration to generate federated, interoperable and normalised patient data: Lessons from the CLINNOVA project
MF
MaximilianFünfgeld
Luxembourg Institute of HealthChief Medical Information Officer
From patient data to business opportunities
Building an algorithm using patient data is not sufficient to build a successful digital health company. A solid reflexion around the business model is needed.
· What are the different business models in digital health?
· What are the European market’s specificities and challenges?
· Who pays for the services?
· Medical device or non-certified technologies? The question of certification in the business model reflexion.
May 14, 2024
2:35 PM2:45 PM
Business opportunities in digital health: Views from the European market
JW
JeromeWittamer
Expon CapitalManaging Partner
May 14, 2024
2:45 PM2:55 PM
Creating start-up ecosystems around medical equipment investments
ZT
ZiedTayeb
Myelin-HFounder & CEO
May 14, 2024
2:55 PM3:40 PM
Round table I Business models: Navigating challenges of use cases and managing data access
AJ
AntoineJomier
Incepto MedicalCEO & Co Founder
MM
MarcMolitor
DoctenaCo-Founder
SS-M
StéphanieSilvestri - MODERATOR
LuxinnovationTransformation Project Manager
ZT
ZiedTayeb
Myelin-HFounder & CEO
AV
AlinaVorontsova
PsyTech VR LuxembourgEuropean Market Leader
May 14, 2024
3:40 PM4:10 PM
Coffee Break
Market access: The journey towards certification and reimbursement
Market access for digital health technologies includes the challenging step of certification. Certification is mandatory for market access, but not enough to access social security reimbursement.
· A look at the different processes to access reimbursement for each country
· The need for harmonisation
May 14, 2024
4:10 PM4:20 PM
Clinical Evidence for CE marking and proof of value in Europe
JK
JochenKlucken
Uni Luxembourg, LIH, CHLChair of Digital Medicine
May 14, 2024
4:20 PM4:30 PM
The reimbursement of mobile medical applications in Belgium: why we adapted the mHealth pyramid?
UC
UllaCahay
National Institute for Health and Disability Insurance (NIHDI)Policy officer
May 14, 2024
4:30 PM4:40 PM
Harmonisation of evaluation standards for digital medical devices in Europe
MM
MarcoMarchetti
AgenasDirector HTA Department, National Agency for Regional Health Care (Agenas), Italy & Co-Chair, HTA Member State Coordination Group (HTACG), EU
May 14, 2024
4:40 PM5:15 PM
Round table I Certification and market access: Good practices for reimbursement
SB
StefanBartosch
DMACCEO
MB-M
MagaliBoers - MODERATOR
Ministry of Health and Social Security LuxembourgDigital Health
UC
UllaCahay
National Institute for Health and Disability Insurance (NIHDI)Policy officer
MJ
MihaelJakovac
Kranus HealthHead of Market Access
MM
MarcoMarchetti
AgenasDirector HTA Department, National Agency for Regional Health Care (Agenas), Italy & Co-Chair, HTA Member State Coordination Group (HTACG), EU
Good practices for the clinical validation of digital technologies
The clinical validation of digital health technologies is a challenging step due to the complexity of the selection of the endpoints and the search for the right partners. This segment of the conference explores the following areas:
· Engagement of patients in clinical trials
· Specificities of digital technologies in clinical trials
· Readiness of society and patients for digital technologies and preventive solutions
May 15, 2024
9:05 AM9:15 AM
Promoting trustworthy AI in healthcare in Europe – European Commission initiatives
HW
Hannah-MarieWeller
Unit H3, DG CONNECT, European CommissionPolicy Officer
May 15, 2024
9:15 AM9:30 AM
Modelling and Methodological challenges for clinical evaluation of Digital Medical Devices based on AI
SZ
SarahZohar
InsermDirector of Research
May 15, 2024
9:30 AM9:45 AM
How patient voices can shape the future of healthcare/Advocating for enhanced patient involvement in healthcare/ Driving change through active engagement
MT
MilanaTrucl
European Patients’ ForumPolicy Officer
May 15, 2024
9:45 AM10:30 AM
Round table I Clinical validation: Promoting the adoption of digital technologies by patients and society
RC
RomitChoudhury
Softbrik AICo-Founder & CTO
DT-M
DanielTheisen - MODERATOR
ALAN a.s.b.l. Maladies Rares LuxembourgDirector
MT
MilanaTrucl
European Patients’ ForumPolicy Officer
PVR
PatriciaVan Rompuy
Koios CareQuality and Clinical Trial Lead
SZ
SarahZohar
InsermDirector of Research
May 14, 2024
10:30 AM11:00 AM
Coffee Break
Funding pathways from research to commercialisation
From research to scale-up and commercialisation, investors are essential for the successful launch of a digital health solution.
Each development opens up different funding opportunities.
May 15, 2024
11:00 AM11:15 AM
Article 51 of the French Social Security Financing Act
NL
NatachaLemaire
French Ministry of HealthRapporteur General
May 15, 2024
11:15 AM12:05 PM
Round table I Funding opportunities for digital health technologies: What funding instruments for each stage of development?
CB-M
CaroleBrückler - MODERATOR
Luxembourg Ministry of EconomyHead of Digital Health Technologies
GD
GuilhemDavezac
SNCIEconomic Attaché
HE
HayleyEvery
EIT Health Belgium-NetherlandsEntrepreneurship Lead
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