The event will take place on the Belval Campus, MSA 3.500
26 October 2022
12:30 – 14:00:    Registration & networking lunch with industry exhibition
14:00 – 14:30:    Opening speech from Prof. Jochen Klucken, FNR-PEARL Chair (UL/LCSB, LIH, CHL), Head of Digital Medicine Group
14:30 – 15:00:    Welcome address from Ministry of Higher Education and Research; Ministry of Health
Session 1: Translation into European markets
15:00 – 16:50:    First steps of the European Task Force for Harmonised Evaluation of Digital Medical Devices 
                          Louisa Stüwe,French Ministry of Health and Prevention, France
                           Digital therapeutics and the challenge of finding evidence: Germany’s way and experience
                           Dr. Johanna Ludwig, Unfallkrankenhaus Berlin, Germany
2x Industry Flash presentations 
Coffee break with industry exhibition and poster session
16:50 – 18:55:     EIT Health Forum
European Harmonization of clinical evaluation of digital medical devices

To harmonise the innovative health technology assessment procedures across Europe, a European Taskforce has been generated by France, Germany, coordinated by EIT Health and co-chaired  by EUnetHTA, with the overall goal of enabling a joint approach for European access to reimbursement for digital medical devices (DMDs). 

The Taskforce – composed of academic experts, policy makers and representatives of national competent authorities – is committed to harmonise the taxonomy of the digital medical devices, evidence criteria and (re-)assessment methodologies in order to support Europe-wide patient access to DMDs through reimbursement.

This session will feature a proposed framework to operationalise a harmonised regulatory and assessments framework across Europe with a special focus on (A) the conceptual clarity around DMDs, (B) the evidence criteria for technology assessment and (C) the healthcare system integration & social acceptance evaluation framework.

Speakers:
EIT-Health and Digital medical Devices: Cristina Bescos, EIT-Health
Rapporteur Taskforce – RecommendationProf. Jochen Klucken, Luxembourg
French Strategy: Louisa Stüwe, eHealth Project leadFrench Ministry of Health and Prevention, France
Health Technology Assessment in Europe: Marcus Guardian, CEO, EUnetHTA, Netherlands
Roundtable discussion “Luxembourg: A Model for European Implementation of digital medical devices”
This session will feature insight of experts from innovation points of view, covering Translational Research, Payer, Market access, Regulatory and Real World Data. It will also include contributions from EU Taskforce members.
Moderation:
Jochen Klucken, Luxembourg; Fuzsina Mezei, EIT-Health
Panelist:
Christian Oberle, President of Health Insurance, Luxembourg
Carole Brückler, Digital Health Technologies at Ministry of Economy, Luxembourg
Anna Chioti, Lead NCA, Ministry of Health, Luxembourg
Louisa Stüwe, French Ministry of Health and Prevention, France
Marcus Guardian, EUnetHTA, Netherlands
Sarah Zohar, INSERM, France
Rosanna Tarricone, Univeristy Bocconi, Italy
Closing of day 1-Prof. Jochen Klucken
19:00 onwards:   Networking walking dinner incl. industry exhibition and poster session

 

27 October 2022
Session 2: Digital Medicine Innovation
8:30 – 10:45:      Welcome address
Digital Transformation – Realizing the untapped potential of Health Care Ecosystems for better Outcomes
Prof Magda Rosenmöller, IESE Business School, Spain 
                          Tools for Parkinson Care
                           Prof Jean-Christophe Corvol, Paris Brain Institute (ICM), France 
The use of digital technology for assessing mobility in patients with Parkinson’s disease
Prof Anat Mirelman, Tel Aviv Sourasky Medical Center, Israel
 
2x Flash presentations 
Coffee break  
Session 3: New Digital HealthCare services – Market access
10:45 – 12:45:    Market access and market entry for digital health apps in Germany 
                          Dr. Simon Reif, ZEW Mannheim, Germany 
2x Flash presentations
ProCarement – Virtual heart centers as-a-service and lessons learned to accelerate time-to-market for DxTx 
Jörg Trinkwalter, ProCarement, Germany
 
Digital Health Applications in Germany – perspectives on regulation, market access and implementation in a digital ecosystem
Dr. Anne Geier, Spitzenverband Digitale Gesundheitsversorgung, Germany
 
FNR Presentation
12:45 – 14:15: Lunch break including industry exhibition and poster session
Session 4: Data-driven HealthCare
14:15 – 16:35:    AI for Future Healthcare
                           Prof Björn Eskofier, University Erlangen, Germany 
Innovating digital mobility outcomes for personalised healthcare: How to let the world know 
Prof Beatrix Vereijken
, Norwegian University of Science and Technology, Norway 
2x Flash presentations 
Coffee break  
Digital Biomarkers in Personalized Healthcare 
Prof Holger Fröhlich,
Bonn-Aachen International Center for Information Technology, Germany 
Closing statement