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 – 14:20:    Opening 
Prof. Jochen Klucken, FNR-PEARL Chair (UL/LCSB, LIH, CHL), Head of Digital Medicine Group
Prof. Rejko Krüger, FNR-Pearl Chair (UL/LCSB, LIH, CHL), Director of Transversal Translational Medicine (LIH), Coordinator for National Center for Excellence in Resarch-Parkinson’s Disease (NCER-PD)
14:20 – 14:30:    Welcome address from Ministry of Higher Education and Research; Ministry of Health
Session 1: Translation into European markets – Chair: Prof. Jochen Klucken
14:30 – 15:00:    First steps of the European Task Force for Harmonised Evaluation of Digital Medical Devices
Louisa Stüwe,French Ministry of Health and Prevention, France
15:00 – 15:30:     Digital therapeutics and the challenge of finding evidence: Germany’s way and experience
Dr. Johanna Ludwig, Unfallkrankenhaus Berlin, Germany
15:30 – 15:40:    Flash presentation:
How Digi-HTA will support introduction of innovative digital health technologies in Finnish Healthcare – Dr. Jari Haverinen, FinCCHTA, Finland 
15:40 – 16:10:    Coffee break incl. industry exhibition and poster session
EIT Health Forum

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.

16:10 – 17:10:    European Harmonization of clinical evaluation of digital medical devices – Chair: Dr. Carole Brückler
Speakers:         Rapporteur Taskforce – Recommendation: Prof. Jochen Klucken, Luxembourg
French Strategy: Louisa Stüwe, eHealth Project lead, French Ministry of Health and Prevention, France
Health Technology Assessment in Europe: Marcus Guardian, CEO, EUnetHTA, Netherlands
EIT-Health and Digital medical Devices: Dr. Cristina Bescos, Director of Innovation, EIT-Health
17:10 – 18:10:    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:      Chairs: Prof. Jochen Klucken, Luxembourg; Fruzsina Mezei, EIT Health
Panelist:            Christian Oberle, President of Health Insurance, Luxembourg
Dr. Carole Brückler, Digital Health Technologies at Ministry of Economy, Luxembourg
Dr. Anna Chioti, Lead NCA, Ministry of Health, Luxembourg
Louisa Stüwe, French Ministry of Health and Prevention, France
Marcus Guardian, EUnetHTA, Netherlands
Prof. Rosanna Tarricone, Univeristy Bocconi, Italy
18:00 – 18:15:    Closing of day 1-Prof. Jochen Klucken
18:15 – 21:00:    Networking walking dinner incl. industry exhibition and poster session

 

27 October 2022
Session 2: Digital Medicine Innovation – Chair: Prof. Rejko Krüger
8:30 – 8:35:        Welcome address by Prof. Rejko Krüger
8:35 – 9:05:        Digital Transformation – Realizing the untapped potential of Health Care Ecosystems for better Outcomes 
                          Prof Magda Rosenmöller, IESE Business School, Spain 
9:05 – 9:35:        How to address unmet needs in Parkinson disease with digital medical devices
Prof Jean-Christophe Corvol, Paris Brain Institute (ICM), France 
9:35 – 10:05:     The use of digital technology for assessing mobility in patients with Parkinson’s disease
Prof Anat Mirelman, Tel Aviv Sourasky Medical Center, Israel 
10:05 – 10:25:    Flash presentations:
Usability experience of remote sleep monitoring: an overview and future challenges of remote sleep monitoring in individuals with neurodegenerative diseases – Immi Biswas, Digital Health and Care, University of Bristol, England
Effects of Turning and Dual-Task on Instrumented Time-Up-and-Go Gait Features in Parkinson Freezers – Stefano Sapienza, Luxembourg Centre for Systems Biomedicine, Luxembourg
10:25 – 10:55:    Coffee break incl. industry exhibition and poster session
Session 3: New Digital HealthCare services – Market readiness – Chair: Christian Oberlé
10:55 – 11:25:    Market access and market entry for digital health apps in Germany
Dr. Simon Reif, ZEW Mannheim, Germany 
11:25 – 11:45:    Flash presentations
Application readiness of digital therapeutics- a new type of digital medical devices – Sijmen Van Schagen, Luxembourg Institute of Health, Luxembourg
MyPal Platform – Enabling ePROs for Palliative Care – Dr. Pantelis Natsiavas, INAB – Institute of Applied Biosciences, Greece
11:45 – 12:15:    ProCarement – Virtual heart centers as-a-service and lessons learned to accelerate time-to-market for DxTx
Jörg Trinkwalter, ProCarement, Germany 
12:15 – 12:45:    Digital Health Applications in Germany – perspectives on regulation, market access and implementation in a digital ecosystem (virtual talk)
Dr. Anne Geier, Spitzenverband Digitale Gesundheitsversorgung, Germany 
12:45 – 12:55:    FNR Presentation – Dr. Sean Sapcariu, Programme Manager
12:55 – 14:25:    Lunch break including industry exhibition and poster session
Session 4: Data-driven HealthCare – Chair: Dr. Maximilian Fünfgeld
14:25 – 14:55:    AI for Future Healthcare
        Prof Björn Eskofier, University Erlangen, Germany 
14:55 – 15:25:     Innovating digital mobility outcomes for personalised healthcare: How to let the world know
Prof Beatrix Vereijken, Norwegian University of Science and Technology, Norway 
15:25 – 15:45:    Flash presentations 
Grasping the power of real-world data: Applying OMOP CDM patient outcome measures – Dr. Ania Cwojdzińska, ITTM S.A., Luxembourg
“Primum non nocere”: Digital tools and their impact on mental load of users: The E3 task force project – Dr. Corinne Isnard Bagnis, PUPH AP-HP.Sorbonne Université, France
15:45 – 16:15:    Coffee break incl. industry exhibition and poster session
16:15 – 16:45:    Digital Biomarkers in Personalized Healthcare
        Prof Holger Fröhlich, Bonn-Aachen International Center for Information Technology, Germany 
16:45 – 16:55:    Final closing speech by Dr. Gregor Baertz, President of the Board of Directors at LIH, Hôpitaux Robert Schuman