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.
EIT-Health and Digital medical Devices: Cristina Bescos, EIT-Health
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
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.
Jochen Klucken, Luxembourg; Fuzsina Mezei, EIT-Health
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