Perspectives and Challenges for EU Market Access of Digital Medical Devices Passed
Tuesday May 20, 2025 15:30 - 16:15 Innovation area
Moderator: Louisa StuwePanelists: Jari Haverinen, Jérôme Fabiano, Mikael Rinnetmäki
Track: Innovation Area
The integration of Digital Medical Devices (DMDs), including AI-driven technologies, into healthcare systems is expanding rapidly. These innovations hold the potential to enhance patient care, refine diagnostics, and improve operational efficiency. However, several barriers hinder their seamless adoption:
Regulatory Heterogeneity: Complex national regulatory landscapes across EU Member States
Lack of Standardized Evaluation Criteria: Disparate assessment frameworks across different nations and regions represent hurdles for EU-wide market access of DMDs
Economic and Financial Constraints: Existing reimbursement and funding models struggle to adapt to the rapid pace of technological progress.
Limited Integration into Healthcare Practice: The absence of DMDs in healthcare pathways leads to hesitancy among professionals in adopting these solutions
This session will present preliminary findings from the European Taskforce for Harmonised Evaluation of Digital Medical Devices (EvalEUDMD), focusing on:
- Exploring the regulatory differences between EU Member States and strategies to navigate these frameworks effectively
- Presenting the development of a standardized EU classification and evidence matrix to assess DMDs based on their function, application, and required supporting data.
- Evaluating the implications of the Health Technology Assessment Regulation (HTA R) on market access.
Topic
Policy
Seminar type
Live + On site
Lecture type
Panel
Objective of lecture
Tools for implementation
Level of knowledge
Intermediate
Target audience
Management/decision makers
Politicians
Organizational development
Keyword
Management
Innovation/research
Government information
Lecturers
Louisa Stuwe Moderator
Project Director
Digital Health Delegation of the French Ministry of Health
Louisa Stüwe is a Franco-German health policy professional with 12 years of experience currently working as project director at the Ministerial eHealth Delegation of the French Ministry of Health and Prevention, focussing on national and EU-level projects in the field of digital health innovation. Before joining the French Ministry of Health in 2021, Louisa worked for the French public-sector body Health Data Hub focusing mainly on the development of the European Health Data Space. She also worked in international organizations like the WHO and the World Bank as well as the pharmaceutical industry. She teaches at Sciences Po Paris and EMLyon. She holds a Master of Public Administration from Sciences Po Paris and a Master of Public Health (MPH) from the French School of Public Health (EHESP).
Jari Haverinen Panelist
Senior Planning Officer
FinCCHTA
Mr. Jari Haverinen received his PhD (2024) and M.Sc. in Electrical Engineering (1999) from the University of Oulu, Finland. He had an 18-year background in the telecom industry before transitioning to the digital health field. He was responsible for developing a new health technology assessment (HTA) method called Digi-HTA. Digi-HTA was the first HTA method in its field to support a wide range of digital health technologies (DHTs), such as digital health apps, Digital Therapeutics, AgeTech, AI, and robotics. His current role is Senior Planning Officer at the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA). His main responsibility at FinCCHTA is the Digi-HTA assessment process and its further development. He has also worked as a researcher at the Faculty of Medicine of the University of Oulu, where his research has focused on developing new HTA methods for DHTs and eHealth research.
Jérôme Fabiano Panelist
Deputy Director
EIT Health France
A graduate in International Relations and European Affairs (Sorbonne) and in Management and Strategy (SKEMA), with over 10 years of experience in healthcare and innovation, I am Deputy Managing Director: I lead the operations and strategic development of KIC France.
Management and coordination of the France team, supervision of daily activities and operations.
Representation of EIT Santé France to stakeholders in France and Europe.
Development of the member network and strengthening of cooperation between members.
Positioning and influencing EIT Health France at the regional, national, and European levels.
Supervision of financial, legal, and administrative aspects.
Implementation of new strategic initiatives and development of structuring projects.
Active engagement in the French healthcare innovation ecosystem.
Mikael Rinnetmäki Panelist
Founder
Sensotrend Oy
Diabetes apps, HL7 FHIR, patient access to data, reimbursement models for remote monitoring services and digital therapeutics.