The adoption of Digital Medical Devices (DMDs) including AI-based technologies in healthcare is growing exponentially, promising groundbreaking improvements in patient care, diagnostics, and operational efficiency. Yet, the path to integrating these technologies into healthcare systems remains challenging for innovators:
❎ Regulatory uncertainty can delay market entry.
❎ Lack of harmonized evaluation frameworks across countries and regions creates inefficiencies.
❎ Economic and financing models for DMDs struggle to keep pace with technological advancements.
❎ Healthcare trajectories not including DMDs, resulting in lack of uptake by healthcare professionals
📅 At the Health & Tech Summit, the plenary session "Evaluation, Regulation, Market Access Across EU & USA – Heal or Heaven for Innovations?" on December 18th in PariSanté Campus, takes a deep dive into strategies to address these challenges.
This session will unveil the initial results of the European Taskforce for Harmonised Evaluation of Digital Medical Devices (EvalEUDMD), including:
☑️ The first EU classification grid and evidence matrix, designed to evaluate DMDs by their application, functionality, and required scientific evidence.
☑️ A discussion on the impacts of the Health Technology Assessment Regulation (HTA R)
☑️ Insights into how the EU and USA differ in their approaches and how to navigate regulatory frameworks
🎙️ Meet the Panel
Moderated by Louisa Stüwe, Project Director - Innovation & Europe, French Ministry of Health, this panel brings together global leaders shaping the future of digital health market access:
Peter Marks, Director, CBER, FDA, USA
Pr. Peter Pitts, President, Center for Medicine in the Public Interest, USA
Magali Boers, Ministry of Health and Social Security, Luxembourg
Barbara Höfgen, Head of Digital Health Applications, BfArM, Germany
Dr. Sarah Zohar, Director of Research, INSERM, France
Corinne Collignon, Head of Medical Device Evaluation / Digital Health Mission, Haute Autorité de Santé, France
Jérôme Fabiano, Deputy Director, EIT Health France
✨ Who Should Join?
⏩ DMD, AI developers and industry leaders: Learn how to navigate the evolving regulatory and market landscape.
⏩Healthcare professionals: Discover how these frameworks will impact clinical adoption and patient outcomes.
⏩ Policymakers and advisors: Get inspiration from international DMD policies that balance innovation and safety.
🔗 Discover the Full Summit Program & Register here: https://lnkd.in/eDitcxMf
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