CSMD-Horizon Conference 2025: Shaping the Future of AI and Digital Health in MedTech
On 4–5 November 2025, Brussels became a hub for innovation in healthcare technology during the CSMD-Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence.
This year’s event marked the merger of two leading forums, the Conference on Clinical Studies with Medical Devices (CSMD) and the Horizon Conference on Clinical Investigations and Market Access, creating a unified platform to explore both the opportunities and challenges surrounding AI-enabled medical devices and digital health technologies.
The conference brought together regulatory experts, clinical leaders, R&D professionals, and MedTech innovators to discuss how AI and software are reshaping clinical studies, regulatory frameworks, and patient care.
Key Themes
- Defining Clinical Evidence Requirements for digital health products from patient, payer, and regulator perspectives.
- Navigating AI in Medical Devices – balancing innovation, risk, and patient access.
- Designing Clinical Studies for Software-Based Devices – enhancing engagement and data quality.
- Ethics and Bias in AI – promoting fairness, transparency, and accountability.
- Real-World Evidence and Post-Market Surveillance – maintaining safety and compliance amid continuous software updates.
Tom Melvin presented on early feasibility studies (EFS) for AI-enabled and digital health technologies.
He highlighted that these technologies often have different needs and objectives during early feasibility compared to traditional implantable medical devices. Understanding clinical validity for products brought to market using synthetic or historic data, and examining how digital health solutions integrate with clinical workflows, are critical steps in ensuring effective and safe adoption.
Findings from a recent JMIR publication were also shared, demonstrating that EFS for digital health technologies is valuable but remains underutilized in current research and development practices.
Alongside Tom Melvin’s presentation, Jennifer Braten Jackfrom MediTrials introduced progress on protocol template development, designed to streamline clinical investigations and promote greater consistency across studies.
Why This Matters
As AI and digital health solutions continue to transform healthcare, robust regulatory frameworks and reliable clinical evidence are vital to ensure patient safety while accelerating innovation.
The CSMD-Horizon Conference 2025 provided a collaborative forum to exchange insights, address emerging challenges, and shape the future of MedTech and digital health.