Early Clinical Investigations for Digital Health Technologies

The rapid rise of Digital Health Technologies (DHTs), including AI-enabled Medical Devices (AIeMD), promises to transform healthcare by improving diagnostics, personalizing treatment, and enhancing patient monitoring. AI-driven tools, especially Software as a Medical Device (SaMD), enable earlier interventions and more effective care. Yet unique challenges in clinical validation, evidence generation, and regulatory alignment underscore the need for robust frameworks that ensure safe, effective innovation. In the European Union, the Medical Device Regulation (MDR, 2017/745) governs most DHTs and all AIeMD. The MDR seeks to expedite access to innovative technologies while ensuring their safety and performance. However, for DHTs and AIeMD, meeting MDR requirements can be particularly challenging due to the dynamic, iterative nature of these technologies and their early-stage feasibility and validation needs. While the MDR lays a foundation, additional complexities arise from the EU AI Act, which addresses safety, transparency, and ethical considerations for AI-based technologies. Navigating these intertwined regulations creates a dual compliance burden for innovators. Early Feasibility Studies (EFS) are limited clinical investigations conducted early in device development to evaluate design concepts and preliminary safety and performance. Despite their potential to validate safety, de-risk product development, and refine technologies in real-world settings, EFS remain underutilized in DHTs. The Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) Program aims to create a standardized, widely applicable EFS framework aligned with EU regulations. Ongoing research explores regulatory gaps, draws from international guidance, and reviews the challenges posed by DHTs under both the EU AI Act and the Medical Device Regulation. In parallel, stakeholder interviews shed light on requirements for early clinical evidence and existing EFS practices. Together, these insights will inform a harmonized EU EFS program specifically tailored to the needs of DHT developers. Ultimately, a harmonized EU EFS program can foster iterative development, streamline compliance, and guide the safe adoption of DHTs and AIeMD. By aligning regulatory expectations with technological advances, EFS can accelerate innovation while preserving patient safety and promoting better outcomes.