Introduction
Digital health technologies (DHTs) span mobile apps, telemedicine, wearables, and software for clinical decision support. As regulation and validation evolve, early feasibility studies (EFSs) have emerged as a potential way to gather real-world, human-centered data early in development. This article summarizes stakeholder insights from a qualitative study conducted across EU digital health companies and contract research organizations (CROs), outlining current use, barriers, and recommendations for a harmonized EU framework that aligns with the MDR and the AI Act.
What are Early Feasibility Studies in DHTs?
Traditionally used for high-risk medical devices, EFSs are small, early-stage clinical investigations intended to assess initial safety and performance under real-world conditions, often enrolling fewer than 20 participants. In digital health, the concept is evolving to support iterative software changes, AI feature upgrades, and human-centered design. EU-wide adoption of a structured EFS approach could help developers validate usability, workflow integration, and clinical value before large-scale trials.
Methods of the Qualitative Study
The study used semistructured interviews with 15 participants from 12 DHT companies and 3 CROs, covering MDR risk classes I–III. Interviews explored how firms interpret regulatory evidence needs, experiences with EFS-like activities, expectations for an EU EFS program, and views on the EU AI Act. Data were analyzed thematically to identify recurring barriers, opportunities, and stakeholder-driven recommendations.
Key Findings
EFS Awareness and Adoption in DHTs
While the concept of EFSs is recognized, many participants use terms like pilot studies or early clinical investigations rather than formal EFSs. Larger AI-centric firms conduct multiple EFS-like studies yearly, whereas smaller companies often avoid EFSs due to resource constraints and regulatory ambiguity. There is strong interest in formalizing EFSs as a core part of EU development pathways for DHTs.
Regulatory Friction: MDR, AI Act, and Fragmentation
Respondents described the MDR as largely hardware-oriented, with clinical evidence frameworks not fully aligned to agile software updates and AI changes. Planning clinical investigations for DHTs is challenging within a framework that emphasizes preclinical validation and documentation. Fragmented EU member-state requirements and variable notifier body expertise further complicate cross-border development and data sharing. The unclear interaction between MDR and the AI Act adds another layer of complexity, particularly for AI-driven features.
Human Factors and Early Evidence
Participants stressed that EFSs provide critical usability and human interaction data, enabling design refinements before larger trials. However, the perceived burden of regulatory submissions and documentation can deter uptake. Several firms highlighted a mismatch between iterative software development and rigid regulatory cycles, noting that some features are delayed or first launched in non-EU markets due to perceived regulatory rigidity.
Alternatives and Complementary Approaches
To circumvent burdens, firms use simulations with retrospective data, real-world evidence from provider networks, synthetic datasets, and in-silico feasibility analyses. Pilot collaborations with academic centers focus on user feasibility rather than formal EFSs. While cost- and time-saving, these approaches may miss nuanced human-centered data that EFSs uniquely capture.
Views on an EU Harmonized EFS Program
There is broad appetite for an EU-wide EFS program tailored to DHTs, featuring: DHT-specific guidelines, cross-EU harmonization, a clear EFS pathway, and a collaborative regulatory culture. Stakeholders want predictable timelines (roughly 6–8 weeks for feedback) and standardized documentation templates to reduce administrative burden. A centralized EU portal for templates, guidelines, and updates was repeatedly recommended, along with educational tools and forums to build a shared knowledge base.
Implications for Policy and Industry
Harmonizing EU approaches to EFSs could accelerate safe, iterative innovation in DHTs and AI-enabled medical software, while reducing fragmentation and uncertainty. Aligning EU practice with international models—such as the US FDA’s EFS framework and the German DiGA guidance—could provide practical templates and processes. An EU EFS program should avoid reproducing hardware-centric assumptions and instead be co-designed with digital health stakeholders to reflect software iteration, data-driven risk management, and patient-centered design.
Recommendations for a Future EU EFS Program
- Develop DHT-specific, harmonized EU guidelines with clear pathways and templates.
- Establish a centralized EU portal and community tools to share learnings and resources.
- Promote structured dialogue between innovators and regulators from early in development.
- Incorporate international best practices while tailoring to EU MDR and AI Act realities.
- Ensure the framework supports iterative software updates without excessive re-submission burdens.
Limitations and Next Steps
The study focuses on DHT companies and CROs; regulators, clinicians, and patients offer complementary perspectives. Future work should triangulate these findings with regulatory documents and cross-stakeholder dialogues to refine an EU EFS blueprint.
Conclusion
Early feasibility studies hold potential to unlock safer, faster, and more user-centered digital health innovations in Europe. Realizing this promise will require an EU-wide, DHT-tailored EFS framework that harmonizes regulatory expectations, reduces administrative burden, and fosters ongoing collaboration among industry, regulators, and healthcare stakeholders.
