ASSESS-DHT made substantial progress in 2025 toward its goal of harmonised assessment frameworks for digital health technologies across Europe. The project delivered core methodological tools, advanced scientific understanding through high-impact publications, and strengthened stakeholder engagement to ensure practical uptake.
Methodological Foundations Established
Throughout 2025, the consortium consolidated existing assessment methods into core technical outputs ready for practical testing:
- Taxonomy categorising digital health technologies by life cycles and assessment requirements, covering digital therapeutics, AI tools and telehealth solutions.
- Landscape analysis reviewing European HTA frameworks, identifying priority gaps that the new methodology addresses.
- Specifications for the European Repository of evidence, including initial content inventory to support developers and assessors continent-wide.
- Interim piloting manual with complete criteria, specialist pathways and workflows prepared for case study testing with real-world technologies.
- Communication plan detailing stakeholder messages, channels and timelines.
- Interim dissemination report documenting outreach progress to date.
- Engagement strategy mapping project assets to stakeholder needs through expert input, roundtables and planned consultation activities
Scientific Contributions On Safe Digital Health
Consortium partners published extensively on regulation, safety and deployment challenges. Key 2025 contributions include:
- Examination of human-AI interaction in real-world healthcare settings (npj Digital Medicine).
- Roadmap for regulation-compliant Living Labs supporting AI and digital health development (Science Advances).
- Advocacy for built-in open feedback mechanisms in AI-enabled technologies (Nature Medicine).
- Cybersecurity requirements for medical devices, comparing EU and US expectations (Computational and Structural Biotechnology Journal).
- CORE-MD clinical risk score for regulatory evaluation of AI medical software (npj Digital Medicine).
These eleven peer-reviewed articles build on 2024 publications addressing flexible regulation and performance monitoring, establishing ASSESS-DHT as a leading voice in trustworthy digital health deployment.
Stakeholder Engagement Delivered
The four-level engagement strategy generated practical input over the first 24 project months:
- Preparatory work completed for the broad open consultation planned post-month 20, ensuring wide stakeholder validation.
- Seven targeted expert assignments refined framework elements through the established expert pool.
- Collaboration outreach identified over 40 EU initiatives, with meetings held with six priority partners to explore joint opportunities.
- Two sustainability roundtables addressed long-term framework uptake and repository viability, with agendas and attendees documented for transparency.
Sustainability and 2026 Roadmap
Key assets—taxonomy, assessment manual, repository specifications—have been mapped to stakeholder needs and sustainability pathways. The European Repository emerges as a central resource supporting DHT developers, HTA bodies and decision-makers continent-wide.
With the taxonomy, landscape analysis, evidence-repository specifications and interim assessment manual in place, ASSESS-DHT enters 2026 ready to intensify piloting of its framework with real-world digital health technologies. Framework piloting begins with selected case studies alongside the open consultation and tool refinement based on stakeholder feedback. Continued communication, engagement and scientific publication will support the project’s goal of delivering a robust, widely usable framework for assessing DHTs across European health systems.