ASSESS DHT is a European initiative that will increase the adoption of trustworthy and effective Digital Health Technologies (DHTs) across Europe. It aims at enabling a more coherent digital single market, for health systems and patients to access DHTs from all over Europe.
Examples for DHTs include telemedicine, wearables, health and wellness apps, electronic health records, digital twins, remote monitoring systems and clinical decision support systems as well as various other applications that use AI, machine learning or virtual reality in healthcare and medicine.
Establishing a novel framework for the simplified assessment of DHTs in Europe
The objective of ASSESS DHT is to consolidate and simplify existing methods and tools for approval of innovative DHTs. The project will develop a new fit-for-purpose generic assessment framework, harmonized for Europe and aligned with the proposed European Health Data Space (EHDS) Regulation. This framework will address differences between settings and respond to the methodological challenges with assessing DHTs, including their benefits for patients and their role in the digital transformation of health systems.
A framework that considers different DHT categories and offers guidance
The framework will include specialized pathways for different categories of DHTs specified through a novel evidence-based typology. It will consider phased adoption (going beyond fast track models like DiGA), complex life-cycles, iteratively developed AI. It will also include a detailed health technology assessment manual plus specific guides on topics such as cybersecurity. The project will develop a sustainable repository containing the ASSESS DHT framework, pathways and clear criteria, a semantically searchable evidence library, checklists and tools to support companies generate evidence. It will further provide proof of the health system value from DHTs, and online communities of practice.
ASSESS DHT is organized in four pillars:
Consolidation and Preparation to collate and synthesize the existing assessment frameworks and tools, state-of-the-art findings from initiatives, projects, relevant standards and regulatory inputs. This will be combined with learnings from HTA partners and invited experts about challenging areas in assessing innovative DHTs as well as delivery and patient engagement needs.
Toolkit Development – including pathways for special case DHTs and a fast track pathway. The objective is an overarching manual for the assessment of DHTs.
Testing and Validation through nominated case studies. The feedback will be used to refine the framework and tools.
Uptake and Sustainability – engagement with external stakeholders to focus on the most important challenges and to review the proposed framework. Finally, they should endorse and promote the new framework across Europe.
Consortium:
- empirica Gesellschaft für Kommunikations- und Technologieforschung mbH, Bonn, Germany
- The European Institute for Innovation through Health Data (I-HD), Stombeek-Bever, Belgium
- Fundacion Publica Andaluza Progreso y Salud M.P., Sevilla, Spain
- TUD Dresden University of Technology, Dresden, Germany
- HTA Austria – Austrian Institute for Health Technology Assessment, Vienna, Austria
- The Dental and Pharmaceutical Benefits Agency, Stockholm, Sweden
- International Diabetes Federation Europe, Brussels, Belgium
- The Université libre de Bruxelles, Brussels, Belgium
- Technische Universität Berlin, Berlin, Germany
- Better Care SL, Sabadell, Spain
- Heartkinetics, Charleroi, Belgium
- Tech4Care SRL, Ancona, Italy
- University of Oxford, Oxford, UK
- NICE – National Institute for Health and Care Excellence, London, UK
Facts and figures
Coordinator: empirica
Number of Partners: 14
Start Date: January 1, 2024
End Date: December 31, 2026
Total Funding: around € 6.4 million
This project has received funding from the European Union’s Horizon Europe research and innovation program under grant agreement No. 101137347.
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.