The first European Digital Health Technology Assessment framework co-created by all stakeholders along the value chain

Project Information

EDiHTA

Grant agreement ID: 101136424

DOI

10.3030/101136424

EC signature date 28 November 2023

Start date 1 January 2024

End date 31 December 2027

Funded under

• Health

Total cost

€ 7 532 870,00

EU contribution

€ 7 532 870,00

Coordinated by

UNIVERSITA CATTOLICA DEL SACRO CUORE
Italy

Periodic Reporting for period 1 - EDiHTA (The first European Digital Health Technology Assessment framework co-created by all stakeholders along the value chain)

Reporting period: 2024-01-01 to 2025-06-30

Summary of the context and overall objectives of the project

Health systems across Europe are under growing pressure to deliver high-quality services amid shortages of healthcare professionals, ageing populations, and limited resources. Digital health technologies (DHTs) – including telemedicine, mobile apps, and AI-based tools – offer significant potential to improve care delivery and ensure sustainability. Yet existing health technology assessment (HTA) frameworks are fragmented and not designed to assess the specific characteristics and added value of DHTs.

EDiHTA will deliver the first European digital HTA framework that is flexible, inclusive, validated, and ready for use. It will support assessments of different DHTs at various stages of technological maturity and from multiple perspectives (e.g. payers, hospitals, society). Co-created with stakeholders across the healthcare ecosystem – HTA agencies, regulators, clinicians, patients, and developers – the framework will be piloted in major hospitals and with technology providers across Europe.

EDiHTA aims to harmonise HTA practices, improve the availability and quality of real-world evidence, and accelerate access to DHTs. The project applies a multi-stakeholder, multidomain and modular approach, and integrates social sciences to address ethical, legal, organisational and societal aspects of digital health, supporting value-based decisions for European health systems.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first reporting period, EDiHTA laid the scientific and methodological foundations for a European HTA framework tailored to digital health technologies (DHTs). The project conducted in-depth analyses of cybersecurity regulations, real-world evidence (RWE) integration, and data governance under the European Health Data Space (EHDS), identifying critical regulatory intersections and harmonisation opportunities. These efforts highlighted the importance of embedding cybersecurity, transparency, and data protection directly into HTA processes to support trust, compliance, and efficient market access.

A Europe-wide stakeholder and policy review helped define a harmonised taxonomy for DHTs and identified significant variation in existing HTA guidance. The resulting consensus-based classification provides a shared foundation for future assessment work. Building on these insights, a set of 13 core assessment domains was co-developed through a structured and participatory process, reflecting diverse stakeholder needs and covering key criteria such as clinical effectiveness, safety, and organisational impact.

These conceptual elements were then translated into an operational framework and toolkit. Evidence requirements were mapped across domains, maturity stages, and technology types (e.g. AI, telemedicine, mobile apps), and guidance materials were drafted to support practical use. The framework is designed to be modular, user-friendly, and interoperable, ensuring adaptability across settings and stakeholder perspectives.

To support real-world validation, the project prepared for pilot testing by selecting representative technologies, defining evaluation protocols, and establishing data governance and ethics safeguards. These pilots will test the framework’s robustness and usability in clinical settings and ensure its alignment with European HTA and regulatory standards.

Together, these achievements represent a major step toward delivering a harmonised, inclusive, and evidence-based HTA framework for digital health technologies in Europe.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The project has already begun to generate results that move significantly beyond the current state of the art in HTA of DHTs. By harmonising and advancing existing frameworks, EDiHTA is addressing long-standing fragmentation in methodologies, regulatory processes and evidence standards across Europe. The innovative framework and digital platform are designed to accelerate safe and effective DHTs from development to clinical uptake, ultimately reducing healthcare costs, enabling cross-border deployment, and improving patient outcomes. To ensure further uptake and success, key needs have been identified: continued stakeholder involvement through co-creation and piloting, further demonstration and validation in real-world clinical settings, tailored educational and training modules, and the establishment of sustainable governance and business models. Supportive regulatory and standardisation activities, including workshops and roundtables with HTA agencies and regulators, will be essential to embed the framework in European practice. In parallel, a hybrid intellectual property strategy and commercial pathways, such as licensing and subscription-based training tools, will secure both open science dissemination and industrial exploitation. At the end of the project, EDiHTA will deliver a validated, inclusive and ready-to-use HTA framework and digital platform, a set of educational resources, new evidence-based standards, and a reservoir of data and methodologies to support continued innovation and international uptake.