EDiHTA

Project information

Full title: European Digital Health Technology Assessment framework co-created by all stakeholders along the value chain (EDiHTA)

Duration: 48 months (1 January 2024 - 1 January  2028)

Status: Ongoing

Funding programme: HORIZON-HLTH-2023-IND-06-07, Grant agreement no. 101136424

What will the project do?

EDiHTA will be the first flexible, inclusive, validated and ready-for-use European Health Technology Assessment (HTA) framework. The project’s goal is to allow the assessment of different Digital Health Technologies (DHTs), such as telemedicine, mApps and AI, at different Technology Readiness Levels (TRL), territorial levels and from the perspective of beneficiaries and providers of healthcare.

Stakeholders will participate in designing, developing, and validating the framework. It will be tested in real-world settings in five prominent European hospitals, and through an open piloting program involving DHTs developers.

As DHTs are expected to improve both the quality and delivery of healthcare services for European countries, EDiHTA's main goal is to capture the real added value of DHTs.

What are the expected outcomes?

• An analysis of the European HTA policy landscape and legal, security and privacy requirements, including European Health Data Space
• A map of the stakeholders involved in HTA in Europe
• An interactive digital platform will guide stakeholders according to their needs, while providing user guidance and methodological support.
• A fit-for-purpose HTA framework for DHTs that integrates existing assessment domains and methods with new ones to inform decision-making

What is EPFs’ role?

Part of a large consortium, the European Patients’ Forum will bring the patient perspective into each stage of the process set out by EDiHTA. EPF will contribute to the patient perspective in defining relevant endpoints and criteria.

Why does this matter for patients?

• While developing DHTs, the needs and requirements of patients must be included to ensure appropriateness, fairness and accessibility
• HTA has an overarching impact on the healthcare framework. As the ultimate beneficiaries of healthcare, patients need to be equipped with the skills to ensure meaningful uptake of DHTs

The consortium

EDiHTA brings together a multi-disciplinary consortium of 16 partners from 10 European countries with key expertise in HTA research, including 3 HTA agencies, 4 clinical partners as end-users of DHTs and a patient organisation, one NGO specialised in HTA, a global quality assurance and risk management company and notified body for MDR certification:

• Università Cattolica del Sacro Cuore
• Stichting Radboud Universitair Medisch Centrum (RUMC),
• Region Syddanmark
• Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer
• Johann Wolfgang Goethe-Universitaet Frankfurt Am Main
• Agenzia Nazionale per i Servizi Sanitari Regionali
• Agencia de qualitat I Avaluacio Sanitaries De Catalunya
• Universitetssykehuset Nord-Norge Hf 9
• Dnv As (Dnv)
• European Health Management Association
• Eit Health Ev (Eith)
• European Patients’ Forum (EPF),
• Fundacja Instytut Polityki Zdrowotnej (Hpi)