A European framework for the assessment of digital health technologies: conceptual advances, challenges, and future...

Digital health technologies (DHTs) are transforming healthcare by enabling for example new care models, improving patient access and engagement, and streamlining healthcare workflows. They have the potential to increase efficiency, reduce administrative burdens, and enhance the overall quality of care. However, across Europe, DHTs evaluation frameworks remain fragmented, and while new approaches continue to emerge, they often focus on specific types of DHTs or particular stages of the product lifecycle. Moreover, traditional Health Technology Assessment (HTA) frameworks have been developed mostly to evaluate medicinal products, which may limit their applicability to DHTs, ultimately constraining health systems' ability to capture DHTs' added value. The European Digital Health Technology Assessment (EDiHTA) is a EU-funded project, which started in January 2024 to co-create an HTA framework for DHTs in order to face these challenges. It is aimed at co-developing together with different key stakeholders a comprehensive and flexible assessment framework tailored to different DHTs, applicable across DHTs lifecycle and across EU member states. In this perspective article, we present our concept design that is being used as foundation of the development of the EDiHTA framework, and we address current challenges in the assessment of DHTs, and the opportunities that lie ahead.