Plain Language Summary

What is it about? Digital health technologies (DHTs) are increasingly being integrated across European healthcare systems to optimize resources, enhance system responsiveness, and improve health outcomes. Despite their potential benefits, existing health technology assessment (HTA) methods lack flexibility to address the diverse and rapidly evolving nature of DHTs, which differ significantly from pharmaceuticals and medical devices traditionally evaluated through HTA. This disconnect creates barriers to market access and implementation of valuable digital innovations. The European Digital Health Technology Assessment (EDiHTA) project was launched to develop a harmonized and flexible HTA framework specifically tailored to digital health technologies, bringing together 19 partners from 10 European countries including policy makers, HTA agencies, industry, patient organizations, and academic institutions.

How was the research conducted? The research employed a mixed-methods design focusing on 5 key stakeholder groups: national decision makers, HTA agencies, technology developers, healthcare providers, and patients. Researchers used the Innovation Health Technology Assessment Methods framework to structure stakeholder involvement and identify needs and requirements for evaluating digital health technologies. Data collection involved literature reviews, surveys, interviews, and focus groups with 97 participants across Europe representing diverse perspectives and experiences with DHTs. Thematic analysis was performed by 2 reviewers to synthesize evidence and identify points of consensus and conflict regarding digital health technology evaluation, with triangulation across stakeholder groups to map past and present practices while envisioning future approaches.

What were the results? The study identified 5 main themes reflecting stakeholder perspectives on digital health technology evaluation. All stakeholder groups agreed on the need for harmonizing HTA methods across Europe while maintaining flexibility for national contexts. Stakeholders valued DHTs that align with existing healthcare goals, demonstrate interoperability with current systems, and prioritize patient-centered design. There was strong consensus that comprehensive assessment requires structured collaboration across stakeholders, though perspectives differed on implementation. Stakeholders supported a modular, flexible framework allowing staged entry of DHTs with reassessment as evidence matures. Key assessment domains should include clinical effectiveness, safety, organizational impact, and DHT-specific characteristics like interoperability and usability.

Why are the results important? These findings highlight the urgent need for coordinated approaches to DHT evaluation that can overcome current fragmentation in European HTA practices. A harmonized framework would streamline decision making, enhance cross-border collaboration, create more predictable pathways for developers, and potentially reduce inequalities in access to digital innovations. The modular approach supported by stakeholders could enable countries at different levels of digital maturity to implement appropriate assessment processes while maintaining flexibility for local priorities. This research directly informs the development of the EDiHTA framework, which will provide practical guidance for evaluating diverse DHTs across their lifecycle.

What are the strengths and weaknesses of this study? A key strength of this research is its inclusive approach incorporating diverse stakeholder perspectives across multiple European countries, enabling identification of both consensus points and areas of disagreement in DHT evaluation. The main limitation is the relatively small stakeholder sample primarily composed of individuals already engaged in HTA activities, which may introduce bias. Future research should build on these findings through framework piloting and validation, with the EDiHTA project planning to test its approach with both internal hospital-based sites and external DHTs through an open call to ensure real-world applicability and value recognition across diverse contexts.

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