Toward a Harmonized Health Technology Assessment Framework for Digital Health Technologies in Europe

AbstractObjectivesThe increasing use of digital health technologies (DHTs) in Europe presents opportunities and challenges. Although DHTs could enhance care delivery and health outcomes, existing health technology assessment (HTA) methods often lack flexibility to address their diverse, fast-evolving nature. This article explores the perspectives of 5 stakeholder groups—policy makers, HTA agencies, technology developers, healthcare providers, and patients—regarding the development of a harmonized HTA framework for DHTs within the Horizon Europe funded European Digital Health Technology Assessment (EDiHTA) project.MethodsFindings are drawn from mixed-method research, including stakeholder surveys, interviews and focus groups with 97 stakeholders across European countries. The analysis of the data was performed per each stakeholder group through thematic analysis to identify points of consensus before identifying needs and requirements across stakeholders, relevant to the development of EDiHTA, using the Innovation Health Technology Assessment Methods framework.ResultsResults from 8 focus groups and more than 45 interviews are presented concentrating on 5 main themes. The emerging themes focus on the need for harmonization of HTA methods related to DHTs, the current characteristics of DHTs that are most highly valued, the importance of multistakeholder collaboration, the principles of a concept design for EDiHTA framework, and the discussion on the most relevant domains and criteria to be considered.ConclusionsStakeholders agreed that a harmonized HTA framework is needed; however, differences persist regarding timing and flexibility of evaluation, evidence types, and stakeholder involvement. The EDiHTA project will address differences through framework piloting, supported by multistakeholder workshops and expert advisory groups.