Standardizing the evaluation of digital health technologies across Europe: the EDiHTA framework

Abstract Digital Health Technologies (DHTs) might contribute to the transformation and sustainability of healthcare systems making possible to offer personalized interventions and foster and improved and equal access to health services. Albeit the approval and reimbursement of DHTs is increasing worldwide, the complex regulatory landscape and the fragmented assessment environment represent a potential barrier to DHTs implementation. This is also linked to methodological challenges to their assessment due to DHT specific technical characteristics and implications. The EDiHTA project is a 4-year Horizon Europe Research and Innovation Action funded under call HORIZON-HLTH-2023-IND-06-07 that has started on January 1, 2024. Its goal is to deliver a comprehensive and flexible HTA framework for DHTs that integrates existing assessment methods with new ones to inform the decision-making process at the macro (policy), meso (management providers) and micro (clinicians) levels considering the requirements of all relevant stakeholders and a life cycle approach. The project foresees the co-creation of the EDiHTA framework concept design through stakeholders involvement and the development of a platform aimed to make the application of the assessment framework possible digitally in a standardised way. The EDiHTA framework will be then validated by end-users through a pilot phase. The project has already assessed the impact of EU regulations for the development of the framework and is now approaching to the definition of the underlying concept design based on the mapping of available assessment frameworks and stakeholders’ needs and the taxonomy of DHTs. This presentation will show the activities done so far and the final concept design of the EDiHTA framework that will be then finalized and digitalized for the pilot validation phase. Speakers/Panellists Stefan Buttigieg Malta Ministry for Health, Valletta, Malta