ASSESS-DHT will increase the adoption of trustworthy and effective Digital Health Technologies (DHT) across Europe, enabling a more coherent digital single market, for health systems and patients to access DHT from all over Europe and giving industry a European market. We will develop a new assessment framework, beyond the existing models, capable of uniform HTA adoption across Europe, addressing new assessment challenges in Digital Therapeutics, AI and telehealth. Our consortium comprises 4 HTA bodies, the European Observatory on Health Systems and Policies, 5 academic and not for profit organisations with expertise in EU Regulation, DHT development and assessment methodologies, data protection, data quality, interoperability and cybersecurity. Patients and health professionals are included through the International Diabetes Federation and European Society of Cardiology. We include the DHT industry through companies with products for us to assess through a formal methodology mimicking actual HTA assessments – 3 as partners, some through an open call and industry-wide consultation via DIGITAL EUROPE. We will engage healthcare payers and ministries through our Advisory Board. We will co-create our overarching assessment framework with specialised pathways for different categories of DHT specified through a novel evidence-based typology. We will cater for phased adoption (going beyond fast track models like DiGA), complex life-cycles, iteratively developed AI, consolidated in a comprehensive HTA assessment manual plus specific guides in topics like cybersecurity. We will develop a sustainable repository containing the ASSESS-DHT framework, pathways and unambiguous criteria, a semantically searchable evidence library, checklists and tools to support companies with evidence generation, evidence of health system value from DHT, and online communities of practice.

Clinical trials increase in size, complexity and costs. This is fuelled with the need to demonstrate effects in more complex therapeutic areas, and to detect subgroups with different benefit and safety responses. Complexities, rigid clinical control, physical distance and (perceived) burden put patient engagement under pressure. (S)low recruitment and retention compromise efficiency, generalisability and validity of traditional, site-centred trials. Remote Decentralized Clinical Trials (RDCTs) and hybrid approaches address these challenges. RDCTs are an operational strategy for technology-enhanced clinical trials, which enable (semi-)continuous data collection and real-world evidence generation, increase patient recruitment and retention and decrease patient and investigator burden and costs. Trials brought to the home of patients. Paradigmatic changes in EU clinical trial design are required to fully benefit from the digital era. Yet, the feasibility of running RDCTs needs to be rigorously demonstrated toge

The Feel4Diabetes project addresses “HCO5-2014: Global Alliance for Chronic Diseases: prevention and treatment of type 2 diabetes”. The aim of this project is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in Europe. Methods: The PRECEDE-PROCEED Model will provide the theoretical framework for the development, implementation and evaluation of the Feel4Diabetes intervention. The framework has two phases, namely the PRECEDE and PROCEED phase. During the PRECEDE phase, the target population as well as behaviours related to type 2 diabetes and their determinants will be identified. Existing research programs and guidelines for type 2 diabetes prevention, policies, legislation, local infrastructure and human resources will also be recorded. Based on the knowledge gained from this phase, a low-cost and applicable in low-resource settings community-based intervention programme will be developed, with the active engagement of local stakeholders, providing access to the existing infrastructure and human resources wherever feasible. During the PROCEED phase, the intervention will be implemented and its process, impact, outcome, cost-effectiveness and scalability will be evaluated. The results of the intervention will be disseminated, aiming to embed it into policy and practice. Consortium: The Feel4Diabetes multidisciplinary consortium incorporates the necessary expertise on diabetes prevention, behaviours, nutrition, physical activity, policy and health economics. It consists of 10 partners from 7 universities, 1 research institute, 1 advocacy group and a small-medium enterprise, representing European low-middle income, high income and under socioeconomic crisis countries.