In order to strengthen the sustainability and resilience of health services and systems a unique consortium of governmental and funding organizations plus research institutes, has expressed the ambition to systematically learn from the organisation of care in other settings. Overall objective of TO-REACH is to provide groundwork for a future joint research programme that will contribute to the resilience, effectiveness, equity, accessibility and comprehensiveness of health services and systems. We will do so along two work streams: A) We will develop a research program on cross-border learning from good (or even innovative) models of care and the conditions needed to transfer them to other settings for implementation. It could refer to anywhere in the care chain depending on the priorities as identified in a Strategic Research Agenda (SRA) within this project. Conceptual, methodological and empirical advancement will be achieved through 4 meta-questions that will instruct research under a future joint research programme, linking to what counts as good models of care, what are the conditions required for transferability, what are the conditions for up-scaling, and how do they contribute to the performance of health care organisations and systems. B) We will build a platform for funding organizations that allows for collaboration and coordination in the project and projected joint research programme. This will synchronize priorities and activities, hence improving the quality and applicability of research with a focus on the topic areas as described under A. TO-REACH will pursue five specific objectives: Mapping health system challenges and priorities by synthesizing different materials and stakeholder inputs; Developing a framework and providing a knowledge synthesis on the above-mentioned meta-questions; Establishing sustainable cooperation of research funding bodies and links with other initiatives; Developing a SRA through agenda setting at European and Member State level; Disseminating the results of TO-REACH.

Digital health technologies (DHTs) are expected to improve both the quality and delivery of healthcare services for European societies while ensuring the sustainability of Europe`s healthcare systems. DHTs are also able to collect real-world data and evidence relevant for decision makers. However, the implementation of DHTs implies new methodological challenges to the standardisation of assessment criteria. Existing Health Technology Assessments (HTAs) are unable to capture the real added value of DHTs. EDiHTA will be the first flexible, inclusive, validated and ready-for-use European HTA framework reaching TRL 6-7, allowing the assessment of different DHTs (e.g. telemedicine, mApps, AI) at different TRLs, territorial levels (national, regional and local) and perspectives (e.g. payer, society, hospital). All relevant stakeholders will contribute to its design, development and validation. The digital framework will be piloted in real healthcare settings in 5 major European hospitals and through an open piloting scheme with European DHT developers. The principles of EDiHTA are to 1) promote a holistic approach involving all stakeholders for consensus building at national and European levels; 2) define a common terminology, harmonise and enrich existing HTA frameworks and create an open repository with frameworks, guides, articles and HTA methodologies; 3) optimise assessment processes along the DHT life cycle; 4) follow a multi-stakeholder, multi-domain and modular approach; 5) co-create EDiHTA solutions; and 6) provide a validated and ready-for-use digital HTA framework for DHTs. Next to leading academic groups in HTA research, our multidisciplinary consortium includes HTA agencies, clinics as DHT end-users, technology providers and a patient organisation with links to the broader European healthcare landscape of regulatory bodies, policymakers and payers. EDiHTA will leverage its network to accelerate the market entry of new DHTs for the benefit of European society.

In childhood, adolescence and young adults (CAYA), melanoma is under-studied and non-existing tailored clinical guidelines and standardized approaches lead to a very low diagnostic accuracy. The MELCAYA project aims to understand risk factors and determinants of melanoma to improve the prevention, diagnosis and prognosis of melanomas in CAYAs through a strong international consortium with experts from 10 countries in different disciplines (e.g. oncology, paediatrics, ethics, policy making), and sectors (e.g. academic centers, SMEs, hospitals, patient associations). MELCAYA will work on different approaches. 1) By integrating existing reference European cohorts and registries, studies of genetic and environmental risk factors and progression of melanoma in CAYA will be performed through different omic methods, and a novel taxonomy of CAYA melanoma will be generated. 2) MELCAYA will also develop image-based robust and trustworthy machine learning tools and a pan-European second-opinion platform for better diagnosis specifically designed for CAYA. 3) Moreover, the validation of minimally and non-invasive disruptive tools based on artificial intelligence and volatilomics detection from exhaled breath and skin will lead to earlier detection and more accurate prognosis of melanoma in CAYA. 4) Finally, through the evidence gathered, MELCAYA will design and implement public health strategies and will actively involve patients and the general population. The results of MELCAYA will maximize its impact by making its data and results accessible and re-usable through integration into UNCAN.eu. This action is part of the Cancer Mission cluster of projects on ‘‘Understanding".

With ever-increasing complexity of novel health technologies, Health Technology Assessment (HTA) methodologies have been evolving rapidly. However, there is now a lack of harmonization on the methodological needs of HTA bodies against the varied methodologies and tools. There is a need for a solution that allows for continuous dialogue between HTA bodies and academia, a solid, unified base for implementation of fit-for-purpose methodologies and long-term upskilling on HTA expertise. SUSTAIN-HTA aims to upskill the pan-European HTA body workforce and harmonise HTA expertise via a robust education and training framework that ensures continuous uptake of novel, need-based HTA methodologies. Aligned to the methodological developments as part of the new EU HTA regulation, the project will set up a mechanism for dialogues and interaction between HTA bodies and academia to regularly assess HTA-bodies’ needs in parallel with a methods observatory that ensures up-to-date knowledge of latest HTA methods. Prioritized methods will be piloted within HTA bodies and, after endorsement, implementation will be supported by a harmonized training and education framework that will be established to upskill the HTA experts. A long-term dissemination and communication structure among all stakeholders will be established to guarantee a feedback loop between HTA needs, methods assessment and associated training needs. Via the collaboration of 5 universities, 7 HTA bodies, 2 SMEs and one non-profit organization, SUSTAIN-HTA brings together extensive experience in (coordinating) previous European funded HTA-related projects including HTx, EHDEN, COMED and GetReEal. With this, SUSTAIN-HTA has the background for establishing sustainable business models that ensures continuity of project outcomes and activities in years beyond the project. SUSTAIN-HTA will support European leadership in the HTA field reach HTA bodies across at least 15 European countries with hundreds of people upskilled.

EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs. To be effective this approach requires evidence generation plan to be developed since early stages of product development, by engaging all relevant stakeholders. At present, in the EU there are no standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies (EFS), clinical investigations allowed by ISO 14155:2020 conducted early in the development aiming to inform the product development. The ambition of the HEU-EFS project is to develop a harmonised framework for the EU EFS Program, as one integrated step of evidence generation cycle. Project objectives include: (1) conducting research/analysis on state of play (i.e., characteristics, challenges, impacts) of pre-market programs for MDs, including EFS; (2) building a sustainable network of stakeholders at EU/national level to promote/support EFS implementation; (3) developing a sound, widely applicable, harmonised EU methodology and formulating recommendations to uptake EFS; (4) undertaking pilots to test the proposed framework; (5) developing instruments to monitor the EFS performance; and (6) implementing a dedicated, sustainable, open access online portal dedicated to EFS methodological framework, best practices and network. To achieve these goals, the HEU-EFS consortium has been designed including a wide range of relevant stakeholders: research organisations, HTA bodies, patient organizations, healthcare providers, SMEs (including health technology developers, legal experts, and a CRO), and 6 major private companies that are part of a pre-identified industry consortium. An Advisory Board made of competent authorities, notified bodies, medical and biomedical engineering professional associations, networks and industry trade association will collaborate to the success of the initiative.