The overarching aim of IMMERSE (Implementing Mobile MEntal health Recording Strategy for Europe) is to advance the transformation of mental health care in Europe intro true person-centered care, focused on the needs of each individual seeking help for mental health problems, while giving them an active role in their treatment process and decision-making. In order to do so, IMMERSE has identified the Experience Sampling Methodology (ESM), a structured diary technique, as the methodology that puts the service user at the heart of their treatment. IMMERSE will integrate 20 years of research evidence on ESM into an innovative, clinical digital health tool, Digital Mobile Mental Health (DMMH), in close collaboration with stakeholders and extending it with mobile sensing data and innovative machine learning models. DMMH consists of an ESM app, assessing self-reports of mental state in daily life, a data-platform that allows the analysis of these data, and dashboard for visualization and feedback. IMMERSE will thoroughly evaluate strategies, processes and outcomes of DMMH implementation at 8 sites in 4 countries in Europe representing different contexts for implementation evaluation. At the same time, IMMERSE will identify and overcome key barriers and strengthen facilitators for implementation, transfer and scale-up of DMMH to routine mental health clinical practice by closely collaborating with relevant stakeholders, aligning the innovative DMMH tool to their needs. Similarly, the diverse ethical, legal and policy challenges and requirements will be identified and DMMH will be developed and implemented accordingly. Finally, IMMERSE is set out to do a cost-benefit analysis of the implementation and present a framework for future implementation of DMMH, including forecasting scenarios, aiming at a further scale-up of DMMH across 4 countries in Europe and beyond. IMMERSE thus offers a unique potential to significantly innovate mental health care in Europe.

Scientific excellence, and acceptance by health authorities of results derived from research on personalised medicine require standards ensuring validity and reproducibility. The objective of PERMIT is to establish, with all relevant stakeholders and invited experts, recommendations ensuring the robustness of personalised medicine trials, which also requires validation of the stratification methods. In a series of workshops participants, partners and selected experts will address the various aspects of methodology, design, data management, analysis and interpretation in personalised medicine research programmes, with the objective to reach consensus and publish recommendations. A mapping of the literature will inventory methodological practice in the various steps of personalised medicine programmes (WP2) and identify needs in terms of standardised methodology. WP3 will address the design of the stratification and validation cohorts, including the issue of the statistical power and the quality of data. WP4 will focus on the use of the stratification algorithms and the robustness the stratification methods. WP5 will address the translational step needed to select treatments to be tested in each of the clusters. WP6 will be dedicated to randomized clinical trials testing treatments in each cluster (including umbrella / basket designs), or comparing the personalised vs. non-personalised approach. Recommendations and publications in scientific journals, a final meeting and webinars will foster adoption and implementation (WP7). The PERMIT consortium is composed of participants: pan-European research infrastructures (ECRIN, EATRIS, ELIXIR-LU/UNILU), funders (DLR), HTAs (KCE, ISCIII), patients (EPF), regulatory (ISS), data protection (TMF) and scientific experts, whereas partners represent stakeholders interested in the quality of evidence generated by personalised medicine research (industry, medicine agencies, ethics committees, funders, journal editors, HTAs, BBMRI).

The creation of a European Health Data Space is one of the six strategic priorities for the newly elected European Commission. The European Health Research and Innovation Cloud (HRIC) will be one of the future cornerstone pieces for this area. HealthyCloud will deliver a Strategic Agenda including a Ready-to-implement Roadmap for the HRIC ecosystem. The Strategic Agenda will incorporate the consolidated feedback of a broad range of stakeholders: the European Commission, the Member States and regional, national, European and international relevant initiatives. These agents will be invited to be part of the HealthyCloud’s Stakeholders’ Forum, designed to facilitate the dialogue among them and the Consortium, and to act as an umbrella to bring together similar efforts in specific domains. HealthyCloud has been organized around four fundamental objectives that cover 1) interactions with stakeholders to ensure their voices are included as part of the Strategic Agenda; 2) the inclusion of Ethical, Legal and Societal aspects in the design of the future HRIC ecosystem; 3) the sustainable access, use and re-use of health-related data considering a progressive adoption of the FAIR principles; and 4) the technological solutions in terms of computational facilities and mechanisms to enable distributed health data analysis across Europe. The project is driven by two real-world use-cases (Cancer and Atrial Fibrillation) to ensure that propositions by domain-specific and technological experts are technically and ethically sound and legally compliant. The ultimate goal is to propose an ecosystem that builds and reinforces the trust of patients and citizens in the use of their health data for research. HealthyCloud is a 30-month project that brings together 21 organizations with broad and yet complementary expertise, including 5 Research Infrastructures (ELIXIR, ECRIN, EATRIS, BBMRI and Euro-BioImaging) and 3 Joint Actions (InfAct, iPAAC and eHAction) related to health research.