Public deliverables - Preciseu

PUBLIC DELIVERABLES

This section provides access to Preciseu’s core outputs. Below you will find a collection of public deliverables created to support your understanding and engagement with the work of the project.

D1.4 Year 2 Annual Work Plan

This deliverable, produced under WP1 sets out the Annual Work Plan for the project’s second year (months 13 to 24). Drafted in parallel with the M12 Internal Progress Report, it verifies the achievement of the ten objectives defined for Year 1, covering governance, communication branding, ELSI/GEDI assessment, mapping of personalised medicine in the participating regions, hackathon co-creation, and engagement with EU networks.It then defines the Year 2 strategic priorities: consolidating the deployment of PRECISEU on the foundations laid in Year 1, accelerating the operationalisation of the Innovation Support Programme (WP9), advancing data and infrastructure frameworks (WP4 and WP5), and launching cross-regional joint actions aligned with the EP PerMed Strategic Research and Innovation Agenda. The plan maps these priorities to the project’s General and Specific Objectives, details the calendar of tasks and deliverables, and allocates the resources committed for the period.

D2.2 Communication & Dissemination Toolkit

The Communication and Dissemination Toolkit is in line with the scope of the Dissemination, Outreach and Communication Plan (D2.1). The toolkit has been developed in English. It includes the visual identity elements and indications on communication tools and channels to be used for dissemination and outreach.

Elements of this kit are project logo and brand, project PPT templates, templates for internal and external monthly electronic newsletters, elements for PRECISEU Platform (D2.4) and use of social media (mostly LinkedIn) to notify stakeholders about the project’s progress, calls and actions.

D2.4 PRECISEU Platform

The PRECISEU website will be one of the project’s primary communication, dissemination, and outreach resources.

Its aim is to provide visitors with non-confidential information about the project and its activities, giving access to outcomes and linking to project-generated resources and outputs, as well as to the project`s social media and news.

It is conceived as a living tool, envisioned to grow during the first two years of the project with different uploads of information. The initial structure and approach included in this deliverable will be revised and adjusted to ensure alignment with the project strategy.

D3.1 Initiatives mapping

Delivered under Work Package 3 (Interregional Collaboration and Partnership Bridging) and led by Innovation Agency Lithuania, this report compiles a structured inventory of personalised medicine initiatives identified across the consortium’s regions and Ukraine, drawn exclusively from a targeted partner survey. Initiatives are organised into four thematic domains (Research and Innovation, Patient Perspective, Policy and Regulation, and Ecosystem) and further classified by typology, producing a factual baseline of the European personalised medicine landscape. For each domain the report highlights the geographical spread, structural diversity, governance and funding models, and emerging patterns, concluding with cross-cutting observations on how the catalogued initiatives feed the Regional Innovation Valleys agenda. The mapping is intended to inform PRECISEU’s interregional collaboration activities, identify complementarities between high-performing and emerging ecosystems, and provide an evidence base for work on the secondary use of health data and advanced therapies.

D3.2 Case Study Hungary

The deliverable is a comprehensive analysis of Hungary’s ecosystem in the context of personalized medicine, in particular regarding advanced therapies and with a particular focus on digital health innovation.

The primary objective is to evaluate the current state and prospects of country’s PM landscape, including the existing legal framework, innovation agenda, SWOT and potential synergies with other EU regions.

D3.3 Case Study Poland

Europe aims to lead in deep-tech innovation by connecting talent with top companies and supporting breakthrough solutions. The Regional Innovation Valleys (RIVs) initiative strengthens regional innovation, especially in less advanced areas, by funding interregional projects aligned with EU priorities.

A key focus is healthcare, with Personalised Medicine (PM) central to improving quality of life for 448 million citizens. PM tailors treatments to individuals’ genetic profiles and supports prevention. The PRECISEU initiative accelerates PM adoption by linking regional ecosystems, improving health data use, supporting advanced therapies, and ensuring patient access—advancing the EU’s vision for a sustainable, innovative, and health-focused future.

The partners of PRECISEU identified the relevance of highlighting the challenges of an effective implementation of Personalised Medicine model across EU by aligning their actions to the events taking place during the Presidencies of the EU. At the moment of publication of this case study, Poland holds the presidency of the Council of the EU (for the second time) between 1 January 2025 and 30 June 2025.

D3.4 Case Study Denmark

Produced within Work Package 3, this case study was scheduled to coincide with Denmark’s Presidency of the Council of the European Union in the second half of 2025 and provides a country-level analysis of the Danish personalised medicine ecosystem. It describes the national health system, the health data landscape, life sciences clusters and networks, professional associations, regulatory bodies, academia and research centres, and reviews the legal framework for the primary use of health data as well as national and regional innovation agendas. The deliverable then presents a SWOT analysis and a selection of transferable good practices, notably the Digital Health Centre and the National Whole Genome Sequencing Center, together with initiatives on gender diversity in life sciences. The conclusions highlight Denmark’s strengths in eHealth maturity and EU network leadership, while flagging persistent gaps such as limited integration of multi-omics into routine clinical practice, skills shortages, regional disparities, and identifying opportunities in training, infrastructure and Nordic–Baltic cooperation.

D4.1 PRECISEU readiness framework (Readiness/maturity assessment framework)

The report of Task 4.1, “Assessing Readiness to EHDS”, presents a systematic approach for evaluating the technological, regulatory, organisational, and societal readiness of health data information ecosystems across PRECISEU-countries in Europe for integration into the European Health Data Space (EHDS), as part of the PRECISEU project’s Work Package 4 “Use of Health Data”.

To achieve this, the consortium developed the Maturity Grid Model (MGM), a standardised assessment tool with three levels of EHDS readiness that collects and compares essential EHDS requirements such as governance, technical infrastructure, health data readiness, resources, societal readiness, data privacy and security, access and control, unified market to EHR systems and innovation capacity. The assessment process is based on desk research and the analysis of existing reports and policy papers from the respective PRECISEU countries or regions, with all results transferred to the MGM and visualised in abridged versions in clear factsheets for each participating country or region.

This readiness framework provides a transparent and harmonised baseline for identifying strengths and gaps in EHDS implementation at the European level. The results serve as a foundation for further project activities, such as developing targeted recommendations for policymakers, informing joint interregional projects, supporting the design of interoperable health data infrastructures, and guiding capacity-building measures to enhance cross-border data sharing and the adoption of personalised medicine. Ultimately, Task 4.1 and the PRECISEU framework support the sustainable and effective realisation of the EHDS vision, enabling secure, innovative, and patient-centred healthcare across Europe.

D4.2 Interoperability framework

Issued under Work Package 4 (Use of Health Data) and led by the Barcelona Supercomputing Center, this deliverable establishes the Interoperability Framework that will govern the exchange and reuse of health data within PRECISEU and its forthcoming Joint Interregional Projects. Building on a literature and policy review and on expert interviews, the framework is structured around the four layers of the European Interoperability Framework (legal, organisational, semantic and technical) and anchored in nine foundational principles, including FAIR data, privacy by design, patient-centric consent, cross-border sharing, security, equity, and sustainability.

The document differentiates and provides recommendations for both primary and secondary use of health data along the full data life cycle, surveys the state of the art in member states represented in the consortium, and addresses the implications of artificial intelligence applications. It is explicitly aligned with the European Health Data Space, the TEHDAS recommendations, the FAIR principles and the EU Data Strategy, serving as a reference for new health data initiatives and the upgrading of existing infrastructures.

D4.3 Guidelines for Joint Interregional Projects on Personalised Medicine

This companion deliverable, developed under Work Package 4 and led by the Barcelona Supercomputing Center, translates the Interoperability Framework of D4.2 into operational guidance for the Joint Interregional Projects to be financed through the PRECISEU Open Call. The Guidelines follow the HealthData@EU and TEHDAS data life cycle and provide structured recommendations for each of its phases (data collection, standardisation, publication, discovery, access, use and finalisation), complemented by sections on project management, governance, data privacy and security, supported by cross-border use cases.

The document is intended to give Open Call applicants a practical reference for designing cross-regional projects that meet PRECISEU’s expectations on interoperability, FAIR principles and the responsible secondary use of health data, while remaining consistent with the GDPR and anticipating the requirements of the European Health Data Space. Beyond the immediate scope of PRECISEU, the Guidelines are positioned as a transferable good practice reference for any interregional initiative in Europe pursuing data-driven personalised medicine.

D5.1 State-of-the-art of ATMP value chain

EATRIS, together with European partners under the EU-funded PRECISEU project, is leading an initiative to map Advanced Therapy Medicinal Product (ATMP) capacities across Europe. The goal is to create a coordinated, data-driven infrastructure that ensures equitable access to advanced therapies such as gene, cell, and tissue-engineered treatments.

While ATMP science is advancing quickly, access remains uneven across EU countries due to differences in infrastructure, regulation, and clinical capacity. This mapping project establishes a sustainable, structured process—to be maintained by EATRIS and partners—that provides a comprehensive overview of Europe’s ATMP landscape, highlighting strengths and gaps in:

– Academic and translational research centres
– GMP manufacturing and processing facilities
– Clinical trial sites and hospitals
– National regulatory and logistics systems

In essence, the initiative aims to support better coordination and capacity building for ATMP development and delivery across Europe.

D6.1 Cross Regional Report

The PRECISEU project—PeRsonalised medicine Empowerment Connecting Innovation ecoSystems across EUrope—aims to accelerate the development and equitable implementation of personalised medicine (PM) across Europe. This D6.1 Cross-Regional Report, led by Sahlgrenska Science Park, maps systemic barriers and promising practices in ten European regions/countries: Flanders (BE), Sofia (BG), Catalonia (ES), Baden-Württemberg (DE), Crete (EL), Emilia-Romagna (IT), Lithuania, the Netherlands, North East Romania, and Västra Götaland (SE).

D7.1 Handbook on Training

This Handbook constitutes Deliverable 7.1 under Work Package 7 (Training and Cultural Change) of the PRECISEU project. It captures the design, implementation, and cumulative insights from the eight editions of the PRECISEU Personalised Medicine (PM) School, conducted across the project’s lifecycle. More than a record of events, this deliverable serves as a strategic and transferable knowledge resource—demonstrating how decentralised, regionally embedded training initiatives can advance a connected, inclusive, and innovation-driven European ecosystem for personalised medicine.

D7.2 “Awards” PRECISEU Best Practice Recognition - Management and Guidelines

This Management and Guidelines document assembles all tools and workflows of the PRECISEU Best Practice Recognition to ensure its persistence throughout the overall runtime of PRECISEU. It is a deliverable to be available at M13 of the project in its first version. It may be updated and improved over time.

This document also serves as a core deliverable (D7.2) under Task 7.2 of the PRECISEU project. Its first version is submitted at Month 13 (M13) of the project and may be updated and refined over time in response to feedback from applicants, evaluators, and partner organizations. Future iterations may incorporate insights gained from the first recognition cycle, as well as the evolving needs of the project and its stakeholders.
This deliverable lays the foundation for interlinking the Best Practice Recognition with other project activities, including its integration into the PM School training programme (T7.3) and the Policy Biodesign workstream (T7.4). Recognised practices may be featured in training curricula, used as case studies in policy co-creation labs, or serve as models for regional implementation plans—amplifying their value and contributing to cross-WP synergy.

D7.3 Design Thinking for Policymaking - Guidelines

Biocat has devised a program inspired on Stanford Mussallem Center for Biodesign’s Policy Program. Biocat has already been implementing for years Stanford-based Design Thinking Methodology with its d·HEALTH Program, following Stanford University’s Biodesign methodology program for graduates.

The program is aimed for researchers and professionals who want to learn about entrepreneurship and innovation in healthcare. Several partners in the PRECISEU consortium have also expertise in Design Thinking methodologies to boost generation of cocreated ideas, products and services (Biovia, POP, CLustER, HLSCB, SSP…). Those will actively participate in some of the phases of the program, either in this first pilot edition in Barcelona or in the future editions in Flanders, Sofia or Emilia Romagna. Other partners involved in this task are Salut (Health Department, Government of Catalonia), ClustER, and POP (Platform of Patients’ Organisations). Those will be actively participating in the program in its different editions.