The major activities and deliverables of the EDITH-CSA project were the following:

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• Large Public Meetings. A range of public meetings were held in Leuven, Rome, Paris and Amsterdam, each playing a crucial role in shaping the roadmap. These events brought together all stakeholders, including experts from academia, industry, healthcare, regulatory bodies, and patient organizations. The meetings featured plenary sessions, strategy panels, and focused breakout discussions that addressed key themes such as integration challenges, ethical and regulatory concerns, sustainability, and business models. The Paris meeting set the foundation for discussions on how the VHT should be integrated into healthcare systems, defining the necessary infrastructure and governance framework. Participants explored the balance between standardization and flexibility, ensuring that the VHT framework could accommodate both existing and emerging technologies. The Amsterdam meeting built upon these discussions, focusing on the refinement of the roadmap and its recommendations, validation of platform developments, and the creation of sustainable business models. Keynote speakers at both events provided insights into the evolving landscape of digital twins, AI in healthcare, and regulatory frameworks, helping align the roadmap with global trends and challenges.

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• Stakeholder Engagement via Focus Groups and Workshops. A key component of the roadmap implementation involved extensive stakeholder engagement to gather perspectives from diverse actors in the healthcare ecosystem. A broad stakeholder mapping allowed to lay out the entire ecosystem and its diverse actors and provided a solid basis for further engagement activities. Such activities included multi-stakeholder focus groups across Europe, which brought together clinicians, patients, industry leaders, regulators, and policymakers to discuss the potential impact of the VHT. Reflexive workshops were also conducted within the consortium and with ad-hoc expert groups, providing opportunities for refining the discussion on the social and ethical dimensions of digital twins. Breakout sessions held during the public meetings in Paris and Amsterdam further facilitated in-depth exploration of specific issues, such as regulatory barriers, clinical adoption, and the integration of VHT applications into existing medical workflows. Additionally, a series of Advisory Board meetings involving the Industry Advisory Board (IAB) and the Advisory Group of Stakeholders (AGS) ensured that the roadmap remained relevant and aligned with stakeholder needs. These discussions provided valuable insights into business models, legal considerations, and the broader technological infrastructure required to support the VHT.

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• Roadmapping Activities. Building on stakeholder engagement as well as the public on-site and on-line meetings, the roadmapping process focused on translating insights into actionable steps. The roadmap was continuously refined to address gaps in collaboration, visibility, and adoption strategies while ensuring that all technical, regulatory, and economic considerations were accounted for. Stakeholder contributions were systematically integrated, ensuring a balanced and inclusive approach.  A significant milestone was the validation of the roadmap through direct engagement with the ecosystem, ensuring that it aligns with real-world needs and expectations. By leveraging input from experts and end-users, the roadmap provides clear pathways for development, adoption, and scalability, setting the stage for the long-term success of the VHT. In addition, both AGS and IAB were extensively consulted on the content of the roadmap and its recommendations, and their feedback was integrated into the final version of the roadmap. This provided a high-level expert validation to the final roadmap.  Given the extensive length of the final VHT roadmap, an extended summary was produced for policy makers, providing a high-level description of the context, the ecosystem needs, the proposed solution, the challenges and the recommendations for the realization of the VHT. This extended summary also went through a public and advisory board consultation and validation process. 

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• Development of the proof-of-concept VHT Platform. To further inform the roadmap, a proof-of-concept (PoC) federated cloud-based repository and simulation platform, key components of the VHT infrastructure were developed. This PoC repository incorporated EDITH use cases and placeholders for external contributions, which were collected through an open call for participation. This development played a crucial role in defining data and metadata requirements, ensuring compliance with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles and establishing a legal framework for resource sharing. Insights gathered from this process were represented in the VHT roadmap. A governance framework for the platform was drafted and presented, detailing user roles, responsibilities, and access policies. Additionally, standardization procedures were proposed to enhance interoperability between data sources, simulation models, and digital twin implementations. The PoC framework addresses key aspects such as accessibility, trustworthiness, data privacy, and liability, thereby fostering a secure and trustworthy ecosystem. Proposals regarding the technological infrastructure, coupled with legal considerations – including data protection and intellectual property, and quality insurance procedures have been comprehensively detailed. In order to test the needs identified during this part of the EDITH activities, demonstrators were built, starting with an analysis of the EDITH use cases and subsequently implementing them in an existing HPC model execution environment.  The proposed design of the simulation platform architecture was further refined with AI-driven workflows, high-performance computing (HPC) integration, and modular architectures, which will ensure scalability and efficiency in executing VHT simulations.

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• Legal and Regulatory Analysis. A crucial element of the roadmap’s implementation was ensuring compliance with European and international regulations governing digital health technologies. A thorough regulatory analysis was conducted to assess the current landscape, identify gaps, and propose policy recommendations. These efforts were compiled and used to outline a structured approach to regulatory alignment. Among the key considerations were data protection, security, intellectual property rights, and ethical concerns. The roadmap proposes standardization measures to align with GDPR, the AI Act, and medical device regulations, ensuring that VHTs meet legal and ethical requirements for safe and responsible deployment. Additionally, it emphasizes the importance of trust, transparency, and user control, particularly when handling patient data and integrating digital twins into clinical workflows.

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• Sustainability and Business Modelling. Tackling the issue of ensuring the long-term sustainability of the VHT was a central focus, leading to the development of a comprehensive business model portfolio. This portfolio examined market opportunities, economic viability, and stakeholder engagement strategies, providing a framework for future funding and commercialization. In addition to financial sustainability, efforts were made to establish a governance structure that supports continued development beyond the CSA funding period. The concept of a VHT Marketplace was introduced, defining models for resource exchange, service monetization, and stakeholder collaboration. By mapping market dynamics and identifying potential barriers to adoption, the roadmap provides a strategic blueprint for scaling VHTs within the healthcare ecosystem.

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Website EDITH: European Virtual Human Twin
Website EDITH Zenodo community: Search Open Access Resources of the EDITH Coordination and Support Action
Website European Commission: EU Funding & Tenders Portal