EDITH CSA Deliverable 3.2: final draft of the VHT roadmap

The Virtual Human Twin (VHT) is a groundbreaking initiative aimed at revolutionizing healthcare by creating personalized, comprehensive, and dynamic digital representations of individuals. It is envisioned as a systematic, ever-growing digital and quantitative representation of actionable knowledge in human pathophysiology, encompassing data, models, and insights from diverse disciplines. The VHT will transform healthcare by improving diagnostics, enabling personalized treatment plans, and enhancing clinical decision-making.  However, realizing this ambitious vision requires addressing a myriad of technical, infrastructural, ethical, legal, and social implications.

This document presents a comprehensive roadmap outlining the essential elements and strategies for the successful development and implementation of the VHT. The roadmap is structured in six distinct parts, each focusing on a specific aspect crucial to the initiative's success.

Part 1 establishes the rationale and context for the VHT, exploring the convergence of global healthcare needs, emerging trends, and technological advancements that drive its development. This section emphasizes the importance of stakeholder engagement, involving researchers, clinicians, patients, policymakers, and industry representatives in a collaborative effort to shape the VHT's vision and ensure its relevance. It delves into the key concepts of Digital Twins (DTs), highlighting their role as fundamental building blocks for the VHT.  This part also provides an in-depth analysis of stakeholder needs and challenges, identifying potential barriers to the adoption of the VHT and outlining strategies to mitigate them.

Part 2 of the roadmap focuses on the technological foundations of the VHT, exploring how to effectively organize and integrate diverse resources, such as data, models, workflows, services and tools, to establish a robust and interoperable platform. Advanced data-generating technologies allow to capture the intricacies of human biology and (patho)physiology. DT models are at the core of the VHT, ranging from data-driven, utilizing AI, to knowledge-driven, built upon mechanistic understanding. The credibility of resources needs to be rigorously established and documented, as it provides a quantitative measure of trustworthiness and reliability for the data and models within the VHT. Integration of resources to create multi-scale and multi-organ digital twins necessitates standardized approaches to characterize and annotate models. AI tools can be leveraged to enhance data quality, accelerate resource integration, and identify gaps in the current knowledge base of the VHT.

Part 3 delves into the crucial infrastructural elements required to support the development, deployment, and sustainable operation of the VHT. This part emphasizes the need for a robust and secure infrastructure capable of handling the complexities of data storage, model integration, and collaborative research within the VHT ecosystem. To realize the ambitious goals of the VHT, a trinity of interconnected software components is required: the Catalogue, the Repository, and the Platform. The Catalogue serves as the central hub for discovering and accessing VHT resources, providing detailed metadata and facilitating efficient resource retrieval. Complementing the Catalogue, the Repository provides secure and reliable storage for the vast amounts of data and models that constitute the VHT, ensuring their accessibility and preservation. The Platform, built on top of the Catalogue and Repository, offers a suite of tools and services to enable users to interact with the VHT resources, execute simulations, and analyse results. This part emphasizes the importance of adopting open standards and interoperable technologies to facilitate seamless data exchange and collaboration with other initiatives and infrastructures in the EU.

Part 4 focuses on the essential ethical, legal, social, and regulatory considerations that are crucial for the responsible development and implementation of the VHT. This part emphasizes the need for a comprehensive framework that addresses the complex ethical, legal, and societal implications of this transformative technology. Establishing a robust and interoperable VHT requires the adoption of common standards for data formats, model descriptions, and terminology, to ensure data quality, facilitate data integration, and enable meaningful comparisons across studies and populations. Additionally, a robust ethical and legal framework must be established to ensure the responsible use of VHT technology and protect individual rights and privacy. This includes addressing data security, informed consent, data ownership, and the potential for bias and discrimination. Following Responsible Research and Innovation principles will be crucial in navigating these complexities, to establish trust and facilitate social acceptance of the VHT.

Part 5 delves into the crucial aspects of engaging users, promoting the adoption of the VHT, and ensuring its long-term sustainability.  This part emphasizes the need for a multifaceted approach that incentivizes participation, addresses user concerns, and fosters a vibrant VHT ecosystem. It emphasizes the importance of creating a user-friendly interface, providing clear documentation, and offering training and support to facilitate user adoption. This part furthermore explores various business model strategies, including public funding, private investment, subscription models, and data licensing agreements, highlighting the importance of a phased approach that adapts to the evolving landscape of the VHT ecosystem. Establishing a VHT Marketplace is envisioned as a key facilitator for connecting VHT creators and consumers, promoting the exchange of resources, and fostering a sustainable economic model for the initiative. The roadmap also underscores the significance of integrating the VHT with existing research infrastructures and leveraging national and European funding opportunities to secure long-term sustainability.

Finally, part 6 brings together the key findings and recommendations from the previous parts, outlining a tentative timeline of activities for the successful rollout of the VHT over the next decade. It stresses the need for a collaborative effort involving all stakeholder groups to realize the full potential of this transformative technology and integrate it effectively into the healthcare landscape. This section highlights the importance of continuous investment in research and development to advance VHT technologies, expand the knowledge base, and address emerging challenges. It also emphasizes the need for ongoing dialogue and collaboration among stakeholders to ensure that the VHT evolves responsibly and equitably, ultimately contributing to the well-being of individuals and society as a whole. 

The VHT roadmap provides a comprehensive framework and set of recommendations for stakeholders to effectively contribute to the development and implementation of this transformative technology. Embracing the principles outlined in this roadmap will pave the way for a future where healthcare is personalized, predictive, and participatory, leading to improved health outcomes for all.