Artificial Intelligence and Data Visitation (AIDV) WG Plenaries

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Joint-Meeting Session April 25, 2025

Governance of Digital Twins in Human Biology and Health

Plenary: RDA 25th Plenary Meeting [part of International Data Week 2025]

Submitted by

Irina Varfolomeeva

Recording

Slide

Meeting objectives

Collaborative notes https://docs.google.com/document/d/1VqdFh5zE77kQKtV_xkC7wegtKFJMR4ir/edit

Principle Objective
This session explores the ethical, legal, and regulatory governance of human digital twins in the fields of human biology and human health, building on the work being done on Immune Virtual Human Twins (VHTs) and the subset of Immune Digital Twins (IDTs). It combines work done in the EOSC-Future/RDA AIDV-WG with that being carried out in the RDA BIDT-IG. With a focus on integrating an ELSI framework for ethics-by-design principles, the session engages a global, interdisciplinary audience to operationalize trust, accountability, and compliance in the use of digital twin technologies for personalized health.
The session situates its discussion within and beyond the foundational work of the EDITH project (e.g. D3.2 VHT Roadmap and D6.2 Code of Conduct). While EDITH established a high-level roadmap and early-stage regulatory framing, this RDA session aims to advance more granular implementation strategies for ethically robust and legally harmonized digital twin ecosystems, with emphasis on open science infrastructures, global data flows, regulatory sandbox testing, and stakeholder governance. It addresses these needs within the context of evolving digital and AI regulation as well as the European Health Data Space (EHDS). It specifically addresses the regulatory tensions and ethical edge-cutting challenges emerging from the complexity of human biological systems modeling and their use for clinical decision-making and the development of personalized health interventions through research.
Specific objectives
• Present and gather feedback on the Integrated ELSR Framework for Health Digital Twins.
• Evaluate challenges where current legal frameworks (e.g., GDPR, AI Act, EHDS) fall short for digital twins in health.
• Showcase outputs from AIDV WG that complement and extend EDITH’s Code of Conduct efforts.
• Promote coordination between technical, legal, and clinical communities on regulatory harmonization.
• Identify strategic priorities and RDA contributions for advancing global alignment in digital twin policy and governance.

Meeting presenters

Francis P. Crawley (EOSC-Future/RDA AIDV WG & BIDT IG) , Perihan Elif Ekmekci (EOSC-Future/RDA AIDV WG & BIDT IG) , Others to be confirmed

Meeting agenda

1. Welcome and framing by session chairs (5 min)
2. Overview of the Integrated ELSR Framework and outputs of BIDT & AIDV (10 min)
3. Use case examples highlighting limitations of current regulation (15 min)
4. Panel discussion: Beyond EDITH – implementing governance, consent, and accountability for IDTs (30 min)
5. Audience dialogue and contributions (10 min)
6. Next steps: toward a harmonized RDA-endorsed toolkit and white paper (5 min)

Target audience

medical researchers, digital twin technologists, healthcare providers, ethicists, data protection authorities, legal scholars, regulators, AI/ML developers, civil society actors

Group Activities and Scope

This is a joint meeting of two RDA Groups: EOSC-Future/RDA AIDV-WG and BIDT-IG. (The application form appears to be the same for a single WG/IG meeting.)
The EOSC-Future & RDA Artificial Intelligence and Data Visitation Working Group (AIDV-WG) addresses ethical, legal, and social challenges of Artificial Intelligence (AI) and Data Visitation (DV) affecting of state-of-the art data technology impacting scientific exchange in the context of data sharing and the European Open Science Cloud (EOSC). The AIDV-WG was established through a competitive call for proposals for RDA Working Groups focusing on the development of solutions for the European Open Science Cloud (EOSC), working in conjunction with the European Commission-funded project EOSC Future.

The WG Building Immune Digital Twins aims to foster a network of collaborators and experts in all
relevant research areas. The ultimate goal of the WG is to help create a long-term interdisciplinary
immune digital twin community willing to take on the challenges of this exciting new field.
It is essential to understand that the field of medical digital twins is fundamentally new in its premise
and ambition. It is a crucial tool for the realization of personalized medicine.

Additional links to informative material

Expected Outcomes
• Refined Integrated ELSR Framework with community input.
• Strategic alignment between AIDV guidance
BIDT recommendations
and EDITH roadmap principles.
• Draft outline for an RDA white paper and toolkit extending EDITH’s Code of Conduct.
• Enhanced collaboration between EU and international efforts aligned with FAIR/CARE/TRUST principles.

Outreach
• EOSC-Future Project
• Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)
• Open Science infrastructures (e.g.
EOSC
EGI
GOSC
AOSP
AORC
ARDC
OSF)
• Figshare
Mendeley Data
Dataverse
• EDITH Consortium
• ELIXIR; Genomic Data Infrastructure (GDI) Project; GA4GH Data Sharing Standards; Human Genome Project II ELSI

Short Group Status

Both groups are active.
This is a joint meeting of two RDA Groups: EOSC-Future/RDA AIDV-WG and BIDT-IG.

Estimate of the required venue room capacity

Up to 30

Applicable Pathways

FAIR, CARE, TRUST - Adoption, Implementation, and Deployment
Data Infrastructures and Environments - Discipline Focused
AI meets data: exploring use cases, applications and innovation

Avoid conflict with the following groups

Artificial Intelligence and Data Visitation (AIDV) WG
RDA / CODATA Data Systems, Tools, and Services for Crisis Situations WG

Please indicate at least (3) three breakout slots that would suit your meeting.

Breakout 2. Monday, 13 October 2025, 06:00-07:30 UTC
Breakout 4. Wednesday, 15 October 2025, 23:00-00:30 UTC
Breakout 5. Thursday, 16 October 2025, 03:30-05:00 UTC