Jerina Hoxha
28.11.25
CERTAINTY’s 2nd stakeholder workshop showcases progress and co-creation on Virtual Twin prototype
The CERTAINTY consortium marked a major milestone in its journey towards personalised immunotherapy with the successful completion of its second stakeholder workshop on 4 November 2025. Held virtually, the session brought together a diverse group of participants, multiple myeloma patients, clinicians, legal and regulatory experts, and project partners, to review and refine the first prototype of the Virtual Twin (VT).
Following on from the initial requirements defined during the first workshop, this second edition served as a critical checkpoint for validating both technical developments and ethical alignment. Participants engaged in structured discussions focused on usability, explainability, legal compliance, and real-world deployment of the VT in the clinical setting.
A Patient-Centric Digital Innovation
Central to the workshop was the demonstration of the patient-facing dashboard, which now includes visual representations of treatment history, options for reporting symptoms, and prompts to aid shared decision-making with clinicians. Patients praised the progress and emphasised the importance of clearly communicating the supportive role of the VT, not as a decision-maker but as a guide.
Discussions highlighted the need for transparency on model uncertainty, richer symptom reporting, and the inclusion of patient values, preferences, and emotional well-being in the tool's design. The proposed integration of a personalised prompt generator and plain-language educational resources was also met with enthusiasm.
Clinical Integration and Decision Support
Clinicians explored the VT's potential to streamline tumour board preparations and support treatment planning, especially in time-constrained settings. A use case was presented showing how the VT can auto-populate slide decks, summarise patient data, and surface predictive insights to enhance discussions. Priorities included seamless integration with hospital information systems, click-friendly interfaces, and printable one-page summaries for tumour board use.
There was consensus that the VT must adapt to the diverse practices across Europe, supporting both large cancer centres and smaller clinical environments.
Ethics, Regulation and Compliance-by-Design
A legal expert provided an in-depth review of the EU’s Medical Devices Regulation (MDR) and AI Act, concluding that the VT would likely qualify as a high-risk AI system under current and upcoming regulations. While research-use exemptions apply during the project phase, the consortium was encouraged to pursue a compliance-by-design approach to facilitate eventual clinical adoption.
Key topics included classification under MDR, AI explainability obligations, data protection (GDPR), and the importance of documenting roles, responsibilities, and risk management strategies from the outset.
Looking Ahead
The second workshop not only validated CERTAINTY’s direction but also strengthened its commitment to co-creation. By embedding the perspectives of those who will ultimately use and be affected by the VT, the project ensures that technological innovation aligns with human values and regulatory requirements.
Next steps include incorporating workshop feedback into the next VT prototype, advancing technical integration, and preparing for the third stakeholder workshop, which will focus on feasibility testing and expanded clinical use.