Follow us on X
Follow us on Linkedin
Real-world-data enabled assessment
for health regulatory decision-making

REALM Project Successfully Engages MSAB in Key Stakeholder Meeting

On September 20, 2024, the REALM project team held a productive meeting with members of its Multi-Stakeholder Advisory Board (MSAB) to present key project updates and gather feedback on critical components of the project. The virtual meeting, led by Michel Dumontier (UM), Gabrijela Radić (RISE), and Gökhan Ertaylan (VITO), was attended by board members representing diverse fields, including regulatory bodies, healthcare professionals, and data ethics experts.

The meeting covered REALM's goal of developing a regulatory sandbox for evaluating medical software devices, particularly those driven by artificial intelligence. The session included a comprehensive overview of the REALM project with key components such as the regulatory toolbox, data resources (real-world and synthetic data), and use cases being highlighted.

Picture3

During the meeting, the MSAB members raised insightful questions regarding the project's use cases, stakeholder involvement, and alignment with regulatory frameworks. Key takeaways include:

  • Use Case Complexity: MSAB members inquired about the rationale behind the selection of use cases, which span across diverse medical environments, from hospitals to outpatient care. The project team clarified that use cases were selected to challenge the regulatory framework with cutting-edge technologies, including AI-powered medical applications.

  • Stakeholder Interaction: The team emphasized the importance of ensuring that diverse stakeholders—such as healthcare providers, patients, and regulators—are considered when developing the project’s infrastructure.

  • Alignment with AI Regulations: The discussion also touched upon how REALM’s sandbox model aligns with the European AI Act and upcoming regulatory frameworks. The team highlighted its future plans to integrate with regulatory sandboxes and testing environments as they are established.

Picture1

A significant portion of the meeting was dedicated to discussing the Key Exploitable Results (KERs) of the project. The advisory board members provided valuable feedback on several key outputs, including:

  1. Blockchain Software Certification Process
  2. REALM Data Catalog
  3. REALM Academy

These results are designed to create a lasting impact on the medical software certification process, improve the quality of medical software, and provide necessary training and resources for stakeholders. Through interactive polling and discussion, the advisory board members ranked the KERs based on their interest, potential impact, innovation, and commercialization potential. The Blockchain Software Certification Process emerged as the most promising result, viewed as, both highly innovative and commercially viable.

Board members also called for further clarification on certain aspects, such as the REALM Infrastructure and Blockchain Certification Process, and encouraged the team to explore opportunities for wider stakeholder engagement and sustainability.

The REALM project team thanks the MSAB members for their time, expertise, and valuable feedback. Their insights will be instrumental in shaping the project’s continued progress toward improving medical software certification and ensuring a robust regulatory framework for AI-driven healthcare technologies.

Stay tuned for more updates on our progress as we move closer to realizing the full potential of the Realm Project.

Learn more about the REALM MSAB and its members by visiting https://www.realm-ai.eu/about/advisory-board