REALM Infographic: Patient Group Representative Perspectives on the Oversight of AI in Healthcare

Abstract

This infographic summarises key findings from the REALM Stakeholder Workshop: Patient Group and Medical Charity Perspectives on the Evaluation of Medical AI, held on 19 March 2026 in Brussels, Belgium. The workshop formed part of the Horizon Europe project REALM (Real-World Data and Evidence for Regulatory Assessment of Artificial Intelligence–Based Medical Devices), which brings together academic, clinical, regulatory, and industry partners across Europe to develop improved approaches for the evaluation, benchmarking, and governance of AI-based medical software. The event brought together 9 representatives of patient organisations and medical research charities from 5 European countries. Participants engaged with presentations on two REALM demonstrator cases — PGx2P (pharmacogenomics-informed prescribing support) and COPowereD (prediction of COPD exacerbations) — before taking part in structured group discussions on: trust in medical AI, access and regulatory oversight, and what should matter in evaluating medical AI systems. The workshop highlighted several key themes: trust in medical AI must be actively earned through transparency, explainability, and meaningful human oversight; regulation should be both robust and adaptive to technological innovation; evaluation frameworks should move beyond technical performance to include quality of life, usability, fairness, representativeness, and real-world patient experience; and patient perspectives should play a central role in shaping future AI governance and evaluation practices. The findings from the workshop will contribute to the development of REALM’s best practice guidelines and living-lab activities. For more information on the REALM project, see:https://realm-ai.eu/

Ähnliche Arbeiten