REALM Consortium Meets in Split for General Assembly

From 23–25 June 2025, the REALM consortium held its General Assembly in Split, Croatia, hosted by RISE – Research and Innovation Services. Project partners participated both in person and online to re...

New infographic highlights key insights from the REALM Patient Workshop

REALM has published a new infographic summarising the key findings from the Stakeholder Workshop: Patient Group and Medical Charity Perspectives on the Evaluation of Medical AI, held on 19 March 2026...

REALM Academy Workshop showcases platform capabilities and advances in AI medical device software evaluation

On 14 April 2026, the REALM Academy brought together key stakeholders from across the European health data and AI ecosystem in Brussels for a hands-on workshop titled “From Data Federation to Medical...

REALM Academy Patient Workshop brings patient perspectives into Medical AI discussions

On 19 March 2026, the REALM project welcomed representatives from patient organisations and disease-oriented medical research charities across Europe to Brussels for a dedicated stakeholder workshop.

Advancing the Future of Real-World Evidence: REALM at the MetReal Multistakeholder Workshop

2–3 March 2026 | Copenhagen

REALM participated in the MetReal Multistakeholder Meeting organised by the REDDIE project and hosted by the Danish Medicines Agency in Copenhagen. The two-day workshop b...

REALM Academy Webinar Explores Federated Access to Real-World Data

The REALM Academy webinar “RWD Access Webinar – Introducing REALM, National Nodes, and Data Transfer Agreements”, held last week, brought together interested participants to present the vision, techni...

REALM Consortium Aligns for Final Project Year

The REALM consortium met online last week to align partners ahead of the project’s periodic reporting phase and to discuss priorities for the year ahead, which marks the final year of the project. The...

REALM Announces First 2026 Webinar and Upcoming Stakeholder Workshop

Europe’s healthcare systems generate enormous volumes of real-world data (RWD), yet challenges around access, governance and interoperability continue to hinder its full potential for research, innova...

REALM Academy Workshop 1: Multi-Stakeholder Insights for Evaluating Medical AI

5 November 2025, Brussels, Belgium

How should we evaluate AI medical devices when evidence standards are evolving and stakeholders have competing priorities? This question guided REALM Academy's fir...

REALM at the CSMD-Horizon Conference

Janaki Raman Rangarajan from VPH Institute and Vincent Uyttendaele from the University of Liège represented the REALM project at the recent CSMD-Horizon Conference, a key European forum dedicated...

REALM Academy Launches First In-Person Workshop on Medical AI Evaluation

The REALM project is pleased to announce its first in-person REALM Academy Workshop, 'Multi-Stakeholder Insights for Evaluating Medical AI,' scheduled for 5 November 2025, in Brussels, Belgium.

T...

REALM at the OHDSI Europe Symposium 2025

On July 7, 2025, the REALM consortium actively contributed to the 6th European OHDSI Symposium held at the historic Old Prison in Hasselt, Belgium. This year's event brought together hundreds of res...

REALM Consortium Meets in Warsaw to Drive Forward AI-Based Medical Device Software Evaluation

The REALM consortium convened for its 3rd Progress Meeting from 23–25 June 2025, hosted by the University of Warsaw in the historic heart of Warsaw. For the direct benefit of patients, the interdiscip...

REALM Launches First HTA-focused Training on AI in Medical Software Evaluation

On 11–12 June, REALM hosted its first health technology assessment (HTA)-focused online training, bringing together HTA body representatives, regulators and evaluators from across Europe to explore...

New REALM publication #13

A new publication from the REALM consortium covers Ethical and social considerations of applying artificial intelligence in healthcare—a two-pronged scoping review.Emanuele Ratti, Michael Morris...

REALM Online Training for HTA Agencies and regulators in AI-Powered Medical Device Software Evaluation

As part of the REALM Academy, REALM is inviting Health Technology Assessment (HTA) agencies and regulatory bodies across Europe to join an interactive two-day online training on 11th and 12th J...

REALM Project Feedback on MDR/IVDR Regulations

The REALM project, dedicated to fostering responsible innovation in the health and life sciences, actively contributed to the European Commission’s recent public consultation as part of its targeted e...

New REALM publication #12

Mahmoud Ibrahim, Yasmina Al Khalil, Sina Amirrajab, Chang Sun, Marcel Breeuwer, Josien Pluim, Bart Elen, Gökhan Ertaylan, and Michel Dumontier are the co-authors of the new REALM publication on "Gene...

First REALM Webinar on AI enhanced Medical Device Software Evaluation attracts regulators and healthcare professionals

Online, 25 March 2025 – The REALM project consortium hosted a public webinar to showcase how real-world data and AI evaluation tools are set to reshape the regulatory landscape for the evaluation of...

Upcoming REALM Webinar: Transforming Medical Device Software Evaluation with Real-World Data

As artificial intelligence (AI) and machine learning (ML) revolutionize medical device software (MDSW), notified bodies, regulatory bodies, health technology assessment (HTA) agencies, and developers...

REALM at Multi-Stakeholder Workshop on RWD in Regulatory & HTA Decision-Making

On February 6th, members of the MetReal cluster organised the first Multi-Stakeholder Workshop on Real-World Data (RWD) in Regulatory and Health Technology Assessment (HTA) Decision-Making at BfAr...

Keynote presentation from Prof. Michel Dumoniter at the EGC 2025

Today, REALM's coordinator, Professor Michel Dumontier from Maastricht University will give a keynote lecture at the EGC2025 Conference in Strasbourg, France.

The lecture is titled "Towards ...

New REALM publication

Professor Michel Dumontier and Assistant Professor Chang Sun from Maastricht University co-authored the newest edition to the REALM publications library with the article "Generating unseen disea...

Halfway through: Two years of the REALM project

Two years ago, 15 partners from six countries kicked off the EU-funded REALM (Real-world data Enabled Assessment for Health Regulatory Decision-Making) project, which aims to revolutionise the evalu...

REALM Partners Advance Platform Development at the Technical Workshop

From 27th to 29th November, partners in the REALM project gathered in Brussels for a technical workshop organised by VITO. The three-day meeting focused on partners working together to refine the...

Highlights from the MetReal Cluster meeting in Bonn

The representatives from the MetReal Cluster projects gathered on the 31st of October in Bonn, Germany. Coordinated by the Real4Reg project team, the meeting was an opportunity to discuss collaborat...

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 c...

REALM Stakeholder Survey: Shaping the Future of Medical Software Innovation

The REALM Project is committed to advancing healthcare innovation through collaboration and cutting-edge technology. By bringing together a diverse group of stakeholders—including regulatory authori...

Watch Our New Animated Clip: Discover How REALM is Revolutionizing Medical Device Software Development

Medical doctors are frequently overwhelmed by data and paperwork, while software developers for medical devices struggle to keep their solutions compliant with ever-evolving regulations. This is large...

Publication updates in the REALM library

The past few months have been very productive for the REALM partners with a few new publications being published.

We updated our website with a new Publications web page. This dedicated section wil...

EU AI Act Enters Into Force

The European Artificial Intelligence Act, the world's first comprehensive AI regulation, came into force today. Aiming to ensure trustworthy AI use, the Act classifies AI systems by risk levels: minim...

REALM at CAiSE Conference

REALM project partners Ankur Lohachab and Visara Urovi from Maastricht University wrote a publication titled: "A Blockchain-Based Approach for Model Card Accountability and Regulatory Complianc...

REALM at the fifth European OHDSI Symposium

The fifth European OHDSI Symposium, "Scaling up reliable evidence across Europe", was held from June 1st - 3rd, 2024, at Steam Ship in Rotterdam, the Netherlands.

OHDSI’s mission is to improve heal...

REALM 2nd Progress Meeting in Heraklion

Heraklion, May 22-24

The second progress meeting of the REALM project (Real-world-data Enabled Assessment for heaLth regulatory decision-Making) was successfully held in Heraklion from May 22nd t...

Symposium Artificial Intelligence in Medicine and Healthcare

The Symposium on Artificial Intelligence in Medicine and Healthcare, organised by the Department of Advanced Computing Sciences, Faculty of Science and Engineering, Maastricht University, starts tod...

Digital Health Horizons conference

Last week, our Dr Michael Morrison from the Centre for Health, Law & Emerging Technologies, University of Oxford, organised and was part of a panel on "Ethics of AI in Healthcare" at the Digital H...

First International Symposium on Digital Twins in Healthcare

Today marks the initiation of the First International Symposium on Digital Twins in Healthcare, an event set to redefine the landscape of medical innovation. From May 16-17 2024, experts in the fil...

REALM Steering Committee Reviews Project Progress and Plans Ahead

Yesterday, the leading members behind the REALM project met for their regular steering committee meeting. The session served as a platform for partners to exchange updates on the advancement of their...

New publication in the REALM library

Another publication in the REALM library. Emanuele Ratti from the University of Bristol, together with Federica Russo, wrote a publication titled: "Science and values: a two‑way direction".

Th...

Update on the AI Act Agreement

On Wednesday, the European Parliament approved the Artificial Intelligence Act that ensures safety and compliance with fundamental rights, while boosting innovation.

The draft AI act, which will be...

Job opening at REALM

VITO is looking for an enthusiastic junior researcher to join them in the group of Digital Precision Health and the PhD community working on the REALM project.

Do you have a background in bioinfo...

Lorentz Centre Workshop 2024

Life Sciences with Industry Workshop 2024

Registration is now open for the Life Sciences with Industry Workshop organised by NWO and Lorentz Center. The workshop will be held at the Lorentz Center i...

REALM on the AI act

After a long and turbulent legislative process, the AI Act is about to be passed. On 8 December 2023, the EU institutions reached a final compromise on the text of this groundbreaking legislation. The...

DIA Innovating Clinical Trials in Europe Conference

On Wednesday, November 15th, our project co-coordinator, Dr Gokhan Ertaylan from VITO, presented the aims of the REALM project at the DIA Innovating Clinical Trials in Europe Virtual Conference. The...

A network event on responsible governance of AI in healthcare

The Oxford Network for Sustainable and Trustworthy AI in healthcare (OxSTAI) is delighted to announce a network event on responsible governance of AI in healthcare.

The event will take place at the...

MetReal Cluster meeting

On October 30, the MetReal cluster gathered all the representatives from sister projects. Representatives from Real4Reg, ONOVACULATE, REDDIE, More-Europa and REALM shared the current status of their p...

REALM General Assembly meeting in Brussels

Brussels, Belgium, 19th-20th October 2023

The REALM (Real-world-data Enabled Assessment for Health Regulatory Decision-making) project aims to develop a collaborative framework through which regul...

Save the date: REALM General Assembly meeting

The REALM project is delighted to announce its upcoming two-day face-to-face consortium meeting, scheduled for October 19th to 2oth in Brussels, Belgium. This event will be held at the HOEK 38 and h...

REALM at the 77th Systems Architecture Study Group (SASG) meeting

The 77th Systems Architecture Study Group (SASG) meeting, centred around the theme "AI Experiences", took place on Monday 3 July with resounding success. Hosted by NXP at their impressive facilities a...

New MetReal research cluster launched

On 3rd of March 2023, the REALM partners were invited at the European Commission to meet with representatives of four other projects funded under the same call (HORIZON-HLTH-2022-TOOL-11-02) to kick-o...

REALM Partners Lead Workshop on Precision Health: Exploring Personal Health Data and GDPR Compliance

We are excited to announce that REALM Partners are participating in the workshop "Life Sciences with Industry 2023” organised by the Dutch Research Council at the Lorentz Center. The workshop will exp...

Towards Neurosymbolic AI: REALM Coordinator holds talk

In March 2023, Dr. Michel Dumontier, Distinguished Professor of Data Science at Maastricht University, founder and executive director of the Institute of Data Science, and co-founder of the FAIR (Find...

EU Knowledge Valorisation Week 2023: Learn More on Turning Research into Solutions

Join stakeholders and policymakers at the EU Knowledge Valorisation Week between 25th and 28th of April 2023. The annual event highlights best practices promoting the uptake of research results and sc...

New EU Research Project REALM Multi-Stakeholder Ecosystem for the Co-creation and Evaluation of Medical Device Software

On the 19th-20th January 2023, the Kick-off meeting of the interdisciplinary consortium of the European research project REALM, takes place in Maastricht. The consortium is led by Distinguished Profes...