Real-world-data Enabled Assessment for Health Regulatory Decision-Making

The REALM project was set out to develop a collaborative framework through which regulatory authorities, software developers, healthcare professionals and policy officers can jointly create and evaluate innovative medical device software.

To do so, REALM will create a platform dedicated to providing a comprehensive and easily accessible source of essential medical data for various applications. This platform is thought as a medical device software and is being validated and improved through five case studies during the lifetime of the project.

The research carried out by the REALM project is important because it will create a system to test and certify software used in medical devices. The project will also create a catalogue of health data, clinical images, and other information, and organise all data in a way that is easy to use and understand.

YAGHMA’s role in the REALM project is to assess the impact of the demonstrator using our Software Impact Assessment (SIA) tool. YAGHMA will be able to showcase the evolution of the platform’s impact performance and how it is assessed, address emerging risks, and monitor how related policies develop in the chosen pilot countries. Our role will then consist in contributing to the formulation of policy recommendations by identifying risks, opportunities, and potential gaps between the projects’ performance and trustworthy AI disclosures and regulations. This is key to eventually assist public health stakeholders as well as health data processors and controllers in making informed decisions and improving the AI governance in the digital health ecosystem.

The REALM project is funded by the Horizon Europe programme and led by the University of Maastricht (NL).

Other consortium partners are:

  • Comunicare Solutions (BE)
  • Université de Liège (BE)
  • University of Antwerp (BE)
  • VITO (BE)
  • Virtual Physiological Human Institute for Integrative Biomedical Research (BE)
  • European Research and Project Office GmbH (DE)
  • Exus Software Monoprosopi Etairia Periorismenis Evthinis (HE)
  • Metamind Innovations (HE)
  • Traqbeat Technologies PC (HE)
  • Uczelnia Lazarskiego (PL)
  • University of Warsaw (PL)
  • University of Bristol (UK)
  • Centre for Health, Law & Emerging Technologies, University of Oxford (UK)

The project started on the 1st of January 2023 with a total duration of 48 months.

Project website REALM project:



Our contact persons in this project are:

Ivett Jakab
Research Project Manager

Emad Yaghmaei
Director and Senior Consultant