As artificial intelligence and robotics continue to evolve at an unprecedented pace, the healthcare sector is undergoing a digital transformation. Yet, alongside this rapid innovation comes a critical challenge: ensuring that new AI-driven medical technologies are safe, effective, and compliant with rigorous regulatory standards. This is the mission of TEF-Health – a pioneering initiative aimed at validating AI and robotics solutions in healthcare across Europe.
Launched on 1 January 2023, TEF-Health is one of four domain-specific Testing and Experimentation Facilities (TEFs) under the Digital Europe Programme. With approximately €60 million in funding from the European Commission and national partners, TEF-Health brings together 51 partners across nine countries, including leading hospitals, universities, clinical research organisations, and standardisation bodies.
A Critical Infrastructure for AI in Healthcare
TEF-Health exists to bridge the gap between research and clinical application. It offers a suite of physical and virtual environments where AI innovators – especially startups and SMEs – can test, validate, and prepare their medical technologies for market introduction and regulatory approval. This includes AI-driven diagnostic software, decision-support tools, and robotic devices used in surgery, rehabilitation, or nursing care.
Testing will be conducted in real-world healthcare settings, enabling a realistic evaluation of a technology’s functionality, safety, and compliance. TEF-Health also focuses on creating the necessary technical and administrative protocols – such as testing procedures, certification frameworks, and ethical standards – to accelerate regulatory pathways and market readiness.
Supporting Innovation While Upholding Public Trust
Professor Petra Ritter, coordinator of TEF-Health and Head of the Brain Simulation Section at the Berlin Institute of Health (BIH), underscores the initiative’s dual mission: “Our goal is to help technologies reach the market faster, while also building public confidence through robust testing and evaluation.”
Indeed, the facilities will not only offer technical services but also support regulatory, legal, and ethical alignment. This includes developing standardised codes of conduct, certification pathways, and best practices for deploying AI in sensitive healthcare environments.
TEF-Health’s unique ecosystem includes partners such as Karolinska Institutet, the National Metrology Institutes of Germany and France (PTB and LNE), and regulatory authorities like TÜV, ensuring a comprehensive approach to validation, certification, and patient safety.
Advancing Europe’s Digital Health Ambitions
By providing industry access to its testing infrastructure on a fee-based model, TEF-Health is not just a temporary project – it aims to establish a long-term innovation network. These partnerships between academia, industry, and regulatory bodies are designed to sustain momentum well beyond the initial funding period, supporting the full value chain from early-stage development to deployment.
Ultimately, TEF-Health is poised to make a lasting impact. It aligns with the broader goals of Digital Europe: improving the resilience, efficiency, and equity of European healthcare systems, while ensuring that technological innovation adheres to the highest legal, ethical, and quality standards.
