The 6th General Assembly since the start of the European TEF-Health project was held in tandem with the Innovating Health Together conference (IHT). TEF-Health 2024 promised no less than to address the “future of health in Europe”. The events convened on October 15 in the beautiful city of Porto, Portugal. Thanks go out to Cristiana Costa and her team from the Institute Pedro Nunes (IPN) for organizing the event. Aiming to facilitate and push the validation and certification of AI and robotics in medical devices, the EU-funded project Testing and Experimentation Facility for Health AI and Robotics (TEF-Health ) gathers interdisciplinary experts from industry, academia, and other players.
This general assembly meeting focused on synchronizing all partners in their efforts to develop physical and virtual testing services, as well as discussing the next steps for defining quality metrics for data and AI models. Fraunhofer IIS is providing essential testing facilities and services for this new digital innovation cluster, including several clinical research services as well as four physical validation services. The first agenda item was a workshop at the University Hospital Center of São João (CHUSJ) that underscored our commitment to the TEF-Health project. We engaged in several fruitful discussions with our partners, clearing up some critical points concerning the physical services planned for small and medium sized enterprises (SMEs) to test their AI and robotics products.
On the second day, we were greeted by several representatives of the meeting venue, the Super Bock Arena. We realized at that point, that we were wholly underdressed for this occasion in comparison to these fine gentlemen.
Nevertheless, the day started with a very constructive meeting on how to proceed with defining quality metrics. These metrics will enable SMEs and other stakeholders to quantitatively evaluate their AI products in terms of generalizability, robustness, trustworthiness, fairness, and explainability. Exciting new publications are on the way, so stay tuned!
We would like to thank our partners in crime in achieving this goal: Patrick Schwabe (Physikalisch-Technische Bundesanstalt), Ilaria Campioni (Istituto Superiore di Sanità), Nikolaos Matskanis (CETIC), Guillaume Bernard (LNE Paris), and Markus Wenzel (Fraunhofer Heinrich Hertz Institute).
After introductory keynote talks from the host institute (IPN) and its Director António Cunha, the talk of Petra Ritter (Charité Berlin) highlighted what TEF-Health is all about: helping SMEs through the regulatory jungle when developing medical devices with AI capabilities. Notably, the invited representatives form Lisbon, Berlin, and Brussels, gave us new insights into the importance and goals of the TEF initiatives from the perspective of the EU commission, as well as the Portuguese and German governments. Another key aspect was provided by Maxime Rossi (HUmani) and Anne-Laure Cadji (Multitel), who gave an inspiring talk on how to effectively communicate the benefits of the TEF-Health project to SMEs: We are here to help and support them get their products on the market.
The third day highlighted the significant progress that has been made since the project started just last year:
- 400 physical and virtual services are available on the TEF-Health website, ready for SMEs to peruse.
- The first call enabled several SMEs to access a selection of 40 Portuguese services for validating their AI and robotics products.
- A first draft for a dynamic certification process for trustworthy AI is underway.
- Serious games were conceptualized to train TEF-Health staff on understanding regulatory hurdles in AI and robotics development for healthcare.
In sum, TEF-Health is a unique and very ambitious project, and there is an immense number of issues to resolve in order to really help SMEs bringing their AI and robotics products to market without being deterred by the EU AI Act. Nevertheless, TEF-Health will be a cornerstone in the EU’s strategy to foster innovation in these fields.
Image copyright: Fraunhofer IIS / Maximilian Oppelt & Tobias Sebastian Zech, TP21 / Boris Nalbach
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