60 million for faster market launch of AI and robotics
1/13/2023 Regulation News

60 million for faster market launch of AI and robotics

The EU project TEF-Health, launched in January, aims to evaluate innovative approaches from artificial intelligence (AI) and robotics in the health sector and bring them to market maturity more quickly. The 51 participating project partners from nine European countries are receiving European Union funding of 60 million euros, two million of which will go to the Berlin Institute of Health (BIH) at the Charité.

Circuit board and ai micro processor Symbolic photo

TEF-Health (Testing and Experimentation Facility for Health AI and Robotics), aims to create testing infrastructures in the EU to develop standards, test innovations and certify new products. The new EU-funded project with a total budget of about 60 million euros aims to "facilitate and accelerate the validation and certification of AI and robotics in medical devices", explains project leader Petra Ritter, who coordinates the consortium and heads the "Brain Simulation" working group at BIH.


Taking a close look at technologies

"With TEF-Health, we primarily want to test new AI approaches in realistic environments," says Ritter. This applies to new software used in patient care or diagnostics, for example, as well as to devices that are controlled by the intelligent programmes and partly work directly on humans - surgical or nursing robots, for example. "We will evaluate how market access and acceptance of these intelligent technologies can be facilitated," says Ritter.


The plan is for the project partners to develop new regulatory and ethical requirements, including, for example, standardised test protocols and certifications or a specific code of conduct for use. In addition, the necessary technical and administrative procedures must be developed and created. On board with TEF-Health are therefore not only leading hospitals, universities and clinical research institutions such as the Karolinska Institute, but also notified bodies such as the TÜV or the German Physikalisch-Technische Bundesanstalt and its French counterpart, the "Laboratoire national de métrologie et d'essais", or LNE for short. The newly created evaluation resources and infrastructures will be available to the industry in the form of fee-based services. "A broad application of these extensive testing and evaluation tools will not only accelerate the market access of innovative AI and robotics technologies, but will also ultimately strengthen the confidence of the public in these new developments," explains Ritter.