On 13 June 2024, the new Regulation (EU) 2024/1689 on Artificial Intelligence came into force, establishing a harmonised regulatory framework that redefines the requirements for the development, control and implementation of AI-based products in the European Union. This regulation poses important challenges and opportunities for technology companies in the Basque Country’s healthcare sector.
Within the framework of the OSASUN KM0 project, the participating companies are carrying out an exhaustive extraction of the requirements of the regulation, and clear connections are being established between each of these requirements and the functional blocks where they apply. This task includes the definition of the global architecture of the IA framework, a crucial step to create a robust, transparent system aligned with the strict standards set by the regulation. This tool will be applied by the companies in the consortium to adapt their processes and products to the new AI legal framework.
SYSTEMILEC WEALTH, S.L.U. (hereinafter referred to as SABELEC®), dedicated to the development and manufacture of innovative products for the prevention and treatment of wounds through electrostimulation, plays an important role in this project. SABELEC® focuses R&D on electrode equipment to deploy cybersecure monitoring tools for healthcare personnel to control on different devices that self-adaptive electrotherapy recreates the natural endogenous bioelectrical ecosystem correctly. In addition, it is adapting AI data processing to the new Regulation.
On its way to implementing AI in its solutions, SABELEC® works closely with the Tekniker research centre, which plays a key role in the development of HW/SW platforms and secured interfaces for smart electrode-based systems.
At the same time, SABELEC® is collaborating with Digitalentu, experts in advanced digital solutions, to integrate artificial intelligence technologies to further drive innovation in its products. Digitalentu is helping to select the most suitable algorithms for this type of device and has developed a dashboard for automatic monitoring and analysis of data related to electrostimulation treatments. This analysis will facilitate real-time decision-making and improve the effectiveness of treatments, ensuring that they are perfectly tailored to the patient’s needs.
Thus, the collaboration between the companies participating in the OSASUN KM0 project not only contributes to compliance with the requirements of the new regulation, but also positions the companies at the forefront of the development of smart technologies for health. As the project progresses, comprehensive solutions are being created that not only comply with current regulations, but also strengthen the foundations for a healthy future based on AI.
