Timișoara, 25 February 2026
Artificial intelligence is already changing how diagnoses are made, how medical devices are developed and how health services are organised. But for these technologies to reach patients safely, innovation needs a clear regulatory framework and constant dialogue between those who research, those who develop and those who apply. This was the focus of the regional event “Artificial Intelligence in Health: Academic Leadership, Innovation and Smart Regulation”. It took place on 25 February 2026 at the West University of Timișoara (UVT) and was organised in collaboration with ROHEALTH – The Health and Bioeconomy Cluster.
The event brought together representatives of the academic, medical and business communities for an applied discussion on the role of artificial intelligence in health. At the centre of the discussion was the balance needed between innovation and responsible regulation.
Opening
The programme opened with a welcome address by Prof. Dr. Marilen Gabriel Pirtea, Rector of the West University of Timișoara. The address highlighted the role of universities in developing and validating new technologies.
From compliance to innovation: a workshop on MDR and IVDR
Flaviana Rotaru, President of ROHEALTH, led a workshop on regulations and essential requirements for medical devices. The workshop moved from compliance to innovation. The discussion highlighted the challenges arising from the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). It also examined their impact on the development of AI-based medical technologies.
For MedTech companies, especially SMEs and start-ups, understanding these requirements from the development stage onwards makes the difference between a product that reaches the market and one that stays stuck in certification.
Practical tools: the NoBoCap platform
The session on NoBoCap tools was presented by Luminița Arhip (ALTFACTOR). She introduced the NoBoCap Environment platform and the e-tools developed to help professionals navigate the European regulatory framework.
NoBoCap (Notified Body Increased Capacity) is a project funded under the EU4Health programme. It aims to increase the capacity of notified bodies and to support the European MedTech sector. Its results include digital tools that help classify medical devices and identify applicable codes. The project also offers training programmes for professionals in the field.
The Romanian Artificial Intelligence Hub: concrete applications in medicine
The Romanian Artificial Intelligence Hub (HRIA) was presented by Assoc. Prof. Dr. Cosmin Bonchiș, Prof. Dr. Eva Kaslik and Lect. Dr. Sebastian-Aurelian Ștefănigă. The presentation highlighted the concrete applicability of artificial intelligence in medicine and health.
HRIA is Romania’s largest national project dedicated to research and innovation in artificial intelligence. It is coordinated by the National University of Science and Technology POLITEHNICA Bucharest, in partnership with six universities across the country, including UVT, and with eight innovative SMEs. One of its main research directions is AI in medicine and health. The UVT team gave an overview of the project and the main results obtained in this field.
Funding opportunities
The event closed with a session on funding opportunities, presented by Delia Dorneanu (Frontier Vertex). Participants gained a practical overview of the sources available for developing innovative projects.
An ecosystem built through collaboration
The event in Timișoara showed that developing AI in health is not only about technology. Knowledge of regulations, access to funding and collaboration between universities, clinics and companies matter just as much. Through initiatives like this, ROHEALTH continues its mission of connecting players in the health and bioeconomy ecosystem, so that innovative ideas become real solutions for patients.
We thank the West University of Timișoara for the collaboration, all speakers for their contributions and all participants for their engagement.
