The project develops methodologies to ensure the safety, effectiveness and compliance of AI applied to healthcare, in line with the new European regulations.
A national project is developing methodologies to ensure the safety, efficacy and compliance of artificial intelligence applied to healthcare, in line with the new European regulations.
AI validation makes its way onto the European regulatory agenda
The MedAIVeritas project has emerged against a backdrop of profound transformation in the digital health sector. Furthermore, it responds to the European Union’s emerging requirements regarding the regulation of artificial intelligence.
The initiative focuses on developing validation processes to ensure that AI systems meet requirements for safety, efficacy and ethical compliance.
It therefore aims to create robust methodologies to assess clinical models before they are used in a real-world setting.
Safety, transparency and ethics at the heart of development
The project is structured around five main methodological areas. These include transparency, cybersecurity, data ethics, robustness and regulatory compliance.
Consequently, the processes developed aim to cover at least 80 per cent of the regulatory requirements applicable to AI systems in healthcare.
In addition, the models will be tested using clinical data and applied to language- and image-based systems.
The aim is clear: to reduce risks associated with the unregulated use of AI, such as cyberattacks, algorithmic bias or data integrity failures.
Digital solutions for hospitals and manufacturers
The project’s results will underpin two new digital solutions. These tools will support manufacturers and hospitals in managing the compliance of AI systems, such as medical devices.
This will make it possible to carry out automated audits and continuously assess the regulatory compliance of the solutions.
The project thus helps to accelerate the safe adoption of artificial intelligence in the healthcare sector.
A multidisciplinary consortium with international ambition
MedAIVeritas brings together a consortium of seven organisations, including companies and institutions from the scientific and technological sector.
This collaboration enables advanced research to be combined with practical application in a clinical context.
According to Mariana de Oliveira, a researcher at Complear and project coordinator, “this initiative aims to develop methods to ensure the compliance of artificial intelligence applications in healthcare”.
She adds that the main contribution lies in “creating metrics and benchmarks to ensure that clinical AI models are safe, robust, transparent and ethical”.
On the role of European funding, he emphasises that “COMPETE 2030 has enabled Complear to set up and lead an extremely competitive consortium, bringing together partners from industry and academia in an unparalleled collaboration”.
Preparing medical AI for the regulatory future
The MedAIVeritas innovation lies at the intersection of technology and regulation. Furthermore, it seeks to anticipate the requirements of the European AI Act and the Medical Devices Regulation.
As such, the project serves as a foundational framework for the future of AI in healthcare.
Ultimately, the aim is to ensure that technological innovation evolves safely, ethically and with confidence for both professionals and the public.
21 July 2026