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RISK-AI - Responsible Innovation and Social Knowledge in Artificial Intelligence

AI will play an increasingly important role in diagnostics and treatment. If the technology is to benefit patients and staff, it must be used responsibly and transparently, and within a clear framework regarding risk and liability.

Project period

Start: 1 January 2026
End: 31 December 2028

RISK-AI is a Nordic-Baltic research project that brings together researchers, clinicians, technology experts, patient representatives, and decision-makers around a shared goal: to develop a new, practical way to understand and manage risk associated with the use of AI in healthcare.

Aim

The project will link the requirements of the EU’s new AI Act with the healthcare sector’s expectations regarding the responsible and ethical use of AI. It will examine how to be ambitious about new technology while simultaneously taking potential risks seriously—spanning everything from legislation and management to the interaction between patient and clinician.

Together with healthcare professionals and patients, the project will investigate when the risk associated with using AI is perceived as acceptable in a clinical setting and when it is not - as well as the strategies clinicians employ to protect patients and prevent errors.

RISK-AI builds upon an existing model for assessing the value of AI in medical imaging (MAS-AI). The updated model is being tested on two real-world AI solutions within the healthcare sectors of Norway and Latvia. In doing so, the project will examine how accountability, transparency, and patient safety can be integrated from the outset.

The project aims to deliver a range of practical tools, recommendations, educational materials, and outreach resources - targeted at clinicians, managers, patients, authorities, and others working with AI in healthcare -to help the Nordic-Baltic healthcare sectors move from good intentions to concrete practice, ensuring that AI becomes a safe and meaningful tool in patient care.

Read more about the project at RISK-AI.eu.

Partners

  • Norwegian University of Science and Technology, Norway
  • Norwegian Centre for E-health Research, Norway
  • Vestre Viken Health Trust (VV), Norway
  • University of Oulu, Finland
  • University of Latvia, Latvia
  • Odense University Hospital (OUH), including CAI-X and the HTA Unit

The Norwegian University of Science and Technology is leading the project.

CAI-X is responsible for Work Package 5 – Dissemination and Communication. OUH’s HTA unit is responsible for the further development and testing of the MAS-AI framework, incorporating the concept of responsible risk.

Funding

The project is funded by NordForsk.

Lena Lykke Jønch-Clausen

Project Manager

Odense University Hospital, Department of Clinical Development - Innovation, Research & HTA


(+45) 2452 1116
Iben Fasterholdt

Iben Fasterholdt

Senior Researcher, PhD

Odense University Hospital, Dept. of Clinical Development - Innovation, Research & HTA


(+45) 2979 6704
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