Foreword 

The national coordination project Better Use of Artificial Intelligence (AI) was carried out from 2019 to 2023 as part of the National Health and Hospital Plan 2019–2023. During this work, a need was identified for clearer frameworks on how to ensure the quality of AI systems to support their safe and effective use in the health and care sector. 

As a result, the subproject Frameworks for Quality Assurance was initiated in August 2023, following an initiating phase conducted in close dialogue with the health sector, including workshops held in spring 2023. The subproject is now part of the Joint AI Plan for the Health and Care Services 2024–2025. This report presents the work completed to date. Further communication, updates, and development of guidance materials will be carried out in line with the priorities of the Joint AI Plan. 

The following health agencies have contributed to the work: The Norwegian Directorate of Health / Directorate for e-Health, The Norwegian Medicines Agency / The Norwegian Medical Products Agency, The Norwegian Institute of Public Health, and The Norwegian Board of Health Supervision, joined later by The Directorate for Radiation Protection and Nuclear Safety. Representatives from The South-Eastern Norway Regional Health Authority (South-Eastern Norway Regional Health Authority) and Sykehuspartner Hospital Trust have also participated. The work has been led by The Norwegian Directorate of Health. 

A user panel was established, consisting of potential external users of the guidance materials, and in addition, experts in the field. The panel included representatives from Haukeland University Hospital, Akershus University Hospital, Vestre Viken Hospital Trust, Bærum Hospital, LIVV Health, the Centre for Patient-Centered Artificial Intelligence (Senter for pasientnær kunstig intelligens) at the University Hospital of Northern Norway, DNV, Norwegian Computing Center, Sykehusinnkjøp, the National Centre for E-health Research, Stavanger Municipality, Drammen Municipality, Trondheim Municipality, Bergen Municipality, and the Norwegian Association of Local and Regional Authorities (KS – kommunesektorens organisasjon). 

The expert network Artificial Intelligence in the Norwegian Health Services (KIN) has provided continuous and valuable contributions through professional input and discussion. 

Oslo, 18th December 2024

Last update: 23. mai 2025