Table 1 Definitions and key facts about the Norwegian system of regulating quality and safety in healthcare

• The regulatory framework sets out three generic criteria for incidents being considered “serious”, and thus require reporting the national reporting system [40,41,42]. These criteria are: (1) The patient dies or is subject to severe harm, (2) which is considered a result from the treatment given (or lack of treatment), (3) and where the outcome is unexpected due to expected risk.

• In addition to the hospitals’ and health professionals’ obligation to report, the public, patients, and informal caregivers have the right to report [43]. Reports are supposed to be registered through the national reporting system and government-based web site called “melde.no”.

• Patient injuries registered for 2022 in Norwegian hospital settings, measured by Global Trigger Tool, were shown to have a slight reduction, with a patient injury occurring in 12,6% of hospital stays in 2022 against 12,8% in 2021 [44].

• In 2021, a total of 4473 cases of serious incidents were registered by the County Governors. 856 out of 2241 cases were assessed, with one or more violations of legislation appointed in 38% of the cases. 225 cases were forwarded to the Norwegian Board of Health Supervision for potential administrative reaction against individual health professionals. 104 planned inspections in the specialized healthcare services were conducted [45].

• Hospital internal risk management and quality improvement efforts should be based on the Quality Improvement Regulation (QIR), a regulatory, national framework for the managerial role and managerial responsibilities in relation to quality and safety enhancing work [46].

• Evidence-based guidelines are developed and implemented at local and/or regional organizational system levels. National-based guidelines are developed by the Norwegian Directorate of Health to support the services in their application of state-of-the-art knowledge and to facilitate consistency of the services offered across the country [47].

• Registries and national quality indicators are administered by the local and regional health trusts and the Norwegian Directorate of Health, and the indicators are expected to be applied by the hospitals in their efforts to improving quality [48].

• Fines and revocation are available regulatory responses being administered and issued by the Norwegian Board of Health Supervision [40]. Fines are targeting the organizational level, while revocations are targeting individual health professionals [40].