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Table 1 Conceptual Clarifications

From: Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study

The relationship of Quality, Safety and Resilience
• Different paradigms exist when it comes to resilience. This paper relies on a resilience engineering tradition that has been applied in healthcare [13].
• There is not always a clear distinction between the concepts of quality and safety in healthcare.
• According to the Institute of Medicine, and the Norwegian adoption of the conceptualization of quality, quality consists of six dimensions: clinical effectiveness, patient safety, patient centeredness, care coordination, efficiency, timeliness, and equity [14, 15, 16, 17].
• Some definitions view safety as an “attribute of quality”, and successful healthcare outcomes as results from quality efforts [18]. According to Sheps & Cardiff [18] this view misses that tradeoffs, complexity and variability are important elements in healthcare.
In this paper, we argue that there are different quality dimensions with safety as one dimension. Resilience is about creating and obtaining high quality services (Safety-II). We thus apply a wider definition compared to traditional literature focusing on risk and safety (Safety-I). Our perspective is in line with the ongoing Resilience in Healthcare Research Program (2018–2023) [12].
• We define resilience as “the capacity to adapt to challenges and changes at different system levels, to maintain high quality care” [12].
Resilient Performance
• According to Hollnagel [19], any organization that manages to respond to, monitor, learn from and anticipate both expected and unexpected events would in a strict sense have potential for resilient performance. Performance, however, is complicated to study and to measure theoretically because it depends on context and local circumstances.
In this paper, the potential for resilient performance is explored as the potential to adapt regulatory requirements into daily work practices.
• Legal and regulatory matters are primarily developed, applied and disputed within national borders. This makes legal terminology and regulatory activities multifaceted and not easy to interconnect on an international scale.
This paper defines the phenomenon of regulation generally and specifically:
1. as a general governmental mechanism/instrument (including inspection; supervision).
2. as one specific Norwegian regulatory framework; regime referred to in this paper as the Quality Improvement Regulation with a capital “R” in “regulation”.
In this paper a regulatory system of Internal Control is defined as enforced self-regulation characterized by the organization’s individual responsibility to apply systematic measures to ensure that all organizational activities are planned, organized, carried out and maintained in accordance with governmental requirements- and health legislation [20].
• We define performance-based regulation as a regulatory instrument that requires certain outcomes (achieved or avoided) without specifying any solutions [9].