Table 1.

The five core concepts of Safety-II, their consequences for accountability and regulation, and examples

Theme	Safety-II concept for the theme	Consequences for accountability of healthcare providers	Consequences for regulation	Current examples
Definition of safety	‘Safety’ entails that as many things as possible go right	Providers will have to report on improvements in the number of things that go right, and on underlying argument on what is ‘right’	Providers and regulators need to agree on what is ‘right’ and how this relates to ‘Work As Done’	Regulators’ use of the Short Observational Framework for Inspection as method for inspectors to assess the quality of care for people with dementia
Safety management principle	Proactive; continuously trying to anticipate developments and events	Providers should show they have structures and processes in place with which to respond effectively to unforeseen situations	Regulators will use conversations with boards and inspections on site to assess how consistent the boards stories are with experiences on shop floor	Regulation of care for the disabled through format-free Quality Reports that providers publish
The human factor in safety management	Humans are seen as a resource necessary for system flexibility and resilience. Humans provide flexible solutions to many potential problems	Focus on (interdisciplinary) teamwork, accessibility of higher management for healthcare professionals’ experiences and ‘Joy in work’	Regulators should engage in open conversation with healthcare providers on how they empower their employees to fulfil this role adequately	Requirement for ‘peer support’ after serious adverse events
Accident investigation	The purpose of an investigation is to understand how things usually go right as a basis for explaining how things occasionally go wrong	External accountability will also require healthcare providers to look into what went wrong	Regulators could combine Safety-I and Safety-II by judging whether the healthcare provider has looked into why the event occurred and into what could be done to strengthen resilience	Healthcare providers using ‘functional resonance analysis method’ to analyse adverse events
Risk assessment	Focused on understanding the conditions where performance variability can become difficult or impossible to monitor and control	Providers should report on how the organisation monitors and controls performance variability	Regulators can stimulate or mandate systems that monitor performance variability	Regulators assessing whether providers use ‘Quality Registries’