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Although it is widely acknowledged that health care delivery systems are complex adaptive systems, there are gaps in understanding the application of systems engineering approaches to systems analysis and redesign in the health care domain. Commonly employed methods, such as statistical analysis of risk factors and outcomes, are simply not adequate to robustly characterize all system requirements and facilitate reliable design of complex care delivery systems. This is especially apparent in institutional-level systems, such as patient safety programs that must mitigate the risk of infections and other complications that can occur in virtually any setting providing direct and indirect patient care. The case example presented here illustrates the application of various system engineering methods to identify requirements and intervention candidates for a critical patient safety problem known as failure to rescue. Detailed descriptions of the analysis methods and their application are presented along with specific analysis artifacts related to the failure to rescue case study. Given the prevalence of complex systems in health care, this practical and effective approach provides an important example of how systems engineering methods can effectively address the shortcomings in current health care analysis and design, where complex systems are increasingly prevalent.

This chapter seeks to understand the emergence of new institutions of business regulation, standard-setting and governance commonly referred to as multistakeholder initiatives (MSIs), and to consider their implications both from the perspective of regulatory effectiveness and sustainable development.

The analysis synthesizes the findings of a review of 20 such initiatives. It draws on a wide body of literatures and conceptual insights to understand the emergence of these new approaches to international business regulation. The assessment of their emergence, performance, and impacts highlights the complex dynamics of regulatory change.

The findings caution against simple generalizations about the positive or negative outcomes of these new forms of collaborative governance. Their somewhat mixed record can be partly explained by the diverse set of interests, preferences, and agendas of the actors involved; variations in institutional learning, capacities, and power relations; as well as how such initiatives are nested in broader institutions and structures. This points to the need, raised in the conclusion, for intellectual pluralism in advancing knowledge of the effectiveness of new regulatory institutions.

The analysis aims to go beyond studies that (i) tend to focus on just one or a few cases; (ii) that ignore the implications of such initiatives for development in the Global South; and (iii) draw on narrow bodies of theory and literature to understand complex issues.

As a standard procedure of human factors engineering, the design of complex systems (e.g., operator interfaces) starts with analyses of system objectives, missions, functions, and tasks. Perceptual Control Theory (PCT) provides a theoretical framework for guiding this process. PCT is founded on notions from control theory, in which closed-loop, negative-gain, feedback systems can be used to build powerful models of goal-directed behavior and for implementing complex systems (Powers, 1973). One of the strengths of PCT over competing human behavior theories is that it explains how humans can control systems that are subject to a wide variety of external influences. UAV control is through the operators’ interaction with the interfaces in remote control stations. A closed-loop feedback system is crucial for both operators and control systems to understand the states and goals of each other. It is likely that advanced UAV control systems will require operators to interact with automated systems such as IAIs. IAIs are sophisticated and will require knowledge about mission goals, the operators’ goals, and states, as well as the UAV and environmental states. Thus, the methods of analysis used in this research were based on PCT given its engineering origins in control theory and advantages accommodating various external disturbances.