Design-based regulation and patient safety: A regulatory studies perspective

Abstract

The optimal choice of regulatory approach for securing patient safety is an important problem. In this review article, we show how insights from the field of regulatory studies can provide a conceptual apparatus for analysis of important problems in the regulation of medicine and healthcare. Design-based regulation operates through technical constraints that are self-executing. Technology, by concretising rules about proper behaviour and conduct, not only functions as a regulatory instrument, but may also encode particular values and versions of rationality. As debates in the broader area of “code” or “design”-based regulation, including the crime prevention context have highlighted, design-based approaches may have significant social, political and ethical implications. Though design-based regulation can be an attractive solution where there is widespread agreement about what constitutes good medical practice, it is considerably more problematic where there is contestation about what constitutes an error and who owns the definition of an error. Design-based regulation involves challenges to professional agency and authority, and engages with wider debates about the regulation of the medical profession. It is vital that the introduction of patient safety technology is sensitive to the values and motives that get encoded in design.

Introduction

The study of regulation and governance has emerged in recent years as a distinct interdisciplinary field that brings together legal scholars, philosophers, criminologists, political scientists, economists, sociologists and other social scientists (Braithwaite, Coglianese, & Levi-Faur, 2007). The field has already produced challenging insights that have been influential in areas as diverse as criminal justice, the environment, and finance. With some exceptions, and notwithstanding something of an empirical turn on medico-legal research, its penetration into health been more limited to date. In this review article, we seek to show how ideas and insights from the field of regulatory studies help to draw into focus and provide a conceptual apparatus for thinking about important problems in the regulation of medicine and healthcare. To illustrate our analysis, we identify technology as a regulatory modality, and offer a critique, from a regulatory perspective, of action-forcing technology as a means of securing patient safety.

In offering such an analysis, it is useful to note that the field of regulatory studies is home to a number of distinct sub-fields. One of these is defined by its concern with finding the most effective and efficient regulatory instrument or technique for achieving a defined aim (for example, preventing fraud). Other branches engage in forms of more normative analysis, and are interested in the values and principles that should inform the scope and form of legitimate regulatory design and decision-making. This kind of analysis is often directed towards broader concerns of legitimacy (for example, whether it is – morally and otherwise – acceptable for employers to access employees’ email traffic to deter fraud). This second approach aims to highlight the importance of institutional, political and ideological constraints that might or should influence the choice of regulatory instrument beyond considerations of effectiveness. It forces attention not only on the instrumental functions of regulatory instruments (i.e. what they are intended to achieve) but also on the criteria for regulatory legitimacy that should inform the use of particular instruments and on to the expressive functions of such instruments (i.e. the ways in which they “make statements” or convey meanings). We take up these latter themes, as well as others, in the discussion that follows. We will point to intriguing points of convergence and analytic similarities between ideas from regulatory studies and from other fields, including science and technology studies, but suggest that a regulatory perspective offers many opportunities for refreshing, renewing and revitalising long-standing problematics in the sociology of the health professions and the social sciences applied to health more generally.

One of the insights of regulatory studies, particularly through the work of the influential legal scholar Lawrence Lessig (1999), has been the recognition that regulation (understood as the purposive control of social and economic activity) does not occur solely through “traditional” instruments such as legal rules. Thus, technology, also described as “architecture”; “code” or “design” (Yeung, 2008), may also operate as a regulatory modality, to the extent that Lessig proposes that “code is law” because of its impact on controlling behaviour. Though technology has a long history as a regulatory modality (e.g. use of castle moats to deter illegal intrusions), its recent ascendancy has raised questions about whether design-based forms of regulatory intervention conform to the standards of participation, accountability and transparency expected of more traditional forms of regulation, and about the kinds of values or virtues that technology expresses or symbolises (Brownsword, 2005, Lessig, 1999).

Design-based regulation can take several forms, but “action-forcing” technology is the particular focus of this paper. This is distinguished from other forms of regulation in several ways, including how rules are encoded and how they are enforced. In most regulatory modalities, sanctions (such as incarceration, fines, or peer disapproval) regulate behaviour ex post; they discourage but do not prevent. Design-based regulation, by contrast, works ex ante: it uses technical constraints to stop, or significantly inhibit, action at the moment it is attempted (Yeung, 2008). Action-forcing design thus seeks, for most practical purposes, to exclude non-compliance. A simple example is the encrypted document, which encodes the rule “no unauthorised access” and enforces it at the same time. The encryption represents the difference between approaches that rely on setting rules and asking people to obey them (“do not open this document unless you have permission”), and approaches that seek to exclude non-compliance. Within STS, the idea that technological artefacts may have agentic effects is well-established, as is the idea that “things” have politics (De Laet and Mol, 2000, Winner, 1980). For scholars within regulatory studies, the prospect of the Rule of Law being displaced by the Rule of Technology is unsettling (Brownsword, 2005), not least because of the dawning recognition that technology can have profound regulatory effects, but lack the safeguards typically built into democratic systems of rule-making and enforcement.

Examination of design-based regulation within the field of healthcare is timely. First, regulation of healthcare and health professionals is now undergoing significant reform in several countries, and there is a need to avoid confining discussion to traditional forms. Second, an increasing emphasis on design and technology has been a remarkable feature of healthcare, especially (though not exclusively) in the patient safety movement, but has been largely considered narrowly in terms of effectiveness rather than more broadly as a regulatory strategy. Third, as technology becomes increasingly powerful, the concerns that have been raised about design-based regulation in areas such as crime prevention alert us to some potentially troubling parallels with healthcare.

Two contrasting examples – wrong route drug administration and re-use of single use devices – will be used to animate our discussion, but we begin by offering an account of how technology has been legitimated as a regulatory modality in controlling the work of professionals in healthcare. To keep the discussion focused, we concentrate primarily on doctors, but much of our analysis will apply more broadly.