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

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.