Redesigning safety regulation in the NHS

Healthcare relies on a variety of regulatory activities to manage risks to the public and drive improvement. However, the regulation of patient safety in healthcare, and in the NHS in particular, is ‘bewildering in its complexity and prone to both overlaps of remit and gaps between different agencies’ (1). Regulatory activities touch every single aspect of care delivery and place considerable demands on professionals and organisations alike, in the form of Inspections, certification, accreditation, revalidation, and compliance reporting, and other activities. In this paper we argue that the safety regulatory system, as seen from the perspective of provider organisations, is much larger and more complex than usually supposed. Whileindividual regulators may achieve valuable impact, the regulatory system as a whole is unnecessarily burdensome, produces multiple unintended consequences and, most importantly, fragments and dilutes regulatory impact. We discuss the nature of theseproblems and set out a series of practical proposals for addressing these seemingly intractable but critical challenges