Intended for healthcare professionals


Redesigning safety regulation in the NHS

BMJ 2020; 368 doi: (Published 16 March 2020) Cite this as: BMJ 2020;368:m760
  1. Charles Vincent, professor of psychology1,
  2. Eirini Oikonomou, research fellow1,
  3. Jane Carthey, human factors and patient safety specialist2,
  4. Carl Macrae, professor of organisational behaviour and psychology3
  1. 1Department of Experimental Psychology, 49 Walton Street, New Radcliffe House, University of Oxford, Oxford OX2 6AE, UK
  2. 2Jane Carthey Consulting, London, UK
  3. 3Nottingham University Business School, Jubilee Campus, Wollaton Road, Nottingham NG8 1BB, University of Nottingham, UK
  1. Correspondence to: C Vincent charles.vincent{at}

Charles Vincent and colleagues argue that patients will be better protected by a well designed, simpler, integrated regulatory system

Healthcare relies on a variety of regulatory activities to manage risks to the public and to drive improvement. But 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.

We argue that the safety regulatory system, as seen from the perspective of provider organisations, is much larger and more complex than usually supposed. Individual regulators might achieve valuable impact, but the system as a whole is unnecessarily burdensome, produces multiple unintended consequences, and, most importantly, fragments and dilutes regulatory impact. We discuss the nature of these problems and set out a series of practical proposals for tackling these critical challenges.

What is regulation?

Regulation can be defined as the “processes that aim to shape, motivate, monitor, and modify the practices and technologies within organisations so as to achieve some desired state of affairs.”2 Regulatory activities take many forms, not all of them formal or backed by coercive or legal force.3 The work of regulating patient safety reaches from the “ivory towers” of policy making and standard setting to the “adobe huts” of local participation and frontline decision making.4

Regulation is achieved in multiple ways and by many different organisations. Statutory regulators, such as the Care Quality Commission and the General Medical Council, conduct inspections, monitor standards, and carry out a range of other activities. Many other organisations exert a regulatory effect on NHS organisations in the sense of inspecting, monitoring, influencing …

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