Should healthcare providers do safety cases? Lessons from a cross-industry review of safety case practices

Authors : Mark A. Sujan, Ibrahim Habli, Tim P. Kelly, Simone Pozzi, Christopher W. Johnson


Healthcare organisations are often encouraged to learn from other industries in order to develop proactive and rigorous safety management practices. In the UK safety–critical industries safety cases have been used to provide justification that systems are acceptably safe. There has been growing interest in healthcare in the application of safety cases for medical devices and health information technology. However, the introduction of safety cases into general safety management and regulatory practices in healthcare is largely unexplored and unsupported. Should healthcare as an industry be encouraged to adopt safety cases more widely? This paper reviews safety case practices in six UK industries and identifies drivers and developments in the adoption of safety cases. The paper argues that safety cases might best be used in healthcare to provide an exposition of risk rather than as a regulatory tool to demonstrate acceptable levels of safety. Safety cases might support healthcare organisations in establishing proactive safety management practices. However, there has been criticism that safety cases practices have, at times, contributed to poor safety management and standards by prompting a “tick-box” and compliance-driven approach. These criticisms represent challenges for the adoption of safety cases in healthcare, where the level of maturity of safety management systems is arguably still lower than in traditional safety–critical industries. Healthcare stakeholders require access to education and guidance that takes into account the specifics of healthcare as an industry. Further research is required to provide evidence about the effectiveness of safety cases and the costs involved with the approach.


Safety case; Regulation; Certification; Safety management; Healthcare

Citation: Mark A. Sujan, Ibrahim Habli, Tim P. Kelly, Simone Pozzi Should healthcare providers do safety cases? Lessons from a cross-industry review of safety case practices doi:10.1016/j.ssci.2015.12.021

Received: 26 July 2015 Revised: 17 November 2015 Accepted: 14 December 2015 Available online: 2 January 2016

Copyright: @ 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CCBY license (


This work was funded by a research grant from the Health Foundation (Registered Charity Number: 286967). Robin Bloomfield, Nick Chozos, David Embrey, Jamie Henderson, Floor Koornneef and Alberto Pasquini were part of the research team. George Cleland and John Medhurst provided input to reviews on regulatory practices in healthcare and railways. We would like to thank the participants of the stakeholder workshop. We also acknowledge the discussions with members of the Medical Devices Group of EWICS TC7.

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