In the UK and several other countries, including Norway, Australia and New Zealand, operators of safety-critical systems, such as nuclear power plants, public transportation systems and defence equipment, must develop a safety case to demonstrate that their systems are acceptably safe to operate. In these countries, the development, review and maintenance of safety cases are regulatory requirements.
In the NHS in England, manufacturers of health information technology have been required to submit clinical safety cases since 2013. However, this is a domain with a narrow technological focus and limited organisational support.
Mark Sujan and Ibrahim Habli discuss why they think safety cases would be a valuable addition to Safer Clinical Systems and patient safety practice?