Introducing safety cases for health IT

Introduction of IT in the health domain can potentially benefit the quality of the delivered healthcare, also contributing to increase safety. However health IT systems themselves can have safety implications and can result in accidents. Creating a safety case has been in practice in numerous domains and is starting to be adopted in the health IT domain with the most notable example, that of the UK National Health Service (NHS), Information Standards Board for Health and Social Care (ISB) standards (formerly DSCN 14/2009 & DSCN 18/2009). Safety cases can be thought of as a defensible, comprehensible and clear argument, supported by evidence that a system is acceptably safe in its operational context. This paper presents the main areas of safety case practice and its implication for the health IT development and stakeholders.