Avoiding epic fails: Software and standards directions to increase clinical safety

Document Type

Conference Proceeding


SEdith Cowan Universityrity Research Institute, Edith Cowan University


Faculty of Health, Engineering and Science


School of Computer and Security Science / eHealth Research Group




Originally published in the Proceedings of the 3rd Australian eHealth Informatics and Security Conference. Held on the 1-3 December, 2014 at Edith Cowan University, Joondalup Campus, Perth, Western Australia. Available here


The safety issues related to IT and software are gaining more exposure within the Healthcare industry. While software and computing was seen as a panacea to a range of preventable clinical errors, the introduction of healthcare IT has of itself presented patient safety issues. It is the inherently complex nature of healthcare, and its delivery, that creates increasing patient safety concerns in the application of IT and software. This position paper provides a collation of current work in international standards and highlights the drivers for the necessary change required to address patient safety in the use of healthcare IT software and systems. Software development and deployment has already altered and standards to oversee these are only just catching up. The need to revise such standards has been recognised and is underway, however a clash of cultures is delaying the emergence of Standards traditionally developed and governed by Standards Development Organisations (SDOs). The impact of this is that whilst standards are being informed by current software trends, the standards developers themselves are struggling to assimilate the rapid changes in the market. Whilst SDOs are cooperating more closely, there is an increased need for the involvement of the healthcare software development community and e-health informaticians in the standards process to narrow the gap in standards relevance. Such involvement would expand the currently narrow field of experts with the appropriate skills, background, knowledge, and experience in healthcare software risk analysis, security, privacy, and standards development.



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