Abstract
The paper describes the current regulatory situation in England with respect to medical devices and healthcare providers. Trusts already produce evidence to the Healthcare Commission that they operate in accordance with standards set out by the Department of Health and the NHS. The paper illustrates how the adoption of an explicit goal-based argument could facilitate the identification and assessment of secondary implications of proposed changes. The NHS is undergoing major changes in accordance with its 10-year modernisation plan. These changes cannot be confined to the Trust level, but will have NHS-wide implications. The paper explores the possibility of an organisational safety case, which could be a useful tool in the management of such fundamental changes.
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Sujan, M.A., Harrison, M.D., Steven, A., Pearson, P.H., Vernon, S.J. (2006). Demonstration of Safety in Healthcare Organisations. In: Górski, J. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2006. Lecture Notes in Computer Science, vol 4166. Springer, Berlin, Heidelberg. https://doi.org/10.1007/11875567_17
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DOI: https://doi.org/10.1007/11875567_17
Publisher Name: Springer, Berlin, Heidelberg
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