Potential Shortcomings of the Safety Case

When used to accurately summarise risk, communicate controls and contribute to a safety culture, the safety case is an invaluable tool in assuring a HIT system. However, the value of the safety case can quickly be eroded should it be seen as an administrative exercise or a simple means to an end to satisfy management, a regulator or contractual requirement. All too often the potential hazards associated with a system are only thought about when development of the safety case begins. This 

Health and Social Care Information Centre. ISB0129. Clinical risk management its application in the manufacture of health IT systems version 2. UK Information Standard Board for Health and Social Care. London. 2013. 

International Organization for Standardization. EN ISO 14971 2012. Medical devices. Application of risk management to medical devices. Geneva 2012. 

The Agile Manifesto. [Online]. 2015 [cited Jul 2015. Available from HYPERLINK http // www.agilemanifesto.org/,http //www.agilemanifesto.org/. 

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