Benefits of the Safety Case

Safety cases are gradually being adopted in the HIT domain especially in the UK in order to comply with safety standards ISB 0129/0160 [7]. Outside the UK the term safety case is not widely used [8] but nevertheless reports which achieve the same purpose are becoming increasingly prevalent and may take other names such as a Safety Analysis Report. The safety case and its development has a number of benefits to manufacturers, healthcare organisations and ultimately to patients. These can be broadly categorised as [9]  

A typical HIT project might involve hundreds of different individuals each with their own responsibilities and areas of interest. Frequently the controls required to mitigate the clinical risk will need to be implemented by many different stakeholders often across organisational boundaries. Ensuring that each control is examined can be a complex task and the development of the safety case allows there to be a single point of truth for what needs to be done and by whom. 

There are at least of a couple of other subtle benefits of the safety case. For manufacturers, products which are delivered along with a well thought-out safety case create a perception of quality, attention to detail and responsibility. The value which this adds to a product is very real and can generate a competitive edge over products from alternative suppliers. Manufacturers are quite justified in marketing the fact that a product has been subject to a safety assessment particularly where there is a statutory or regulatory requirement to comply with a standard. 

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