January 26, 2015
Who’s to blame when things go wrong, the clinician or the ICT?
Health IT systems rarely cause harm in isolation; instead they form just one component of a complex ecosystem in which human operators co-exist and interoperate with technology. It is also naïve to conclude that any non-technical influential factor in contributing to risk exists exclusively in the domain of ‘user error’. Whilst it is the case […]
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January 13, 2015
The role of the Clinical Safety Officer – a poisoned chalice?
We know that Health IT systems can introduce risk into the clinical environment. UK Safety Standards ISB 0129 and 0160 call for suppliers of Health IT systems and their implementing healthcare organisations to undertake Clinical Risk Management activities to manage that risk. In particular the Standards require organisations to nominate a Clinical Safety Officer (CSO), […]
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October 1, 2014
Safety cases in Health IT - What’s all the fuss about?
The industry has come to accept that Health IT (HIT) systems can both mitigate and introduce risk in healthcare delivery. Suppliers and healthcare organisations need to take proactive steps to manage risk in the deployment and maintenance of these systems. Both the FDA and UK’s HSCIC (under ISB 0160 and 0129) require us to formulate […]
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August 4, 2014
“This is a MASSIVE clinical risk!!” – describing defects in health IT
So you’ve identified a problem with your Health IT system and you know that it could contribute to clinical risk. What next? Often the most fruitful activity is to write it down ready for your risk assessment - carefully, unemotionally and objectively. Doing this brings together a clear understanding of the problem at that point […]
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December 10, 2013
What exactly is Clinical Risk?
We often find ourselves trying to explain what we mean by terms like ‘risk’ and ‘clinical risk’. There are many definitions and it’s important for us to remain consistent, especially when we communicate across organisational boundaries. Ask the average person and they’ll probably say that risk is ‘the chance of something bad happening’ – or […]
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November 13, 2013
Project risk log and hazard log – are they the same thing or different?
We cover this topic in our SCCI 0160/0129 Clinical Risk Management Course but here are some thoughts on the subject. Many of us who have worked on large projects are used to the idea of a risk log – arguably an essential component of any well-managed project. However, safety standards such as SCCI 0129 and […]
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October 10, 2013
Five key differences between the Medical Device Directive and SCCI 0129
Are you confused by the different safety standards and regulations which apply to eHealth? Certainly the relationship between the Medical Device Directive (MDD) and eHealth Safety Standards SCCI 0129 and SCCI 0160 can, at times, be complex. The SCCI Standards tell us that only one or the other can apply to a particular product so […]
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October 2, 2013
Five tips for getting started in Clinical Risk Management
NHS England has recently indicated that all eHealth products (with the exception of Medical Devices) need to comply with Safety Standard ISB 0129 and ISB 0160. Suppliers and healthcare organisations are at different stages of maturity in gaining compliance. Proactively managing risk in eHealth technology is the right thing to do – it benefits patients […]
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