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...

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...

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...

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...

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...

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...