SCCI 0129 and SCCI 0160 set out the requirements for managing clinical risk in health IT systems in England. Unfortunately, the array of different documents often causes confusion. There are several documents, several versions of those documents, periodic renaming and different places on the web they are stored. Let me try to put that confusion to...
This week I’ve been developing a hazard log for an innovative health IT product. Constructing a hazard log from scratch can be a daunting experience and many see it as a labour-intensive tick-box exercise. But done properly, the activity really makes you examine the product – often you are the first person to look at...
With the Clinical Software Usability Survey (cSUS) reaching a key milestone recently, my thoughts have turned to the overlap between usability and safety in health IT. When I run seminars on SCCI 0129 and SCCI 0160 compliance I often pose delegates the question, “Can usability issues in health IT systems impact patient safety?”. The dilemma often...
When health information systems exhibit faults the clinical impact ranges from inconvenient to dangerous, in some cases clinical safety can be compromised. But users are remarkably resourceful and when clinicians are reliant on systems to safely deliver care they are motivated to get the information they need. Complex applications often have more than one way of...
Many of us have done it. You’re with a patient and you launch that handy little app which you’ve just downloaded to your smartphone. It might perform a useful calculation, crunch through an algorithm or generate some essential clinical advice. During a busy day’s work, clinical apps can save us time, paper and brainpower. But...
Manufacturers of Medical Devices expend a great deal of effort and money in assuring their products, after all they are usually required to do so by law. In eHealth the story is quite different. Health IT products such as Electronic Health Records don’t usually meet the criteria for being Medical Devices despite being capable of...
When I run SCCI 0160 courses in clinical risk management in Health IT I like to ask attendees lots of questions. I often feel that I learn as much as they do at these sessions. One question in particular nearly always gets a predictable answer; how do you manage risk in your health IT systems...
When we picture the hazards which Health IT could introduce, some risks to patient safety immediately come to mind; corrupt data, the wrong patient, missing data, system unavailable, etc. But hidden within the depths of Electronic Medical Records (EMRs) and other Health IT solutions lays a more mysterious hazard, one which can be hard to characterise...
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...
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),...