Author: Adrian Stavert-Dobson
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18 October 2017, by , in Blog, No comments
As suppliers of Digital Health systems gradually comply with the SCCI 0129 safety standard, healthcare organisations are increasingly finding themselves on the receiving end of Hazards Logs and Safety Cases. But what should they do with them? SCCI 0160 clearly requires healthcare organisations to undertake their own risk assessment but the Standard says remarkably little...
digital health don't do this
19 September 2017, by , in Blog, No comments
Okay…everyone listening? What follows is a sin. There’s a regulatory pit in the digital health industry. And if you fall into it, it’s a crime, morally and legally. Many breaches in digital health regulation can be forgiven. There’s a lot to remember; SCCI 0129, the Medical Device Directive, Security, Privacy, IGTK, GDPR – they all...
24 July 2017, by , in Blog, No comments
Most digital health manufacturers and healthcare organisations now realise that SCCI 0129 and SCCI 0160 are important and here to stay. It’s simply inappropriate (some would say reckless) to implement new health IT systems without conducting the clinical risk assessment which these standards mandate. But what about existing systems – those long-standing and trusted solutions...
25 May 2017, by , in Blog, No comments
For anyone who’s been a parent, the sight of your newborn child is undoubtedly the most beautiful and fascinating thing you will ever set eyes on. But, let’s face it, the harsh reality is that not all of those wrinkly bundles are blessed with equally endearing features. Sometimes we see what we want to see…it’s...
5 December 2016, by , in Blog, No comments
Working with manufacturers of health IT systems, it’s fascinating to watch organisations evolve and mature as they implement the SCCI 0129 safety management processes. I consistently see organisations pass through various stages of safety maturity. Proactive assurance and safe design is the ultimate goal. Yet so many organisations, without help, get lost along the way....
24 June 2016, by , in Blog, No comments
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...
Clinical Safety Officer at work
19 May 2016, by , in Blog, No comments
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...
26 April 2016, by , in Blog, 1 comment
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...
Man using a computer
26 February 2016, by , in Blog, No comments
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...
Dr showing patient information
21 January 2016, by , in Blog, 1 comment
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...