Blog
Home / Blog
6 December 2018, by , in Blog, No comments
Being a DCB 0129 or DCB 0160 Clinical Safety Officer is an absorbing and fulfilling role. But, at times, it can be a demanding job. For many, being a CSO isn’t a full-time role and clinicians often find themselves obliged to balance Clinical Safety duties with the stresses and strains of the day job. Often...
23 October 2018, by , in Blog, No comments
Did you know that it’s surprisingly easy to be the manufacturer of a Medical Device without even knowing it? Yes, it’s true. Why does this matter? Well, in law it’s the manufacturer’s responsibility to CE Mark a product as a Medical Device. And if you haven’t, you might have some difficult questions to answer. So...
31 July 2018, by , in Blog, No comments
The DCB 0129/0160 Standards call for risk to be mitigated to As Low As Reasonably Practicable (ALARP). But what on earth does this mean in the real world? It turns out that the concept of ALARP, like the DCB 0129/0160 Standards themselves, is as British as fish and chips and the humble Yorkshire pudding. Historically...
19 June 2018, by , in Blog, No comments
The regulatory landscape is changing, and a little gap was just plugged. Blink and you probably missed it. Just last year we posted a blog article about the sin of CE Marking a digital health product as a Class I Medical Device without actually doing any of the underlying assurance work. Well, it turns out...
18 October 2017, by , in Blog, No comments
As suppliers of Digital Health systems gradually comply with the DCB 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? DCB 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...