May 19, 2023
NDAs in Clinical Risk Management
As a CSO have you ever suddenly found yourself being asked to sign a Non-Disclosure Agreement (NDA)? It can feel uncomfortable, so what’s it all about? An NDA is a legally binding contract or agreement which establishes the extent to which confidential materials can be shared between the relevant parties. An NDA can be a […]
Read MoreMay 9, 2023
Can a healthcare organisation demand that I CE Mark?
We all know that some health software products need to be certified as a Medical Device in certain circumstances. But can a customer or potential customer demand that a manufacturer applies a CE Mark? Is it appropriate to say, ‘I’m only going to buy your software product if it’s certified as a Medical Device’. The […]
Read MoreMarch 27, 2019
The Safehand three-stage approach to evidencing health software testing
Ever wondered how the work of the DCB 0129/0160 Clinical Safety Officer integrates into an organisation’s testing activities? Our three-stage framework sheds light on an otherwise complex area.
Read MoreDecember 6, 2018
Five things you should do today as a DCB 0129/0160 Clinical Safety Officer
Often the key to efficiency and effectiveness is in forming good habits. So, what are the top five things you can do right now to be a proactive and successful Clinical Safety Officer?
Read MoreOctober 23, 2018
Could you be a Medical Device manufacturer without knowing it?
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 […]
Read MoreJuly 31, 2018
As Low As Reasonably Practicable – What does ALARP really mean in Digital Health compliance?
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 […]
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June 19, 2018
DCB 0129 and the Medical Device Directive – One little gap just got plugged
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 […]
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October 18, 2017
Does your supplier’s Safety Case chime as clear as a bell?
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 […]
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September 19, 2017
Whatever you do in Digital Health, don’t do this
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 […]
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July 24, 2017
Do long-standing Digital Health products require assurance under SCCI 0160?
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 […]
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