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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...
SCCI 0129 and SCCI 0160 hazard log and safety case development
11 November 2015, by , in Blog, No comments
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...
clinical safety training
22 September 2015, by , in Blog, No comments
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...
Clinical Risk Management Training
9 June 2015, by , in Blog, No comments
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...