The Royal College of Physicians has just published app guidance that, according to EHI “doctors should only use medical apps with an official CE mark”. EHI goes on to clarify that the guidance “applies to medical apps that can be classed as medical devices, which are bound by EU law to carry the mark.”
The Digital Health & Care Alliance (DHACA), of which this reviewer is Managing Director, is extremely concerned that this advice may seriously impact on the beneficial use of medical apps in the UK as it places the onus of deciding whether an app is a medical device on individual clinicians, a decision that at times even experienced MHRA personnel can equivocate on.
As the original research done by this editor on the topic of medical app take-up demonstrated, clinicians (more…)
The suggestion has been made recently at a couple of events that this editor attended that there is an unnecessary fuss over regulation of medical apps because they are just like medical books; as there is no regulation of books, why the need to regulate medical apps? . In order to try to move to a consensus, this post puts the opposite point of view, to stimulate debate. In summary the arguments of why they are different are:
- We are familiar with books and have worked out how to deal with them;
- Books give formulae and leave users to compute; apps do it all, often without showing their working;
- Tablets and, especially, smartphones have screens that are smaller than books so require a different design.
This issue of course only relates to serious medical apps – something like 99.5% of all health apps available are very unlikely to do serious harm, helping people as they do record things like their fitness and their weight, and so do not require such detailed scrutiny. It is the ones that get close to, or meet, the test of being a medical device that are of particular interest here. The goal is that once clinicians are comfortable prescribing medical apps, and patients are comfortable using them, the NHS will save substantial sums by, for example replacing drugs with apps for a range of diseases where both are effective and apps are far cheaper. There are also huge benefits for clinician-facing apps – properly certified medical apps like Mersey Burns and Mersey Micro are already massively improving patient outcomes and significantly reducing NHS costs.
In more detail, books have been with us for many centuries so we are familiar with their structure, with the processes for their removal from publication if they give dangerous advice, and with the idea of specialist publications accessible by appropriate experts only – the same is not true of apps. In the event that advice in a book was dangerously wrong, (more…)
AAL/Bucharest, The Guardian and Kings Fund
As previously highlighted on Telehealth & Telecare Aware, last week was indeed the week of connected health events. This editor made it to three:
As very much of a supporting act – presenting to researchers on how to do business with the different health organisations across Europe – my principal challenge was getting to the city after the ‘information’ kiosk in the airport told me the hotel I was booked into didn’t exist. Thankfully they were wrong. What I saw of the conference looked good, though there were some bizarre rules on who could have free WiFi.
Wednesday evening brought the Guardian information sharing event which proved especially interesting. (more…)