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…)
As intimated in our review of last year’s predictions, we feel little need to change course significantly, however some are now done & dusted, whereas others have a way to go. The latter include a concern about doctors, especially those in hospitals, continuing to use high-risk uncertified apps where the chance of injury or death of a patient is high if there is an error in them. Uncertified dosage calculators are considered particularly concerning.
Of necessity this is an area where clinicians are unwilling to be quoted, and meetings impose Chatham House rules. Suffice to say therefore that the point has now been well taken, and the MHRA are well aware of general concerns. Our first prediction therefore is that:
One or more Royal College/College will advise or instruct its members only to use CE-certified or otherwise risk-assessed medical apps.
The challenge here of course is that a restriction to CE-certified apps-only would be a disaster as many, if not most, apps used by clinicians do not meet the definition of a Medical Device and so could not justifiably be CE-certified. And apps are now a major source of efficiencies in hospitals – (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…)
DHACA, the Digital Health and Care Alliance, formed earlier this year and already past the 250 members level, is holding its second DHACA-day on 7th October, at Anfield Stadium (yes free tours will be available during the day for those interested).
DHACA, currently part of the TSB-funded dallas programme, was established to grow the use of digital technology in the delivery of health & social care through promoting interoperability and scale. DHACA will be the space where members collaborate on requirements and on solution development, resulting in things being done once, and shared. to achieve this, DHACA is developing a range of member-driven Special Interest Groups (SIGs) that will (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…)
This event was held on April 28th-30th in Victoria in London. It was organised by Pharma IQ and clearly had a strong pharma focus (including the charge which at £1995 for industry attendees clearly discriminated in favour of those with big-pharma sized budgets). It was also held just a few days after the significantly lower-priced Royal Society of Medicine event, and in the middle of a London Tube strike, all of which doubtless contributed to the relatively modest attendance (26 paid). I am most grateful to the organisers for kindly inviting me as one of speaker Alex Wyke’s guests.
As mentioned in an earlier post, there was a similarity with the RSM agenda, so I won’t repeat comments made by the same speaker before. The first up was the 3G Doctor, David Doherty, who gave another of his excellent presentations, although the sound engineer sadly made some of it inaudible. After a review of how we had got to where we are, he suggested that the Internet is about to become a device-dominated network. He drew a parallel between (more…)
This is a brief summary of the main points made at an event on medical apps held at the Royal Society of Medicine on 10th April 2014.
First up was Prof Mike Kelly, Director of the Centre of Public Health at NICE who spoke about how apps could change behaviour. He described what he called “system 1”, the rational reflective system that he associated with Apollo, and “system” 2 the impulsive automatic system that he associated with Dionysus. System 1 is most often targeted by behaviour change, however most people find thinking hard so spend most of their time in system 2 mode, so it is much more effective to “nudge” the automatic system 2, if you can.
Humans are relational creatures, not billiard balls, so (more…)
This series of posts covers some work I have been doing over the past three months: attempting to answer the question of how best to improve the perception by clinicians and patients of the efficacy of health-related apps. This work has been done for the i-Focus project, part of the Technology Strategy Board’s dallas programme.
Part I attempted to summarise the EU regulations covering health-related apps. The point was made that any health-related app must comply with data protection and consumer protection requirements, irrespective of whether the risk level is sufficient for it to be classified as a ‘medical device’. Where an app is classified as a ‘medical device’ it also has to be classified so that the appropriate adjudication work can be determined for it to receive a CE mark (Class I, lowest risk, requires least investigation; Class III, highest risk, requires greatest investigation).
This post summarises the principal findings from discussions with a very wide range of potential stakeholders, (more…)