Soapbox: Why an app isn’t like a book

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…)

Playing games, using apps, promoting wellbeing – RSM event summary (UK)

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…)

Driving up medical app usage in the UK – part II

Introduction

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…)