What follows is a brief summary of the presentations given at the Royal Society of Medicine’s third “Appday”, held on 9th April 2015. All three events have been sell-outs.
Anne Hayes, Head of Market Development at BSI, opened the event with an excellent presentation on the then shortly-to-be-finalised PAS 277 on mHealth apps (now available, free, here). She particularly welcomed the opportunity to present to clinicians, as too often her audience was primarily technologists. The presentation was especially impressive because Anne had only agreed to do the presentation the previous Friday, following realisation by both MHRA & NICE that proximity to the election meant neither could present. Anne explained that PAS 277, as a Publicly Available Specification, is not mandatory – it is essentially a checklist for developers and purchasers of medical apps to consider.
As Prof Susan Michie put it concisely in tweet at the time, the problem in a nutshell with approval is that there is very little information on the content of most medical apps, and almost no evaluation to date.
Ian Hay, Head of Emerging Ecosystems, Orange plc, talked about the challenges of managing Type I diabetes on the GSMA bike ride between Brussels and Barcelona. The event proved the concept of using mHealth, and continuous reading glucometers, to improve the lives of those who otherwise would need to stop what they we doing to take very regular blood glucose readings. Particularly interesting was that some GSMA riders downloaded other apps onto smartphones which disrupted the blood glucose continuous management system (aka artificial pancreas). (This explains the reason why for example Samsung introduced Knox, as a security improvement Android on phones to prevent interference with vital apps.)
Richard Brady, Specialty Registrar General Surgery, Edinburgh Royal Infirmary, updating his previous year’s excellent presentation on “bad apps” observed that only 40% of the 40k “healthcare” apps on iTunes have been shown to be genuine health apps. The first of the deadly sins of app developers he described this year was inequity, the second was lack of expertise employed/quoted, and the third was plagiarism. The fourth was bias or other commercial interests, the fifth was lack of accuracy, & errors, the sixth was lack of security & confidentiality, and finally the seventh was lack of evidence & testing to support the claims of the app. He
Prof Susan Michie, Director of Centre for Behaviour Change, University College London, gave a presentation on using apps to change behaviour. She commented that there is a serious lack of information on what is in most apps and how they work to enable people to decide whether they are effective. As she said, “Unless you know what is in an app, you cannot determine how effective it is likely to be at changing behaviour”. To change behaviour you need Capability, Opportunity & Motivation – the COM-B system. She has identified 93 different behaviour change techniques appropriate to use; above all these though. User engagement itself is the major challenge. She ended with a fascinating story of how she and her team developed the StopAdvisor smoking cessation app using best principles and tested using a 22-month-long RCT.
Alex Wyke, CEO of Patient-View, the publisher of myhealthapps.net stressed that self-care results in lower healthcare costs evidencing quoting a recent Tower Hamlets case study. The principal reason people state as to why they don’t use medical apps is the sheer volume and lack of means to choose most appropriate; the second reason given is that they are unsure of the efficacy of medical apps, and only the third is a preference for face:face consultations with their GP. She went on to say that myhealthapps.net sees three categories of health app: health & wellbeing, disability & accessibility, and clinical apps.
As someone who always seems to have more to say that strict observance of his timeslot will permit, Julian Hitchcock, Counsel, Lawford Davies Denoon, happily increased his customarily excellent legal talk on medical apps to make up for the absence of the MHRA presentation. His focus was on medical and IVD legislation, explaining that software itself can be a medical device if it is used for diagnosis & treatment: he explained how Meddev 2.1/6 gives good guidance on whether software is a medical device – it contains a powerful decision tree. Another important observation he made was that a change of software version may require a new CE certification.
Big changes are afoot with the coming EU regulations both on medical devices & on data management, including the move from directive to regulation (which harmonises interpretation in all Member States). As the new EU regulations proposed for medical devices treat accessories as medical devices in their own right, this will greatly widen the reach of these regulations beyond the scope of the current legislation, as will an expected extension to include indirect effects (currently it is just direct effects).
Pēteris Zilgalvis, Head of Unit for Health and Well-being, European Commission, presented on issues arising from the EU mHealth Green Paper consultation exercise undertaken by the EC in 2014. He explained that the first priority that had emerged from this was the production of a self-regulatory code of conduct on security & privacy (now underway with this editor, representing DHACA members, on the drafting committee)
Dr Tom Lewis, University of Warwick Medical School talked about assessment of medical apps. He described medical app risks from loss of reputation through to both reversible and ultimately irreversible clinical error. He produced a risk matrix with a y axis of chance of harm and an x axis of level of complexity, to enable the classification of the level of analysis required. He raised four future assessment issues: education, user needs, support, and implementation. He disagreed with too much regulation of apps – he suggested that developer self-regulation would prevent bad apps and encourage user choice.
Frans Luijendijk, Founder, Diabelle presented on the diabetic challenges of the GSMA bike ride: if an app’s too difficult to use, patients won’t comply; automation greatly helps compliance, as does adding a bit of fun (eg gamification).
talked about the benefits the online access to mental health apps can provide. She mentioned statistics that 95% of users of Big White Wall feel better, saving £37,000 the NHS per 100 users. On the darker side she said that people with serious mental illnesses die 15-20 years earlier than those who don’t. She stressed the importance of collaboration between clinical/governance/academic/NHS commissioners would be the key to ensuring widespread use of medical apps
Prof Ray Meddis gave the final presentation, on the process of developing an app – in this case as a hearing aid called Bioaid. He introduced the idea of letting users do their own hearing test – this proved too radical for the hearing aid manufacturer for whom his team were working, so the team ported the concept to the iPhone, where it is currently offered as a free app. As a result, it challenges hearing aid manufacturers who charge thousands of pounds for their wares, & audiologists whose tests, he suggested, added little value to hearing aid selection. They are now transferring the technology on to a chip to provide a far cheaper hearing aid that people can self-adjust to their needs, without needing to visit an audiologist: massive disruption in action!
For those with Android phones, like this editor, it is perhaps just worth explaining that the latency is currently too great to make a Bioaid app work successfully – however when the Bioaid device is on the market, we can all look forward to good hearing at low cost.
In due course videos for most, if not all, of the above talks will be available on the RSM video site. Watch this space.