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 apps will only work as part of an interventional programme that recognises the parts also played by materials, competence and meanings (including the significance of information). The actual behaviour change achieved will be determined by ambiance, design, signals & cues, behavioural options . He concluded that there is a need to focus on context of use, and on human interaction; in short, understanding human behaviour IS rocket science.
The was followed by Inderjit Singh, Technology Office, DH Informatics Directorate and Stuart Harrison, Head of Safety Engineering, Clinical Safety /Solution Assurance, HSCIC who described the HealthApps Library accessible through NHS Choices. They explained the processes used to review apps: safety (checked using ISB0129) is the only criterion for inclusion, not efficacy, cost etc. There are now some over 250 apps in the NHS health apps library. As yet no app in the library has CE certification. Currently the library only covers patient-facing apps – in response to a question about clinician-facing apps, they suggested that possibly one or more Royal Colleges would be better placed to manage these.
Rowan Pritchard Jones, Consultant Plastic Surgeon , St Helens and Knowsley NHS Trust and Hon. Clinical Lecturer, University of Liverpool, gave us a brilliant description of the challenges of being the first to secure a CE certification for an app, Mersey Burns. To determine the correct fluid infusion for resuscitation there are 19 calculations involved for major burns victims that most emergency doctors will have to calculate about twice a year (the frequency that most encounter a serious burns victim). The trial they ran showed the app scoring vastly better than manual calculations starting with the Lund & Browder chart, whence the benefit of the app. His biggest challenge in getting CE mark though was providing written instructions with the app, as required by the Medical Devices Directive.
Richard Brady, Dept. of Surgery, Royal Infirmary of Edinburgh was on next describing the seven deadly sins of bad apps with some appropriately humorous graphics. Originally safety concerns from mobiles included nosocomial bacteria infections, fire risk & disturbing fellow patients in the same ward with loud conversations. The first deadly sin he highlighted was inequity of treatment, his second was lack of expertise; his third was plagiarism; his fourth was bias/commercial interest; his fifth was inaccuracy/errors; his sixth deadly sin was a lack of testing & evidence to support the outcome promised and the seventh was lack of security & confidentiality – examples were given of all seven, perhaps the most worrying being a review of opioid converters he co-wrote where he showed a range of conversion factors produced by the different apps tested of 13.
Following this came Elizabeth Edwards, Academic Clinical fellow, Barts & the London School of Medicine & Dentistry, Centre for Primary Care & Public Health, Blizard Institute who talked about the smoking cessation game she had built. She pointed out that most health apps do not contain theoretically consistent behaviour change techniques. The challenge she said for public health to match the reach of Kandy Krush. Apparently 50 year old women are the largest gaming market so it is expressly not just a technique that only appeals to the young. The game she built is a multi disciplinary collaboration including three sources of public engagement.
The last presentation before lunch was by Alex Wyke, Chief Executive of PatientView whose website is myhealthapps. She spoke about the patient perspective on apps and explained how her website ranks apps based on patient feedback; she made the key point that health care systems will be more sustainable with patient involvement. The website highlights the importance of self-care & self-management in addressing unsustainable demand on healthcare. She maintained that patient empowerment is an equally important recent development to mHealth technology. She suggested that apps can help with support, information, awareness, loneliness and doctor-patient relationships. There still remain vast choice, safety and reliabillity issues to overcome though.
The afternoon began with as comprehensive as possible a presentation in half an hour on the EU and US regulatory regime by Julian Hitchcock, Counsel at Lawford Davies Dunoon who explained that he normally took three days to cover all the ground. (An even briefer summary can be found in my introduction to medical apps, that Julian kindly checked over before it was published on Telehealth & Telecare Aware.) One point he made very strongly was the scary new data protection regulation gestating in EU Parliament – if enacted it will have profound effects on all aspects of medical practice, including medical apps. FDA regulations criticized for inclusivity & lack of clarity; problems also evidenced by their reviewing only 100 apps in 10 years.
This was followed by Dr Raj Lal Sharma, Editor-in-Chief of Mindapps, who described his mental health apps directory. Particularly impressive was the video shown of the app review process that featuring the engagement of both professional- & end-users.
Next came Claudia Pagliari, Senior Lecturer in Primary Care, Edinburgh University, who gave an inspiring presentation on evidence gathering to support medical apps claims. She explained that an evidence base is one of the critical factors in deciding if technologies will survive. She identified risks are often overlloked, such as the lulling of a patient into a false sense of security so they do not visit doctor in time for a cure. She also highlighted reputational risk such as the supplier of a rheumatology app that had serious errors. She introduced the concept of “crowd curation” of medical apps as a way forward, as so few apps are evidenced with research, and what there is is not strong evidence.
Prof Jeremy Wyatt, Fellow, Leadership Chair in eHealth Research, Leeds Institute of Health Sciences, gave an excellent presentation on app assessment criteria, culminating in an audience discussion and electronic voting. Evidencing that RCTs needn’t take ages to set up, he said he was able to find 900 triallists for an online RCT trial within five days. His guiding light on the definition of quality is Donabedian’s 1966 landmark paper which highlighted the importance of structure, processes and outcomes .
This editor then presented the findings of his work on improving the perceived efficacy of medical apps, as previously decribed here. A key element of that proposal is expanding the remit of NICE to encompass medical apps so that their cost effectiveness can be directly compared to that of drugs.
The meeting ended with a presentation on myHealthPal by Peter Jackson, who described how the founder Mike Barlow, had been inspired to create the app when diagnosed with Parkinson’s.
There was a vigorous debate among delegates, especially as a scheduled part of Jeremy’s session. The conclusions that this editor drew from this were:
- medical apps have a great potential to improve public health, at low cost;
- equally, there was potential for doing serious harm, which would set the topic back many years, if apps were not properly certified and policed;
- the process for developing and certifying apps remains extremely opaque;
- there is a recognition of the importance of being able to compare the clinical effectiveness of drugs and medical apps.
In this context, this editor working as a Director of DHACA, is seeking to draw together interested parties, immediately to respond to the EC’s Green Paper on medical apps and, on a longer term, to clarify the process of developing and certifying apps, particularly expanding NICE’s remit. Joining DHACA remains free; invitations to participate will only be sent to members.
Presentations were videoed so a selection will be available after the RSM’s new website goes live. Some of the presentation material, most notably Julian Hitchcock’s fact-packed presentation, will also be available to attendees.