Oxford AHSN Map My App Event 29th Jan 2014

Editor's Notes

• #3: We all know that mobile computing has really taken off in the last few year and has developed beyond recognition since those early days The demand for and use of smartphone and tablet or mini tablet devices impacts on many aspects of our every day lives as consumers.
• #4: We now use software in a manner that influences our lives, our decision making and in some cases controls our healthThis is taken from a 2008 article describing a conference where hackers managed to demonstrate with ease how they could potentially control an implanted pacemaker device via the on board software.We are becoming increasingly dependent as a society on some of these technology innovations but may be playing catchup on some of the implications of use.
• #5: So who are some of the healthcare users or digital omnivores in this current landscape. This is a selection of some of the many stats that are out there.Not surprisingly younger generations have embraced the technology but uptake continues to increase across several clinical professions and some of the data is shown here. In the case of EU doctors the % smartphone usage doubled in 2 years from 2010.Another trend that is gaining momentum is the increased use of tablets or mini tablets in healthcare.
• #6: So we are here this evening to talk about mobile apps and a roadmap.Let’s quickly look at some health app stats
• #7: So the uptake and use of apps is continuing at pace. Expectations are high. As a dedicated NHS IP and Innovation management service we are inundated with app ideas which probably account for about 35% of our disclosures.This feels like it has all of the signs of the early days of the gold rush but in reality it is more like the lawless wild west. It’s not just me saying this, the academic literature is filled with articles from clinical groups and professional bodies expressing concern regarding the use of apps, quality and clinical safety. The wanted poster shows a picture of the uChek urine analysis app. Users use the phone camera. Take a picture which then is analysed by the app and out pops the analysis on the app to influence clinical treatment. This high profile app (for all of the wrong reasons) fell fowl of the FDA regulator in the US as it was deemed to be medical device and was unvalidatedand no FDA approval was sought. apple has started taking a stronger line on health apps registration in their apps store to the extent that there is evidence suggesting that certain type of health apps will only be accepted if they have been suitably validated and the clinical or pharmaceutical data has been provided from a reliable source.So times are changing!
• #8: This brings us on to the roadmap. The health and efficiency rewards associated with the technology can be substantial. So we hope that that roadmap is a means by which people are encouraged and explore their app ideas but that they go into the venture with their eyes open and know where they can get further assistance
• #9: We have current broken the roadmap down into 6 distinct stages. Those of you familiar with software development may feel that stage 3 users testing is actually part of the stage 2 development phase, you are not necessarily wrong but we have separated out for a reason which I will come back to later.
• #11: Key stage to build a solid foundation and also to stress test whether you should proceed with the app development and whether you have stakeholder buy-inNeeds Assessment: Where are you at the moment, what are your goals? Gap analysis. Do you really need to develop the app?Competitive analysis: what else is out there? Is it validated? Does it meet your needs? Followed by a go no go decisionStakeholder analysis - Who are the stakeholders (individuals or organisations) that need to be involved in the app design and development or kept informed? Who will the app impact on? Is there a hardware or platform preference? Will the target audience pay for the app, want a free app, or expect it to be bundled into an existing service? Does the profile of the target audience lend itself to a particular commercialisation approach?Development – Do you plan to outsource the development or develop in-house?Business justification case – proportionate to the nature and complexity of the app. A number of factors to consider.In a brief and clear statement can you articulate what the mobile app is, what need it is addressing and what it means in terms of value to the organisation or to the patient / consumer? E.g. For patients with advanced rheumatoid arthritis the iDocstar is a mobile app used by clinicians to radically simplify the complex process of patient assessment for biologic therapies, guide patients onto appropriate treatments, and save the organisation £xxx,000 per annum.Patient / organisational benefit – eg supports CG50 or specific NHS or PH outcomes framework
• #13: We have added a very simple interpretation of a design and development process here. In reality it will often involve iterative loops and most software developers will use their own rapid and usually agile methodology to develop the app in a cost effective manner.User Requirements Specification or User Requirements Document (URD): This document specifies what the app really needs to do for the customer or end user and what the developer will provide. Use Cases are often used to walk through the user steps or interactions with the proposed app. The Systems Requirements Specification seeks to identify understand and plan for the organisation and user impact of the proposed app and the manner in which it will integrate with other systems and the business environment. Data stored on device? A survey by HP suggests that more than 86% of apps tested from the app store showed a variety of security vulnerabilities. ICO document, “Privacy in mobile apps: guidance for apps developers” sets out clear guidance to assist compliance with the Data Protection Act 1998 (DPA) and ensure users’ privacy. South England NHS Trust – exampleWireframes are rudimentary visual schematics that represent the framework or layout of an app to accomplish a particular purpose or objective. Unlike wireframes screenshots will give the first indication of what the user interface or app screens could look like.
• #14: Added this to emphasis the need to think about the choice of platform and its implications for app design. Again in many instances the developer will walk you through this.There are different pros and cons associated with the range of platforms currently on the market. Taking android as an example.Samsung 40% share of android market but in theory developing for the android platform? Over 400 different devices currently on the market unlike Microsoft and Apple which have a much smaller ecosystem.
• #15: Another area that is being debated at the moment and there is a view that android is more suseptable to this. The market may be runnign different versions of the operation system. In terms of Android there are a number of devicess running earlier versions of the OS prior to Kitkat. This may be important as you think about what you are developing and the way the app needs to interact with the device.I am not against android – far from it. One could argue that the lower price of hardward (cf apple) and wider range may make the platform accessible to your target market, but you need to ne aware of some of these factors specific to the platform or ecosystem.
• #17: STAGE 3 is another critical stage in the roadmap and deliberately separated outRobust user testing is critical not just in terms of functionality but how users react, behave or respond to the app.Remember the user retention stats from earlier 22% never user the app more than once!Word of mouth, family and friend referralPersonalisation of apps is a one of the current topics of conversation as as way of maximising the app impact and user experience.Data from this can also contribute to the technical file for a medical device CE registration.
• #18: I’ve put this up just to reinforce that the healthcare community is still getting to grips with the way in which apps are being used. This is an article from the 2014 Postgraduate medical journal describing the way in which junior doctors use their smartphones in clinical practice and theoverall usability – so the community is really starting to ask pertinent questions about the way in which mobile devices and apps should be used in day to day practice.
• #20: The completed app needs to be subjected to a thorough review by relevant stakeholders within (and possibly outside) the organisation. The extent of the review(s) will be dependent on the functionality of the medical app and its intended use.Different types of healthcare apps will require a different approach to manage risk in both the development and use of the app. There are a number of technology standards such as IEC 62304 is a harmonised standard for software design in medical products adopted by the European Union and the United States. The Health and Social Care Information Centre website describes the current clinical risk safety standards. Current legislation requires all NHS organisations and their staff developing mobile applications must manage app development in accordance with relevant information standards.ISB 0129 Clinical Risk Management: its Application in the Manufacture of Health IT SystemsISB 0160 Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
• #22: Current guidance allows NHS organisations to be exempt from the Medicines Device Directive and CE marking if the software is being used internally or strictly for research purposes (See MHRA Bulletin 18, February 2011).
• #23: What if I want to distribute the app elsewhere and perhaps for free?Customer or Developer: who is responsible for compliance with the MDD?Manufacturer means " the person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party". Class I - generally regarded as low riskFor example a standalone clinical decision support app interpreting clinical data, which will influence clinical intervention or interaction with the patient. E.g. Mersey Burns App.Class IIa - generally regarded as medium riskFor example the Withings Blood Pressure App - direct physiological measurements using smartphone enabled blood pressure cuff or short term indwelling urinary catheterEssential requirements stipulate that the principles of safety should be integral to the design of the product and that the product should be suitable for its intended purpose. Manufacturers must provide objective evidence of how the design of the device meets the essential requirements via a technical file. CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives.
• #26: Withings
• #27: Yes this is a fast moving technology field and it may look a bit scaryThere are a number of credible app developers out there that can guide users around many aspects of the app development and maybe even marketing. However if truth be told this really needs to be done in partnership. Most of the developers will dependent on your to help with clinical input and testing, assistance with clinical safety standards. Also unlike a medical device manufacturer, the medical device directive may also be a new task to grasp for many of the software developers.Don’t be put if this sounds too challenging. Use the roadmap and seek assistance.