The Journal of mHealth - Vol 2 Issue 4 (August 2015)

WHAT’S INSIDE

NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

The

Journal of mHealth The Global Voice of mHealth

August 2015 | Volume 2 Issue 4

Making Sense of the Data Also inside: Gaming for Health Data Driven Proactive Healthcare INTERVIEW Transforming Patient Data into Actionable Insights

INSIGHT Designing mHealth Apps: Five Areas Not to Miss

RESEARCH mHealth in Developing Countries

mHealth Interventions Wheel

Assessment Set up any form of information capture

Clinician

Patient Data

Providing required level of support & integration to healthcare providers

Capture data directly from medical & healthcare devices

Caregiver

Alerts

Helping carers to support & monitor relatives

Intelligent monitoring for patients, carers & HCPs

Treatment Management

Careplan Patient’s summarized view of their key data & progress

Helping manage treatments, clinical visits, tests & vaccinations

Content

Goals Management

The right information & educational content delivered in the right way & time

Setting and managing pre-defined & personalized goals

Reward Acknowledging patient progress & achievement

Exco InTouch’s health solutions are patient centric self-care models that allow patients, carers and healthcare professionals to interact, support and be involved in patient care remotely.

The system is built on a modular platform of functionality that can be combined with individual workflows, rules and content to create a highly specialized therapeutic product.

These functions, part of a larger library, are built as generic modules that can be configured and adapted to deliver specific programs, as well as being presented with a look and feel that reflects patient and customer needs. These programs and platforms are built on the background of systems that have supported hundreds of thousands of patients in clinical trials.

Editor's Comments

Welcome I often get asked whether collecting more and more health data is of genuine use or simply creating so much ‘noise’ that it becomes a distraction? I think that the answer to this is that it can be both.

Simply amassing vast volumes of data on patients, conditions, payer information, treatments, etc. that is then stored in databases provides little or no real benefit to a health system and is unlikely, in the long term, to change the way in which health services are provided.

Conversely, when used in a logical, analytical and integrated fashion then large volumes of data actually have the potential to significantly transform the way in which modern health services are provided. Bringing together multiple data sources and allowing that data to be shared, analysed and truly understood so that actionable insights may be derived, makes the process of data-driven healthcare a valuable proposition!

Appropriate analysis of data can deliver key insights exactly when they are needed, and in ways that fit within care pathways and working practices. It can also drive changes in behaviour, by suggesting changes based upon historical trends as well as real-time fluctuations in collected data. Properly integrated into workflows data begins to promote changes in culture that ultimately lead to improved outcomes and efficiencies.

Technology on its own though is only part of the equation. There is considerable talk about right patient, right treatment, and right time and by failing to integrate and present insights in ways that are intuitive and easily applied to existing workflows, treatment plans, patient care pathways and operational activities often means that the real potential benefits are not fully realised.

Mobilising data has revolutionised many industries and we are now really beginning to see this in healthcare. True, it is not without its challenges and problems.

But, we can already see many different projects, products and services that are placing the right data in the hands of the healthcare professionals, patients, and those users that really need particular information, at exactly the right time to make it useful and actionable.

In this issue we include articles that discuss the data question from a variety of perspectives. We consider: practicalities of data management and data analysis, design, user experience, and challenges. Above all we present exemplar cases of where, and how, health and medical data is being used in truly innovative and meaningful ways. And, how the impact of mobile technology is allowing that data to be shared and utilised across organisations and by users throughout the healthcare ecosystem.

Also as a quick mention, we have been really pleased to see how rapidly The Journal of mHealth audience and network has grown, and in response to this we are excited to be announcing a number of new services, that will become available over the next couple of months. Designed to improve your reading experience as well as give you access to leading knowledge, expert advice and tools – these services aim to ensure that you remain at the cutting edge of the mobile, digital and connected health industry.

Published by Simedics Limited www.simedics.org Editor: Matthew Driver Design: Jennifer Edwards For editorial, research and paper submissions, and advertising opportunities please contact: Matthew Driver matthew@simedics.org +44 (0) 1756 709605 Subscribe at www.thejournalofmhealth.com The editor welcomes contributions for The Journal of mHealth. Submissions can be sent to the editor by email, images and graphics should be submitted in high resolution format.

The opinions expressed in this publication are not necessarily shared by the editors nor publishers. Although the highest level of care has been taken to ensure accuracy the publishers do not accept any liability for omissions or errors or claims made by contributors or advertisers, neither do we accept liability for damage or loss of unsolicited contributions. The publishers exercise the right to alter and edit any material supplied. This publication is protected by copyright and may not be reproduced in part or in full without specific written permission of the publishers.

ISSN 2055-270X © 2015 Simedics Limited

Matthew Driver Editor

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Table of Contents

Making Sense of the Data

In This Issue 24

Designing mHealth Apps: Five Areas Not to Miss In another addition to our expert network of mobile and digital health leaders we include an article written by Scott Hague (Development Director and Owner of London based Digital Healthcare Agency Integrated Change) discussing essential aspects of UX design that all mHealth developers should consider.

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Transforming Patient Data into Actionable Insights In this interview we speak to Derek Gordon, General Manager of the Health Information Technology Group at Healthline, about how to harness the potential of structured and unstructured data to improve outcomes, reduce costs and turn patient data into actionable insights.

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Walking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications We continue our series of expert articles on the digital health regulatory landscape, with a discussion by Bradley Merrill-Thompson, of law firm Epstein, Becker & Green, that considers U.S. medical device regulation and the degree to which technology companies can promote their products for medical use without becoming regulated.

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Table of Contents

Industry News 8

FDA Approves iOS-based Spinal Cord Stimulation Trial System

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mHealth Market to Grow at an Impressive CAGR 33.5% between 2015-2020

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Chimaera Device Paves Way for Wireless Pain Relief

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App Design Could Save Lives with Early Pneumonia Detection

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PCHA, HIMSS and Games for Health Announce Strategic Partnership

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Novartis Pharmaceuticals Launches Smart Watch App for the Visually Impaired

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Vida Health and AstraZeneca Launch New App for Post-heart Attack Recovery

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Human Organs-on-Chips Wins Design of the Year 2015

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Pioneering Health App Launches Tool to Help Achieve Digital Healthcare Vision for Self-care

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Partnership to Study a Patient Tablet App for Enhanced Recovery After Surgery (ERAS)

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Digital Health: Making Sense of the Data

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Fuelling a New Generation of Health Insights

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Learning from Digital Health Data

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Data Driven Proactive Healthcare

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Data Protection: How Technology is Revolutionising Healthcare

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Professional Qualifications in Wireless & Digital Health

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Real-Time Clinical Information Platform Driving Improved Outcomes

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Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers and Pressure Sores

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mHealth in Developing Countries: A Model for the Improvement of Global Health and for Reverse Innovation in the U.S.

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Gaming for Health

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Upcoming Events

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Advertisers Index

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MIT Turns Hacking Medicine Program into an Institute to Study Digital Health

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Your Smartphone Knows If You’re Depressed

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The Global Voice of mHealth

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Digital Health: Making Sense of the Data

Digital Health: Making Sense of the Data

By Dr Alexander Graham Dr Alex Graham is a medical doctor by background, having trained in London before entering the business world. He is currently a founding partner at AbedGraham, a research and strategy consultancy which assists global IT corporates to navigate the clinical, organisational and commercial complexities of the UK’s National Health Service (NHS). He is also medical director of EMEA for Imprivata.

One of the better analogies I have come across regarding healthcare data is the one with the faulty car engine. How can we know so little about ourselves, when even our car dashboard tells us immediately when something even small goes wrong, such as a flat tyre or a broken light? How often do otherwise healthy people take their blood pressure or check their blood sugar? I must admit I have no idea what mine is, and I used to tell people how to manage their conditions!

We are approaching an inflection point in data gathering for healthcare. The advent of sensors, internal and external, electronic health records and patient portals means that the sheer number of discrete data points will only rise exponentially. One of my favourite statistics is that the world is producing as much data every two days as it was in the whole of time up to the year 2003, which is truly staggering. Of course, healthcare always lags behind most other industries but the avalanche of numbers, diagnoses, treatments, interactions and histories is coming and we are not prepared for it at all as things stand currently.

Think about how much data is produced from a single patient even now. Primary care records, hospital admissions and treatments, community care, day-on-day and year-on-year. And what do we do with all that data? For the most part, hold it in user and institution specific silos without any attempt to glean real benefit from it.

I remember in A&E, the sheer number of patients who came from primary care, the community or even just walk-ins that you couldn’t find so much as an allergy status about. Not only are we not realising the benefits of data, we are causing harm both clinically and financially.

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So data is the key then to a successful healthcare system? No, data on its own is almost entirely useless. The mere collection of numbers, statistics and records serves almost no purpose if there is not a concerted course of action to turn that into tangible knowledge. Take a patient’s allergy status, for example. Having the data as a stand-alone point on the EHR or a drug chart is fine, but it only becomes real knowledge when the prescription is made (or rather hopefully not made) for that particular drug. Or when we look at cohorts of patients and see whether heart failure as a side effect is higher or lower than the status quo. Or how symptoms quantitatively respond to the latest medication. That is the real challenge here, making sense of the data so that patients and healthcare professionals can actively change the way they look at their health. Here are a couple of things I think are important in data in healthcare.

Structured and Unstructured Data The issue with most data is that it is not in nice neat columns in the same software packages and the same for every single patient. Most is concealed in the sprawling mass of handwritten notes and siloed departments. Data analytics as much as possible requires the collection of structured data that is easier to work with on a mass scale. The advent of single-provider EHRs or even the use of integration engines in the best of breed (multiple disparate providers doing different packages) model mean that a push towards standardisation can be made, although this must be considered as a viable entity in the design and adoption of these upcoming tech-

nologies. Even if data is unstructured in nature however, such as patient scans or handwritten notes, the advent of technologies such as machine learning and natural language processing mean that we can start to generate actionable insights.

Incentivisation The main question however, is not can the technology handle it (even with its limited use in healthcare, I trust advanced technology to do what it says on the label almost completely) but how do we handle the human element of data and knowledge? How do we get all the individual stakeholders in the system to jump on the bandwagon? Because the first question I have for any revolutionary analytics tool or the like, is how are you going to benefit everyone in the system? How will you convince the patient to wear their sensor? How can you make sure you don’t add to the workload of a community nurse? How can you make sure (cynical I know, but let’s not pretend this doesn’t matter), that a hospital doesn’t lose revenue or incur greater costs? Those are the real questions around what is ‘actionable’ data, because if you have the greatest collection and analytics machine in the world without incentivised individuals, then data will never become knowledge.

I have no doubt that analytics platforms running on a constant stream of digital data underneath will help to change the way we practice medicine but until we refine the catchment and transformation into knowledge and understand how to fit data into workers’ working patterns, we will continue to lose out on the possible benefits. n

Fuelling a New Generation of Health Insights

Fuelling a New Generation of Health Insights

Aimed at advancing the quality and effectiveness of personal healthcare, the Watson Health Cloud from IBM, established earlier this year, provides a secure and open platform for physicians, researchers, insurers and companies focused on health and wellness solutions.

The future of health is all about the individual. With the increasing prevalence of personal fitness trackers, connected medical devices, implantables and other sensors that collect real-time information, the average person is likely to generate more than one million gigabytes of health-related data in their lifetime (the equivalent of more than 300 million books).

However, it is difficult to connect these dynamic and constantly growing pools of information with more traditional sources such as doctor-created medical records, clinical research and individual genomes – data sets that are fragmented and not easily shared. A highly scalable and secure global information platform is essential to pull out personalised insights to help people and providers make timely, evidence-based decisions about individual health-related issues.

“All this data can be overwhelming for providers and patients alike, but it also presents an unprecedented opportunity to transform the ways in which we manage our health,” said John E. Kelly III, IBM senior vice president, solutions portfolio and research. “We need better ways to tap into and analyse all of this information in real-time to benefit patients and to improve wellness globally.”

IBM Watson Health is creating a more complete and personalised picture of health, powered by cognitive computing.

Empowering individuals to understand more about their health,

while doctors, researchers, and insurers can make better, faster, and more cost-effective decisions.

Watson Health Cloud Builds on Core Strengths Building on strengths in cognitive computing, analytics, security and cloud, the new Watson Health Unit aims to dramatically improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily.

The Watson Health Cloud platform allows this information to be anonymised, shared and combined with a dynamic and constantly-growing aggregated view of clinical, research and social health data. It is hoped that the vast ecosystem of IBM clients, partners and medical researchers will surface new connections between these diverse and previously siloed healthcare data sets, and spur the creation of a new generation of data-driven applications and solutions designed to advance health and wellness.

Individual patients and larger health populations alike will benefit as providers share and apply those insights in real-time to drive better, faster and less expensive treatments.

The medical community is one of the earliest adopters of Watson cognitive computing technology, where IBM has collaborated with leading hospitals and research institutes including Memorial Sloan Kettering Cancer Center, University of Texas MD Anderson Cancer Center, the Cleveland Clinic, the Mayo Clinic and the New York Genome Center to advance Watson’s healthcare capabilities and to help transform how medicine is taught, researched and practiced.

Continued on page 6

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Fuelling a New Generation of Health Insights IBM's most sophisticated data analytics capabilities.

Continued from page 5

Innovative partners including Welltok, Modernizing Medicine, Pathway Genomics and GenieMD are already u s i n g Watson’s cognitive computing capabilities, giving rise to a whole new breed of health apps that are redefining how individuals and organisations think about personal health management. Cognitive computing systems learn and interact naturally with people to extend what either humans or machine could do on their own. They help human experts make better decisions by penetrating the complexity of Big Data.

“Watson Health builds on years of collaborative relationships with leaders across the healthcare ecosystem,” said Michael Rhodin, senior vice president, IBM Watson. “The ground breaking applications of Watson’s cognitive computing capabilities by medical clients and partners clearly demonstrate the potential to fundamentally change the quality, efficiency and effectiveness of healthcare delivery worldwide. We’re excited to broaden access to world-class technology and to work with our partners to transform health and wellness for millions of people.”

Capturing Real-time Data to Optimise Personalised Decision-making IBM is collaborating with Apple, Johnson & Johnson and Medtronic to create new health-based offerings that leverage information collected from personal health, medical and fitness devices. The results will be better insights, real-time feedback and recommendations to improve everything from personal health and wellness to acute and chronic care. These relationships are non-exclusive, and IBM anticipates many more companies to leverage the Watson Health Cloud platform.

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IBM and Apple will expand their partnership with IBM Watson Health Cloud to provide a secure cloud platform and analytics for Apple's HealthKit and ResearchKit. This will support health data entered by customers in iOS apps and also arm medical researchers with a secure, open data storage solution with access to

August 2015

Johnson & Johnson will collaborate with IBM to create intelligent coaching systems centred on preoperative and postoperative patient c a r e , including joint replacement and spinal surgery.

Solutions will be mobile-based, accessing the Watson Health Cloud and leveraging IBM Watson’s cognitive capabilities. Johnson & Johnson will also look to launch new health apps targeting chronic conditions, which currently cost consumers as much as 80 per cent of the $7 trillion global healthcare spend.

Medtronic will leverage the Watson Health Cloud insights platform to collaborate with IBM around delivery of new highly-personalised care management solutions for people with diabetes. The solutions will receive and analyse patient information and data from various Medtronic devices including insulin pumps and continuous glucose monitors, and use this information to provide dynamic, personalised diabetes management strategies to patients and their providers. n

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Journal of mHealth The Global Voice of mHealth

Learning from Digital Health Data

Learning from Digital Health Data

By Keith Nurcombe Keith Nurcombe has worked in healthcare for over twenty years spending the last few years working with businesses in the health and technology space, most recently building O2 Health where he was Managing Director until the end of 2012, since then he has been providing consultancy services to businesses.

These days we are collecting levels of health data that eclipse what we have collected in the past. Traditionally, we collected large amounts of patient specific data including conditions, basic personal information as well as centrally controlled data points such as LTC management and public health data.

More recently as technology has leapt forward, especially in the wearable’s market, the amount of data that we and our health practitioners can collect has expanded exponentially.

We now have data that gives us information about conditions we may have, such as blood pressure and our sugar levels as a diabetic. To that we have added information about how much exercise we are doing, how well we are sleeping, what we are eating and even these days where we are and what we are doing.

The connotations of this are almost endless but it does start to produce some really interesting debates about what we can record and what we can really learn from the data.

As more and more services become digital and start to engage patients in their healthcare, for me, the debate is now around what we start to uncover about populations and

their health that we currently don’t know.

So let’s look at some of what we might be able to tell from this data; information that we could have used in the past had we collected it.

As an example, let’s start to understand what impact the diabetic patient’s diet has on their condition. We know about their diabetes. The patient knows what they should be eating. But perhaps now we can use technology to help the patient make choices and then record those choices, so that we can see the difference it makes in their condition.

Previously, this would have meant a healthcare professional sitting the patient down, hearing what they have done and commenting on what they might do next. Now we have access to datasets that show what the patient ate, where they ate it and when they ate - simply from a smart phone.

Seems easy! But the data becomes really powerful if both the patient and healthcare professional have access to it. It allows the conversation to become discussion based, factual and meaningful for both parties.

We know that GPs here in the UK are over-worked and dealing with increasing demand from patients, which they are

struggling to meet. In the past we might have known how many people called their surgery but that was the extent of the data in terms of unmet need along with large numbers of patients going straight to other services like Accident and Emergency.

Imagine now a digital front end that the patient engages with for booking appointments, video consultations with healthcare professionals, accessing self-care. Now at each step of that, we can know what data the patient consumed, how many patients have accessed the service, when, at what time and on what day. This allows the GP surgery to deliver the right services at the right time, for them and for the patient, in a format that suits both.

What is also key here is that patients want to be able to access their healthcare services digitally like they do their banking or their online shopping not at the choosing of the healthcare professional.

For me, we need to move past some of the patient identifiable information and personal health record issues and really see what the simple data that we can collect can do for the patient, the healthcare professional and also for the system and ultimately the payer.

Let’s keep a perspective on what we really want to achieve! n

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INDUSTRY NEWS News and Information for Digital Health Professionals

FDA Approves iOS-based Spinal Cord Stimulation Trial System the treatment will work for them with no invasive surgery.

“By providing a more patientfriendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they’re receiving from spinal cord stimulation.”

St. Jude medical has announced that its new wireless spinal cord stimulation trial system has been approved by the FDA. The system, which received a CE Mark in June 2015, is a fully wireless system designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.

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The device allows patients to test out spinal cord stimulation treatment before having a permanent device implanted in their back. This helps determine if

August 2015

For many patients, SCS therapy can be an effective option for managing chronic pain. The therapy relies on a small implanted device and thin wires (known as leads) to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibres to the brain, which reduces the sensation of pain. Prior to receiving a permanently implanted SCS device, patients undergo a minimally invasive “trial” period to evaluate the therapy. Yet for some patients, complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to SCS therapy.

With the Invisible Trial System, St. Jude Medical has removed these barriers, allowing patients to more effectively eval-

uate their SCS therapy. The system relies on Bluetooth® wireless technology to provide patients a safe, secure and entirely wireless SCS trial experience. Rather than a complex controller, the St. Jude Medical Invisible Trial System provides patients with a more intuitive iPod touch digital device as a controller, while physicians will utilise an iPad mini digital device to program and evaluate their patient’s therapy.

“Patients undergoing SCS trials consistently tell us about challenges they find in navigating the SCS trial system, from programming the device, to discomfort from the programming cables, to management of both issues. These hindrances may impede the integration of the technology into their daily activities, which shifts their focus away from evaluating the effectiveness of SCS therapy,” said pain specialist Dr. Jason E. Pope, president of Summit Pain Alliance in Santa Rosa, Calif. “By providing a discreet trial system, St. Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems.”

One of the key system features of the St. Jude Medical Invisible Trial System is the use of a small external pulse generator (EPG) as the system’s power source. Because the EPG uses Bluetooth wireless technology to communicate between the patient’s iPod touch controller and the stimulation system, the over-

Industry News all device profile has been reduced so the system can be worn discreetly under a patient’s clothing. The effect is that the system feels essentially “invisible” to the wearer, providing a more comfortable trial experience that allows patients to focus entirely on their system’s therapeutic impact during their trial.

“When we developed the new Invisible Trial System, we took into account physician and patient feedback that current

trial systems were in some cases preventing patients from adequately assessing their therapy,” said Eric S. Fain, M.D., group president of St. Jude Medical.

“By providing a more patient-friendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they’re receiving from spinal cord stimulation.”

The iPod touch controller offers patients

a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient’s physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth wireless technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus increasing the patient’s comfort. n

mHealth Market to Grow at an Impressive CAGR 33.5% between 2015-2020 A new report by Allied Market Research, titled, “Global mHealth Market (Device, Service, Application, Stakeholders and Geography) - Size, Industry Analysis, Trends, Opportunities, Growth and Forecast, 2014-2020”, has valued the global mHealth market at $10.5 billion in 2014 and forecasts it to grow at a CAGR of 33.5% during 2015-2020.

Other key findings from the report suggest that blood pressure monitors hold the largest share in the global mHealth device market, followed by blood glucose monitors and cardiac monitors. Geographically, it was observed that the North American region retained a leading position in the overall mHealth market throughout the analysis period.

The report also highlights the current state of the market identifying the opportunities and risks for development.

Advanced mobile and wireless technologies are recognised for their role in transforming the face of healthcare services across the globe and driving growth in the mHealth market. Moreover, the continued growth in coverage of mobile cellular networks, rapid advances in mobile technologies & applications, increasing lifestyle diseases and growing awareness among patient population in emerging economies, are some of the key factors fostering global market expansion.

On the contrary the market faces certain difficulties. Device accuracy, technology infancy in middle and lower income economies, weak reimbursement coverage, uncertainty in government regulations in certain regions, and low adoption among ageing population is hampering the market growth to a certain extent.

It is observed that a major proportion of the mHealth devices market (~71%) is collectively commanded by BP monitors, blood glucose monitors and cardiac monitors. The reasoning behind this market share is attributed to the increased affordability of mobile compatible devices, integration of innovative

technologies in monitoring devices and the increase of lifestyle disease such as diabetes, stroke, and COPD. Within the market for mHealth services, diagnostic, monitoring and treatment services collectively account for about 74% of the market.

The report identifies North America and Europe as the two largest markets for mHealth. Collectively they account for 67% of the market revenue in 2014. It also suggests that they are expected to remain as the leading global markets throughout the forecast period.

Early adoption of innovative technology, large patient population and high capacity to pay for services are some of the key factors responsible for the growth of mHealth market in these regions.

However, the market outlook across developing economies appears favourable owing to the increasing awareness of chronic diseases, supportive government regulations and increased healthcare expenditure.

Key findings from the study: »» Blood glucose meters are projected to be the fastest growing segment in global mHealth devices market registering a CAGR of 41% during the forecast period »» United States continues to be the leading market in the North America mHealth market throughout the forecast period »» Asia-Pacific is projected to be the fastest growing mHealth market registering a CAGR of 35.9% during 2015-2020 »» United Kingdom, France and Germany collectively accounts for a 45% share in the Europe mHealth device market in 2014 »» Cardiovascular and diabetes mHelath application market remains the lucrative market segment for manufacturers For more information about the report, visit the website at https://www.alliedmarketresearch.com/mhealth-2015-market n

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Industry News

Chimaera Device Paves Way for Wireless Pain Relief A prototype surgical tool that combines preoperative CT data with state-of-the-art sensing technology could put the ability to carry out complex operations in the hands of many more doctors, according to its developers.

The hand-held device, called Chimaera, could revolutionise the delivery of miniaturised neurostimulators to specific nerves, and give many more patients access to pioneering new pain management technology.

Different regions of the brain are known to be linked to areas of perception, such as pain. Neurostimulation involves applying electric impulses to nerves to alter brain activity in a specific area.

"Pain is simply a series of electrical signals as transmitted through the nervous system, whether that's pain from a broken leg or pain from a headache. So by putting an electrical signal directly into target nerves, you're able to lessen, override or deliver particular signals which influences how your brain is experiencing things," explained Simon Karger from technology developers Cambridge Consultants.

The main challenge with neurostimulation procedures is safely accessing the correct nerve - which might be deep in the face or behind an eye-socket - and implanting the device without complications for the patient.

Chimaera is designed to make implanting neuromodulators to nerves much easier by integrating surgical, sensing and implant delivery functions in one intelligent device. It uses preoperative CT (computerised tomography) scan data to create a 3D X-ray image of the patient, enabling surgeons to identify critical structures, such as nerves and blood vessels. This combines with the intraoperative data from Chimaera's sensing technology to guide the surgeon to the precise location of a procedure, helping to ensure the surgical device stays on a predetermined safe pathway.

The real-time data generation is designed to be used in conjunction with optical wearable technology, such as Google glass.

This means a surgeon can literally 'see' exactly where they are

within the body at any point during an operation. Once the target nerve has been reached the sensors also let the surgeon know, and the implant can then be deployed down the device.

Karger said their aim was to figure out how neuromodulators - measuring less than a centimetre in length could be implanted as simply and quickly as possible. Chimaera, he said, could allow doctors around the world perform a procedure that can currently only be carried out by a handful of people.

"With Chimaera, what we've done is we've combined smart sensing technology, pre-operative planning, we've taken small implant form-factors; and we've combined both implant delivery with surgical tool to provide a completely connected, unified surgical system that has the potential to take a surgery that maybe only four or five people in the world can carry out today and make it accessible to a broad cross-section of general surgeons. By doing that we make it accessible to a much, much broader patient population," he said.

The developers said that while most of today's surgical tools are largely passive, offering surgeons little feedback, Chimaera opens the door to a new generation of neurostimulation implant procedures. It could, they say, enable more surgeons to carry out complex operations at lower risk and with better results for patients.

While it may be some time before a device like Chimaera is in surgeons' hands, Karger said it could pave the way for wireless pain management for patients using, for example, their mobile phone: "Imagine a migraine sufferer who literally as they feel the onset of their migraine, can reach for their cell phone and dial-down the pain. That is a life-changing therapy for that patient. And crucially what it does is it changes that patient from a patient into a consumer; they don't need to feel like a patient anymore."

Developers Cambridge Consultants say Chimaera is the equivalent of a 'concept car' that demonstrates their vision for the next generation of surgery. They say that all of the technologies that are used in Chimaera currently exist, and they are now looking for partners to lead a product development cycle to turn it into a medical device ready for market.

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Source: Reuters n

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Industry News

App Design Could Save Lives with Early Pneumonia Detection A team from Uganda’s Makerere University is the only African winner in the 2014-2015 Big Ideas Contest for its app that could aid in early detection of pneumonia.

The app, which won Makerere a tie for second place in the global health category of the contest, combines a cell phone prototype with specially developed cell phone applications. This enables it to make a detailed analysis and preliminary diagnosis of “lung crackles” through digitised audio recordings from a patient’s chest.

The team intends to have a connection to a modified stethoscope for better readings of lung sounds and the device will be able to store and send chest recordings as digital files so that they can be expertly analysed at a later point if necessary. In addition, the stethoscope would be embedded in a vest to ensure continuous monitoring. Since the recorded sound can be stored on the cell phone as a digital file, it can be sent later

on for expert analysis through the cloud.

The Big Ideas judges were particularly impressed by the proposal due to the danger pneumonia presents to patients – particularly in the developing world – and due to a high success rate in treatment if detected early.

“The affordability and wide availability of cell phones make them an innovative platform for the development of simple medical diagnosis capabilities for use in the field,” the judges said. “This is especially true in under-developed countries where skilled medical practitioners and their most sophisticated devices are often thin on the ground.”

The team was one of only two international universities to win an award in the completion, which was organised by the University of California (UC) Berkeley.

The other international winner was a team from Australia’s Monash University that developed an advanced reading tablet for young children.

The contest aims to encourage students to use skills gained at university outside their courses on passion projects that could better the world.

Teams put together initial proposals and Big Ideas helps them turn these into action throughout the course of a year by providing funding, support and encouragement.

All of the projects are at very early stages and will need significant development before working applications are available.

Other teams that won awards in the same global health category as Makerere included a UC Davis team that designed a sand-and-plant system for treating wastewater on a large scale (tied first place); a UC Berkeley team that designed a programme to increase training in cervical cancer screening methods (tied first place); and a UC Berkeley team that developed a method for removing fluoride from water that is appropriate to the culture, environment and technology of rural India (tied second place). n

PCHA, HIMSS and Games for Health Announce Strategic Partnership Games for Health annual conference integrated in the 2015 mHealth Summit, November 8-11 in Washington, DC The Personal Connected Health Alliance (PCHA) at HIMSS and the Games for Health Project have announced a strategic partnership to deliver comprehensive resources and business development opportunities to the gaming community. HIMSS and PCHA are focusing on advancing personal health technologies in care delivery, including mobile and connected health, that empower and engage providers, patients and consumers in health and wellness.

Games for Health is the leading voice and professional community in the field of health games, representing the full spectrum of health technologies. Together with PCHA and HIMSS, this partnership will bring greater focus to cutting-edge games and gaming technologies covering the spectrum from wellness to disease management.

“Gaming technology is playing an increasing role in care delivery and the management of health and wellness,” said Richard Scarfo, Vice President, Personal Connected Health Alliance at HIMSS, and Director of the mHealth Summit. “Our strategic partnership with Games for Health compliments PCHA’s support of the full continuum of technology-driven health and wellness. Gaming technology is becoming an important addition to social media, wearables and mobile health, as well as an adjunct to clinical care management.”

As part of this collaboration, Games for Health will host a portfolio of activities at both this year’s mHealth Summit and the HIMSS16 Annual Conference. The Games for Health University will once again return to the 2015 mHealth Summit on November 8, featuring a full-day tutorial focused on how and when games should be used in the health and healthcare secContinued on page 12

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Industry News Continued from page 11

tors. The Games for Health annual meeting, also taking place at the Summit, will cover topics including exergaming, physical therapy, disease management, health behaviour change, biofeedback, rehab, epidemiology, training, cognitive health, nutrition and health education. The mHealth Summit, hosted by HIMSS and the Personal Connected Health Alliance, will take place November 8-11, 2015, at the Gaylord National Resort and Convention Center in the Washington, DC, area.

Within the mHealth Summit’s Connected Health Pavilion on the exhibit floor, Games for Health will showcase the use of videogames and video game technologies to improve health and healthcare from both a provider and patient perspective. This interactive, hands-on exhibit area will inform and demonstrate how health and healthcare providers and organisations can use game technologies as part of a strategic approach in healthcare delivery.

Beth Bryant, President of the Games for Health Project, will continue to lead all management activities and event logistics for

PCHA’s programs related to games, game technologies and gamification solutions that are impacting health and healthcare. “Partnering with HIMSS and the Personal Connected Health Alliance is a major milestone for our community, placing us on a global stage at the mHealth Summit. This year, we are bringing together thought-leaders, innovators and clinical experts to advance game technologies and the gaming community,” added Bryant.

The Games for Health Project supports community, knowledge and business development efforts to use cutting-edge games and game technologies to improve health and health care.

This year’s mHealth Summit theme, Anytime, Anywhere: Engaging Providers and Patients, reflects a shifting focus from traditional patient care to a more dynamic, interactive and patient-driven experience. Keynote presentations, panel sessions, special events and a vibrant exhibition floor will explore existing and emerging technologies changing care delivery, including mobile devices and apps, telehealth services and personal connected health. n

Novartis Pharmaceuticals Launches Smart Watch App for the Visually Impaired pean Forum Against Blindness (EFAB).

Cutting-Edge Technology

Novartis Pharmaceuticals has announced the release of new features for its ViaOpta applications, and the extension for use with smart watches. The discreet, hands-free nature of using the ViaOpta app with wearable devices, such as Apple Watch and Android Wear, provides users with an experience that seamlessly fits into their existing routines allowing those with visual impairments to navigate daily life with even greater ease.

Real-World Patient Benefits ViaOpta Nav is the first turn-by-turn navigation app available for a wearable device designed specifically for visually

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impaired people, providing voice guidance and vibration settings, which alert the user to upcoming intersections and landmarks. The users can ask for their exact position, add waypoints to a calculated route, and find nearby destinations or landmarks and save them as favourites.

Users and their caretakers can also share and access a person’s exact location.

“With the help of ViaOpta apps, people with impaired vision can do things such as walk to a nearby café, go to the pharmacy, and pick up their grandchildren at the kindergarten–helping to increase confidence and independence and maintaining discretion,” explains Ian Banks, Chair, The Euro-

“Novartis is committed to providing innovative solutions which go beyond medicine, like these apps for the visually impaired which benefit their daily quality of life,” said David Epstein, Head of Pharma Division, Novartis Pharmaceuticals. “We are proud to contribute and play a role in making these simple and convenient tools like the ViaOpta Daily and ViaOpta Nav apps available around the world.”

Globally, more than 285 million people live with vision impairment and blindness1. In order to reach as many of these people as possible, ViaOpta apps are now available in several languages, with additional languages currently in development.

Highlights of Additional New Features for ViaOpta Apps: ViaOpta Navigation: Points-of-Interest Feature: The user will now be able to see Points-of-Inter-

Industry News est nearby, divided into categories, find information on them and set a navigation to a specific point-of-interest. This also includes information on specific accessibility facilities around them, such as tactile pavement and crossings, traffic lights with sound (provided that this information is available on OpenStreetMaps for the area which the user is in).

Extended Map Coverage: The app coverage has been extended to the whole world, although coverage is less in rural areas.

ViaOpta Daily: New Object Recogniser Feature: Identifies objects in the user’s field of vision when user points the camera of the device at an object.

Addition of Scene Recogniser Feature: The user will be able to point the camera of the device at a desired direction or place and the voiceover will tell the user what is in front of them to help them navigate unfamiliar environments.

Continuing a commitment to digital excellence The smartphone versions of these patient apps won the prestigious European Excellence Award in 2014, the first year they were available. Downloaded over 6,700 times during the first two months after launch, these apps allow users to retain and in some case regain their independence and have been praised both for innovation and for reallife impact. n

Vida Health and AstraZeneca Launch New App for Post-heart Attack Recovery Vida Health and AstraZeneca have teamed up to launch a new app for recovering heart attack patients that should help people recover faster from, and better cope with, the trauma associated with such life-threatening experiences.

Heart disease is the leading cause of death for both men and women in the U.S. Every year, about 735,000 Americans have a heart attack, and more than a quarter of those patients suffer from repeat attacks, according to the Centers for Disease Control. Heart disease is caused by several hereditary and lifestyle factors, and recovery from the first attack requires ongoing support to help prevent a second one. That’s where Vida Health and AstraZeneca’s Day-By-Day app comes into play.

The app, which is launching through a trial program at Duke University, is a HIPAA-compliant smartphone application that will walk patients step-by-step through the recovery process using live digital coaches and educational materials, like videos, articles, and food journals, to help patients implement lifestyle changes and adhere to their new drug regimen. It’s an extension of Vida Health’s current cloud-based smartphone app, which provides personal health coaching services on both Android and iOS devices for a range of chronic conditions.

“We’ve already seen that we’ve improved outcomes and lowered costs for other needs: Seven out of eight people lose weight using Vida Health,” said Stephanie Tilenius, CEO of Vida Health, who will speak Tuesday at Fortune’s Brainstorm Tech roundtable on the state of digital health. “We see ourselves as a platform that cuts across multiple channels to engage chronic care patients, and our partnership with AstraZeneca is an extension of that model.”

After a heart attack, patients are often given a list of changes they need to make in order to prevent a second attack. (People who have had an attack are at a much higher risk for another one.)

At the same time, these people are also experiencing a range of

challenging emotions, from anxiety to depression to information overload. It’s a period where hands-on rehabilitation can make a significant difference, helping patients understand what medications to take when, how to change their eating habits or quit smoking, and how to slowly develop an exercise routine.

Sticking to a new medication regimen is a core concern for heart attack patients. Poor adherence to drug regimens generally causes about 33% to 69% of medication-related hospitalisations and accounts for $100 billion in annual health care costs, according to a 2005 study published in The New England Journal of Medicine.

The app will also help AstraZeneca interact with patients “beyond the pill.” The app is unbranded, meaning users won’t see the pharmaceutical company’s name anywhere on the service, and it has been designed to focus on the patient, regardless of exactly what company’s drugs they have been prescribed.

“The science is the core of our business, but patients today are expecting more,” said John McCarthy, vice president of global commercial excellence at AstraZeneca. “We see that taking advantage of technology alongside the power of science is the best thing for patients. It’s about extending the customer experience.”

AstraZeneca will be covering the cost for all users participating in the program. The effort will give the pharmaceutical company a better idea of how they can engage with consumers beyond their daily dosages, as well as give the firm insight into how patients are using daily medications during recovery.

“We are focusing on patient problems while working within the pharmaceutical business that we fit within,” he said. “It allows us to have a greater impact across an institution that’s looking to address all of their patient population.”

Source: Fortune n

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Industry News

Human Organs-on-Chips Wins Design of the Year 2015 even more to translate the Organs-onChips technology into a commerciallyavailable system that can be used to design better and safer products for humans, as well as creating a new era of applications in the personalised health space.”

The Organs-on-Chips technology is based on pioneering work conducted

by Donald Ingber, M.D., Ph.D. and his team at the Wyss Institute for Biologically Inspired Engineering at Harvard University.

Recognised for its potential to reduce animal testing, revolutionise the development of new drugs, and open a new era of personalised health Emulate’s Human Organs-on-Chips has been named the overall winner of the ‘Design of the Year’ award by London’s Design Museum.

Organs-on-Chips emulates human biology to understand how diseases, medicines, chemicals, and foods affect human health. The technology involves placing living human cells in micro-engineered environments to create a microchip embedded with hollow microfluidic tubes each lined with human cells, through which air, nutrients, blood and infectioncausing bacteria can be pumped.

The chips are manufactured in a similar way to microprocessors, only instead of moving electrons through silicon, these chips push minute quantities of chemicals past cells from lungs, intestines, livers, kidneys and hearts. The microfluidic networks let the chips mimic the structure and function of complete organs, making them an excellent testbed for pharmaceuticals.

The complete integrated system provides a window into the inner-workings of the human body, enabling the prediction of human response with greater precision and detail than today’s cell culture

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or animal-based testing.

“This winning design is a great example of how design is a collaborative practice embracing expertise and know how across disciplines. Its selection as Design of the Year 2015 also signifies a desire to recognise and award design that can significantly impact society now and in the future,” said Gemma Curtin, who is the Designs of the Year 2015 exhibition curator.

“This is the epitome of design innovation – elegantly beautiful form, arresting concept and pioneering application” The award is selected by design experts, practitioners, curators and academics from around the world, who were united in their responsibility to select a winner that emphasises design’s impact on our lives now and in the future, solving diverse problems with innovation and intelligence.

“We are deeply honoured that our Organs-on-Chips have been awarded Design of the Year, and we are passionately following our mission to apply our new living products for a range of applications to improve human health,” said Geraldine A. Hamilton, Ph.D., President and Chief Scientific Officer of Emulate.

“This prestigious recognition inspires us

Each Organ-on-Chip can contain tens of thousands of cells in tiny, hollow channels and is approximately the size of a USB memory stick. The Organson-Chips are designed to recreate human biology, emulating dynamics of organs at the cellular level with unprecedented precision, reproducibility and control.

Emulate’s team has designed a range of Organs-on-Chips, including the lung, gut, kidney, skin, eye, and blood-brainbarrier, which can be linked together into a ‘Human-On-Chips’ system. The products are now being used commercially to improve innovation, design and safety for industrial applications in the areas of pharmaceuticals, personalised medicine, agriculture, cosmetics and chemicalbased consumer products.

This year is the first time the prestigious Design of the Year award has been presented to a product from the field of medicine, and there was strong competition from various industries, including Google’s self-driving car and several other notable designs. Human Organson-Chips received their nomination from Paola Antonelli, the Museum of Modern Art’s Senior Curator of Architecture & Design and Director of R&D. “This is the epitome of design innovation – elegantly beautiful form, arresting concept and pioneering application,” said Antonelli.

Organs-on-Chips are featured at the Design of the Year exhibition, which is open to the public through March 31 2016, at London’s Design Museum. n

Industry News

Pioneering Health App Launches Tool to Help Achieve Digital Healthcare Vision for Self-care mHealth developer Health Fabric is helping deliver the vision of patient-centred digital health by launching the Health Fabric Store where UK clinicians and commissioners can create, share and recommend care plans with their patients and reap the potential benefits of digitally-driven self-care.

Launched at this year’s Commissioning event in June 2015, the Store will help patients, carers and healthcare providers to improve care and reduce the need to use health and care services – part of the NHS’ vision for personalised health and care, and which could go some way towards achieving Tim Kelsey’s (NHS England’s National Director for Patients and Information) ambitious vision of using IT to help save the NHS 13.7bn GBP per year.

“Long term health conditions now eat up almost three quarters of the health service budget,” said Satnam Bains, chief executive officer of Health Fabric.

“At the same time, many people want to be more involved with their own care. This technology bridges the gap between patient

and provider by using clinically relevant care plans and translating them into patient-centric healthcare information and activities.”

The need for better self-care was a central theme to the NHS’ Five Year Forward View; the cost of chronic conditions is expected to cost £5bn GBP per year by 2018. By providing patients with clinically verified care plans created by healthcare providers, the Health Fabric Store helps to address this by giving patients the knowledge, skills and capabilities they need to manage their own care and symptoms – a key ambition for NHS digital health.

All of the plans available have goals, actions and supportive information to help the patients manage long term conditions such as diabetes and COPD. These plans are then translated into a care diary, a set of reminders and other essential data and activities that the patient and clinician can use together to help better manage their care. MyHealthFabric can also integrate with the person’s health record, with the organisation already an accredited partner of major GP system supplier EMIS. “As a company we work with people living with type 2 diabetes, who want to be able to take control of their lives and self-manage,” said Kate Walker, founder of Diabetes and You, which has provided plans for the Store. “Health Fabric allows them to do this by providing them with access to their own records as well as educational materials, so they can learn and implement what helps their personal health and wellbeing.”

Her views were echoed by Rosie Walker, education director of Successful Diabetes, which has also provided information. “The idea of Health Fabric's care plans is excellent - to give people the opportunity of finding something that suits them exactly and an opportunity, where it's available, to link all their health and wellbeing information in one place.”

Accessible by patients through the MyHealthFabric app, which can be downloaded via Google Play and iTunes and is available on NHS apps, the Store is open to organisations that have developed care plans that work for patients and professionals alike, such as health and care charities, clinical commissioning groups, and bodies looking to harness technology to develop new models of care.

This is the latest in a series of Health Fabric developments that have seen them covered in the recent Connected Health report from the Deloitte Centre of Health Solutions. Health Fabric was chosen as one of ten Department of Health-supported apps in 2013, and is working with clinicians and commissioners across the country on realising the vision of a patient-centred digital health ecosystem that will enable the behaviour change essential for the future of NHS care provision. n

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Partnership to Study a Patient Tablet App for Enhanced Recovery After Surgery (ERAS) McGill University Health Centre’s (MUHC) Steinberg-Bernstein Centre for Minimally Invasive Surgery has partnered with SeamlessMD, a company which provides a cloud-based patient engagement solution for surgery, to study the performance of a patient tablet application for Enhanced Recovery After Surgery (ERAS).

The study, which is funded by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), will determine whether a patient tablet application can improve patient adherence to ERAS care processes, reduce manual labour needed for data auditing and improve patient outcomes.

Enhanced Recovery After Surgery (ERAS) programs are a patient-centred approach to integrate evidence-based interventions into a coordinated, multidisciplinary care plan encompassing the entire perioperative pathway. A growing body of research has shown ERAS programs to significantly reduce hospital length of stay and patient morbidity for major surgery.

The MUHC’s Steinberg-Bernstein Centre for Minimally Invasive Surgery has

long been a leader in ERAS care, having first implemented an ERAS program for colorectal surgery in 2006, and developing programs in thoracic, urologic, orthopaedic and hepatobiliary surgery through a dedicated Surgical Recovery team.

"We are excited to be working with SeamlessMD to use technology to improve patient care. Currently, the ERAS protocol and audit tool is resource intensive and requires additional personnel. We also wanted new ways to engage patients in their recovery. We have been looking for an innovative solution to help with this,” says Dr. Liane Feldman, Principal Investigator for the study and Director of the Steinberg-Bernstein Centre for Minimally Invasive Surgery, as well as the co-chair of the MUHC’s Surgical Recovery team.

The first phase of the study will be a single group feasibility pilot. Each patient will receive a tablet loaded with the application at the bedside in the hospital. The custom application has been designed to educate patients about each day’s ERAS milestones and track their adherence.

The application links education, recovery planning, and daily self-assessment to a plan of care. By using the application, patients will be self-auditing their

adherence to the ERAS protocol, and this data will be available in real-time to the clinical team. After, the second phase of the study will involve a randomised control trial.

“For the past few years, we have established our technology as the go-to solution for pre-operative and post-operative patient engagement. By collaborating with the MUHC, we are excited to demonstrate that an ERAS module on our platform can improve patient engagement and outcomes in the in-patient setting. Together, we are bringing a more coordinated effort to advance perioperative care,” says Dr. Joshua Liu, CEO of SeamlessMD. n

Online Symptom Checkers Put to the Test The first wide-scale study of the accuracy of general-purpose symptom checkers has found that although the online programs are often wrong, they are roughly equivalent to telephone triage lines commonly used at primary care practices— and that they are better than general self-diagnosis and triage using internet-searches.

Symptom checkers are often hosted by medical schools (including Harvard Medical School), hospital systems, insurance companies, and government agencies (including the United King-

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dom’s National Health Service). This type of software asks users to list their symptoms, using methods such as multiple-choice checklists and free text entry. Once a program has collected the information, the computer returns a list of potential illnesses that might cause the listed symptoms and suggests whether the patient should seek care immediately, visit a doctor in the next few days, or use self-care methods, such as resting at home.

“These tools may be useful in patients who are trying to decide whether they should get to a doctor quickly, but in many cases,

Industry News users should be cautious and not take the information they receive from online symptom checkers as gospel,” said senior author Ateev Mehrotra, associate professor of health care policy and medicine at HMS and Beth Israel Deaconess Medical Center.

Published in the BMJ, the study, led by researchers at Harvard Medical School (HMS), created standardised lists of symptoms from 45 clinical vignettes that are used to teach and test medical students and then input those symptoms into 23 different symptom checkers. Overall, the software algorithms that the researchers studied listed the correct diagnosis first in 34 percent of cases. The correct diagnosis was included in the top three diagnoses in the list in 51 percent of cases and in the top 20 in 58 percent.

Overall, the 23 symptom checkers provided correct triage advice in 58 percent of cases, with the checkers performing much better in more critical cases, correctly recommending emergency care in 80 percent of urgent cases.By comparison, other studies have found that Internet search engines for urgent symptoms led to content that suggested emergency medical treatment only 64 percent of the time.

with the most accurate diagnoses (Isabel, iTriage, Mayo Clinic, and Symcat) were not on the list of the programs that did the best job of recommending the appropriate level of care for a given case (Healthychildren.org, Steps2Care, and Symptify).

Symptom checkers are part of a larger trend of both patients and practitioners using online platforms for a range of health care tasks, such as patient-doctor chat sessions and algorithmic tools used to aid the diagnosis and triage of patients, the researchers said.

The symptom checkers that were evaluated tended to be overly cautious, encouraging users to seek care for situations where staying at home might be reasonable. The researchers noted that this tendency toward conservative advice encouraged people to seek unnecessary care—an outcome that health care reform strives to minimise in order to reduce costs.

“The tools are not likely to go away,” said first author Hannah Semigran, HMS research assistant in health care policy. “With symptom trackers, we’re looking at the first generation of a new technology. It’s important to continue to track their performance to see if they can reach their full potential in helping patients get the right care.”

In many cases, getting the exact diagnosis may not be as important as getting the correct advice about whether—or how quickly—to go to the doctor.

The study which was funded by the U.S. National Institutes of Health highlights a growing requirement for supporting evidence to help patients and consumers select and use online and digital health products and services. As more and more people choose to use digital tools to help them better understand their own health requirements then the healthcare industry will have to find ways to communicate which tools are effective. Going forward, we are likely to see many more studies of this nature, which will help in this process.

“It’s not nearly as important for a patient with fever, headache, stiff neck, and confusion to know whether they have meningitis or encephalitis as it is for them to know that they should get to an ER quickly,” Mehrotra said.

The researchers found a great deal of variation between checkers, but none was without limitations; for example, checkers

Source: Harvard Gazette n

MIT Turns Hacking Medicine Program into an Institute to Study Digital Health Medical devices and information technologies have flooded the airwaves with health-related data, but the underlying question of whether the onslaught of digital-health products has made people healthier remains.

Now a new institute spun out from the

Massachusetts Institute of Technology is aiming to help answer that question.

and telemedicine programs that seemed out of reach 20 years ago.

Billions of dollars were spent last year on digital-health products, and billions more were invested in start-up companies making wearable sensors, big-data platforms, analytics, fitness trackers, apps

Information about how the technology may be shaping people’s health and is being answered in bits and pieces by health-system players who have their Continued on page 18

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Industry News Continued from page 17

own vantage points for observing certain disease-and-treatment trends.

To help sew the information together into a larger picture, the MIT Hacking Medicine program—which examines the intersection of technology and healthcare—is being spun out as a non-profit institute that will gather health-care stakeholders together and hammer out actual methodologies to determine the value of digital health products.

“There’s so much hype now,” said Zen Chu, MIT senior lecturer and faculty director of Hacking Medicine. “It’s great, in a way. It’s early stages, and there are so many start-up companies. But they’re all having the same trouble. What’s actually working, and how do you prove that?”

digital-health landscape is big on bold claims, but short on conclusive evidence.

“The country is moving to value-based care,” said Malay Gandhi, a Rock Health managing director, about the move to reimbursing medical costs based on patient outcomes rather than the number of patients treated. “So [digital-health products] need to be able to prove they are valuable.”

Mr. Gandhi said getting to that point will be far more complicated than simply proving a product works.

“Clinical trials can show efficacy,” he said. “For digital health, you need to show effectiveness. That’s different. The people who pay for things, like insurers, they want to see effectiveness.”

Apps, connected medical devices and other high-tech bells and whistles don’t just need to be embraced by consumers, he said. They need to be accepted and recommended by doctors, as well as reimbursed by major insurance companies.

Where a drug can be shown to be efficacious when taken as directed, a digitalhealth program—for example, a weightloss application—will in many cases have to demonstrate it has caused significant behaviour change in a patient in order to be deemed effective, he said.

Rock Health, a San Francisco seed investor and major engine for new digital-health innovations, agreed that the

The digital-health companies being evaluated will have to show data on user engagement and behaviour, the way

other tech companies do, he said.

Most importantly, digital-health companies will need to show they actually cut the cost of administering care if they expect to be embraced by hospitals and insurance companies, Mr. Gandhi said.

According to Mr. Chu, who will be helping to run the new non-profit institute, this data on human behaviour change can be attained—but only by bringing together a wide range of different stakeholders.

The Hacking Medicine Institute will invite pharmaceutical and medicaldevice companies, policymakers, hospital administrators, doctors, insurance companies, self-insured employers and company founders from across the spectrum of digital health, Mr. Chu said.

The institute will come out with white papers that offer guidelines on evaluating digital-health programs, and will evaluate digital products that seek to help in the treatment of major diseases.

The institute aims to form its first working groups in early October, Mr. Chu said.

Source: WSJ n

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Industry News

Your Smartphone Knows If You’re Depressed Time spent on smartphone and GPS location sensor data detect depression You can fake a smile, but your phone knows the truth. Depression can be detected from your smartphone sensor data by tracking the number of minutes you use the phone and your daily geographical locations, reports a small Northwestern Medicine study.

The more time you spend using your phone, the more likely you are depressed.

The average daily usage for depressed individuals was about 68 minutes, while for non-depressed individuals it was about 17 minutes.

Spending most of your time at home and most of your time in fewer locations -as measured by GPS tracking – are also linked to depression, as is, having a less regular day-to-day schedule.

Based on the phone sensor data, Northwestern scientists could identify people with depressive symptoms with 87 per cent accuracy.

“The significance of this is we can detect if a person has depressive symptoms and the severity of those symptoms without asking them any questions,” said senior author David Mohr, director of the Centre for Behavioural Intervention Technologies at Northwestern University Feinberg School of Medicine. “We now have an objective measure of behaviour related to depression. And we’re detecting it passively. Phones can provide data unobtrusively and with no effort on the part of the user.”

The research could ultimately lead to monitoring people at risk of depression and enabling health care providers to intervene more quickly.

The smart phone data was proven to be more reliable in detecting depression than having participants answer daily questions about how sad they were feeling on a scale of 1 to 10. “Their answers may be rote and often are not reliable”, said lead author Sohrob Saeb, a postdoc-

toral fellow and computer scientist in preventive medicine at Feinberg.

“The data showing depressed people tended not to go many places reflects the loss of motivation seen in depression,” said Mohr, who is a clinical psychologist and professor of preventive medicine at Feinberg. “When people are depressed, they tend to withdraw and don’t have the motivation or energy to go out and do things.”

While the phone usage data didn’t identify how people were using their phones, Mohr suspects people who spent the most time on them were surfing the web or playing games, rather than talking to friends.

“People are likely, when on their phones, to avoid thinking about things that are troubling, painful feelings or difficult relationships,” Mohr said. “It’s an avoidance behaviour we see in depression.”

Saeb analysed the GPS locations and phone usage for 28 individuals (20 females and eight males, with an average age of 29) over two weeks. The sensor tracked GPS locations every five minutes.

To determine the relationship between phone usage and geographical location and depression, the subjects took a widely used standardised questionnaire measuring depression, the PHQ-9, at the beginning of the two-week study. The PHQ-9 asks about symptoms used to diagnose depression such as sadness, loss of pleasure, hopelessness, disturbances

in sleep and appetite, and difficulty concentrating. Then, Saeb developed algorithms using the GPS and phone usage data collected from the phone, and correlated the results of those GPS and phone usage algorithms with the subjects’ depression test results.

Of the participants, 14 did not have any signs of depression and 14 had symptoms ranging from mild to severe depression.

“The goal of the research is to passively detect depression and the different levels of emotional states related to depression”, Saeb said. “The information ultimately could be used to monitor people who are at risk of depression to, perhaps, offer them interventions if the sensor detected depression or to deliver the information to their clinicians.”

Future Northwestern research will look at whether getting people to change those behaviours linked to depression can improve their mood.

“We will see if we can reduce symptoms of depression by encouraging people to visit more locations throughout the day, have a more regular routine, spend more time in a variety of places or reduce mobile phone use,” Saeb said.

The study was published July 15 in the Journal of Medical Internet Research.

Source: Northwestern University n

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Data Driven Proactive Healthcare

Data Driven Proactive Healthcare

By Sébastien Deletaille, CEO, Real Impact Analytics Health organisations collect and store a lot of historic data on patients but lack the real-time data and tracking to tackle major threats to human health like large-scale epidemics or natural disasters.

When we look at the recent outbreak of Ebola in West Africa, this real-time information on the disease was typically not available making it extremely difficult for aid workers to not only treat those affected but also look at how to stop it spreading even further.

There is data available in the form of that produced on a daily basis when individuals use their phones. In extreme cases, like the Ebola outbreak, this data could be used to support humanitarian initiatives but only if how it is used doesn’t breach subscribers’ privacy. By not taking the telco data in its raw form but by aggregating the data and looking at community patterns, insights to support aid workers can be achieved without any access to personal details.

Using anonymised mobile data records, healthcare organisations can track population movements during an outbreak, enabling healthcare professionals to stay one step ahead of the illness, sending resources to where it’s expected next. People can be advised of their closest source of help, and officials can even use the data to ensure quarantine measures are being adhered to.

Real-time data has real results While historical data has its uses, there’s no substitute for realtime data. Healthcare organisations, governments and donors are used to gathering huge amounts of data on patients and populations, but there’s exceptional value in being able to track anonymised community data in real-time.

Mobile technology allows us to monitor population movements in real-time and not just by using call or phone signal data. Network counters, mobile internet searches, and even handset data, can be used to track population movements. Anonymised data can be used to predict the development of a disease outbreak without compromising privacy.

For example, if residents of an area that’s fighting an ongoing battle against an epidemic travel away from urban centres into surrounding rural communities, mobile data can show that as it happens. Scientists and healthcare professionals can use the data to predict the spread of the disease, prepare quarantine areas and divert medical aid to affected areas. Governments can use the information to establish health centres, and inform people where their nearest source of help can be found.

Providing accurate information during an emergency

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Using real-time data alongside historic patient data, health-

August 2015

care providers can work out where they need to send vaccines (based on which places are interconnected by people frequently moving between them). They can also advise individuals of their nearest points of care (based on where they currently are). For the organisation, this healthcare centre can be used as a place to collect further data on the situation as it’s unfolding. Information that they can feed back into their databases, allowing them to form a more accurate picture of the real situation, and enabling them to provide people with the vital information that they need. All this data then also provides a roadmap for helping to prevent a similar outbreak in the future.

Allocating medical professionals and supplies When healthcare providers and other organisations invest in medical services and equipment, especially in less developed countries, it’s often reactive. For example, after the outbreak of an epidemic there will be fundraising efforts and often global scientific attempts to find a cure or a vaccine for the virus.

As recent disasters and epidemics have shown, affected populations see real-time data as vital during a crisis. People need to know where they can go to get help, where the nearest shelter is and what they can do to protect themselves.

While fundraising and investment is needed at the time, funding also needs to go into prevention. Ensuring that vulnerable communities are well supplied with qualified medical staff, sterilisation equipment and basic preventative treatments can go a long way to stopping the spread of diseases before they become epidemics.

Organisations can revolutionise the way they service these communities by analysing the vast amount of data collected – discovering, for example, what time of year there’s likely to be extra demand for certain medicines, or finding out how far people in remote communities have to travel to reach a healthcare centre.

This data enables providers to allocate resources in a way that better suits the local communities and if necessary plan for temporary healthcare centres to be available where and when they are most needed.

Analysis of real-time data is even more important, especially during a national disaster or health crisis. An organisation may think it needs to send an extra team of doctors into one village that has been struck down by an illness, but a couple of families from that village may have travelled to relatives in a neighbouring region, potentially bringing the virus there. By sending medical personnel to the region that is now at risk, the spread of the virus might be more easily contained.

Maintaining quarantine Real-time data can be used to monitor and control the effectiveness of an existing quarantine; plan for future quarantines by showing how people react; and to measure the impact of an

Data Protection: How Technology is Revolutionising Healthcare existing quarantine on the spread of the illness.

But quarantines aren’t just about collecting accurate data and analysing it. Putting a community into quarantine is always a last resort by governments and will only be used when it is necessary for the greater good like with an outbreak of Ebola or the Black Death.

The reason it is a last resort and its use it highly regulated is that it involves qualitative factors, namely human behaviour, relationships and emotions. Health care professionals may advise family members to inform them about a sick relative, but many families will ignore instructions and try to care for the infected person themselves, until perhaps they too fall victim to the same condition.

Data can also be used to identify who the social influencers

may be in a given area, and healthcare professionals can focus on convincing these people about the merits of the quarantine measures being enforced. There’s no guarantee that their influence will convince all families to abandon what they see as their duty, but it may help to persuade some.

Real-time data saves lives The important thing to remember about data is that it is useless until it has been analysed and applied to fix a problem. Historical data can be a useful tool for predicting future trends and analysing past behaviour, but anonymised real-time data allows organisations to act immediately by providing people with timely medical care, information and protection from infection. n

Data Protection: How Technology is Revolutionising Healthcare

By Dale Jessop, CTO, Exco InTouch

Every week, news stories around the world emerge of data security breaches.

Sadly, these are becoming ever more prevalent and sizeable, and no industry is exempt - including healthcare1. Ensuring privacy and security is paramount both in terms of data protection for the patient, as well as enhancing patient confidence in trial participation.

But now, some good news: the clinical trials and healthcare arena is undergoing a very noticeable technological revolution. With gathering pace, the pharmaceutical industry is beginning to embrace

technology in a move that is both as encouraging as it is overdue. Digital solutions are now becoming essential both for eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient Reported Outcomes) capture, as well as the healthcare sector, as the industry has realised that it can lead to increased adherence, better health outcomes and, crucially, billions of pounds saved worldwide.

The need to protect patient data and provide the most secure environment possible during a clinical trial and real world healthcare situation has, quite rightly, never been more vital. This is, in the main, due to multiple, often complex regulations across different geographic territories, such as compliance with HIPAA, Safe Harbor and EU Data Protection, which are central to safeguarding data privacy in clinical and commercial health services.

This comprehensive approach provides confidence for patients that their data will be safe, which, most crucially, reduces a major barrier to enrolment in multi-country programs. The advent of global clinical studies has meant that sponsors need to consider the legislation that vendors are expected to adhere to in order to provide the level of confidence to all stakeholders. Therefore, it is imperative sponsors ensure that the vendors they contract with abide by the respective legislation that governs their

main place of business, for example Safe Harbor, if contracting with a US legal entity and expecting to collect EU patient data, and EU Data Protection if the vendor is based within the EU member states and is collecting EU member states’ patient data.

Using technology to ensure data control So, how can technology help meet these guidelines? Firstly, unique PINs are created by users to ensure control over who is entering the data within the ePRO device. Not only is this reducing the risk of fraudulent data entry, but the restricted access also prevents others from seeing the record, and therefore, it enhances data confidentiality.

One of the most fundamental methods of data protection is data encryption.

With mobile ePRO, both the transmission of data and the offline storage of resting data can be readily secured via this methodology. Furthermore, any ‘sensitive’ data such as Personally Identifiable Information (PII), or indeed the actual content of the completed questionnaire/diary (Protected Health Information (PHI)) are encrypted to ensure data protection.

BYOD – dispelling the security myth With the ‘BYOD’ (Bring Your Own Continued on page 22

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Data Protection: How Technology is Revolutionising Healthcare Continued from page 21

Device) approach becoming more prevalent in clinical trials and the real world healthcare arena, the need to meet data privacy and security regulations becomes ever more important.

The principle difference between a BYOD approach and a provisioned one is that BYOD is more cost-effective, alongside encouraging increased adherence from patients. Controls have increased as the user of the device is being kept in contact without any qualification, and therefore it is important to place security at the heart of the technology to ensure that the highest standards of data security and safety are provided.

The myth that provisioned devices are somehow more naturally secure than the use of personal ones is slowly but surely being debunked. Best practice is to understand data protection regulations and develop a platform that complies with regulation guidelines. Through ensuring separation of PII, the use of data encryption for locally stored data

on the device, in transmission (i.e. over the internet), within study databases and the inclusion of permissions for data handling in the ethics/IRB-approved consent process, it is possible to build security and protection controls into software, whether delivered through a provisioned device, or, in the case of a BYOD approach the patient’s own mobile device.

Striving for excellence However, the drive for regulatory stringency does not have to stop there. Pharmaceutical companies can and should keep tabs on less obvious measures which affect privacy policies, by carrying out a comprehensive audit to ascertain what the vendor does in its day-to-day business dealings. Does the vendor have the relevant certifications? How seriously does it take its data protection responsibilities? How important is data protection within the culture of the organization, and is it willing to be as transparent on this matter as is needed?

Much of the above can be assessed

Some things just... ...stand out from the crowd

Global Digital Health 100 The most innovative companies in the field of digital health Nominations for 2015 now open, for more information please visit www.thejournalofmhealth.com

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through the Quality Management System (QMS). Any QMS worth its name should lead to data privacy at every level of the organization and its systems.

Three elements here are crucial: the environment which hosts data should be independently validated; the hosting environment should also include an intrusion detection system to protect against security threats; and an audit trail of data changes is also paramount.

It is not now simply a case of ‘if ’ pharma companies will work with vendors who have taken these steps and incorporated them into the way they run their business, but ‘when’ – that much we have seen first-hand. At ground level, security in the clinical trials and real world healthcare arena cannot and must not be compromised – but neither should it. Increased security is part of the virtuous circle of timely engagement, an improved user experience, and – most vital of all – improved health outcomes.

1. World’s Biggest Data Breaches http:// www.informationisbeautiful.net/visualizations/worlds-biggest-data-breaches-hacks n

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The Journal of mHealth

23

Designing mHealth Apps: Five Areas Not to Miss

Designing mHealth Apps: Five Areas Not to Miss

By Scott Hague

ect should be invested in design.

Studies suggest we spend 2 hours and 42 minutes each day using our mobiles, with some 86% of that time being spent using mobile apps1. With so much time spent using applications, it’s no surprise that users are becoming savvier and savvier.

So, in this post, I’m going to share with you 5 of the basics that are so often overlooked when designing a mobile app:

Users are no longer new to mobile.

It’s been almost 9 years since the first iPhone came along and more than 5 years since the first iPad was launched.

Users have seen countless applications in this time and numerous changes to their mobile operating systems. With constant improvements to these mobile operating systems and apps becoming increasingly intuitive, it comes as little surprise that the expectations of users are getting higher all the time.

First up is getting your teams and stakeholders all lined up, working as a super slick machine.

That’s great news for me personally. It means we simply have to keep working hard to provide the very best user experience designed to meet the objectives of the end users. If the user experience isn’t aligned to the user objectives, an app will quickly fail and there’s the added potential backlash of a slew of negative reviews on the App Store and on social media channels.

Bad user experience design is estimated to cost users 30 minutes a day. It’s lost time that users don’t appreciate losing and can result in lost revenue and brand exposure for the company behind the app.

There’s a misconception with app development that the development itself is the most important part of the project. It might be the most expensive, but it’s by no means the most important in terms of ensuring the success of your app. Getting the UX design wrong can spell disaster for a mhealth app – or any app for that matter.

Design is about how the app works, not how it’s programmed. It’s about the people using it, not the code. Development makes the design a reality. But given the importance of how an application works, a significant part of the proj-

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1. Link up your teams and remove the silos

Developers will need to see the wireframes and any potential graphical mockups produced for the app. What we do at Integrated Change is produce these first, before fully committing to any programming cost.

You see, what may look simple could actually turn out to be a major piece of development work. For example, we developed an iOS and Android app for The Wellington Hospital in London. On Android however, the style of the various pop-ups and calendar pickers that were displayed to allow users to perform an action varied between devices; in some cases massively, as shown below.

What we also discovered is that some date and time pickers on some Android devices are separate, whereas we wanted to combine them both, into one single pop-up.

Our objective was to create a consistent and ‘familiar’ brand experience across all Android devices, essentially forcing our own pop-ups into the code and bypassing those from the handset manufacturer’s Android layer. This meant that we had to design and develop custom pop-ups for Android. Sounds straightforward, right?

Well, it was actually a major piece of development work, which wasn’t planned, meaning we had to realign some of the project milestones.

The result however (as shown above), is a pop-up that is attractive, easy to use and consistent across all Android devices and operating systems.

Custom ups for hospital Android

designed and developed popAndroid allowed a consistent brand experience across all devices whilst providing the

Designing mHealth Apps: Five Areas Not to Miss stantly visible and we can refer back to it at all times. This helps us to avoid veering off track.

Almost 8 years ago, when I was first getting involved in mobile app development, a situation where one of our designers asked a member of the sales team; “Why is the client creating this app?

It seems pointless.”

Once you have the profile defined (remember you could have several key profiles), consider starting a workshop.

We’ve just finished an app workshop with a UK government agency and recently conducted two app workshops with the National Children’s Bureau and The Anna Freud Centre, a leading mental health charity for young people. (you can read more about how to structure a workshop at www.integratedchange.net/developing-a-healthcare-app-for-young-people)

The response was, frankly, inadequate.

He simply responded that the client knew what they wanted. And perhaps the client did know what they wanted.

But they had failed to take into account what their customer wanted. And that brings us onto point 3.

3. Profile, workshop, refinement user with quick and easy access to the most common functions of the app.

The lesson here is to make sure that you keep your designers talking to your developers, clients talking to your account managers and project managers talking to everyone. No silos should ever exist.

2. Know the objective and know the problem This is one of my favourite aspects of what I call the design discovery stage.

When we start working with a healthcare client, we validate exactly why they want to develop an app. Yes, people will say that they know but once you start to fire off some direct questions, it soon becomes apparent that really, they don’t know. There’s often a significant difference between what a client wants and what they need and it’s our job to understand the objectives and align these.

Digital can ease, and in some cases solve, many healthcare problems, from workflow and patient engagement to administrative inefficiencies. But if there isn’t a problem to solve, why bother? You’ll simply amass costs and spend a lot of time on a project unnecessarily.

You have to make sure that the objective or problem is very clearly defined and, just like in point 1 above, that everybody is aware of it. We often pin the core objective to the wall, so that it is con-

Persona profiling seems to be used as a fancy buzzword these days but in actual fact, the concept has been around for centuries. It still amazes me however, how little is known about creating a profile of your end user. In a sales environment, if you didn’t have a buyer persona or ideal customer profile, you would be flying blind trying to gain business.

The same goes for design. It’s no different. Creating a profile doesn’t have to be a complex task but you must know who your end user is, what they want, why they want it and how they want it to be delivered.

We have some free templates that you can use for this exercise for free download (www.integratedchange.net/webinar-recordinghow-to-write-your-healthcare-app-brief).

At Integrated Change, we are big fans of workshops. They provide a wealth of rich information and insights, which you wouldn’t normally get from other exercises. Once the workshop is complete, analyse and retest your app design plans.

Then implement what you know and keep validating. Running a second workshop can help with this.

4. Content This is such an important part of the design process and, going forward could be a key element in helping to get your app discovered. The actual level or volume of content must be determined early, along with the tone and language that you should have determined from point 3 above.

You don’t want to force users into scrolling endlessly to read huge volumes of text and you should bear in mind that Continued on page 26

The Journal of mHealth

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Designing mHealth Apps: Five Areas Not to Miss Continued from page 25

the amount of text will also determine the layout of the screens and placement of calls to action or other action related buttons.

As an example, we created an app to allow consultants to book ad-hoc theatre space for patients. The page contained several paragraphs of text advising on the process preceding the ‘book theatre’ space button.

On an iPhone 5 and above, this posed no issue, but on an iPhone 4s, the button wasn’t visible and the last paragraph ended perfectly right (unintentionally) at the bottom of the screen – because of this, it wasn’t obvious for the user to scroll down.

Once the content is in place, make sure that it reads well, is relevant to the app or screen and that there are no spelling mistakes. When we develop mobile apps for healthcare professionals, we check and double-check the spelling and grammar and then check it again.

Here is a great example: Which one looks correct and would you notice instantly? ‘general practitioner’ or ‘general practioner’ Some may notice instantly but on the whole and according to research at Cambridge University2, the human mind does not read every letter by itself but the word as a whole. The sentence could be a total mess but you could still read it without issue.

I urge you to check and double check and get somebody else to do this also.

My view is that spelling mistakes like this can be embarrassing and lose you hard earned credibility, especially if you are targeting a general practitioner!

And on the note of content, make sure you have all of the pop-ups covered too. Aspects such as no connection or returned server error messages should be clear, well written and simple to understand. Here are a few examples where they missed that point totally; to the user, they provide nothing but confusion and irritation.

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5. Prototype it Waiting for the app to be programmed to gain feedback is a waste of time. You could gain feedback really quickly by creating a non-functioning prototype that just allows you to validate the user journey with the end users.

Providing feedback to something on paper is very different to having it in your own hands, using it and providing feedback–it’s a whole different setup and mind-set.

Whilst prototyping may add cost initially, certainly in the early stage of the project, it’s definitely going to save you further down line.

There are many ways to prototype an app. We are big advocates of Form (www. relativewave.com/form) and inVISION (www.invisionapp.com). They both allow you to build a small section of your app prototype, gain feedback and then rapidly make a change before signing off.

Prototyping will help to make sure that you have the most commonly used elements in the right place (such as key action buttons - at the bottom to the right) and aspects such as placing the back or cancel button in the top left, as this is furthest point away from where the hand rests. Additionally, prototyping will help to determine the page depth of the app. Generally, users shouldn’t go any further than three pages into the app before having to press ‘back’.

Summary We could have listed several more points in this post but for us, these are the most common points in designing an app that are missed. In summary, what we have

listed here isn’t really rocket science and it isn’t anything new. It doesn’t need to be.

It’s all too easy to forget about why the app is being created, end up changing lanes and move in a direction that is going to take you on a completely different route. If you do this, you’ll miss the objective and wonder why engagement is low.

Of course, you can’t please everyone but do you need to? Facebook releases updates to its app every two weeks. But Facebook has the vast cash reserves to do so and a phenomenally broad user base of varied ages, demographics and social backgrounds.

For the healthcare space and for you reading this post, that doesn’t apply. But equally it doesn’t mean that you must forego spending more time on design discovery than any other part of the project.

References 1. http://www.adweek.com/socialtimes/ mobile-users-spend-86-time-apps-32gaming-17-facebook/146991 2. http://www.mrc-cbu.cam.ac.uk/people/matt.davis/cmabridge/ About the Author Scott Hague is Development Director and Owner of London based Digital Healthcare Agency Integrated Change.

Working with the likes of NHS England, Parkinson’s UK and Europe’s largest Private Hospital, The Wellington Hospital, Integrated Change specialise in designing and developing mobile applications exclusively for the healthcare industry. @integratedchg scott@integratedchange.net www.integratedchange.net n

September 9-10, 2015

The Omni Hotel

San Diego

Connected Health Summit: Engaging Consumers analyzes the roles of connected health technologies and innovations in driving changes in consumer behaviors and business models.

CONFERENCE SESSIONS

KEYNOTES

• Engaging Consumers for Coordinated Care

Steve Burger AVP of Business Development & Connected Health, Internet of Things (IoT) Organization

• Personalizing the Consumer Experience: Challenges and Best Practices • Incorporating Health Platforms into Consumer Engagement Strategies

AT&T

• Affecting Behavioral Change: Expert Guidance from Consumer-Facing Industries

John Mattison, MD Chief Medical Information Officer & Assistant Medical Director

• New Care Service Models for Consumers

Kaiser Permanente

• Integrating Wearables for Consumer Care

• Service Providers in the Connected Health Market • Integrating Health Analytics into Business Strategies

Kristine Mullen Vice President, Wellness Strategies & Solutions

• Partnerships in the Connected Health Market

Humana

• Implementing Technology for Accountable Care

ADVISORY BOARD

SPONSORS RECEPTION

ADVISORY

EVENT

AARP

Medtronic, Inc.

ADT

Mpulse Mobile

Care Innovations

Omron Healthcare

Cigna

Orange Healthcare

Higi Humana Johnson & Johnson Health and Wellness Solutions

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www.ConnectedHealthSummit.com

Real-Time Clinical Information Platform Driving Improved Outcomes

Real-Time Clinical Information Platform Driving Improved Outcomes Having access to timely and relevant data that can provide a complete clinical perspective on an individual patient should be the foundation for modern, efficient and effective health services.

Ensuring that data is mobilised across the healthcare network can deliver improved patient outcomes, ensure that resources are properly allocated and drive significant efficiencies. The task of developing such a network though is significant.

Medopad is a digital health platform that has been designed to provide doctors and nurses with the capability to access realtime data feeds from across the healthcare system. As a pointof-care solution it integrates existing clinical data, delivers it to mobile devices and provides a platform to create clinical and productivity apps that can intuitively use that data.

The system works by collecting information from disparate hospital databases and collating them into a central source. By integrating with the wide variety of data streams from within the hospital organisation and the wider primary care environment it enables a collated view of an individual patient’s record. Allowing access to data from historical medical files to X-ray and MRI scans, all at the touch of an iPad. Developed closely with BMI Healthcare and the UK NHS, Medopad has identified key problems associated with interoperability, security concerns, and other issues that have in the past prevented systems like this from succeeding and then worked to develop a solution that fits within existing workflows and care pathways.

This has meant that the solution is intrinsically tailored to overcome real, everyday problems associated with healthcare technology. Not only has the solution been designed to improve access to information, it has also been built to operate as a platform that can be integrated across many different clinical and operational activities within the healthcare organisation. It is already in use at a number of hospitals, including London’s Royal Free.

Collaboration is a major component and by giving doctors the information they require and then also giving them the option to share that information with colleagues, specialists and patients it becomes much easier to make informed decisions based upon a full picture of the available data. With the ability to make informed joint decisions comes an increase in the overall quality of care.

By developing bespoke applications that work with particular cohorts of patients, or patients receiving particular treatment, Medopad can also integrate real-time information from monitoring technologies and health wearables used to monitor

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patients during the course of their treatment and care plans.

This facility enables clinicians and care teams to easily receive and access real-time, actionable data, from which more accurate insights about treatment and condition management can be determined.

Collecting a complete picture of a person’s medical condition and treatment, rather than the traditional snapshots of health, that are generally recorded during one off appointments, means that it is possible to more accurately understand a patient’s complete medical experience. This in turn improves the clinical decision process and can result in improved outcomes.

The company has gained significant recognition in recent months for an application designed, using the platform, to work specifically with the Apple Watch that allows for the monitoring and management of cancer patients receiving chemotherapy treatments.

Effective cancer treatment relies heavily on the administration

Real-Time Clinical Information Platform Driving Improved Outcomes

of strict drug regimens, however the complexity and potency of prescribed drugs often leads to a range of side effects. As a result, patients sometimes struggle to stay motivated, forget to take their prescriptions and see a lapse in the accurate recording of side effects. As soon as a patient experiences a negative reaction they can record their symptoms using the smartwatch and the data is sent instantly and securely to doctors using the Medopad platform.

This delivers a number of powerful outcomes. Doctors can adjust drug regimens in real-time to provide even greater levels of proactive care and patients are provided chemotherapy treatment tailored specifically to them. Furthermore, connecting patients directly to doctors reduces side effect-related visits to hospitals, which in turn alleviates the pressures on medical staff and the associated financial costs.

Dr Rich Khatib, CEO at Medopad, said, “The latest statistics show one in every two people are expected to experience cancer during their lifetime. It is clear that treatment and patient monitoring must improve if we are to continue our global fight against cancer. Our easy-to-use Apple Watch application transforms how patients monitor their illnesses on a daily basis. Individuals can directly contribute to their own treatment regimens and regain the feeling of control, a vital component of dealing with challenging illnesses.”

“Cancer treatment is a challenging journey. Adherence to complicated treatment regimens, and the streamlined recording and reporting of health issues during treatment are of paramount

value. Medopad's Apple Watch chemotherapy application is an exciting new development in medical technology that can transform the quality and safety of care for patients, carers and care providers. This can eventually reduce the cost and improve the outcome of treatment for cancer patients,” said Dr Siamak Arami, MD, MRCP, MD (Res), FRCPath - Consultant Haematologist at King’s College Hospital NHS Foundation Trust.

Approximately 10% of the UK NHS’s annual budget is dedicated to cancer treatment and a single pill can cost upwards of £1,000 per day. When a patient misses a drug, not only is there the potential for a significant physical impact, but there is also a compliance concern. Doctors trust their patients to take their prescriptions regularly and the comparatively low cost of an Apple Watch assists doctors and patients during that process. The Medopad platforms ensure that this relatively complex project can be easily managed and deployed. n

Find out what’s on across the mHealth industry in our Upcoming Events section on page 45 The

Journal of mHealth The Global Voice of mHealth

The Journal of mHealth

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Walking a Fine Regulatory Line

Walking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications

By Bradley Merrill Thompson Tech companies have noticed the mhealth market. They have products like smart phones, routers, and other communications equipment that have uses in many different industries, including healthcare. They want to enter the healthcare market but they wish to avoid regulation by the U.S. Food & Drug Administration (“FDA”).

Unfortunately, many of those companies struggle to understand the definition of a regulated “medical device” and the degree to which they can promote their products for medical use without crossing the line into FDA territory. Many, for example, want to know whether, in their promotional materials, they can discuss medical uses without having to comply with U.S. medical device requirements.

The answer is yes, but they need to walk a fine line.

1. It all starts with intended use The foundation of medical device law is the concept of intended use. Paraphrasing the U.S. statute a bit, the line that defines a regulated medical device is drawn based on how the manufacturer intends its customer to use the product.

Generally speaking, if the manufacturer intends the customer to use the product in the diagnosis or treatment of disease or other conditions, FDA will regulate the product as a medical device.

This definition tends to frustrate people who like clear-cut rules. Compared to a rule, for example, that the Federal Communications Commission regulates all nonfederal use of the radio frequency (RF) portion of the electromagnetic spectrum, the medical device definition is certainly less precise. But the principles behind it are relatively clear.

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Intent is established through evidence.

Think of any murder trial you’ve seen on TV. The government establishes the intent of the alleged murderer through evidence-- evidence that typically includes statements by the defendant that reveal his intent, or actions from which the judge or jury can infer intent.

Establishing intent for the use of medical -related products is likewise evidencebased. The government first and foremost looks at the promotional claims the manufacturer makes, and the uses of the product those claims suggest.

2. Understanding general versus specific intended uses Here is where things get interesting. Interpreting words has never been a simple exercise. The fact is words have lots of different meanings, and when you string them together in various ways they can have very subtle differences in meaning.

Let’s say I have a mobile app that uses the camera and the screen on a smart phone to view stuff at a 10 X magnification. In promoting the sale of that app, there are hundreds of ways I might describe it but let’s look at two.

First, I could call it a “magnifying glass app.” Its function is to make stuff look bigger.

Second, I could call it a “dermatology magnifying glass that is useful in looking at moles to assess them for possible melanoma.”

Under U.S. law, clearly I can sell an app that I promote as a magnifying glass without any need to comply with FDA requirements. That app quite simply is not a medical device.

At this point, a philosophy major may be

thinking that, using syllogistic logic, if an app that can be used to magnify anything is lawful without FDA compliance, then an app that could be used in any manner that is consistent with that intended use would likewise not require FDA compliance. If the philosophy major also majored in math, he may think in terms of sets, and conclude that any product intended to fall within the set defined by the general purpose magnifying glass claim should likewise be lawful.

The problem is: the philosopher would be wrong. FDA does not regulate the first intended use but does regulate the second, even though logically it fits within the first.

FDA is not run by philosophers, but rather by clinicians. The more specific intended use is regulated even though the general use is not because there are risks associated with the specific claim that are not present in the general claim.

FDA explains its thinking in a guidance document entitled “General/Specific Intended Use” issued in November 1998. While that guidance does a very deep dive on this issue in the context of determining the risk of a medical device, the reason specific intended uses might trigger FDA regulation is that customers are entitled to rely upon claims the manufacturer makes as validation of the particular promoted use.

A customer who buys a magnifying glass app with no specific claims around it understands that it is simply a magnifying glass and the manufacturer is not recommending any particular use of it.

A customer who buys a magnifying glass app where the manufacturer says that it is useful for detecting melanoma in moles now has reason to believe that the manufacturer has tested the magnifying

Walking a Fine Regulatory Line glass app to determine its suitability for that purpose. That means the app must work for that specific function. Customers are likely to rely on the claim.

3. Manufacturer intent versus customer use Key to understanding the concept of intended use is appreciating that it is the manufacturer’s intent, and not the customer’s actual use of the product, that matters. The burden of regulatory compliance falls on the manufacturer, so it is only fair to impose the FDA requirements when that intent crosses the regulatory line. Manufacturers cannot be held responsible for all of the uses to which a customer might put a product. Under FDA’s rules, an orthopedic surgeon can go to a hardware store to buy a saw for a surgical procedure. FDA would have no jurisdiction over that act. Instead, the doctor’s conduct is a state regulatory issue regarding physician licensing, and a medical malpractice issue under state tort law.

4. Promotional guardrails for staying out of regulatory waters To sell a general use product that includes a medical use without complying with FDA requirements, a tech company needs to make sure that all the evidence points to a general purpose use. Admittedly, that’s a bit easier said than done.

I will offer three guardrails tech manufacturers ought to observe in marketing their general purpose products. a. Always include context Tech manufacturers should remember to always present their products with an emphasis on their general purpose functions. General purpose, generally speaking, can be communicated two different ways.

• First, the marketer can stay at a very high level in its description of the intended uses: “this cell phone is for communication purposes.” If your claims end right there, you have no FDA issue.

• Second, the marketer can illustrate the general range of uses. “This cell phone is for communication purposes and can be used by people for personal communications, workplace productivity, managing investments and healthrelated purposes.” While not as neat and

clean as the first example, as explained more below, this too should work.

5. Collaborating with medical device partners

If the health functionality is presented in a broader context as simply one part of an illustration, FDA typically will not treat that as a medical device type claim.

Indeed, in the marketing arena, it’s almost impossible to stay truly general and still adequately convey what the product does. Often, for example, advertisements and packaging will include pictures of users. The picture of the user will convey some information, for example a business person would convey office productivity where a nurse would convey a medical purpose. The manufacturer needs to make sure that it is always conveying the fact that this is a general purpose article with a wide range of applications, one of which may be use in a medical setting.

Never skip the general use.

More and more, tech companies are collaborating, each focusing on their core strength and collaborating with others for work outside their domain. The temptation is for tech companies that make general purpose IT equipment to collaborate with medical device manufacturers, to communicate that the general purpose articles can support medical device use. That’s fine, but do not let that cause you, as the tech manufacturer, to get sucked into the medical device world.

b. Avoid specific medical feature claims Remember the policy behind regulating medical specific claims: customers are likely to rely on specific claims when determining whether an article is suitable for their own purposes. The more a tech manufacturer touts specific features of their general purpose article as somehow specially or uniquely helpful to a medical purpose, they are creating an impression in the customer that this product has been in fact designed and tested for the medical purpose.

For example, a cell phone manufacturer should not promote some specific design feature whose only purpose is to make the cell phone compatible with an EKG accessory. That would take the cell phone out of the realm of a purely general use article, and make it an accessory to the EKG device. Customers would be entitled to rely on its functionality with an EKG accessory. c. Avoid medical benefit claims In addition to avoiding medical feature claims, avoid making medical benefit claims. Don’t say, for example, that patients who use your cell phone with an electronic stethoscope app can better manage their arrhythmia. If you start claiming medical type benefits to using your general purpose product, you are very likely crossed the line into regulated medical device territory.

If you are a cell phone manufacturer, for example, a company that makes a medical device app that can be used to control a blood pressure cuff, for example, can promote the use of its app with your cell phone, but that doesn’t mean that you can do likewise. The app developer’s promotion does not cause the cell phone to be regulated. But if you as the cell phone manufacturer decide to go on a campaign to promote the use of your cell phone with that app, you are running the risk of making that cell phone a regulated accessory to the app.

6. Guardrails on training and support After the sale, it is possible to inadvertently suggest that your general purpose IT product is actually a regulated medical device if you start to train users and support them in medical device type uses.

You can certainly teach a doctor how to use your cell phone. Indeed, you can teach the doctor how to install apps on your cell phone. And, if those apps happen to include regulated apps and they are loaded the same way as any other app, you’re still okay.

What a tech company should not do is provide any special training or support unique to a medical application. As I said, if a customer buys your product for a medical purpose, it means they have taken it upon themselves to validate its use for that purpose, and provide their own instructions for use specific to that purpose. If instead, the tech company provides any of those specialized instructions for use, the tech company is essentially saying that it intends its customers to use the product in that manner. As already explained, that’s what Continued on page 32

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Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers...

Continued from page 31

crosses the line into regulated territory.

Conclusion There are many general purpose IT technologies that are extremely useful in healthcare. There is nothing wrong with technology companies selling to physicians, and there is nothing wrong with physicians choosing technology to use that may require their own assessment and validation. So long as the tech company doesn’t cross the line and specifically suggest a

medical device type use, FDA compliance is not required. Healthcare is finally entering the digital age. Fortunately, the law is unlikely to stand in the way of doctors and the tech companies trying to help them, so long as these guidelines are observed.

About the author BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA

regulatory, reimbursement, and clinical trial issues. He has served as regulatory counsel for Continua Health Alliance; as counsel to AdvaMed for payment issues; as General Counsel to the Combination Products Coalition, the mHealth Regulatory Coalition, and the CDS Coalition(focusing on clinical decision support software). He has been recognised by his peers for inclusion in The Best Lawyers in America© (2015) in the field of FDA Law and was recommended in the Life Sciences category by The Legal 500 United States (2014). n

Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers and Pressure Sores Diabetic foot ulcers are a major complication for patients suffering from diabetes. Through the condition they often lose sensation and feeling in the extremities, meaning that they are more prone to problems such as minor cuts, bruises or blisters. The inability to identify pain from the foot also means that these small wounds are often left unprotected or untreated, and overtime these can quickly worsen and develop into ulcers.

The cost of treating diabetic foot ulcers and amputations is significant. The NHS in England spent an estimated £639 million–£662 million in 2010-2011, which accounted for approximately £1 in every £150 spent by the NHS during that period.

6,000 people with diabetes have leg, foot or toe amputations each year in England, many of which could be avoided, and around 61,000 people with diabetes are thought to have foot ulcers at any given time. These ulceration and amputation substantially reduce quality of life, and are associated with high mortality.

The scale of the problem is significant and up until now there have been few options for diabetics to easily monitor their feet.

Now, a new sensor technology developed by Scottish company HCi Viocare is hoping to improve the way in which diabetic foot ulcers are monitored with the development of connected wearable diabetic insoles that are designed to help diabetic patients monitor their feet and prevent diabetic foot ulcers.

Low cost, ‘smart’ insole The technology, which can be incorporated directly into footwear or simply implemented using insertable insoles, uses a network of 21 inexpensive sensors incorporated into the insole to process pressure and shear data and then analyse that data in real time. The self-contained device can then connect to the wearer’s smartphone and alert them when it detects events

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that are of concern. The information can also be downloaded and used by doctors to track patterns of risk or remind wearers to regularly check their feet.

Dr. Christos Kapatos, CTO and co-founder of HCi Viocare has led the development of the technology over many years of research and development. He describes the benefits of the innovation, “By monitoring the pressure and shear experiences of their feet in real-time, we can alert them [patients] about risky behaviour or bad footwear and if recommended thresholds of pressure, over time, are exceeded. Clinical studies have shown that as long as patients are focused on their feet and have a good management regime, they can prevent ulcers without any other intervention. We want to provide that focus. The insole is also a handy tool for blood glucose monitoring needs: it can record your activity better than with worn devices, tell you your weight and give you a much more accurate estimation of calories expended.”

The company’s shear sensor measures the ‘squashing’, rather

Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers... than rubbing, of skin, and it is the combination of pressure and shear that is the root cause of pressure ulcers.

“The sensors within the insole are capable of measuring plantar pressure and shear, which is something that has been previously difficult to measure, except in expensive, complex lab environments.” says Heleen Kist, Chief Operating Officer at the company in an interview with The Journal of mHealth.

“The connected insoles have been designed using off-the-shelf components so that they can be manufactured easily and inexpensively. We hope that a consumer product targeting diabetic patients would cost somewhere in the region of £200-250.

This is a vast saving on the current technologies in clinical use, and allows for an understanding of real-life walking habits as opposed to a short in-clinic assessment.” continues Kist.

One third of the estimated 3.7 million diabetes sufferers in the UK will develop problems such as ulcers, gangrene, infections and deformities because the condition means they lose feeling in their feet. Because they cannot feel pain, they fail to notice small cuts, bruises or blisters developing, which can turn into ulcers and infections. Diabetics are also more prone to increased risk of developing narrowing of the arteries, which leads to reduced blood supply to the feet meaning they take longer to heal. The new device helps to recognise risky behaviour early-on and provide users with warnings and alerts that should allow for more effective management of the condition.

Using the data collected the device analyses the different forces acting upon the foot and determines when the user should be alerted to a concern. This is done using Bluetooth 4.0 only when needed, resulting in a significant extension of battery life. The device is rechargeable meaning that its expected lifespan for a patient is significant.

The device components can be fully self-encased within silicon making them comfortable for extended use, like any other comfort insole. It uses sensors designed to work in hot humid situations, making them ideal for use within a shoe, which in the past has been an environment where traditional resistive or capacitive pressure sensors have failed.

Accurate measurement of foot pressure distribution throughout the gait can also identify asymmetries and provide insight on lower limb dysfunction, helping clinicians find and treat the root cause of biomechanical problems that can lead to pain throughout the lower body. The ability to monitor lower limb activity is

also vital in athletic monitoring applications, and the company is already in discussions with athletic wear manufacturers to licence the sensor technology for inclusion within sports footwear.

Pressure sensor-driven health applications The company is also adapting their sensor technology to be used in Smart Mattresses and Smart Wheelchair Cushions, designed to avoid debilitating pressure sores, and allow patients and care givers more control over their lives.

The mattress and wheelchair cushion will use the electronic sensors to monitor potentially harmful pressure and shear forces among bedridden or wheelchair-using patients. Real-time feedback from the sensors will prompt the mattress or cushion to automatically adjust so that the patient is repositioned to help prevent ulcers forming.

Pressure ulcers affect around 20% of people in hospital across Europe and can affect anyone who is immobile or unable to feel the pain and discomfort that results from sitting or lying too long in one position1. They can have a profound effect on the patient, ranging from mild discomfort to severe pain and in extreme cases the development of life-threatening infections, depending on the severity of the ulcer. They are a significant cost to health care providers. In Europe, the cost of pressure ulcer care, can cost providers up to 4% of their annual budgets2, while in the US, is estimated to cost around $11 billion (USD) annually3.

“We were delighted with the rapid and highly positive response to our Smart Insole invention – a reaction that has led us to expand our range of innovations. Our Smart Mattress and Wheelchair Cushion technology is developed to automatically respond to the pressure feedback from our sensors, adjusting the way the patient is positioned so that pressure ulcers don’t get a chance to form.” says Kapatos.

Going forward the company predicts a variety of additional applications for the technology, including insole-based sensing technology for low-cost motion capture, and as a control mechanism in the gaming industry.

1. Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T. Pressure ulcer prevalence in Europe: a pilot study Journal of Evaluation in Clinical Practice.

2007, 13(2): 227–235.

2. Bennett G, Dealey C, Posnett J. The costs of pressure ulcers in the UK. Age and Ageing. 2004; 33: 230-35.

3. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.) Cambridge Media; Osborne Park, Western Australia; 2014. n

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Transforming Patient Data into Actionable Insights

Transforming Patient Data into Actionable Insights Interview with Derek Gordon, General Manager of the Health Information Technology Group at Healthline As the healthcare industry continues to shift towards value-based care models it has become critical for healthcare enterprises to move beyond simply collecting patient data. They must really understand that data and use it to better predict patient outcomes and more effectively target interventions. The problem with healthcare information is that it is in so many different sources that it makes it difficult to develop a comprehensive picture of what all the data means.

According to IDC Health Insights, more than 80 per cent of today’s health data remains in unstructured formats, such as free-text physician notes, patient histories and hospital admission notes.

Having the ability to aggregate and normalise valuable, unstructured information from disparate sources and then combine it with structured data offers the potential for a more comprehensive view of the patient’s health.

In this interview we speak to Derek Gordon, General Manager of the Health Information Technology Group at Healthline. Healthline have developed a suite of leading intelligent health information and technology solutions aimed at harnessing the potential of structured and unstructured data to improve outcomes, reduce costs and turn patient data into actionable insights.

What have been the main technological changes, over the past five years, which have facilitated health data sharing?

“A few different pieces of legislation, including the federal HITECH Act and Affordable Care Act, include requirements and incentives to move from paper-based patient records to electronic medical records (EMRs). At the same time, these legislative acts spawned several changes in reimbursement models, including a shift away from the old

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fee-for-service model and towards valuebased care, which relies very heavily on patient data analytics to drive better healthcare decisions and outcomes. As a result, there have been dramatic advancements in the digitisation of healthcare.

A majority of hospitals are now meaningfully using EMRs, e-prescribing and more. However, it’s critical that the data from technologies such as EMRs, administration systems, lab systems, and billing and claims systems be shared and analysed to better determine patient needs and risk, properly utilise limited resources and drive toward better outcomes.”

What are some of the idiosyncrasies of trying to collate and analyse health data, as opposed to the data in other industries?

“Healthcare is unique in that the vast volume of information generated each day is rendered fantastically complicated by the esoteric types of data and terminologies used. There are countless diseases and treatments healthcare pro-

viders must be aware of, each with its own billing codes, prescription IDs and more. It’s impossible for any single physician or even a large healthcare system to deliver effective care across all patients without analysing vast amounts of hardto-extract, complicated data.”

Does healthcare data remain siloed, or is it becoming more transparent?

“Today, we are perhaps a small per cent of the way toward using healthcare data effectively. Data still gets stuck in its various silos, making it nearly impossible to create a true longitudinal patient record.

Leading healthcare institutions such as Kaiser, Geisinger, Intermountain, and many well-known medical and cancer centres have been “getting it” for some time—they’ve been doing an amazing job of breaking down silos and aggregating patient data effectively. However, we have a very long way to go, and I hope to see more physicians using patient data regularly to assign the right level of resources to improve patient care and outcomes.”

Transforming Patient Data into Actionable Insights What benefits does analysing unstructured data (in addition to structured data) deliver in terms of healthcare provision?

“As much as 80 to 90 per cent of today’s health data is in unstructured formats like patient histories and physician notes, yet most of it goes unused. It’s unfortunate because there is so much valuable information that lies in all this untouched data. Having the ability to analyse this unstructured data, in combination with structured data, provides several benefits for clinicians, including more accurate risk stratification, increased practice efficiency, optimised patient interaction coding, better, more specific diagnoses, and stronger patient outcomes.”

What are the difficulties associated with combining unstructured data, in terms of issues like privacy?

“We take privacy very seriously. Personal health information (PHI) is more valuable to hackers than credit card information because it has a longer shelf life and is more able to be used in identity fraud.

It’s critical that players who deal with PHI make sure all data is protected, and we have systems and processes to ensure this happens. It’s also important that data traveling from one silo using a particular patient ID is matched accurately with data from another silo, which might use a different ID. This is hard to do, and we’ve got to get it right every time.”

As individual health data expands exponentially - with the growth of personal digital health solutions what type of actionable insights can we begin to expect?

“There has always been an immense gap between provider and consumer access to health information. But we’re seeing this gap slowly closing due to the personalisation of healthcare and increased consumer use of wearables and mobile health apps. These devices help patients and their providers gather valuable insights that will help them better manage their health and the health of their local populations. For instance, devices and applications that track steps can help patients and their physicians to better plan and track against weight loss goals.

Combining current and historical data can also help doctors spot trends and understand what is happening with the

patient. In addition, having aggregated data from multiple patients in a population can even lead a healthcare provider into a new market – such as providing more services for chronic conditions.”

and unstructured patient data – and close those gaps in near-real time. Since the implementation, clinicians at Village Family Practice have seen a 16 per cent improvement in coding accuracy.”

What are the new value pathways within healthcare that these datadriven insights are helping to achieve?

How far advanced is this process, across the industry, and what can we expect for the future?

“Risk adjustment is critical, particularly now as we’re moving to value-based care.

Data analysis is used by many commercial payer organisations to more accurately predict the health costs of each patient and adjust reimbursement rates accordingly. In addition, data-driven insights will no doubt continue to play a key role in moving the needle on improving care delivery and patient outcomes.”

Is this type of stratified healthcare, directed by data insights, achievable at scale?

“It is. We can pretty accurately predict which patients are most at risk for advancing to, say pre-diabetes or chronic diabetes, based on data in the patient record. By digging into the unstructured data where socio-economic, psychosocial and other information is most often found, we can even stratify those in higher risk populations to provide insight as to where limited resources will deliver the highest impact. For instance, someone who is pre-diabetic but who also has strong family and social ties, access to transportation, and is able to adhere to prescribed healthcare regimens may need fewer intervention resources than someone without those supports.”

Do you have any practical examples where analysis of the whole data equation (structured and unstructured) is delivering tangible improvements to health systems?

“Healthline’s Coding InSight application helps providers, payers and accountable care organisations better manage patient population risk and improve health outcomes by effectively closing risk adjustment gaps. Village Family Practice, a multi-specialty group practice located in Houston, Texas, implemented Coding InSight several months ago. Today, the practice can more effectively identify mis-coded or un-coded diagnoses in patient charts – from both structured

“We are frankly still in the early days.

There’s a lot of work to be done. Mind you, I think much of the technology we need today is available and in pretty great shape; it’s just that healthcare is traditionally slow to adopt technologies that make the health enterprise “better, faster, cheaper”—to use a well-worn Silicon Valley trope. At Healthline, we have our own natural language processing (NLP) technologies that we’ve combined with the largest health taxonomy in the industry that make the understanding of unstructured data more comprehensive, more accurate, and more actionable. Add to all that our proprietary clinical rules engine, and we can deliver real impact, both at the point of care and at the level of healthcare administration. This means better-optimised revenues, lower costs, and improved healthcare outcomes. But getting our applications into the right place at the right time, fully integrated into the workflow, is challenging. Healthcare is just really slow around technology adoption.”

As data-driven healthcare becomes more prolific how do you expect this to change the industry landscape?

“One key impact will be at the point of care. Physicians today see a huge volume of patients each day. They just do not have the time to deeply consider the entirety of a patient’s health record.

Our Coding InSight application essentially automates the process of physician reflection by scanning the entire patient record and recommending what the doctor might want to cover with their patient. Moreover, risk management is a key aspect of how health providers and payers will compete on the new healthcare stage. Our value proposition extends beyond determining how patients are coded for risk and reimbursement, however. We expect to drive further innovations in solving gaps in care, population health analytics and care coordination.”

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mHealth in Developing Countries Continued from page 35

Are there any risks that we should consider with this type of approach?

“We can’t lose sight of the importance of our healthcare professionals in the delivery of health diagnoses and services.

Too often, software is divorced from workflow; interfaces are disconnected from the realities of how professionals need to interact with them; and analytics provide too much of the unnecessary or the just plain wrong. Healthcare professionals and administrators will be much

better at their jobs if they have access to the complete range of data they need.

And they’ll only be able to leverage that data if we can deliver it in ways that’s accessible and accurate and actionable.

Too many software vendors are failing to understand this critical imperative.”

What are the principle steps that the industry needs to take in order to facilitate the transition to datadriven healthcare delivery?

“For us, it comes down to three key mea-

sures: are we delivering data that is accessible, even at the point of care; is that data accurate; and is that data actionable? I’m always asking how we’re doing on our ‘Three As’: accessible, accurate, actionable. Anyone working in healthcare big data and analytics should be concerned with this question. An obsessive focus on the ‘Three As’ will have a transformative effect on healthcare delivery and administration, which will lead to lower costs, optimised revenues, and, most importantly, improved health outcomes for all people.” n

mHealth in Developing Countries: A Model for the Improvement of Global Health and for Reverse Innovation in the U.S.

By Steven W. Stavrou

Introduction

Abstract

In 2009, The World Health Organization published a report titled The Financial Crisis and Global Health, which brought light to global health issues that were expected to arise from the global financial crisis of 2007-2008. Among the principle concerns highlighted in this report, the risk of health services and health outcomes in both developed and, as a result, developing nations was the most imperative. The WHO argued that whether from high- or low-income countries, it is the poor that will be hit hardest. In the WHO’s five-point framework for action against this global crisis, pro-health public spending that is “pro-poor” was identified as an imperative investment that should yield positive health outcomes. Additionally, global collaboration between and within countries, as well as a focus on research as a critical tool in monitoring, analyzing, and responding to the health issues in the crisis were among the factors listed as mitigators of the global financial crisis.1

Through technology, particularly mobile and web communications, the world is now more interconnected than ever before.

These technological improvements in communication have played a critical role in global development. Global development, however, is being inhibited by global health challenges.

The challenge of healthcare is now a global issue. The effects of the rising costs of healthcare, a shortage of healthcare workers, and the declining revenues of healthcare institutions are being felt by both the developed and developing worlds. The WHO reports that nearly one billion people lack access to healthcare, or basic medical services. This number, however, is not completely attributed to developing populations. Globally, the “poor” in all countries, both developed and developing will face extreme challenges in the global healthcare crisis.1 mHealth technologies provide low-cost, affordable, available, and accessible healthcare solutions to patients in rural and remote areas in developing countries through the use of mobile devices and cellular networks. Through sheer necessity, low-cost solutions built on a limited number of resources are being created to solve dire health issues in these low-income regions. Developed nations such as the U.S., suffering equally from rising healthcare costs, should look to these nations for low-cost innovations and participate in reverse innovation.

This paper looks at examples of mHealth innovations in developing countries and maps out the challenges in this space as opportunities for global healthcare innovators and entrepreneurs.

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There are several trends that are attributing to the global challenges in healthcare we are facing today. Healthcare costs are rising rapidly. Advances in healthcare technology are actually increasing the cost of healthcare rather than diminishing it.

The worldwide population is aging, which as a result introduces the burdensome and costly challenge of chronic disease management. Both developed and developing countries face what Abdesslam Boutayeb has termed “the double burden,” the challenge of managing communicable and noncommunicable diseases. However, low- to middle- income countries, particularly developing nations, are more exposed to the rise of these diseases due to socio-economic, geographic, and demographic factors.2 Communicable diseases such as HIV/AIDS and Malaria

mHealth in Developing Countries

Exhibit 1: Healthcare Workers Shortage

(image source: Akter, S., Ray, P., “mHealth – an Ultimate Platform to Serve the Unserved.” IMIA Yearbook of Medical Informatics (2010). Print.)

are still relentless threats to health in developing countries. At the same time, the prevalence of noncommunicable disease such as Diabetes and Cancer, normally concentrated in developed regions, are on the rise in developing regions. A lack of health information, a lack of access to healthcare, and a shortage of health workers are allowing these diseases to claim lives around the world.

find healthcare innovations that are solving problems in countries that have far less access to healthcare than we do.

The purpose of this paper is to explore the prospect of mHealth in developing nations, and to encourage healthcare innovators in developed nations such as the U.S. to use mHealth innovations in these regions as benchmarks for low-cost, accessible, available, and affordable solutions to the global healthcare problem. I will begin by defining mHealth as a subset of eHealth, with what I believe to be a more up-to-date definition based on examples drawn from mobile technologies as of 2015. This will be followed by a review of existing literature, highlighting examples of mHealth being used in various developing nations.

Finally, this paper will discuss the concept of “reverse innovation” and discuss challenges (and opportunities) in scaling healthcare innovations to solve global health issues.

The developing world suffers from a significant lack of access to healthcare and basic health services. The problem worsens when healthcare is needed but is either severely delayed or is not sought out at all and a population’s health worsens. Not only does this have a negative health outcome, but it also leads to increased costs and lost income. This is referred to as the “poverty trap,” where poverty leads to poor health, yet poor health maintains poverty.5 Access to healthcare is not the only problem. Geographic and financial availability, as well as the availability of health-related resources are also scarce in lowto middle-income nations. The shortage of health services and healthcare workers has become a challenge. Low income countries have on average 9 hospital beds per 10,000 people, half a doctor per thousand people, and less than one nurse per thousand people. These figures are 4-6 times less than health services availability in upper-middle- to high-income countries (Exhibit 1). Even when healthcare is accessible, it is often of low quality and is not tailored to individual patient needs.

The Global Healthcare Crisis

eHealth & mHealth

In 2013, The Commonwealth Fund conducted a survey dealing with healthcare in 11 developed nations and found that the U.S. significantly lagged behind the ten other advanced countries when it came to the cost of healthcare, access to healthcare, health insurance, and overall affordability.3 The survey found that in 2013, 37% of American adults did not receive proper care because of cost. This number is extraordinarily high compared to the U.K. and Sweden (4-6%). Almost a quarter of Americans had trouble paying or could not pay their medical bills. The next highest country, France, only saw this in fewer than 16% of their population. The United States spends around $8,508 per person on healthcare, with is almost $3,000 more than the next highest country, Norway.3 Americans also had to wait longer for healthcare than in other countries. One in four Americans had to wait six or more days for care.4 As the United States faces challenges in healthcare, or more specifically, healthcare delivery, it is important that we look outside our borders to

The World Health Assembly defines eHealth as “the cost-effective and secure use of information and communication technologies in support of health and health-related fields, including health-care services, health surveillance, health literature, and health education.”6 eHealth technologies include online health information systems, health informatics, telemedicine/ telehealth, and mobile health (hand-held computer and mobile phones). According to the WHO, eHealth covers three main areas of healthcare delivery: Healthcare information delivery for health professionals and for patients through telecommunications and the Internet, e-commerce and e-business practices in health systems management, and the use of IT to improve public health services through, for example, the training of healthcare workers.7 eHealth is making the worldwide delivery of healthcare more Continued on page 38

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mHealth in Developing Countries Continued from page 37

affordable, accessible, and available. For the purposes of this paper, we will focus exclusively on mHealth. mHealth, as a subset of eHealth, differs from eHealth in a variety of ways. At its core, the distinction between mHealth and eHealth is often thought of as the use of mobile devices (PDAs, 2G cellular phones, smartphones) versus desktop computers or laptops and web/internet connection. In this sense, mobile technology is a lot more widespread. There are more people on this earth with access to a cellular device and a cellular network, even in lowincome regions, than there are individuals with a stable and reliable connection to the Internet and a personal computer. As a result, mobile health technology is more widespread and is more personal, as a user can use the functions of their mobile device to personalize their mobile healthcare. Additionally, developing nations do not have the infrastructure or the money to set up the infrastructure necessary to support 20th century information technology such as powerful computers and strong web access. Therefore, they have bypassed this level of technology and have gone straight to mobile solutions. Network connectivity is widely available, and costs significantly less than a stable Internet connection. Additionally, mobile devices are inexpensive and oftentimes free (recycled use). mHealth in Low-Income Countries While availability of and access to healthcare are challenges in developing nations, access to mobile phones is rising rapidly. As of 2010, the World Bank reports that developing nations experience more mobile use than developed nations. Mobile phone users in developing nations account for 77% of the population.8

Fast-forward to 2013, the ICT reported that mobile penetration rates in developing countries have reached nearly 90%. More people have access to a mobile signal than they do to electricity or water.9 The accessibility of mobile phones and cellular networks in developing countries has led the way to eHealth, specifically mHealth, as a low-cost solution to healthcare issues in these nations. mHealth Innovations In Developing Nations Disease Management In South Africa, the spread of Tuberculosis (TB), a communicable disease that attacks the lungs, is a critical issue. Even more concerning, there are patients in South Africa with highly-resistant forms of TB that are being sent home and therefore becoming a greater risk to the spread of the disease simply because they are being discharged from the hospital due to a lack of treatment options. The existence of this high-resistant form of TB is due in part to the mismanagement of the disease.11 SIMPill, a mHealth innovation developed in South Africa in response to this mismanagement of TB, is a pill bottle with a device attached to it that includes a transmitter and a SIM card (Exhibit 2). When the pill bottle is opened, an SMS message is sent to a central server. When the pill bottle is not opened during a set tolerance period, an SMS reminder is sent to the patient (or other caregivers). If the patient still does not adhere, a health worker will contact them directly. In its first study in 2005, 97% of patients said SIMPill helped them take their medicine, while treatment adherence increased almost 10%. In a larger pilot in

Exhibit 2: SIMPill

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(image source: http://www.esato.com/news/simpill-418)

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mHealth in Developing Countries tion, or spectacle prescriptions.18 Electronic Health Data

Exhibit 3: Aravind Telemedicine

(image source: https://mbasic.facebook.com/AravindEyeFoundation?_rdr)

2007, compliance rates were found to increase by 30-70%.12 However, while SIMPill has found success abroad in Europe, it has had difficulty scaling in South Africa.

Information Exchange There are two types of healthcare information exchange challenges that are being solved by mHealth innovations. The first deals with information exchange to patients, either between patient and healthcare professional or between patients. With SIMPill, we have seen information exchange via SMS. However, voice data is also used frequently in mHealth. In Bangladesh, TRCL Ltd., a telemedicine firm, in partnership with Bangladesh’s largest mobile operator, GrameenPhone, established “Healthline,” a health hotline service. Users in rural areas can dial “7-8-9” on their mobile phones and speak with a doctor at a regional call center nearby.13 Users only pay from their pre-paid mobile balance for network usage.

The second healthcare information exchange challenge involves connecting healthcare workers to each other (locally, regionally, nationally) or to other healthcare professionals worldwide. Eye health is a major concern in developing nations. Not only does this health issue take already low-income individuals out of the workforce, but also it is completely avoidable with proper healthcare and treatment.

In India, the Aravind Eye Care System is solving this challenge. In 2013, this network of eye hospitals serviced 3.1 million outpatient visits and performed over 371,000 surgeries.14 The Aravind Eye Care System provides low cost eye treatment to the poorest patients in India, and is profitable today without dependence on donors. Its “assembly-like” process for eye surgery and high patient volume has allowed it to be cost-effective and efficient, and only charge patients the equivalent of $16 for the surgery, two-nights stay, and a month’s worth of medication.15 Aravind has built a regional wireless network, which supports non-physician healthcare providers in their multiple eye centers across India (Exhibit 3). Aravind, with the help of UC Berkeley, has set up “eyecamps” and “vision centers” for people in rural areas.16 Patients at these eye-centers are examined by a nurse, and then via mobile technology receive a 1-2 minute consultation with an ophthalmologist from the hospital, including the transmission of photographs if necessary.17Aravind followsup with patients via SMS about surgery scheduling, medica-

EpiSurveyor, now called Magpi, is a mobile data collection system used worldwide, that was built in Kenya and is fully sustained by its own revenues. Its open source mobile data collection application allows health workers to exchange health information using smartphones.19 Community health workers can download patient information sheets, fill them out on mobile phones, and send them to a central system for analysis.

The application is efficient and easy to use, therefore providing accurate health data and allowing it to analyzing large amounts of health data in a short period of time. In Zambia, South Africa, the application helps track an immunization program by keeping stock of drugs at local clinics. The use of mobile devices and open source technology, plus support from providers such as Vodafone and foundations such as the UN, make this a cost-effective and scalable eHealth data solution.20 Training The global shortage of healthcare workers is another challenge being tackled by mHealth. For perspective, the nurse to population ratio is ten times higher in North American than it is in South America.21 In 2003, the Guatemalan Ministry of Health along with other partners launched TulaSalud. TulaSalud uses mobile phones to provide community health workers with physician support for diagnosing and decision making, and allows them to take calls from the local community for care, organize medical services, and refer patients to hospitals while following up on care.22 Using EpiSurveyor, as we saw in South Africa, TulaSalud can aggregate data and monitor disease outbreak.

Most importantly, TulaSalud delivers remote health training via mobile-based audio conferencing.

Electronic Health Records Electronic medical records provide a perfect example of how healthcare innovation in developing countries is leapfrogging technology by moving directly into the mobile space. Without the appropriate infrastructure for computer systems and web networks, the transition from paper records to electronic health records is nearly impossible. Therefore, healthcare innovators in developing countries have bypassed the 20th century technology infrastructure and gone straight to mobile, which is more accessible, affordable, and widespread.

A U.S.-based startup from California, EHRI, is bringing electronic health records to healthcare workers and patients in Africa and Asia by means of mobile technology. EHRI traditionally provides EHR solutions to hospital networks affiliated with religious institutions. The startup is a good example of American entrepreneurs improving their products and innovating in healthcare by looking abroad. HarmoniMobile, EHRI’s mobile solution for EHRs in developing nations, is low-cost and easy to use. The platform is built on an inexpensive tablet that runs a user-friendly user-interface that is powered by Android and the cloud. This alone brings the cost from millions of dollars down to just thousands.23 The tablets are Wi-Fi enabled, can connect easily to the local cellular network, and can take pictures. This allows doctors in developing nations to monitor Continued on page 40

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mHealth in Developing Countries

Exhibit 4: EHRI HarmoniMobile (EHR)

(image sources: http://ehrinternational.com/harmonimobile/) Continued from page 39

patients, prescribe medicine, take photos of injuries, and scan QR codes that identify a patient via a code on a wristband or card. It also follows the international standards for data capture, enables remote access, structures treatment plans, includes surgical checklists, has communication abilities, and more (Exhibit 4). The data is encrypted and protected by a strong firewall.24 It costs an astonishing $3,000-$5,000 to set a hospital up with this system.

Reverse Innovation McKinsey identified two factors that explain why some of the most compelling innovations in healthcare come from developing nations rather than developed ones. First, the sheer necessity of improved healthcare makes it absolutely imperative that local entrepreneurs innovate.25 Second, a weakness in infrastructure means that there are fewer constraints from entrepreneurs. Included in this is the lack of institutions, regulations, and resources.25 Also, because developing nations are battling the high-cost of healthcare, these healthcare innovations must be low-cost to adhere to a low-income, rural population. This is also referred to as “frugal innovation,” which involves simplifying ideas and focusing on just necessities.26 Finally, these innovations must be stable and reliable because they are being used in rugged, remote environments. In this context, developing countries serve as a laboratory for global health care innovation.27 One successful example of reverse innovation in mHealth is the mini pacemaker developed by Medtronic in India to tackle the issue of the high cost of pacemakers, as well as the shortage in healthcare professionals. India only has 100 electrophysiologists for a population of over one billion people.28 Cardiologists traditionally have to create a pocket in the chest to insert the pacemaker while threading leads through blood vessels and into the heart. Not only is this procedure complex, but it also requires highly trained and skilled healthcare professionals, which there is a shortage of globally. Medtronic’s mini pacemaker is the size of a vitamin pill, and is inserted via catheter through the femoral artery and up into the heart (Exhibit 5). This process does not require the use of a highly skilled specialist, it costs significantly less than a traditional pacemaker, the surgery is less complex and therefore less

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risky, and remote sensors in the pacemaker send out signals via smartphone to a cloud network.29 This innovation will make its way to Europe and the U.S. Challenges While all these projects and pilots show promise for the use of mHealth in developing nations, there are some challenges to globally implementing these technologies and processes. These challenges are also areas of opportunity for global healthcare innovators and entrepreneurs. One of the main challenges involves a lack of theory. In The Promise and Peril of mHealth in Developing Countries, Arul Chib argues that there is a failure of pilot projects in mHealth to replicate and scale to become sustainable ventures. He attributes this to a lack of theory. While mHealth studies do a good job of focusing on the technology and the methodology, they lack the theory, or the theoretical support. We do not fully understand mobile technology; particularly its usage, penetration, and adoption in healthcare and in the nations where studies take place. Therefore, we have no knowledgebase for the implementation of mobile health technology.30 Patricia N. Mechael, in her study titled The Case for mHealth in Developing Countries, argues that before we consider where mHealth can be applied, we must first look at organic examples of mHealth use in developing nations. Her first organic example of the use of mobile technology to exchange health related information comes from Egypt, where a new mother, now living with her husband’s family in a rural area away from access to educated individuals who could consult her on healthrelated issues, uses a mobile phone to contact her mother.10 This exchange of health-related information between mother and daughter is common in Egypt. From studying this behavior, we can further identify opportunities in mHealth.

Additionally, mHealth studies focus heavily on technology usage and job-related data as performance indicators rather than impact factors such as how the mHealth technology has improved the individual using it, the health worker using it, or the whole community. Therefore, while the technology and the usage of the technology in a given developing nation for a given disease and/or set of patients and a local clinic may prove successful, we lack clear evidence of overall improvement

mHealth in Developing Countries Global health issues are being instigated by the rising cost of healthcare. In developed nations such as the U.S., where the cost of healthcare is one of the highest worldwide as revenues for healthcare institutions drop, it is wise to look beyond our own borders and adopt low-cost mHealth innovations being used in developing nations. While the many examples of mHealth solutions showcased in this paper provide much hope for a positive future in global health, there are many challenges to be faced.

Among the most difficult is the scaling-up for mHealth pilot programs to become global ventures and worldwide healthcare solutions. As healthcare innovators and entrepreneurs, we should look to these challenges as opportunities in the global mHealth space, and also begin focusing on mHealth innovations in developing countries.

References Exhibit 5: Medtronic Mini Pacemaker

(image source: http://www.medicalelectronicsdesign.com/blog/medblog/ look-medtronics-miniature-pacemaker)

in healthcare and changes in health behavior.31 Without performance measurements of healthcare outcomes, global scalability is impossible. Furthermore, healthcare delivery programs are designed on the spot, funding streams are fragmented, and there is a lack of standards for capturing what is learned in the field.32 All this inhibits the process of scaling up an mHealth project.

This is the largest and most common challenge in the global mHealth space. Many pilots never become national or international ventures. mHealth experiments focus too much on pilot projects, and not on population health research and the criteria for those types of studies. Scale for mHealth projects can be accomplished in two ways. The first is establishing financial sustainability. The second involves integration with larger healthcare systems and national government programs.33 This has proved most difficult. The lack of scale can also deter reverse innovation; preventing certain mHealth innovations in developing countries from making their way back to developed countries such as the U.S. There is already the challenge of acceptance in the U.S., and American’s believe lo-tech and low-cost solutions are actually a regression rather than a progression.

Another challenge is establishing a global eHealth policy. Individuals, institutions, or regions are making decisions involving eHealth separately. However, an unsuitable policy in one region can hinder eHealth’s ability to become global. Maurice Mars and Richard E. Scott argue for a “glocal” approach, which involves establishing a global eHealth policy that is customized for and catered to local areas.34 McKinsey also comments on the isolation of healthcare innovation, stating that as a largely local activity solving local problems, innovations are not known across systems and borders.

McKinsey argues that healthcare leaders in developed nations need to understand the lessons of innovators in these developing nations to be able to replicate their solutions globally.35 Conclusion mHealth has proven to be a low-cost, affordable, accessible, and available solution to global health issues. While there are many examples of hi-tech eHealth and mHealth solutions in developed nations, the healthcare innovation happening in developing nations in this space is crucial to the global health crisis.

1. WHO. “Report of a High-Level Consultation.” The Financial Crisis and Global Health. Geneva. World Health Organization, 2009. Web. <http:// www.who.int/mediacentre/events/meetings/2009_financial_crisis_report_en_.pdf>.

2. Boutayeb, Abdesslam. "The Double Burden of Communicable and Noncommunicable Diseases in Developing Countries." Transactions of the Royal Society of Tropical Medicine and Hygiene 100.3 (2006): 191-99. Print.

3. C. Schoen, R. Osborn, D. Squires, and M. M. Doty, "Access, Affordability, and Insurance Complexity Are Often Worse in the United States Compared to 10 Other Countries," Health Affairs Web First, published online Nov. 14, 2013. <http://www.commonwealthfund.org/Publications/In-the-Literature/2013/ Nov/Access-Affordability-and-Insurance.aspx>.

4. The Editorial Board. "The Shame of American Health Care." The New York Times. The New York Times, 17 Nov. 2013. Web. 28 Apr. 2014. <http:// www.nytimes.com/2013/11/18/opinion/the-shame-of-american-health-care.html>.

5. Drury, Peter. "EHealth: A Model for Developing Countries." EHealth International Journal (2005): 19-26. Web. 26 Apr. 2014.

6. WHO. “WHO eHealth Resolution.” Who Executive Board Adopts a Resolution on eHealth. World Health Organization, 2005. Web. 01 May. 2014. <http://www.who.int/healthacademy/news/en/>.

7. WHO. “Trade, Foreign Policy, Diplomacy, and Health.” E-Health. World Health Organization, 2014. Web. 27 April. 2014. <http://www.who.int/trade/ glossary/story021/en>.

8. World Bank. “Information and Communications for Development.” Maximizing Mobile. The World Bank. 2012. Web. 23 April 2014. <http://siteresources.worldbank.org/EXTINFORMATIONANDCOMMUNICATIONANDTECHNOLOGIES/Resources/IC4D-2012-Report.pdf>.

9. World Economic Forum. “Amplifying The Impact: Examining the Intersection of Mobile Health and Mobile Finance.” A discussion guide for collaborative insight presented by the World Economic Forum, in partnership with the mHealth Alliance. 2011. Web. 26 April 2014. <http://www3.weforum. org/docs/WEF_HE_IntersectionMobileHealthMobileFinance_Report_2011.pdf>.

10. Mechael, Patricia N. "The Case for MHealth in Developing Countries." Innovations: Technology, Governance, Globalization 4.1 (2009): 103-18. Print.

11. Kelland, Kate. "South Africa Risks Spreading Totally Drug-resistant TB: Study." Reuters. Thomson Reuters, 16 Jan. 2014. Web. 02 May 2014. <http://www.reuters.com/article/2014/01/17/us-tuberculosis-southafrica-idUSBREA0G00B20140117>.

12. Stop TB Partnership. Mhealth To Improve TB Care. Version 1. 2012. Web. 23 April 2014. <http://www.stoptb.org/assets/documents/resources/publications/ acsm/mHealth%20to%20Improve%20TB%20Care.pdf>.

13. Ivatury, Gautam, Jesse Moore, and Alison Bloch. "A Doctor in Your Pocket: Health Hotlines in Developing Countries." Innovations: Technology, Governance, Globalization 4.1 (2009): 119-53. Print.

14. Arivind Eye Care System. 2013. Annual Report 2013. Arivind Eye Care System. Tamil, Nadu, India.

15. Karmali, Naazneen. "Aravind Eye Care's Vision for India." Forbes. Forbes Magazine, 15 Mar. 2010. Web. 01 May 2014. <http://www.forbes.com/ global/2010/0315/companies-india-madurai-blindness-nam-familys-vision.html>.

16. Surana, Sonesh, Rabin Patra, Sergiu Nedevschi, and Eric Brewer. "Deploying a Rural Wireless Telemedicine System: Experiences in Sustainability."

Computer 41.6 (2008): 48-56. Print.

17. Kahn, J. G., J. S. Yang, and J. S. Kahn. "'Mobile' Health Needs And Opportunities In Developing Countries." Health Affairs 29.2 (2010): 252-58. Print.

18. Ravilla, Thulasiraj., Ramasamy, Dhivya. “Efficient high-volume cataract services: Continued on page 44

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Gaming for Health

Gaming for Health

By Phyllissa Shelton and Rebecca Scott The future is here and almost everyone under the age of 60 is familiar with gaming and computer technology. This is surely the next big innovation in healthcare as we seek to hand more responsibility for health outcomes to patients themselves and continuously find ways of reducing unwarranted costs.

Examples of how gaming is achieving these things are being seen today at the National Star College Cheltenham which cares for young disabled adults. More widely gaming technology is being trialled in a range of healthcare centres for patients with a variety of musculoskeletal conditions.

Gaming in Action

engaging and motivating for patients, featuring powerful audio and visual stimuli to help them overcome their limits and regain their motor abilities by exercising.

Patients at the National Star College present with an array of conditions, predominantly Cerebral Palsy and Acquired Brain Injury. These patients have generally experienced a great deal of physiotherapy throughout their lives and the opportunity of offering new, interesting and motivational treatment activities is key to keeping them motivated and on board with their treatment plans.

One of the important features of MIRA is that it gathers a large variety of statistics during game play, providing effective performance and exercise compliance monitoring of patients. Additionally, it functions as a diagnostic tool that measures range of motion (ROM) angles of the affected limb before and after the rehabilitation session and several other physical indices, such as the level of pain or stiffness for a specific limb.

Whilst the use of technology doesn’t replace the patients’ traditional physiotherapy, it plays an important role in augmenting therapy and could potentially reduce the need for more traditional therapies.

It is a valuable tool for Physiotherapists who are able to prescribe a set of MIRA exergames, bespoke for their patient, and be able to monitor the patients' performance qualitatively as well as quantitatively measured by the platform.

At the National Star College, selected patients are incorporating specific gaming exercises within their therapy programme, with promising success. The gaming technology being deployed is MIRA, a software platform of virtual games with the purpose of aiding physical rehabilitation therapies and diagnosis processes of several orthopaedic and neurological disabilities.

The sensor commonly used by the platform for user interaction with the software platform's games and diagnostic tools is the Microsoft Kinect, a 3D camera sensor PC compatible. This device has the capability of recognising the 3D location of the body joints, thus allowing them to be tracked and correlated with video game movements inspired from the usual physical rehabilitation exercises.

The system is composed of a patient management dashboard, providing the ability to create personalised rehabilitation schedules for each patient from a range of video games that are

Currently, the software is most developed for patients with upper limb therapy requirements. This package consists of several adjustable games that evaluate and train the gross and fine motor func-

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tions of the shoulder in particular, with custom options for selecting difficulty, area of movement and time of play. The software is being used in a number of medical centres across the UK, including several clinical trials for patients with neurological conditions as well as orthopaedic conditions.

As would be expected, the patient is actively involved in the choice to use gaming therapy and the patient also plays an important role in providing feedback to aid the continuous development of the software. Not all patients are assessed as suitable. The criteria used to assess users, includes ensuring patients have minimum movement abilities and cognitive awareness, sufficient head control and neck posture and an interest in using gaming therapy.

Whilst Gaming Therapy is a reasonably low-risk technology fatigue, risk of injury due to over-exertion, and incorrect set up of the software need to be considered. Rebecca Scott, Senior Physiotherapist at the National Star College advises, ‘The main consideration needs to be that of monitoring fatigue levels.

Gaming activities can often be distracting which has the risk of masking signs of fatigue leading to unnecessary discomfort of tiredness or muscle over use.

The preliminary assessment and setup can avoid fatigue by setting activities at a low rate initially, which also promotes familiarity with the activity prior to the patient working on specific goals’.

Gaming for Health Reported Benefits Scott describes the benefits to patients and clinicians, “Gaming Software utilising the Kinect technology, such as MIRA, offer advantages to both patients and clinicians. Patients report that they find the activities achievable and enjoyable and particularly like the flexibility of the software allowing activities to be tailored to their individual needs, with the ability to ramp up the exercises and programme as they improve.”

“Individual activities are specifically designed to encourage different physical skills, from upper limb range of movement, balance skills in sitting or standing, stamina, concentration, control of movement during activity, promote posture and body spatial awareness through visual feedback. For the patient this provides objective evidence of improvement in physical ability.”

“For the clinician, the software records data from which they can compare previous sessions and enables adjustment to activities to further tailor the software to the patients’ needs and current ability. Where patients present physical progress the evidence is tangible from the recorded data. (Examples of performance data include points scored in each game, distance the wrist travels, average speed of upper limb movement throughout the game etc.). By adapting the physical requirements of the activities accordingly the therapist can therefore also have a measurable influence on the patients’ improvement’.

Case Studies Example 1: Jack is a teenager with cerebral palsy, weak core muscles and com-

promised postural control. As part of his routine physiotherapy programme he uses a standing frame to promote weight bearing, aid circulation, offer a prolonged lower limb stretch and also to work on his upper body control and core stability through upper limb activities.

Normally, upper limb activities would be of a traditional nature and include throwing and catching or general exercises. Using MIRA, Jack has been able to continue to use the standing frame and work on both his upper limb movement and core through activities set up specifically for him using the software.

In one exercise Jack plays CATCH, which is a game where he has to move his arm to catch objects that appear in several areas of the screen before they disappear, this requires Jack to use wide gross movements on the frontal plane such as stretching. Because Jack’s core stability is compromised he tends to fall to his left side, so the activity has to be

set up so all the activity occurs on his right to encourage more prolonged control of his posture – he has to maintain an upright posture to be able to access the game. Not only does Jack find the therapy more fun than traditional activities, the MIRA software records an array of relevant data from which to compare to previous sessions.

Example 2: Stephen is a young man with an acquired brain injury who has poor upper limb range of movement and poor control of movement. Stephen’s limitations are due to increased tone distally and whilst his range is not significantly compromised, the patterns of his movements are. The main aim of using MIRA with Stephen has been to help develop control of movement as well as encouraging him to maintain, if not improve, his range of movement in both left and right upper limbs.

Several activities have been added to his programme, of which two have been most beneficial. The first, Follow, requires the patient to hover their hand over a box as it moves around the screen.

The muscles have to work with a fine balance of control in order to achieve this, taking much concentration from the patient. The incentive of the game is to keep the hand within the box, if the arm doesn’t stay in the box due to fatigue, poor control or otherwise the soundtrack which is playing fades until the hand returns to the box. For patients motivated by music this game is particularly appealing.

Continued on page 44

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Gaming for Health Continued from page 43

Another game Stephen plays is Move.

This activity requires the same degree of upper limb control but with set movement patterns such as a circle or figure of eight. The patient is required to trace the shape without leaving the designated path. Deviating from the set path incurs a loss of points. In both games the activities can be specifically set up for the individual patients needs and when they show signs of progress the parameters can be altered easily to challenge the patient to achieve improved physical control and skills.

Future Development, Application and Opportunity In these small trials it has been demonstrated that there are particular benefits of introducing gaming therapy including: reductions in the number of outpatient visits patients need to attend in person with physiotherapists; ensuring that follow-up outpatient visits are more worthwhile as results can be shared and discussed; making rehab more enjoyable, easier and fun for patients; improving health outcomes; and, reducing the costs of outpatient physiotherapy.

Guy's and St. Thomas' NHS Foundation Trust has also trialed MIRA with a group of adult patients with neurological pathologies. Mark McGlinchey, Clinical Specialist Physiotherapist at Guy's and St. Thomas' NHS Foundation Trust, believes: "MIRA is an innovative product that could alter the way

therapy is delivered to patients in the future. It has the potential for patients to be more active in their rehabilitation, which should result in improved patient and service outcomes."

Cosmin Mihaiu, CEO of MIRA Rehab Ltd says: “We are very excited about how positively patients and physiotherapists are responding to MIRA. Based on feedback from the institutions using it, we are improving MIRA and adding more exergames to incorporate more exercises”.

Gaming therapy is being developed to help with common disorders such as shoulder injuries and repairs, elderly fall prevention, speech therapy, autism motor control improvement, cognitive rehabilitation, and many more.

The technology could also soon be playing a key role in supporting the rehabilitation of patients with artificial

Continued from page 41 the Aravind model.” Community Eye Health Journal 27.85 (2014): 07-08. Print.

19. http://www.datadyne.org/magpi-mobile/ 20. Akter, S., Ray, P., “mHealth – an Ultimate Platform to Serve the Unserved.”

IMIA Yearbook of Medical Informatics (2010). Print.

21. O’Brien, Paul., Gostin, Lawrence O., “Healthcare Worker Shortages And Global Justice.” Milbank Memorial Fund. October 2011. Web. <http://www.milbank.org/ publications/milbank-reports/158-reports-health-worker-shortages-and-global-justice-2>.

22. http://www.iheed.org/reports/iheedreport_2011.pdf 23. Espinoza, Martin. "Sebastopol Startup Brings E-health Records to Developing Countries." PressDemocrat.com. N.p., 17 Dec. 2013.

Web. 30 Apr. 2014. <http://www.pressdemocrat.com/article/20131217/ business/131219584#page=0>.

24. http://ehrinternational.com/harmonimobile/ 25. Ehrbeck, Tilman, Nicolaus Henke, and Thomas Kibasi. "The Emerging Market in Health Care Innovation." McKinsey & Company. N.p., May 2010. Web. 18 Apr. 2014. <http://www.mckinsey.com/insights/health_systems_ and_services/the_emerging_market_in_health_care_innovation>.

26. Kelland, Kate. "Analysis: Healthcare Sees Emerging Future in Frugal Innovation." Reuters. Thomson Reuters, 20 June 2012. Web. 01 May 2014. <http://www.reuters.com/article/2012/06/20/us-global-innovation-idUSBRE85J0G120120620>.

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28.

29.

30.

31.

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34.

35.

limbs and amputations.

Gaming therapy offers alternatives and replacement treatments for some patients and has been shown in limited studies to be popular with patients and to support good health outcomes. This is the next frontier in health care being co-delivered by patient and clinician in partnership and it is hoped that in the near-future it will be introduced more widely within mainstream physiotherapy and rehabilitation care pathways.

About the authors: Phyllissa Shelton is a Health Innovation Consultant and Mentor and Rebecca Scott is a Senior Physiotherapist at National Star College.

Anyone interested in learning more about these case studies can contact Cosmin Mihaiu directly at cosminmihaiu@ mirarehab.com. n

edge@Wharton." Harvards Clayton Christensen Can Medical Innovation in Developing Countries Disrupt the US Healthcare System Comments.

Knowledge Wharton, 20 Feb. 2014. Web. 21 Apr. 2014. <https://knowledge. wharton.upenn.edu/article/harvards-clayton-christensen-can-medical-innovation-indeveloping-countries-disrupt-the-u-s-healthcare-system>.

Bottles, Ken. “Reverse Innovation and American Health Care in a Time of Cost Crisis.” Physicians Executive Journal. August 2012. Web. <http://ldihealtheconomist. com/media/reverse_innovation_and_american_health_care_in_a_time_of_cost_crisis.pdf>. http://www.medtroniceureka.com/innovation-articles/inspiration/innovating_for_ the_wider_world Chib, A. "The Promise and Peril of MHealth in Developing Countries."

Mobile Media & Communication 1.1 (2013): 69-75. Print.

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Mobile Media & Communication 1.1 (2013): 69-75. Print.

Kim, Jim Yong, Paul Farmer, and Michael E. Porter. "Redefining Global Health-care Delivery." The Lancet 382.9897 (2013): 1060-069. Print.

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Mars, Maurice., Scott, Richard E., “Global E-Health Policy: A Work In Progress.” Health Affairs, 29, no.2 (2010):237-243. Print.

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