The Journal of mHealth Vol 2 Issue 1 (Feb 2015) by The Journal of mHealth

WHAT’S INSIDE

NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

The

Journal of mHealth The Global Voice of mHealth

February 2015 | Volume 2 Issue 1

Digital Health 2015

What Can We Expect?

IN DEPTH

REGULATION

INSIGHT

Latest from the Digital Health 100

FDA Issues New Guidance

5G and the Implication for Healthcare

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

Global Digital Health 100 The most innovative companies in the field of digital health Please see the full list on page 4.

Editor's Comments

Welcome As the Managing Editor here at The Journal of mHealth it has been fascinating to see how digital health has evolved over the past few years. The sheer momentum that now seems to be behind the shift towards digitisation of healthcare is producing some extremely interesting issues, opportunities for change and exciting technological advancements. At the same time it is also producing very constructive debate that is fuelling industry-wide discussions relating to some of the wider ethical, cultural, and practical consequences of using technology-led services and solutions to assist in the delivery of healthcare. In this edition of The Journal we consider some of these issues and how they might evolve, as well as looking at the direction that mobile and digital health technologies are taking, and what we can expect to see from the industry as we progress through 2015. I am in no doubt that we will see many suggestions of how certain technologies announced during the course of the year are going to revolutionise healthcare, but what is becoming very evident is that healthcare is ill-served by continually searching for the next medical Uber. The digitisation of healthcare is not going to be a fast process, nor should it be. Investment in technology needs to be considered, intelligent, and effective. The problem is that healthcare isnâ&#x20AC;&#x2122;t really one industry, it is hundreds of smaller specialties grouped under the same umbrella heading. Technology has the opportunity to penetrate all of these sub-sectors, but the ways in which it will do this are going to be different in most cases. This means many different technologies, or variations and configurations of similar technologies, all working towards specific tasks. The significant part is that for these technologies to deliver real paradigm changes in the culture of medicine, they must be interoperable. This is a huge task and there are many issues involved, which is why it will not happen quickly what we are beginning to see though is real progress towards this goal. We also take a look towards the future. There are many projects currently underway around the world to define and develop a 5G mobile standard, and it is predicted that within the next 5 years this superfast mobile communications network could be available. What will this mean for healthcare? Given the significant growth in the number of connected health systems, mobile medical devices, and next generation health monitors and trackers, that we can expect to be more widely used across healthcare delivery over the next few years, any system designed to increase network capacity, improve data transfer speeds, develop flexible connection options, and maintain stable delivery of connected services is going to be beneficial. What is exciting is that, in the past, we have consistently seen technology adapt to make use of upgrades in networked capabilities, and with the introduction of 5G we can surely expect to see the same.

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 ÂŠ 2015 Simedics Limited

Matthew Driver Editor

The Journal of mHealth

Table of Contents

In This Issue 4

Digital Health in 2015: What Can We Expect? Looking ahead and discussing what we can expect from the mobile and digital health industries as we go through 2015, we consider the major issues facing the industry and the technologies that are having the biggest impact in connected healthcare.

In Depth with the Global Digital Health 100 We continue the coverage of our Global Digital Health 100 Awards by featuring news and articles from some of the 2014 winners.

5G and the Implication for Digital Healthcare It has been suggested that mobile and connected health systems could emerge as one of the biggest applications of future 5G networks. With a number of projects underway, around the world, aimed at delivering the 5G standard by 2020, we take a look at what this technology may mean for the future of healthcare.

February 2015

Table of Contents

Industry News 10

New App Helps Sports Professionals Reduce Stress and Anxiety

Digital Healthcare and Paradigm Shifts in Medicine

Predictions for mHealth in 2015

From Pilot to Take Off Watch mHealth Fly in 2015

Novartis and Qualcomm Launch a $100m Investment Venture to Fund Digital Technologies

FDA Issues Draft Guidance on General Wellness Devices and Apps

Activ8rlives to Develop its First Medical Smartwatch for Continuous Monitoring of Oxygenation for UKâ&#x20AC;&#x2122;s COPD Patients

Digital Mobile Solution Places International Travellers in Control of their Healthcare Worldwide

Apple's Health Tech Takes Early Lead Among Top U.S. Hospitals

Predictions for mHealth: What Do We Need to Think About in the Future?

Major Health Insurance Hacks Bring Fresh Concerns for Data Security

Audio Port Connectivity Platform by LGTmedical is an mHealth Game Changer

Blue Spark Unveils Wearable Bluetooth Thermometer at CES 2015

Smartphone Apps Just as Accurate as Wearable Devices

Oracle and Proteus Integrate Digital Health Feedback System to Help Increase Clinical Trial Accuracy

U.S. FCC to Look Into NewGeneration Wireless Networks

Samsung 5G Development Could Benefit Mobile Health Applications

Upcoming Events

Advertisers Index

Healthcare to be a Focus for Google Glass 2

Innovative Mobile Surgical Training Platform Introduces Customised Feeds for Educational Resources

World-First Insulin Pump for FourYear-Old Australian Boy

UK Design Council Recognises Healthcare Design Among its 70 Ones to Watch

To subscribe to The

Journal of mHealth The Global Voice of mHealth

Please visit our website at www.thejournalofmhealth.com

Samsung Developing Wearable Health Sensor for Stroke Detection

The Journal of mHealth

Digital Health 2015: What Can We Expect?

Digital Health 2015

What Can We Expect?

2014 proved a hugely successful year for the advancement of the mobile and digital healthcare agenda, with penetration of connected health technologies growing among healthcare providers, developers, users, and patients, alike. In this article we look ahead and discuss what we can expect from the mobile and digital health industries as we go through 2015. Do-it-yourself healthcare

A recent report published by PwC Health Research Institute (HRI) suggests that consumers and physicians are increasingly ready to embrace the use of at-home and personal healthcare devices and services.1 The use of technology in daily life has become so ubiquitous that consumers and healthcare professionals alike are beginning to see the benefits in terms of convenience, and reductions in costs of having high-tech

February 2015

personal medical kits that can help diagnose illnesses, flag early signs of trouble, allow recovery and rehabilitation to occur closer to home and to help maintain healthy ways of living.

We have already seen the first stages of this with developers offering a complete range of devices and apps capable of monitoring vital signs, analysing blood and urine samples, tracking medication adherence and much more. 2015 is likely to be the year that we begin to see the best of these devices and smartphone applications begin to penetrate more widely into the consumer market, as people begin to adapt to new ways of accessing and receiving healthcare. The need for a stronger evidence base and supporting regulatory landscape will likely help ensure that only devices/solutions capable of meeting the necessary

standards of quality will survive. In turn this will help increase consumer trust and build confidence among healthcare professionals in the effectiveness of these personal medical tools, which will be critical for gaining wider acceptance. Rise of clinical digital tools Up until now, we’ve seen mobile health funding and revenue generally focused on consumer health devices and apps, but a recent report by Lux Research estimates that clinically-focused mobile health solutions “will soar past consumer-focused counterparts after a slow start due to regulatory approval barriers and slower integration into physicians’ workflow.”2 Analysts anticipate the market for clinical devices (such as connected vital sign monitors and other diagnostic tools) that leverage mobile technologies will grow from $372 million

Digital Health 2015: What Can We Expect? in 2013 to $16 billion in 2023, while consumer health applications will increase from $2.5 billion to $7 billion over the same time frame. Mobile technologies will also allow specialty testing to migrate closer to the point-of-care. Combining smartphones with sensors and purposeful, miniaturised medical devices will allow for portable, cost-effective, point-of-care clinical diagnostic and screening tools to be brought to a broader audience of healthcare providers. These emerging capabilities, along with market trends like the shortage of physicians and the critical need to contain costs, will help fuel growth in the clinically focused mobile health space. Adoption of these tools will depend on ease of use, accuracy, relevancy and how much friction or disruption they cause in the daily workflow of doctors. The objective is to create apps and devices that doctors can’t live without. This means adaptable, time-saving tools that have the potential to make healthcare more efficient by speeding-up diagnosis, improving patient monitoring and reducing unnecessary visits to a physician or hospital. Balancing privacy and convenience Finding the right balance between privacy and convenience continues to be an issue in the connected health space. The 2014 HRI consumer survey found that, for 65% of all respondents, data security was more important to them than convenient access to imaging and test results, doctor’s notes, diagnoses and prescriptions. Recent health security breaches have further compounded the debate over health related information, meaning that cybersecurity measures will have to focus on what stakeholders in the healthcare system demand i.e. health data that is private, secure and accessible. It has been suggested that 2015 will be the year of the healthcare hack, and if recent headlines are anything to go by, this is one prediction that is already proving to be accurate. Many consumers and people within the industry often fail to realise the significant tangible value of health records. The vast amount of personal, financial and medical data, held within an individual’s health record makes it an extremely attractive target for thieves, with stolen records commanding

up to $1,300 per record on the black market. The reason this data is considered so valuable, is that compromised information can be used for both direct financial gain, and for sophisticated identity theft to obtain access to medical services and medications. Given that many healthcare providers around the world are still using legacy IT systems the opportunities for hackers to access records is high. High-tech thieves still manage to circumnavigate bank security measures - an industry that has spent billions trying to secure IT and data management systems, so it is little wonder that the healthcare sector is seen as an easy target. Healthcare cybersecurity has not always been given sufficient priority, but as the volume of data generated by the provision of care continues to grow, then this will have to change. Systems are becoming increasingly connected which, in turn, is leading to an increase in the level of opportunities for intrusion. Many healthcare organisations are turning to cloud-based services to help address and minimise these problems but it remains an evolving issue for all those involved. Although we are likely to see more headlines during 2015 relating to health information breaches, we can also expect considerable discussion, debate, and initiatives to ensure health data security is well addressed. Clarification of the regulatory landscape The regulatory and legislative landscape pertaining to the development and use of digital and mobile health services, is currently extremely fragmented and this continues to hinder both development and deployment of services. Connected medical devices and mobile health services produce some unique problems for governing bodies, and to-date regulatory frameworks around the world have failed to adequately understand, and therefore adapt to, the idiosyncrasies of the connected health market. 2014 saw some clarification on the guidance given in both the US and European markets, with the FDA (in the former) issuing draft guidance on how they would look to handle mobile health apps, connected devices and digital health

solutions, and the European Commission (in the latter) issuing a Green Paper on how to regulate mHealth. Despite this however, the issue in these regions, as in other countries around the world, remains very ill-defined. As we go through 2015, it is expected that the regulatory landscape will remain fragmented. We will hopefully see further activity to properly introduce regulation for connected medical devices and mobile health services, but in all likelihood this means that each country will be looking to implement its own way of regulating these technologies. Many countries like the UK are trying to find ways of regulating the sector, that will ensure safety and efficacy, whilst also recognising that these technologies change and develop rapidly, so the regulations also need to be flexible enough to reflect those changes and advancements, without stifling innovation. In the UK, NHS England has made significant steps towards encouraging a collaborative approach to the issue by working with a range of different official bodies to try and establish a regulatory framework that will encourage innovation, whilst ensuring the effectiveness and necessary levels of safety are maintained. Redefining the conventional One thing that has become apparent in healthcare, as in many industries, is that even though people are generally working with better technology, it is often being used to replicate old ways of working. This means that whilst some efficiency or improvement is derived from the use of the technology, it is not always implemented with a view to changing conventional ways of working. Technology has the potential to transform what we do, not just help us do the traditional things slightly more quickly. Healthcare technology is at a point now whereby there is the option to do both. Enhance the conventional methods of operating, by introducing technology and connected services into the mix, or, perhaps more interestingly there is also the potential to ask “how do we use technology to redefine and redesign conventional ways of working?” Obviously, healthcare - by its very nature Continued on page 6

The Journal of mHealth

Digital Health 2015: What Can We Expect? Continued from page 5

- will always need tactile, human relationships at the core of delivery, but there are many elements of care provision that lend themselves to redefinition through the integration of technology. Redesigning services in this way will take time, but the benefits of doing so could be significant. Evaluating outcomes No one is in any doubt that technologyled services can help deliver cost efficiencies, streamline workflows, and increase industry capacity, the difficulties for the people commissioning and deploying these services is determining which solution to choose from the many different options available. Determining the outcomes and value of technology-led services will be critical, if healthcare managers, commissioners and healthcare professionals are to be able to make informed decisions as to which solution can best deliver results for their patient cohorts. Similarly, as the range of devices and apps targeted at health consumers increases, then there becomes a growing need to establish an evidence base that supports the claims made by providers, so that consumers are able to make informed decisions. Stakeholders across the connected care community are demanding greater access to outcome data, but demonstrating and evaluating outcomes of mobile and digital health solutions can sometimes be difficult, as the solutions do not always fit into traditional healthcare reporting models. That said, a digital healthcare ecosystem has the potential to go beyond convention by revealing outcomes and returns on investment that were previously difficult to assess. In addition to looking at measures like safety and efficacy (from clinical trials) we can begin to consider information from economic data, electronic health records, genomic data, labour statistics, and public health data. It is now also possible to monitor data in real-time, allowing evidence to be collated on the ways in which solutions are being used, actual usage data, and to record things like compliance and adherence to treatment and management plans.

The nature of the technology also builds direct relationships between healthcare organisations and their patients,

February 2015

making it easier to determine patient satisfaction and understand in greater detail the impact that services are having upon actual health outcomes. In an age when the empowered-patient has the opportunity to influence many aspects of their individual care, this means that organisations can begin to understand outcomes at a granular level, thus ultimately allowing solutions to be tailored to meet individual expectations and requirements. User data is routinely used in other industries to showcase the value of a product. With the convergence of market forces and technology in healthcare, patient data will ultimately become a more powerful factor in the measuring of outcomes and value. As mobile and digital health developers increase the capabilities of their systems then the process of measuring outcomes will also become a feedback loop, that continually helps improve the solutions on offer. Big data analytics, and selflearning systems will further enhance this process leading to automated delivery of efficiencies and benefits within the system, simply through its use. Organisations that can demonstrate value to patients and physicians by improving care and outcomes will continue to form symbiotic relationships with customers.1 Open-source for open health In its 2014 report PwCâ&#x20AC;&#x2122;s HRI suggests the move to make health data more openly available will not only increase transparency in the system, but will likely introduce significant opportuni-

ties for the industry. Making data available through open-source initiatives has particular potential for the digital and mobile health sectors, as those in healthcare begin to recognise the value of having rapid and agile development policies, that have delivered so much opportunity in other industries. We are likely to see many more of these types of projects introduced during the course of 2015. Technologies to Watch The start of 2015 has been awash with articles and blogs discussing the vast array of technologies that we can expect during the course of the year. Some of these have been around a while and are now beginning to gain traction for use in the health and medical fields, and some are still very early-stage, but offer promise for the future. Here, we consider some of the technologies and technology-led services that are most likely to become more widely available over the course of the coming year. Remote clinical trials Already this year we have seen the approval of Europeâ&#x20AC;&#x2122;s first fully remote clinical trial. The VERKKO trial which will be conducted in Finland will be the first European remote clinical study to include full electronic informed consent.4 A collaboration between Langland, Mendor and Sanofi will study Mendorâ&#x20AC;&#x2122;s 3G-enabled wireless blood glucose meter with a glucose profiling technology (Mendor Smart) in patients with diabetes. It will also evaluate the feasibility and efficacy of patient engagement and patient-

Digital Health 2015: What Can We Expect? investigator interaction through Clinpal, a platform developed by eClinicalHealth.5 As pharmaceutical companies and medical device manufacturers seek to adopt a more rapid route to market, then the use of this type of trial will become more prevalent. In a similar sign that digital and mobile components are beginning to play a greater role in the clinical trial process, Oracle recently introduced the Health Sciences InForm Medication Adherence Insights Cloud Service. A solution that has been designed to integrate the market-proven “smart pill” system from Proteus Digital Health, to automatically send medication ingestion data directly into the clinical trial database.6 The platform helps researchers more accurately and efficiently track and manage the use of medication during clinical trials—a historically laborious and errorridden process. The new solution automates data collection and captures accurate medication ingestion information. By providing direct and rapid validation of the quantity of medication a patient ingests and the time of ingestion, the service can help health sciences organisations lower the risk of clinical trial failures by identifying medication adherence issues early, improving dosage decisions, and enhancing drug safety. This helps to accelerate trials and reduce costs by eliminating imprecise, time-consuming, and expensive manual processes for collecting adherence data, such as pill counts and patient questionnaires. Pharmaceutical companies, have for a long time, foreseen the benefits that connected and remote monitoring solutions will bring to the trial stage of new prod-

uct developments, and it would seem that the technology is now at a point where those opportunities are beginning to be realised. Greater mobility in telehealth 2014 was a significant year for telehealth project introductions, and the coming year looks set to continue this trend. One thing that we are beginning to see, is growth in the flexibility of these solutions and services as the technology employed moves increasingly towards mobile delivery. Telehealth and telecare has been around for many years now, traditionally being delivered through the use of proprietary systems that have had limited adoption. Healthcare providers wishing to introduce a telehealth care stream were, in the past, required to make significant capital investments in equipment, staffing costs and support services in order to deliver relatively small-scale telehealth projects. What we now see, is telehealth and telecare services migrating towards implementation using mobile technologies. Using technology that is already in a person’s home, or in the case of a smartphone kept with someone throughout most of the day, has made it much easier for provider organisations to deploy telehealth and telecare services, and for those services to be more effectively managed. There is no longer the significant up-front investment needed to deliver tele-consulting services. Similarly, the development timeline has decreased, meaning services can be developed more quickly, and in ways that are adaptable to meet the needs of the provider organisation and the needs of the patient. In the same way, services can be easily scaled-up with minimal additional cost to the over-

all project, which allows organisations to manipulate tele-consultation services to effectively deal with capacity issues. What we are beginning to see, is not only an increase in adoption of these types of services, but also an increase in the level of sophistication with which a system will help deal with the needs of particular patient cohorts. Companies are already incorporating data analytics, and machine learning enhancements within these systems, aimed at providing intelligent controls to manage usage. This helps ensure resources are utilised efficiently and effectively. Clinical integration of wearables ‘Wearable technology’ had to be one of the most commonly used phrases associated with healthcare during 2014, but to date many of the systems available are targeted primarily at the consumer health and wellness market. Whilst these devices have had a profound influence on delivering the current boom in consumer demand for health related technology, that is in turn helping people to become more personally invested in managing their own health and wellbeing, the devices and systems currently available have somewhat limited application beyond helping people to maintain a healthy lifestyle. This looks set to change across both the consumer and the clinical healthcare markets as we progress through 2015. In addition to the release of new health and fitness trackers that will deliver upgraded sophistication, allowing people to monitor heart rate and other vital sign data, we can also expect to see the rise of the medical wearable device. In fact already this year we have seen a significant number of announcements launching wearable devices aimed directly at people with particular medical conditions. Diabetes care is one area where we are starting to see the use of different wearable and implantable connected devices, that can monitor, record, analyse and in some cases influence behavioural or treatment processes. Similar devices with different wearable profiles are also being developed for conditions including; COPD, parkinson’s, dementia, heart related conditions, and physical disabiliContinued on page 8

The Journal of mHealth

Digital Health 2015: What Can We Expect? Continued from page 7

ties. Expect to see many more of these announcements going forward. Visualise the data Healthcare professionals and patients can often find the raw data from devices and monitors difficult to interpret in its original form. Presenting data in a meaningful way that provides some form of context, or gives data relevance, makes it much more useful to both patients and healthcare professionals. Visualisations are an extremely effective method of turning source data into something meaningful. Diagrams, 3D models, graphs, historical charts, dashboards, alerts and indicators are all methods that can be employed to present data in a visual format, so that it is quickly and easily understood. Many healthcare organisations are already looking to develop dashboards and platforms that can help them easily display relevant patient information from a variety of sources. As the number of data sources increases then the need to efficiently process and react to analytical insights will become even more important. The opportunity for data visualisation across the healthcare spectrum is vast, and is expected to continue to grow alongside the introduction of new devices and digital services. Intelligent technology There is consensus across the healthcare community that whilst technology-led services are going to play a significant role in the delivery of modern healthcare,

they must be deployed in an intelligent way. This means: simple integration into workflows; providing the ability to scale and increase capacity, introducing flexibility to allow agile healthcare delivery; and, preventing duplication of services. An algorithmic approach to medicine is something that many are hoping to avoid, but this is not to say that machine learning, intelligent systems, and ultimately artificial intelligence can not have a profoundly positive impact on healthcare. Currently many of the digital systems in use are purely diagnostic or treatment based. What we can expect to see over the relatively near-future is the combination of these elements in order to create systems that can employ some level of ‘intelligence’. By combining different technologies within one system it becomes possible to track a patient’s health, analyse those results, adjust treatment plans, and administer medication or recommend the best course of action, all from within the one platform. This type of informed machine intervention is already used in closed-loop systems for conditions like diabetes, where ‘smart’ blood glucose monitors can analyse results instantly, calculate the necessary insulin dose required, and then communicate that information to a wearable insulin pump, which can administer the insulin directly into the body. This type of system reduces the need for intervention by healthcare professionals, and significantly improves the day-to-day management of a condition like diabetes.7 Also, already in use are predictive eICU systems that can assess vital sign data in real-time, analyse that data, and using advanced predictive algorithms calculate the likelihood of cardiac events well

in advance of them actually occurring.8 This gives physicians advanced warning of adverse events and the opportunity to take preventative action. Systems are also in development that will track trends and fluctuations in a patient’s health in order to catch early signs of heart attacks or strokes. Many of these systems are being designed to be wearable, which allows them to monitor people at risk of these symptoms 24-hours a day. The hope is that by using data analytics and machine learning techniques many more systems we will be able to move into a new era of preventative medicine. References 1. ‘Top Health Industry Issues of 2015: Outlines of a market emerge’. PwC Health Research Institute, 2014. 2. mHealth Showdown: Consumer and Clinical Devices’ Battle for Market Dominance. Lux Research, 2014. 3. “Hackers Sell Health Insurance Credentials, Bank Accounts, SSNs and Counterfeit Documents for over $1,000 per dossier”. Dell SecureWorks, 2013. (http://secureworks.com/resources/blog/ general-hackers-sell-health-insurance-credentials-bank-accounts-ssns-and-counterfeit-documents/) 4. http://www.mendor.com 5. http://www.clinpal.com 6. http://www.proteus.com/oracle-and-proteusintegrate-proteus-digital-health-feedback-system-with-oracle- health-sciences-inform-to-helpincrease-clinical-trial-accuracy/ 7. https://www.jdrf.org.uk/research/overview-of-research-programme/treat/artificial-pancreas/2014-a-year-of- artificialpancreas-breakthroughs 8. http://www.healthcare.philips.com/main/products/patient_monitoring/products/eicu/ n

Digital Healthcare and Paradigm Shifts in Medicine

The pace of change in digital health has been rapid: new devices, new gizmos, new apps - a veritable technology parade, better described as a headlong spring. Medicine is indeed undergoing a revolution with several paradigm shifts that can be presently discerned.

Health Assembly: Open Innovation conference held in Cardiff, earlier this month, Dr Ogan Gurel, Director of the Open Innovation Group and CTO at the Samsung Advanced Institute of Technology (SAIT) discussed how digital healthcare is leading to some of these paradigm shifts in medicine.

During a keynote speech delivered at the recent Digital

In his speech Dr Gurel considered some of the major issues

February 2015

Digital Healthcare and Paradigm Shifts in Medicine that are driving digital adoption in healthcare, and the changes that these technologies are having on the culture of modern medicine. These issues include: the decentralisation of care; the parallelisation of data and logic; the move from explicit to implicit logic; a convergence of the medical and wellness spaces; closer integration of individual and population data; big datadriven medicine involving the integration of information over space and time; the empowerment of primary care; and, the convergence of diagnosis and therapeutics. Some of these transformations are upending medical traditions dating from the time of Hippocrates; and other changes are catapulting 20th century healthcare into the next era. How to survive and thrive amid such a revolution is a critical challenge facing physicians, governments, and technology companies. Discussing this in more detail, Gurel described what he understands some of these issues to mean. Decentralisation of care is something that has already begun within many healthcare systems and with the greater use of mobile and connected solutions this trend is likely to continue. Technology is allowing care to be moved from the traditional settings of hospitals, treatment centres, and doctor’s offices to fit more conveniently with people’s lives. This has profound consequences for both patients and healthcare professionals. Convenience, flexibility, increased efficiency and increased capacity are all possible through this type of care delivery. Traditionally healthcare has been a relatively linear process, in that we move from consultation, to testing, to diagnosis, and finally treatment. ‘Parallelisation’ is a term coined by Gurel to describe how new technology can deliver many of these elements simultaneously or in combinations that were not previously possible. He suggests that “This will have an impact on medical logic that is not currently understood.” By example, you now have products like medical and health trackers that incorporate a whole host of sensors that collect multiple parameters, including medical data, activity levels, genetic information, and environmental data, from a patient simultaneously, helping to deliver relevant insights about a patient all at the same time. Gurel suggests that this ‘parallelisation’ of data collection will naturally lead to the greater convergence of diagnostic and therapeutic activity. An example of this would be having a blood glucose test that almost coincides with the intervention – the application of insulin. When dealing with data we are beginning to see a shift from explicit logic to implicit logic in healthcare. This reflects the rise of data driven medicine, whereby decisions are influenced by implicit logic, which are those rules established using actual data, as it is happening, rather than relying upon historical data (explicit logic) to help inform the decision process. At the same time enhancing data by providing a relevant context is similarly becoming more important. Doctors do not necessarily want the most precise data, but they do require the correct data. This means that the context of information is very relevant for doctors and improving this accuracy over precision can

be more useful. This also requires the integration of systems. Without the interoperability between systems and the collection of different data sources then it is not possible to deliver context based healthcare provision. These are quite substantial changes to the perception and delivery of healthcare. Technology is empowering primary care, by providing easier access to digital health enabled information, like genetic data and context data from sensors and devices. With this it becomes possible for primary care providers to deliver better and more comprehensive levels of care for patients. It is also driving a shift from episodic to pervasive care. By employing digital healthcare monitoring, the process of care becomes more intrinsic and consuming within daily life, as opposed to the conventional paradigms of medicine, where care is delivered at periodic, disparate, points. Gurel likens this to one of the tenants of Hypocrates, “prognosis is one of the ‘most excellent things for the physician to cultivate… digital health technologies allow us to improve the status of prognosis above and beyond simple diagnosis and treatment.” Dr Gurel was speaking at The Digital Health Assembly: Open Innovation Conference. The event, which took place in Cardiff for the first time in February (2015) attracted speakers and delegates from across the globe including MIT Center for Digital Business, World Health Organisation, the European Space Agency, leading companies including Intel, CISCO, Siemens Healthcare and IBM, and an array of organisations charged with modernising healthcare. Speaking at the event David Ford, Conference Chair and Professor of Health Informatics at Swansea University and Deputy Director of The Farr Institute of Health Informatics Research, said: “Digital Health Assembly: Open innovation has brought together a diverse and extremely impressive collection of innovative minds from the healthcare and technology sectors worldwide. The interest in the Conference and the calibre of the delegates and speakers that we have attracted is a great reflection of this exciting and important area of work.” “We are delighted to have been able to bring a number of worldrenowned industry leaders to speak at the three-day event, along with a fascinating mix of great companies that are shaping digital healthcare worldwide.” Dr. Ogan Gurel is a Director of the Open Innovation Group / CTO Office at the Samsung Advanced Institute of Technology (SAIT). He also holds an academic appointment as Visiting Professor at the Samsung Advanced Institute of Health Sciences & Technology at Samsung Medical Center with research interests in protein electrodynamics and terahertz medicine. His nearly 30 years of experience in healthcare spans multiple sectors: biomedical science, clinical medicine, strategy consulting, business development, executive management, marketing, and R&D, with direct expertise in medical devices, mobile health, healthcare IT, medical imaging, and pharmaceuticals. n

The Journal of mHealth

INDUSTRY NEWS News and Information for Digital Health Professionals

New App Helps Sports Professionals Reduce Stress and Anxiety The British Professional Cricketers’ Association (PCA) have launched an innovative new app that has been designed to help players reduce stress and anxiety. The PCA working in partnership with Virtually Free have developed an app which uses four proven relaxation techniques designed to help reduce stress: Calm breathing, Meditation, Deep muscle relaxation, and Self-hypnosis. The app called ‘Stress Free’ introduces users to these techniques through interaction with a virtual doctor (Dr Freeman), who acts as a personal guide, directing easyto-follow demonstrations that teach relaxation techniques and encourage users to utilise the built-in journal and daily goal-setting tools that help to keep people engaged. Speaking at the app launch, Marcus Trescothick, the Somerset and former England batsman, stated: “We all experience stress and anxiety every day but at times this can be so extreme that it becomes an illness. When it gets to that level it can stop us from getting on with our lives or doing the things we love, like playing cricket,” “We at the PCA take stress-related illnesses very seriously and we want to raise awareness of them. We

February 2015

want to build a culture that acknowledges that it is OK - not to be OK. Our aim is to help our members prevent them when possible or seek help in the early stages if not.” “As part of this initiative we have teamed up with a talented team of clinicians and software developers to offer ‘Stress Free’ to our members.” “This app teaches you to practise four different relaxation techniques which

have all shown to be effective in clinical trials. These can help de-stress when anxiety is getting on top of us, but they can also help us become more resilient to stress in general. In particular meditation can build our ability to cope with stress.” “Just like we take our body really seriously ‘Stress Free’ encourages us to practice relaxation skills frequently and train your resilience. You cannot focus on your body and forget your mind. You need both to win the game. We hope

Industry News ‘Stress Free’ will help you achieve your goals.” The ‘Stress Free’ app is the latest initiative from the PCA to put in place measures to help reduce stress-related illnesses. “Stress Free is part of our toolkit and picks up the excellent proactive and preventative work being done by the team of Personal Development Managers and resilience sessions with counties across the country run by our partner LPP,” said Jason Ratcliffe, Assistant Chief Executive of the PCA. “It is an extension of the ‘Mind Matters’ tutorial which we launched three years ago and which has had valuable input from [Professional Cricketers] Tim Ambrose, Marcus Trescothick, Darren Cousins, Graeme Fowler, Andrew Flintoff and Steve Harmison.” “We know that one in four of us will be affected by a mental health episode in any year and ‘Stress Free’ is another tool which we hope will help people to cope with anxiety issues in a very private and

personal environment.” The app has been developed by Virtually Free, a digital health company who produce evidence-based technologies aimed at providing effective, engaging and lowcost access to psychological therapies. The company, which is a collaboration between experienced psychiatrists and games developers, uses games and game dynamics to deliver these solutions and provide technologies to a variety of markets, including consumer, enterprise and sport. Dr Russell Green, Consultant Psychiatrist and co-founder of Virtually Free commented: “These simple but effective treatments are well founded in clinical medical practice and we are providing versions of ‘Stress Free’ to major organisations that wish to take a proactive approach towards managing stress related issues within their populations. We hope that by making the treatments available through accessible technology we can help players of elite sport and others alleviate some of the pressures they face.” Virtually Free’s work has received significant recognition over the course of

the past year. In this time the company has won the Digital Enterprise Awards (DEA), Cambridge University Technology and Enterprise Club (CUTEC) and Cambridge Venture Project. They have also been award finalists at the Pitch@ Palace by HRH The Duke of York, The Appsters Awards, Tech London Advocates: Healthtech Competition, Slush London at Google Campus, Future Decoded by Microsoft and the TIGA Awards, The Venture by Chivas and UK's Best SME Mobile Health-App 2015. The company have considerable experience of designing therapeutic apps to help people overcome different phobias. They have already successfully developed an app called Phobia Free which treats arachnophobia using exposure therapy and augmented reality to help users overcome this fear, and are currently running a clinical trial, with the University of Roehampton, as part of the development process of their latest app for Agoraphobia. The company is currently seeking participants for this trial and anyone interested in finding out more may contact news@virtually-free.com to receive additional information. n

Novartis and Qualcomm Launch a $100m Investment Venture to Fund Digital Technologies Novartis Pharmaceuticals has announced the creation of a joint investment company with Qualcomm Ventures to target early stage companies who offer technologies, products or services that "go beyond the pill" to benefit physicians and patients. "By working with Qualcomm Ventures, Novartis sees the opportunity to take a greater leadership role in introducing new mobile or digital technologies that have the potential to change the practice of medicine and bring more breakthroughs with real benefits to patients and society," said David Epstein, Division Head of Novartis Pharmaceuticals. "We are excited by the potential of digital medicines to further enhance our mission of the right drug for the right patient at the right time helping people live longer with a better quality of life giving more time to do the things that matter to them." Digital and mobile technologies are expected to make a signifi-

cant difference in the pharmaceutical industry. New technologies are emerging such as mobile enabled devices, mobile applications, wearable devices, and technologies for big and small data to enable delivery of the right medicine to the right patients and more robust pharmacoeconomic analyses. The establishment of the joint investment company combines the knowledge of Novartis' innovation in the research, development and manufacturing of innovative medicines with Qualcomm's expertise in digital and mobile technologies. Qualcomm already has a significant investment presence in the digital health sector, and was in fact recognised as one of the largest corporate investors in digital health during 2014, according to both Rock Health and StartUp Health, with a portfolio which includes digital health players like Fitbit, Practice Fusion, AliveCor, Telcare, Sotera Wireless, and AirStrip. n

The Journal of mHealth

Industry News

Activ8rlives to Develop its First Medical Smartwatch for Continuous Monitoring of Oxygenation for UK’s COPD Patients Building on its growing focus of respiratory disease self-management and the rising interest in wearable health devices, UKbased Aseptika has announced plans to accelerate the development of its medical wearable Smartwatch - the BuddyWOTCH. The device which has been designed to continuously monitor blood oxygenation levels in patients with Chronic Obstructive Pulmonary Disease (COPD) within the home environment, also integrates other sensors to measure key vital signs and will automatically send data from the wearer to the Company’s secure cloud-based servers via cellular and wireless networks. The solution comprises a, simple to use, wrist-worn device, providing continuous monitoring and alerting capabilities. The term WOTCH is actually an acronym for the variety of monitoring components incorporated into the device: Walking, Oxygenation, Temperature, Chronicle (image capture of medication, food and liquids) and Heart rate. All the biometric data collected is then transmitted without user intervention, which forms part of the Company’s ‘Always Connected’ strategy that aims to simplify the self-monitoring process for people of all ages and capabilities. Respiratory disease is complex. Patients with COPD tend to have co-morbidities – typically 3.7 additional health conditions[1, 2] , especially those who are less physically active[3]. Therefore in COPD, as in other respiratory diseases, exercise can help improve cardiovascular function, body composition, insulin sensitivity and reduce blood pressure and inflammation[4]. Active COPD patients have higher FEV1 scores (a measure of pulmonary function)[5] and a slower decline in lung function[6] and so motivation to be more active can improve health outcomes. Weight management is also challenging for COPD patients[7] and with it comes higher risk of exacerbations[8]. Aseptika are therefore hoping that the new device will become an indispensable tool for promoting increased physical activity and achieving a healthier weight for COPD patients, thus leading to more effective pulmonary rehabilitation programmes. Motivation and adherence to physiotherapy, medication, physical activity, healthy eating, and monitoring vital signs are all important factors in maintaining respiratory health for those with COPD[9], and early diagnosis and intervention are a critical priority for healthcare providers. The vital signs generated by the device will be combined with data from Aseptika’s patented sputum test, which predicts the onset of lung infections (or exacerbations) in people with long-term respiratory conditions who are chronically infected with the pathogen Pseudomonas aeruginosa, so that they may obtain medical interven-

February 2015

tions earlier, thereby reducing the sometimes devastating effects of repeated exacerbations. The need for the BuddyWOTCH has been inspired by Aseptika’s experience of working with patient volunteers, who have respiratory disease. The company have worked extensively through clinical trials with patients with Cystic Fibrosis and COPD. They are also currently conducting trials of their SENSOR app technology in conjunction with an award winning research team from Portsmouth Hospitals NHS Trust. Commenting on the BuddyWOTCH fast-track development project, Kevin Auton, Co-Founder and Managing Director of Aseptika Limited said: “Our BuddyWOTCH will become an integrated monitoring and alerting system, wearable for the “rest-of-life” by the most vulnerable patients with respiratory disease. Combining sensors to monitor fundamental vital signs of COPD patients, will enable patients and their carers to learn from their data and to better self-manage this long-term condition. Younger family members are often unpaid carers and this innovation will provide them with confidence 24/7 that their older family members are safe or give the evidence that they require support. Equally impor-

Industry News tant as we age, we all want to remain independent and in our own homes for as long as we are able. We need a new generation of simple tools to help us, our families and the network of our clinical supporters, achieve these goals and reduce the growing pressure on our NHS.” “Our solutions will provide “expert” pathways for use by both patient/carers and then GP’s and clinicians to inform, manage and report the success of home care plans so that patients can remain independent at home, with a better quality and more sustainable model of care.” One million pounds of funding to accelerate the development of the device was recently secured through a Phase 2 pre-procurement contract with NHS England’s Small Business Research Initiative Healthcare (SBRI Healthcare), managed by Health Enterprise East (HEE) on behalf of the Eastern Academic Health and Sciences Network. The Company intends to deliver its first production units to NHS clinical partners and beta test volunteers by the end of 2015. References: 1. Prediction of Chronic Obstructive Pulmonary Disease Exacerbation using Physiological Time Series Patterns. Xie Yang et al (2013).

35th Annual International Conference of the IEEE EMBS (2013) Oaska, Japan, 3-7 July 2013.

2. Healthcare utilisation in Chronic Obstructive Pulmonary Disease. A case-control study in a health maintenance organisation. Mapel DW et al. (2000). Arch. Inern. Med. 160(17), 2653-2658

3. Impact of changes in physical activity on health-related quality of life among patients with chronic obstructive pulmonary disease. Esteban C. et al (2006). J. Bras. Pneumol. 32(4), 301-308.

4. Consequences of physical inactivity in Chronic Obstructive Pulmonary Disease. Hartmand, J et al. Expert Rev Resp Med (2010) 4(6): 735-745. 5. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. (2007). Nelson ME et al, Circulation. 116(9), 1094-1105. 6. Regular physical activity modifies smoking-related lung function declines and reduces risk of COPD: a population-based cohort study. GarciaAymerich J et al. Am. J. Respir. Crit. Care Med. 175(5), 458-463.

7. COPD as a multicomponent disease: inventory of dyspnoea, underweight, obesity and fat free mass depletion in primary care. Steuten et al (2006). Prim. Care Respir. J. 15(2). 84-91.

8. Nutritional status, dietary energy intake and the risk of exacerbation in patients with Chronic Obstructive pulmonary Disease (COPD). Halin, R. et al (2005). Respiratory Medicine. Vol 100. Issue 3. 561-567.

9. Effectiveness of a lifestyle intervention and a structured exercise intervention in older adults. Opdenacker L et al (2008). Pre. Med. 46(6), 518-524. n

Apple's Health Tech Takes Early Lead Among Top U.S. Hospitals will invest in technology including apps, wearables, remote monitoring and virtual care, by 2018.

Apple’s healthcare technology is spreading quickly among major U.S. hospitals, showing early promise as a way for doctors to monitor patients remotely and lower costs.

Apple's HealthKit works by gathering data from sources such as glucose measurement tools, food and exercise-tracking apps and Wi-fi connected scales. The company's Apple Watch, due for release in April, promises to add to the range of possible data, which with patients' consent can be sent to an electronic medical record for doctors to view.

According to a recent report by Reuters fourteen of twenty-three top hospitals contacted confirmed that they have rolled out a pilot program of Apple's HealthKit service - which acts as a repository for patient-generated health information like blood pressure, weight or heart rate - or are in talks to do so. The pilots aim to help physicians monitor patients with chronic conditions such as diabetes and hypertension. Insight from the report suggests that other competitors in this space like Google and Samsung Electronics, which have both released similar services, are only just starting to reach out to hospitals and other medical partners.

hospitals avoid repeat admissions, for which they are penalised under new U.S. government guidelines, all at a relatively low cost.

Such systems hold the promise of allowing doctors to watch for early signs of trouble and intervene before a medical problem becomes acute. That could help

The U.S. healthcare market is valued at $3 trillion, and researcher IDC Health Insights have predicted that 70 per cent of healthcare organisations worldwide

Ochsner Medical Center in New Orleans has been working with Apple and Epic Systems, Ochsner's medical records vendor, to roll out a pilot program for highrisk patients. The team is already tracking several hundred patients who are struggling to control their blood pressure. The devices measure blood pressure and other statistics and send it to Apple phones and tablets. "If we had more data, like daily weights, we could give the patient a call before Continued on page 14

The Journal of mHealth

Industry News Continued from page 13

they need to be hospitalised," said Chief Clinical Transformation Officer Dr. Richard Milani. Sumit Rana, chief technology officer at Epic Systems, said the timing was right for mobile health tech to take off. "We didn't have smartphones ten years ago; or an explosion of new sensors and devices," Rana said. Many of the hospitals questioned suggested that they were also eager to try pilots of the Google Fit service, since Google's Android software powers such a large proportion of the smartphone and tablet market. Google said it has several developer partners on board for Fit, which connects to apps and devices, but did not comment for this research on its outreach to hospitals. Samsung said it is working with Boston’s Massachusetts General Hospital to develop mobile health technology. The firm also has a relationship with the University of California's San Francisco Medical Center. Apple's move into mobile health tech comes as the Affordable Care Act and other healthcare reform efforts aim to provide incentives for doctors to keep patients healthy. The aim is to move away from the "fee for service" model,

which has tended to reward doctors for pricey procedures rather than for outcomes.

the 250,000 patients in his system had data from sources such as Jawbone's Up activity tracker and wirelessly connected scales.

One decision that hospitals must still make is whether the difficulty of sorting through a deluge of patient-generated data of varying quality is worth the investment.

"Can I interface to every possible device that every patient uses? No. But Apple can,” he said.

"This is a whole new data source that we don't understand the integrity of yet," said William Hanson, chief medical information officer at the University of Pennsylvania Health System. Apple has recruited informal industry advisors, including Rana and John Halamka, chief information officer of Beth Israel Deaconess Medical Center and Harvard Medical School, to discuss health data privacy and for introductions to the industry. The company said it had an "incredible team" of experts in health and fitness and was talking to medical institutions, healthcare and industry experts on ways to deliver its services.

Apple has said that over 600 developers are integrating HealthKit into their health and fitness apps. Many hospitals and organisations are beginning to evaluate the different methods of how data from health & wellness devices can be effectively integrated into the workstreams of clinicians. Examples of this work include, Cedars-Sinai hospital in Los Angeles where they are developing visual dashboards to present patient-generated data to doctors in an easy-to-digest manner. Experts say that there will eventually be a need for common standards to ensure that data can be gathered from competing systems.

A few hospitals are also exploring how to manage the data that is flowing in from health and fitness-concerned patients, whom many in Silicon Valley refer to as the "worried well."

"How do we get Apple to work with Samsung? I think it will be a problem eventually," said Brian Carter, a director focused on personal and population health at Cerner, an electronic medical record vendor that is integrated with HealthKit.

Beth Israel's Halamka said that many of

Source: Reuters Health n

Major Health Insurance Hacks Bring Fresh Concerns for Data Security Revelations that health insurer Anthem, the United States’ second largest health insurer, has been subject to a major security breach, have bought fresh concerns over data integrity in the health industry. Anthem which has nearly 40 million US customers, revealed that hackers had been able to breach one of its IT systems allowing the theft of personal information relating to current and former consumers and employees. The company has confirmed that while the breach did not compromise medical information or financial details such as credit card or bank account numbers, the information accessed, during what has been described as a “very sophisticated attack”, did include names, birthdays, social security numbers,

February 2015

street addresses, email addresses and employment information, including income data. Anthem said that it immediately made every effort to close the security vulnerability and reported the attack to the FBI. Cybersecurity firm FireEye Inc has been hired to help investigate the attack. An initial statement from the company did not say how many customers and staff had been affected, but subsequent reports have estimated that records of tens of millions of people were taken, making it the largest data breach involving a US health insurer. “This attack is another reminder of the persistent threats we face,

Industry News and the need for Congress to take aggressive action to remove legal barriers for sharing cyber threat information,” US representative Michael McCaul, a Republican from Texas and chairman of the committee on homeland security, said in a statement. The FBI had warned last August that healthcare industry companies were being targeted by hackers, publicising the issue following an attack on US hospital group Community Health Systems Inc that resulted in the theft of millions of patient records. Medical identity theft is often not immediately identified by patients or their provider, giving criminals years to milk such credentials. That makes medical data more valuable than credit cards, which tend to be quickly cancelled by banks once fraud is detected. Security experts say cyber criminals are increasingly targeting the $3tn US healthcare industry, where many companies are still reliant on ageing computer systems that do not use the latest

security features. Unfortunately, while these breaches by themselves are damaging to the individuals affected, they also raise concerns among consumers, patients, and healthcare professionals alike over the increasing use of technology-led health services. A recent PwC Health Research Institute survey found that at a time when data breaches regularly make the headlines, 68% of those surveyed were concerned about the security of data stored in smartphone apps and 76% were generally concerned about the security of their medical data. As the healthcare industry moves increasingly towards a digitally-enabled service model the significance of data security will only increase, and it is therefore essential that the industry works collectively to ensure information security is given the highest priority. Consumers demand trust in the systems in which they entrust their healthcare information, and it is essential that as an industry this demand is met. n

Blue Spark Unveils Wearable Bluetooth Thermometer at CES 2015 Making its debut at the Consumer Electronics Show in January, TempTraq represents a new frontier in digital thermometers. Powered by Blue Spark Technologies’ printed flexible battery the TempTraq is the only wearable Bluetooth thermometer in the form of a soft patch that can continuously and comfortably monitor body temperature for 24 hours.

can easily review temperature data and receive alerts. Designed to provide highly accurate measurements the TempTraq thermometer measures temperatures between 86.0°F and 108.3°F. Unlike other available devices that provide users with only one point of data and offer no continuous monitoring or alerts, the TempTraq app displays both real time and historical temperature data transmitted from the patch in graphical or tabular view, making it possible for caregivers to see fluctuations and quickly adapt treatment.

The company has chosen to initially focus the product at parents, providing them with the ability to continuously monitor child temperature using a nonobtrusive, wireless method, but it is easy to see that the product could have a wide range of healthcare use cases. “TempTraq allows parents to keep a close watch on their child’s temperature without having to continually disturb them,” said John Gannon, president and CEO of Blue Spark Technologies, speaking at the launch. “Our wireless, wearable thermometer gives parents peace of mind and their children the rest they need to get better.” All users have to do is press the “start” button to activate the thermometer and

connect it to the accompanying app via the unique code provided. They then apply the thin, flexible patch thermometer to the underarm of the child, similar to an adhesive bandage. As long as the caregiver is within range of the thermometer (up to 40 feet away) they

For parents who want to share temperature data with their doctors or family members, TempTraq allows users to send recorded information via email. Through the app, parents can also keep track of when their child eats, drinks or takes medicine. For those caring for multiple children, the TempTraq app conveniently allows them to monitor multiple thermometers simultaneously. The product is currently pending an FDA 510(k) premarket review and is not yet available for sale. n

The Journal of mHealth

Industry News

Oracle and Proteus Integrate Digital Health Feedback System to Help Increase Clinical Trial Accuracy Designed to help health sciences organisations more effectively track and manage the use of medication during clinical trials, Oracle has introduced the Health Sciences InForm Medication Adherence Insights Cloud Service. The solution which integrates the innovative and market-proven Proteus Digital Health "smart pill" system automatically sends medication ingestion data directly into the Oracle Health Sciences InForm study database. The solution is a result of a strategic relationship between Oracle and Proteus Digital Health which combines Oracle’s industry-leading clinical data capture and management system, Oracle Health Sciences InForm, with the Proteus Digital Health feedback system to create an innovative product that helps pharmaceutical developers accelerate time to market while reducing costs and improving safety. The platform helps researchers more accurately and efficiently track and manage the use of medication during clinical trials—a historically laborious and error-ridden process. The new solution automates data collection and captures accurate medication ingestion information. By providing direct and rapid validation of the quantity of medication a patient ingests and the time of ingestion, the service can help health sciences organisations lower the risk of clinical trial failures by identifying medication adherence issues early, improving dosage decisions, and enhancing drug safety. This helps to accelerate trials and reduce costs by eliminating imprecise, time-consuming, and expensive manual processes for collecting adherence data, such as pill counts and patient questionnaires. “The medication adherence option uniquely addresses the most critical information in a clinical trial: ‘Did the patients use their medicine properly?’ Combining this powerful new data with the technology, analysis, and capabilities of Oracle Health Sciences creates a game-changing opportunity for drug development,” said Markus Christen, head of global development, Proteus Digital Health.

February 2015

Highly engaged patients that consistently take their prescribed medications as directed are the cornerstone of a successful clinical trial. Researchers have long struggled to effectively and efficiently validate adherence—relying on an arduous and often inaccurate combination of self-reporting and lab tests. This solution not only enables clinical trial sponsors to automatically capture precise and timely data about medication adherence, it can also help accelerate insight about drug efficacy and safety and speed clinical trials, which can, in turn, increase trial success rates. “Oracle Health Sciences InForm Medication Adherence Insights Cloud Service helps health sciences organisations effectively address two long-standing and complex challenges: measuring participant adherence to drug protocols and identifying the optimum dosing regimen for recommended use,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “This groundbreaking solution—the direct result of a collaboration between Oracle and Proteus Digital Health—is a powerful example of how we can rapidly combine our industry-leading clinical trial data capture and management solutions with emerging technologies, such as digital pills, to help health sciences organisations transform the drug development and approval process.” n

Industry News

Healthcare to be a Focus for Google Glass 2 By now it is likely that you will have heard about the demise of Google Glass in its current state, however, Google have now confirmed that they are working on an updated version of the product and it looks like healthcare will be an area of focus for the new design. Google announced in January that it would be closing its Explorer programme and removing the original Google Glass from sale. Following the announcement, which resulted in widespread rumour and speculation, the tech giant has now confirmed that they are in the process of working on Google Glass 2. As part

of the announcement it was revealed that any new incarnation of the wearable technology will seek to build upon the success that the test-bed product has had in the workplace. Healthcare is one specific area of focus that was identified, and it is likely that we will see future incarnation of the wearable technology include elements specifically designed for health and medical applications. As part of the strategic move, the Glass team will move away from its current home at the Google[x] project lab to become a standalone development group within Google, signifying a step change in the company’s approach to the technology development. Similarly, although the Explorer Program has now closed the insights gained from the undertaking are likely to shape the new version of the product. In a Google+ post the company wrote: "Interest in wearables has exploded and today it’s one of the most exciting areas in technology. Glass at work has been

growing and we’re seeing incredible developments with Glass in the workplace. As we look to the road ahead, we realise that we’ve outgrown the lab and so we’re officially “graduating” from Google[x] to be our own team here at Google. We’re thrilled to be moving even more from concept to reality.” The post continues, "As part of this transition, we’re closing the Explorer Program so we can focus on what’s coming next. In the meantime, we’re continuing to build for the future, and you’ll start to see future versions of Glass when they’re ready."

According to The Wall Street Journal, which broke the news about Google Glass 2, the next generation of the wearable device will be introduced sometime in 2015. Google Glass, which launched in 2013, has only been widely available to the public since mid-2014. During this short period numerous questions have been raised relating to privacy and data collection issues stemming from the use of the device. That coupled with the slightly ‘clunky’ design, and lack of clear consumer benefit has meant that it has been slow to attract widespread consumer following. Where the project has attracted significant interest is the potential for workplace applications. Using a device that can display information relevant to particular tasks or elements of a business process, without impeding a person’s ability to conduct tasks, for example using hands-free operation, voice controls, and in-fieldof-vision display has a great many applications for industries like construction,

utilities, as well as healthcare. The medical profession in particular has produced some very interesting use cases for wearable technologies like Glass and this announcement hints at those applications becoming more entrenched within the new designs. Over the past year we have seen a number of developers begin to adopt Glass technology. One example is EHR developer drchrono who have tested Glass as a means of using voice commands to take pictures that are automatically added to a patient’s EHR, as well as record video of consultations or surgeries so that administrative staff

can accurately determine bills. In a similar manner physicians can scroll through relevant medical records or test results in real-time, saving time and allowing unique access to patient data. Other providers, like Touch Surgery a provider of professional surgical training content, are experimenting with the visual feed nature of Glass alongside other wearable devices like Oculus Rift to deliver relevant real-time data to healthcare professionals exactly when it is needed. Whilst we wait to see what Google Glass 2 will bring. What we can be sure of, is that in the foreseeable future wearable computing will have a place in the medical and healthcare professions, but like any new technology, finding a solution that will work effectively and presenting that technology in a form factor that allows it to embed easily within everyday activities takes time. The Google Glass experiment has provided us with one example of how this may work, but we are sure to see many others as we go forward. n

The Journal of mHealth

Industry News

Innovative Mobile Surgical Training Platform Introduces Customised Feeds for Educational Resources even better. One key output of these discussions is My Stream, a tool which delivers a customised feed of research, articles, and news hand-picked by our surgical team. We think it is a simple way for you to stay up-to-date with cuttingedge medical news and remain at (or attain) your peak potential as a surgeon.”

Touch Surgery, the mobile surgical education platform has announced the introduction of new features which provide users with customised educational feeds. The ‘My Stream’ component, which introduces a significant addition to the existing resources of the Touch Surgery platform, aims to enhance the surgical simulation platform by integrating a customisable stream that updates users with medical news and research relevant to specific areas of interest. Touch Surgery is a unique surgical training resource that uses realistic 3D visualisations to guide users through complex operations by breaking them down into their component steps. Working with leading Surgeons and Institutions from around the world the company create accurate and valuable surgical content, with the aim of disseminating the best techniques and procedures to improve the quality of surgery worldwide. The platform, which is available for both tablets and smartphones, includes over 40 different training modules aimed at giving surgical trainees the opportunity to master the necessary cognitive decision-making processes prior to attempting the manual parts of an operation. By basing the visualisations on leading surgical best-practice the app helps

February 2015

ensure that users feel confident in their understanding of a procedure well in advance of the first incision. Used by over 200,000 healthcare professionals worldwide, Touch Surgery aims to be a turnkey platform for the comprehensive delivery of surgical training resources and the My Stream feature has been designed to help deliver this. Announcing the launch the company commented; “We have been gathering feedback from countless surgeons worldwide to understand how we can make our surgical education platform

The foundation of Touch Surgery is to teach surgical education using a process known as Cognitive Task Analysis (CTA). CTA is a new technique in simulation-based education and stems from the fact that a well performed operation relies upon a combination of effective surgical decision making and technical skill. While the principles of CTA are well documented, Touch Surgery is the first company to apply these concepts to surgical education. Although technical skill is undoubtedly of high importance, it is widely felt that intraoperative knowledge and decision making is the most important factor in a successful operation. However, decision making skills are only taught indirectly in the majority of surgical training programs, where training surgeons have to absorb this critical skill by a process of observation and repetition.

Industry News Junior surgeons often find that when watching an operation for the first time, although it is easy to appreciate technical skill it is very difficult to truly appreciate the decision making occurring during the procedure. This is a huge missed opportunity in terms of training experience. Recent research has shown that breaking down an operation into a series of individual steps and decision points can greatly enhance operative understanding and retention of knowledge. Touch Surgery identifies the key steps and decisions within an operation using the CTA method and presents the information within an interactive visual for-

mat that allows someone to perform each step of the operation. The process of interacting with learning material is well known to greatly improve knowledge retention rates compared with traditional methods such as lectures, reading or watching video. In this way the platform provides a very effective and efficient way of training surgeons even before they step into the operating room. Additionally, by distributing their app for free, Touch Surgery is changing surgery by allowing for the dissemination of CTA-based surgical education across the world. n

World-First Insulin Pump for FourYear-Old Australian Boy A four-year-old Perth boy has become the first patient in the world to be fitted with a new pancreas-like pump which researchers say will improve the lives of diabetics of all ages. Xavier Hames suffers from type 1 diabetes and is at constant risk of hypoglycaemia - when low glucose levels can result in seizures, coma or death. But a pump that can predict when blood sugar levels are becoming dangerously low and halt the release of insulin has changed that. Xavier received the device from Princess Margaret Hospital for Children, where he has been receiving treatment for his diabetes since he was 22 months old. Although the pump is similar to others already on the market, it is set apart by the inclusion of the predictive sensor. The device features a sensor that reads blood sugar levels and communicates to the pump, which is connected to the body underneath the skin to administer the insulin. Unlike traditional pumps, this new technology does not deliver a constant stream of insulin to the body. Instead, the device uses an algorithm to track blood sugar levels over time, predicting when insulin is no longer required. This reduces the risk of dangerously low blood sugar levels, known as hypoglycemia. Symptoms of a hypoglycemic attack can be mild and include sweating or fatigue, but in more serious cases, weakness, temporary unconsciousness, organ damage, coma, or death can occur. These typically happen while the person is sleeping (and therefore not eating) because the insulin is still working in their body, bringing their blood sugar to dangerously low levels. Diabetics often have to wake up several times each night in order to monitor their blood sugar. "The majority of hypoglycemic attacks occur at night when a person is asleep and they might not be able to react or recognise the attack," Professor Tim Jones from Princess Margaret

Hospital told The West Australian. "This device can predict hypoglycemia before it happens and stop insulin delivery before a predicted event. This, coupled with the fact that the pump automatically resumes insulin when glucose levels recover, is a real medical breakthrough.â&#x20AC;? "Most parents have to get up two or three times a night to check glucose levels and this might make them feel a little safer at night time if they know they've got this automated system that's going to prevent low glucose," he said. Professor Jones said the technology was not limited to children. "It's just as important in adults if they're living alone or at risk of having problems with their glucose levels. It'll work in any age group," he said. Xavier's mother, Naomi, said it will have a significant impact on her son's life. "It allows him to have more freedom with eating," she said. "He's only four, you can't stop a child wanting a bowl full of pasta, at a party you can't stop a child wanting party food, so the pump allows a lot more freedom. It also allows us to have better control overnight; if you're up every hour overnight then maybe you've got a good indication [of blood sugar levels] but no parent wants to be up every hour, I can guarantee that." After five years of clinical trials by specialists at Perth's Princess Margaret Hospital and hospitals around Australia, the device is now commercially available at a cost of $10,000. Professor Jones said as the technology developed the pump will become cheaper and more accessible. Researchers at the hospital described this as the first step in their efforts to create a fully automatic device that can constantly monitor blood sugar and adjust insulin levels accordingly, reducing the need for patients to conduct finger pricks to self-assess their glucose levels. n

The Journal of mHealth

Industry News

UK Design Council Recognises Healthcare Design Among its 70 Ones to Watch

Showcased as part of the Design Council’s 70th anniversary celebrations, the designers — each chosen for an individual product or project of outstanding design ingenuity and vision — have been selected from hundreds of entrants. The huge range of submissions covered design disciplines from furniture design, architecture and jewellery design, to material experimentation and app development. Bound together by the common theme of designing for the future, and many of them designing to improve people’s lives, they reflect the values that Design Council has stood by throughout its 70-year history. Health experts increasingly recognise the need to design for health and wellbeing, and the following inspirational designs have all been developed to help members of society lead their lives with more ease and efficiency. Hyn Kyung Lee has designed Future Active Wear Collection for Older Adults, a collection of fashion garments designed to encourage the wearer to lead a healthy and active lifestyle by improving muscle strength and flexibility by incorporating gentle exercise functions directly into these garments. Another design helping the elderly is Hand-Healthy by Simon Kinneir, a behavioral and product invention for people with osteoarthritis, designed to help the user engage better with their jointhealth and exercise through cooking. My Med by Matthew Cardell-Williams is a system providing a solution to medication management straight from the pharmacy, aimed at elderly people with limited dexterity, sensory perception and suffering from degenerative mental illnesses. Emily Tulloh’s Summerbug Trike provides back support for disabled children, allowing them the mobility and freedom of riding a bike that will adjust as they grow. Filling a clear gap in the market, Matthew Thompson has created prototypes for an amazing low-cost, low-noise, lightweight prosthetic hand with improved battery life.

Also in the realm of technology, Claire Jeffries has designed

February 2015

an app called Fred, which helps young children learn the basics of first aid. Musical Memory Box by Chloe Meineck gives much needed familiarity and comfort to people with dementia, at an unsettling time in their lives. The design makes use of the profound effect music can have on people with this type of illness. The box contains objects chosen by the owner to represent friends, family and key memories. The Iungo Kettle by James Molkenthin gives blind and partially sighted people assurance, control and normality in their home. The Iungo Kettle communicates via Bluetooth with a smartphone app, which measures the temperature and volume of water in the kettle, and sends push-notifications to the user when it has boiled. CONTACT by Felix Faire is an audio interface where any physical interaction with a table or hard surface generates vibrations that are then transformed into an acoustic and optical performance. In CONTACT, the technology remains hidden so that the user can focus purely on sensations. John Mathers, Design Council Chief Executive, comments: “We are proud to be marking 70 years of the Design Council in 2015 with the exemplary ‘Ones to Watch’ line up of new designers. Ones to Watch offers an exciting vision of our future, with fresh ideas from emerging designers that address important contemporary living challenges from sustainability to health, education to city living and simple but effective ways to improve everyday life. The variety of the designs illustrates the diverse nature of ideas coming out of the UK, and we hope to see these designers producing more exciting work over the coming years.” To view the full line up on the Design Council website please visit: www.designcouncil.org.uk/projects/ones-watch n

Industry News

Samsung Developing Wearable Health Sensor for Stroke Detection A group of Samsung engineers have developed a prototype wearable device that uses a phone or tablet to alert wearers of an impending stroke. By monitoring brainwaves the system aims to detect the early signs of a stroke, and could one day be potentially built into a pair of glasses. The team have produced a prototype solution, the Early Detection Sensor & Algorithm Package (EDSAP), a stroke detection solution using brainwaves. EDSAP allows anyone with a smartphone or tablet to monitor the electrical impulses that are brainwaves, thereby gauging the probability of an oncoming stroke. The objective is to provide early warning, so that those at risk can visit the doctor for a proper diagnosis with sufficient time to prevent the potentially tragic consequences of a stroke. “We approached neurologists, asking them whether this was feasible,” said Se-hoon Lim, the project lead. “They were dismissive, but we wanted to give it a go. Health-related wearable devices are becoming more and more complex, meaning their capabilities are growing increasingly sophisticated.” EDSAP’s sensors are placed on a headset, collecting and wirelessly transmitting brainwave data to a mobile app, where the algorithm analyses the brainwaves and ultimately determines the likelihood of a stroke, all within a 60-second time span. Additionally, by tracking brainwaves for longer durations, EDSAP can leverage its brainwave analysis capabilities to provide additional information related to neurological health, such as stress, anxiety and sleep patterns. Compared to other brainwave sensors in the market, which are more commonly used for device control rather than health-related purposes, EDSAP sensors are unique in a number of ways. Firstly, EDSAP sensors are able to monitor and analyse brainwaves much faster than the 15 minutes or so required for existing brainwave monitoring equipment at hospitals. Secondly, the sensors are able to scan brainwaves in comprehensive detail, largely thanks to the highly conductive rubber-like material discovered by Lim and his team. Thirdly, the sensors are

easy to wear. Saline solutions no longer need to be rubbed into the hair, removing the unpleasantries that have previously been a part of brainwave scanning. More importantly, in part thanks to the rubber-like material, EDSAP sensors can be scaled down into a variety of form factors reminiscent of everyday objects. While the current prototype is in the form of head gear, EDSAP sensors can also be pasted onto the backside of hairpins or eyeglass temples, thereby allowing users to monitor their brainwaves over longer periods of time without the outmoded appearance. Meanwhile, the EDSAP algorithm, which translates brainwave data into stroke detection, is based on analysis of countless stroke patient brainwave data, which has been combined with a range of artificial intelligence and signal processing software. They include, among others, the Peak & Slope Detection software, which allows mobile devices to conduct rapid analysis of brainwave fluctuations and movement. A number of open source software solutions were also used, including FFT and Wavelet. “The ability to precisely measure brainwaves and provide early warning for an imminent illness using a wearable device is a highly meaningful development,” said

Seung-Bong Hong, a neurologist at the Samsung Medical Center in Seoul and a medical advisor to the EDSAP project. “At Samsung Medical Center, we believe that EDSAP’s utility can be expanded and applied to other neurological health issues, such as depression. There are certainly a number of steps that remain for EDSAP, including full clinical trials. Nevertheless, I can confidently say that what these engineers have achieved merits the medical community’s attention.” As EDSAP undergoes further development, its utility in other areas will be assessed. One potential area of implementation, according to Lim, has been in electrocardiograms, or the recording of heart muscle activity. “Compared to the electric pulses of a heart, brainwaves are very faint, making them far more difficult to detect,” said Lim. “EDSAP has proven it can more than handle brainwaves, and we’ve seen EDSAP’s potential role in addressing other neurological problems. We’re now also looking at what EDSAP can do with the heart. Over the next few months, we’ll get a clearer idea of how far the tentacles of EDSAP can reach. Ultimately, we hope that what we end up achieving - will make a lasting difference.” Source: Samsung Tomorrow n

The Journal of mHealth

Predictions for mHealth in 2015

Predictions for mHealth in 2015 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. The end of the year always brings great pause for predictions and thoughts for the future, and technology is no different, especially in healthcare, as digital and mobile health have become somewhat fashionable to talk about. I have read many articles and discussions about what will be different in healthcare technology in 2015, not to mention all the conferences that have taken place around the turn of the year. Common consensus seems to be that a mixture of wearables, complex genomics, nanotechnology and 3D-printing are going to revolutionise hospitals and healthcare immediately by promising everything under the sun without a care for clinical workflows, business cases or return on investment studies. I realise and appreciate that ‘prediction’ articles are often the time to take a look at the more exciting and unusual things on the horizon, but I also can’t help but think that they frequently add to the hyperbole and wooliness around such an important area, and end up actually doing a disservice to the areas they are focused on. As such, these are my predictions (and hopes) for clinical technology, which may not toe the fashionable party lines, but which will deliver the greatest benefits to digital and mobile health as a whole. Sales AND consumption Something I have ascribed to in my business for some time is that the technology out there works (on a technical level) as near as makes no difference 100% of the time, and the problems facing health IT are predominantly to do with change management and adoption and diffusion of technology. Too often

February 2015

I have seen vendors sell into healthcare and either the advertised benefits are not realised or the technology is simply not used at all, and is left gathering dust in a store cupboard which is a colossal waste of resources.

that exists in too many places. Large vendors will dominate the market

More and more though I have seen both healthcare institutions and vendors focusing on uptake and consumption of the technology rather than just getting the sale done and moving onto the next one. Staff are being remunerated based on adoption and diffusion, and it is being highlighted in hospital’s operational IT plans. This is admirable because the (relatively) easy part is making a sale, the difficult and most important issue is making sure that the technology delivers what it says it will do, which is much more time and resource intensive. My hope is this approach will continue to gather pace in 2015.

There exists a narrative in some areas that start-ups will be the companies that ‘disrupt’ healthcare, wresting control of the market from the large slow-moving behemoths. While I have no doubt that some companies will break through and deliver real value or partner with or get acquired by larger companies, the status quo will still largely exist, especially here in the UK, with frameworks and funds conspiring against smaller vendors. If I look at the breadth of solutions and the market gains being made by companies such as CSC, Cerner and Dell, they may not be historically popular in some of the wider community, but their solutions will still be the ones procured by some margin.

Clinical engagement

More outlandish predictions

Fitting in alongside consumption is the rise of clinical engagement in technology. The advent of the CCIO (chief clinical information officer) in an increasing number of NHS hospitals is a critical bridge for technology success and is something that will soar not only in numbers but in impact on the boards of healthcare institutions. I believe that CCIOs and other clinical members of trusts and vendors will be the prime drivers in technology adoption and diffusion. My hope around this prediction is that the clinical and IT department silos that exist in the majority of hospitals then start to be broken down such that we have every department pulling in the same direction and put an end to the ridiculous lack of joined-up-thinking

As described before, there is a weight of predictions, conferences and commentators that continually chastise the status quo, advocate a range of very new and untested solutions and promote ways of thinking that I personally believe are at loggerheads with how healthcare should look in the future. While I would never ban people from their opinions, I do strongly believe that a number of these actions do more harm than good in terms of front-line healthcare delivery and clinical impact, through clinician switch-off and lack of comprehensive stakeholder interaction. However, as more people jump on the bandwagon, the hype may well continue into 2015 as well. Here’s hoping one prediction doesn’t come true! n

From Pilot to Take Off: Watch mHealth Fly in 2015

From Pilot to Take Off Watch mHealth Fly in 2015 Article by Chris Watson

huge financial burden to the healthcare provider and the vendor.

Finally, mHealth is on the agenda. Slowly, but surely, the industry is waking up to the fact that, rather than being a fad, or a flyby-night trend, mHealth is here to stay, and is actively helping healthcare companies which are striving to deliver ever more cost-effective care and improve health outcomes.

Building a robust solution Before a vendor chooses which solution it will roll out with across borders, it must examine its own capabilities. Most apps will submit data back to servers, but can these servers deal with these small packet information sent back to them from each time zone? Can they cope with 10,000 responses loading on a server each morning? Even if they can queue up the information, will it be processed before the next set of data from another country is due to come in? Again, we reach a tipping point.

Across countries and continents mHealth is utilising mobile technology to engage with patients both in clinical trials and real-life situations. mHealth is revolutionising both patient engagement and adherence to healthcare regimens. Preparing to scale-out A study by Cambridge University researchers, in partnership with wireless networking vendor China Mobile, found that mobile health devices and apps have a far greater reach than previously thought1. The challenge for the industry is how to harness this opportunity to scale out. Until now, we’ve generally seen cross-border mHealth programs piloted, before they’re scaled out. However, these pilots have often come to an abrupt end because of lack of funding and an inability to properly evaluate data, leading to frustration and dead ends. Certainly, scaling out a pilot mHealth program into a multinational full patient support service isn’t simple, and many vendors can underestimate the associated challenges. But what are the key considerations and challenges of rolling out pilot self-management solutions into full scale cross-border programs? Delivering mHealth programs across borders presents unique challenges. The multitude of varying and complex regulations and differing patient requirements for the precise type and form of mobile and digital technology to be applied requires providers to be highly adaptable, and to have strong regional knowledge. Key considerations: the numbers game Let us look first at the background architecture of a potential cross-border mHealth solution, and ask some key questions. Can it cope with different elements such as regional settings and date formats, different grammar and punctuation? Is it referencing the relevant time stamp? In short – can the back-end cope with scaling a service from, for example, moving from a 1 country implementation, in 1 language, engaging 1000 patients to a 10 country implementation, using 15 languages for over 100,000 patients? The quandary here is that if a vendor builds several versions of the same app, so there is in essence one app per country, then maintenance costs become prohibitive, requiring large teams to work on these multiple country specific roll-outs. Considerations such as operating system upgrades across all platforms would have to be included in the budget, and this can become a

To test that an mHealth solution will provide the data it should, a vendor must challenge the back-end architecture before launch and check that all the correct mechanics to handle cross-border data are in the system. In a real world situation, a robust support mechanism for the mHealth solution is crucial. A whole host of challenges can arise in the real world, and you need to test whether your solution is up to the job. Can your mHealth solution cope with app and service resurrection in the event of accidental deletion or a change of phone by the patient? And then there is scaling. With one country there is one language, but when a programme is rolled out across borders stress testing should be undertaken to ensure that multi-threading and asynchronous processing are possible. And if there are problems, does the vendor have the wherewithal to monitor and identify system bottlenecks, and, further down the line, can it plan for infrastructure growth to manage increased capacity? Does it have a multi-stakeholder management process – from healthcare provider through to patient – inbuilt? If the answer to all of these questions is ‘yes’, then an mHealth solution can revolutionise the way patient data is collected. Many apps try and address the question of scalability through a hybrid model, where an app will call out to a central server to deliver localised information. This means that not everything is coded in at source, and can be added to as and when the need arises during the patient journey. However, this can become a laborious experience as, due to the larger data movement, the apps may use up some of the users’ data allowance. An alternative to this is to follow a one-to-many approach. This produces a base ‘vanilla app’, which can be customised at a country level. It is becoming increasingly popular but does involve an initial time investment to agree the base principle features to be included into the code base. The advantage of that is that it has one team supplying and maintaining one code base. But what happens when the code base has to branch out due to particular market requirements – where can the mHealth solution go, and Continued on page 24

The Journal of mHealth

From Pilot to Take Off: Watch mHealth Fly in 2015 Continued from page 23

how can you take the service forward in a cost-effective way? Putting the patient first When it comes to scaling out mHealth solutions across borders, it is vital that patients are kept central to all design decisions. Before scaling a solution, the mantra should be ‘pilot, pilot, pilot’. It is naive to think that an app will be road-ready first time around, and it should be tested against different markets and territories before being rolled out internationally. Vendors should identify who the app services and engage with patient focus groups to ensure the app meets their needs, as it is these users that the service is being designed for. Language should be taken into consideration – as it is rare for vendors to have multilingual teams. Most build their apps in Anglo-English, which often doesn’t translate well into other languages. Additionally, many countries have no concept of AM and PM, so a 24 hour clock is required; and a Personalized Identification Number (PIN) means little across huge swathes of the world. Finally, End-user Licence Agreement (EULA) may mean nothing in Europe. Converting solutions to work across borders What, then, will make an mHealth cross-border conversion successful? There is a number of operational factors that are crucial elements of any multi-territory program: »» Users’ data allowance: A scaled-out mHealth solution should have an added value through enhanced content. For example, viewing videos outside of WIFI connection could incur additional charges, therefore cross-border multi-territory programs should have measures built in to either block the content or to issue a warning if a user is viewing content which may impact their data allowance. »» Level of device integration: Data collected in form of medical device readings can be an important part of any mHealth service, hence the impact of medical device integration for global mHealth programs needs to be considered. »» Data synchronisation: It is not just a case of translating the service, full service localisation should be considered as centralised systems must be able to cope with data arriving in different formats across broader time zones. »» App and battery life: It is essential to understand how peripheral device integrations can affect battery life, and what impact on a device’s battery an mHealth app will have. Regulation: a varied landscape Depending on which territory an mHealth solution is being utilised in, there may be specific requirements around where the patients’ personal data is held, and who has access to it. Different territories have varying regulatory requirements regarding data protection and different data protection considerations should be built into the programs at source. For example, economic areas with heightened data protection requirements, such as the EU, can pose additional challenges when trying to adopt a global approach for mHealth programs. Within the EU, despite agreements being in place for the international transfer of personal data (e.g. Safe Harbor), the patients’ perception of the protection applied to their data when it is placed outside of the EU can create a barrier to adoption.

February 2015

The success of any mHealth solution comes down to patients being able to use it within different countries. When it comes to the design, these different levels of data protection can add a level of complexity that simply isn’t needed. There has to be an understanding right at the first-stages of designing cross-border mHealth solutions about what is going to happen to the data and where it’s going to reside, as it can fundamentally influence the design process. Another regulatory consideration when rolling out mHealth programs across international borders is the country-specific End-user License Agreement (EULA) and policies. When it comes to software, a EULA or software license agreement is the contract between the licensor and purchaser, establishing the purchaser's right to use the software. If an app is deemed to be a medical device, the classification varies depending on territory. For example, a Class I device/app within the EU may be deemed to be Class II device in Canada. In this way, the designers of mHealth solutions are forewarned, and have more of a lead time when going through the development phase, and can work to scale out their product by engaging with the current regulation. 2015: the year of cross-border mHealth Scaling out an mHealth solution certainly hasn’t happened overnight. Rigorous testing with a pilot has become essential to hone the technology and comply with the different regulations encountered. However, the technology and framework is now in place and has been proven, and by utilising them I believe that 2015 will see a trend towards the scaling out of mHealth programs across borders, as forward thinking vendors become more agile and responsive. But how easily can mHealth programs cross borders to improve lives? I believe that in 2015, the time is right for the pilot programmes we have seen being undertaken over the last few years to become ready to be scaled out. The next 12 months could be the time when mHealth breaks free and spans the world to improve global health outcomes. References: http://www.csap.cam.ac.uk/media/uploads/files/1/mobile-communications-for-medical-care.pdf n Chris Watson is Product Manager at Exco InTouch. Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 16 years’ experience in the delivery of business and consumer based solutions, the last 6 of which have been focused in the clinical technology industry. He has an extensive knowledge of product and software development processes and is responsible for implementing mobile product strategy at Exco InTouch.

FDA Issues Draft Guidance on General Wellness Devices and Apps

FDA Issues Draft Guidance on General Wellness Devices and Apps In January, the FDA issued new draft guidance documents that outline how they intend to treat low-risk devices intended to promote general wellness with the aim of providing greater clarity on whether, or not, wellness devices or apps cross over into the area of regulated medical devices. This follows a commitment in the FDASIA Health IT Report that was released in April 2014. The FDA is proposing to not enforce regulatory compliance for products that are intended only for general wellness. These products are designed to maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions. The hope is that the policy will foster the development of low-risk products intended to promote a healthy lifestyle. This guidance is of particular relevance for those developing in the digital health space. It is therefore well worth reading the draft documents to gain an understanding of the FDA’s intentions at this time. As these are draft documents there will be a period of consultation during which time the FDA is seeking comments from stakeholders and the industry. Below is a summary of the guidance documents: General Wellness A general wellness product, for the purposes of the guidance, is described as having (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity; or, (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition). If the product’s intended uses are not limited to the above general wellness intended uses, then it is suggested that the guidance will not apply. The first category of general wellness

intended uses involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions. For the purposes of the guidance, this first category of general wellness claims relate to: »» weight management, »» physical fitness, including products intended for recreational use, »» relaxation or stress management, »» mental acuity, »» self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem), »» sleep management, or »» sexual function. The FDA provides some examples of the type of solution that may fall into these categories: »» Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals; »» Claims to promote relaxation or manage stress when there is no reference to anxiety disorders or other reference to a disease or condition; »» Claims to increase, improve, or enhance the flow of qi; »» Claims to improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decisionmaking, logic, pattern recognition or eye-hand coordination;

»» Claims to promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy; »» Claims to promote sleep management, such as to track sleep trends; »» Claims to promote self-esteem, such as to boost self-esteem; »» Claims that address a specific body structure or function, such as to increase or improve muscle size or body tone, tone or firm the body or muscle, enhance cardiac function, or enhance or improve sexual performance; »» Claims to improve general mobility or to assist individuals who are mobility impaired or who have limited mobility in a recreational activity; and »» Claims to enhance an individual’s participation in recreational activities by monitoring the consequences of participating in such activities, such as to monitor heart rate or monitor frequency or impact of collisions. The guidance also includes details of the types of claims that would not fall into this category of general wellness: »» A claim that a product will treat or diagnose obesity; »» A claim that a product will treat an eating disorder, such as anorexia; »» A claim that a product helps treat anxiety; Continued on page 26

The Journal of mHealth

FDA Issues Draft Guidance on General Wellness Devices and Apps »» A claim that a computer game will diagnose or treat autism; »» A claim that a product will treat muscle atrophy or erectile dysfunction; »» A claim to restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball.

may play an important role in health outcomes should be generally accepted; such associations are typically described in peer-reviewed scientific publications. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes.

The second category of general wellness intended uses is comprised of two subcategories:

The guidance gives examples of this category of disease-related general wellness claims:

1) Intended uses to promote, track, and/ or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and 2) Intended uses to promote, track, and/ or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.

»» Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure. »» Software Product Y tracks your caloric intake and helps you manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type 2 diabetes. »» Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.

Continued from page 25

Both subcategories of disease-related general wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s)

The FDA has clarified that the General Wellness policy will not extend to devices that present inherent risks to a user’s safety. Whether a device is low-risk for purposes of the guidance is determined by whether or not the product: 1. is invasive; 2. involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants; 3. raises novel questions of usability; or 4. raises questions of biocompatibility. Where the answer to any of these questions is yes, then the device would not be considered a low-risk general wellness product and therefore not covered by the guidance. The FDA is seeking input on the draft guidance documents from industry and other stakeholders during the comment period. For more information please or to read the draft guidance visit www.fda. gov/MedicalDevices/ResourcesforYou/Industry/ucm430911.htm n

Digital Mobile Solution Places International Travellers in Control of their Healthcare Worldwide The health insurance industry is becoming increasingly interested in how it can help customers achieve better quality of life, reduce premiums for those that actively manage their health, develop better and more efficient relationships with health professionals and differentiate products in the marketplace. Digitisation has a large role to play in this and, as part of this commitment, private medical insurance customers with British multinational insurance company Aviva can now use a specially developed smartphone app that provides access to securely stored personal medical records and immediate access to emergency assistance and medical advice, wherever they are in the world.

February 2015

Produced in partnership with Oxfordshire-based Medelinked, the Aviva International Solutions App - which is available for both Apple iOS and Android smartphones - enables the Company’s customers to record a range of medical details including allergies, conditions, immunisations, medications and tests, and has the ability to store images of scans, x-rays and certificates to complete their health profile. This provides users with the peace of mind that, if they need urgent medical treatment abroad, their medical history can be quickly and safely accessed and shared from their mobile device. The customer has sole control over the information that is stored and can decide whether they wish any healthcare profes-

sional or organisation to view any part of their medical history. Aviva is unable to access any of the data, unless the user chooses to share any records with them. The customer can also choose any information they would like to store in a password-protected Emergency Records area, which a chosen family member or colleague can immediately access in the event of an emergency. When healthcare or emergency support is needed, the app enables customers to dial straight through to Aviva and its 24-hour emergency assistance and medical advice service, as well as to a list of their healthcare providers. There is also a clear step-by-step guide on how to make

Digital Mobile Solution Places Travellers in Control of their Healthcare access to their latest, accurate health data in a form that can immediately inform the health care professional. Using Zaptag to manage all their health data in one secure place would enable individuals to be provided with the best possible care. It would also keep them in control of their own health as individuals become more concerned about their wellbeing and are increasingly proactive in managing their health and fitness.

a claim and details about International Solutions cover.

to their personal medical records and round-the-clock health services.”

The solution also allows Aviva’s customers to get health advice in real-time and chat instantly with healthcare providers – for example their doctor, dentist, physiotherapist, optician, travel clinic - using IM, voice, text, email and video from their desktop using their own membership account.

The App is one of a rapidly growing list of apps, devices and sensors compatible with the Medelinked Health Cloud.

With its worldwide operations, Aviva International Solutions had pioneered a paper-based MyHealthpassport to ensure its customers had key medical data handy at all times. But as digitisation increasingly changed information management in both insurance and medical care they quickly saw the advantages for their customers, and their contracted health professionals, in providing medical records that could be accessed electronically. This in turn led to the work with Medelinked, whereby they were able to use the Medelinked Health Cloud as the basis for the development of an online version of the MyHealthPassport system. Teresa Rogers, head of international at Aviva UK Health says: “The launch of the app marked the next stage of Aviva’s digitisation of its International Solutions offer. As our international customers are increasingly mobile across the globe and remote working on mobile devices has become the norm, we’re delighted to be able to work with a specialist like Medelinked to improve customers’ experience of their International Solutions cover by providing them with safe mobile access

Medelinked, which began life as Zaptag, was founded in 2005 by CEO Ian Gallifant in order to allow individuals to use emerging mobile and cloud technologies to increase the effectiveness of health care. Key to this vision is enabling individuals to securely build their health profile online and to connect and share information with their network of trusted health partners as they wish.

After the initial success of Zaptag, the emergence of cloud storage during the last decade allowed Gallifant and his team to develop their offering. The secure Medelinked Health Cloud now allows user and practitioner generated information to be accessed securely anywhere in the world without the need for the patient to carry the memory stick. Proven with Aviva, the secure Medelinked Health Cloud API is now allowing developers to create a series of new applications that deliver real benefits to the end user, healthcare providers and health professionals alike. Gallifant says, “We are now seeing a dramatic shift in healthcare - individuals have a heightened interest in their own wellbeing and are increasingly interacting with personal technology to manage their lives.

Prior to establishing Zaptag, Gallifant had served extensively with the UK armed forces overseas. This had made him hugely aware of the importance of combat doctors having immediate access to an injured soldier’s medical records.

“At the same time, people are realising they have choices, are gaining control and knowledge and are proactively engaging with health issues. The realisation of support and education from online technology and apps, as well as their increasing availability, is driving new opportunities for improved healthcare services and better outcomes.”

Basic information of this type had long been recorded on the metal `dog tags` of individual combatants. But Gallifant realised the development of encrypted USB memory sticks created the opportunity for civilians to carry their own `health passport` with them, wherever they may be, to be accessed by trusted professionals at the point of care. His vision was to help individuals securely track and monitor their health states and improvements more easily and quickly. And, in sharing vital data with their healthcare providers (doctor, consultant, insurer), to ensure they have

“Personal electronic health records are the way forward for effective healthcare in the future. It starts with past health information being stored in an easily accessible way and provides users with the ability to add to their records and share information easily with the medical providers they choose, to ensure the best advice is given based on previous history, wherever they are in the world. As the information is personal to the user, it will only be provided to those they wish to share it with, and no organisation is able to access the data unless the user chooses to share it with them.” n

The Journal of mHealth

Predictions for mHealth: What Do We Need to Think About in the Future?

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. With mHealth growing at the rate that it is, deployments taking place in lots of markets and developments in technology and delivery really increasing, the market is starting to look at what might happen in the longer-term and what some of the questions and issues might be as we go forward. I, personally, think that there are some issues that we have to think about both as manufacturers/suppliers and also as commissioners/purchasers of care: Deployment at scale - is becoming more critical as commissioners start to look for solutions that serve larger cohorts of patients and work across wider patient groups with multiple conditions and mortalities. So far many of the deployments we have seen, have been smaller trails and set-ups looking at patient numbers of perhaps 200 up to 1,000. As the proven capabilities of these kinds of solutions start to take hold then we are going to have to think about deployments that can go towards 50,000 patients, and deal with comorbidities. This will deliver greater challenges and increase the complexity and scale of

deployments in the community. Technology – this area is increasingly interesting. Almost daily, new pieces of technology, software and devices hit the market and offer new options and new capabilities for patients and healthcare professionals. What is clear to me is that just because a device exists, or can do something in particular, doesn’t mean that we should make use of that function. This is about technology being the enabler rather than the driver and that is key. Technology should allow us to deploy to more people and deploy more effectively. One of the critical things going forward will be to make greater use of the patient’s own devices rather than giving patients lots of new devices which they may not be familiar with and most importantly increases the cost of the deployment and the solution. Integration into healthcare systems and healthcare processes - is for me the real key issue in the next few years as projects scale-up and more patients start to use these kinds of technology. We have to deliver systems that integrate

into existing processes and allow those processes to change and reflect the use of new technologies and solutions. For me, most importantly is the need for the patient to see and understand the data they are collecting and to really understand their condition and how it affects them. A well-managed and motivated patient is a patient who is able to selfcare as much as possible. We need to help patients see and understand their data while giving healthcare professionals the ability to see the data they need to manage the patient as cost-effectively as possible within the healthcare system. Avoiding duplication of services or latent capacity within healthcare As always the key is that when we make change, and we deliver service changes and improvements, that the capacity that is no longer used, or needed, is removed from the system or the cost savings that technology can deliver will not be found. As always, these are challenges that can be overcome and as suppliers and manufacturers we have to work with healthcare professionals and those who commission care to deliver the right level of service. n

EXECUTIVE HEALTHCARE CONSULTING Nurcombe Consulting delivers interim senior management support, strategic business analysis, change management as well as development of plans and capability for entry into the healthcare market in the UK and globally. Experience at end to end business reviews and then implementing required changes to deliver strategic goals and change of direction for businesses. Management support at senior level within organisations to deliver change as well as day to day management of the running of the business. Support in delivering new business opportunities into new markets in the healthcare space with considerable experience in: • Pharmaceuticals • OTC and Consumer brands • Healthcare delivery to patients in their home • Tele-health and tele-care provision • Provision of staff and care for patients in their home and also in NHS and private care settings • Development of private healthcare opportunities working with the NHS and other state providers • Digital Health and the use and deployment of technology to support patient and health outcomes

With over twenty years experience in healthcare locally, regionally and globally this consultancy has the experience to deliver value to your business. For more information please visit www.nurcombeconsulting.com or email nurcombeconsulting@gmail.com

February 2015

How healthy is your

workforce?

dacadoo measures the health and wellbeing of your workforce in real-time. www.dacadoo.com

This could be your ad 40% off

for all new advertisers Contact Matthew@simedics.org for more information Want to learn about the benefits of Field Testing for Health apps & systems? Visit www.pass.ch/fieldtesting

In Depth with the Global Digital Health 100

In Depth Global Digital Health with the

Since we announced our inaugural Global Digital Health 100 Awards List 2014 at the end of last year, we have been overwhelmed by the positive response from all areas of the industry.

100

Here we continue our coverage of the Awards list by featuring news from some of the 2014 winners. We are also extremely pleased to be able to publish this fantastic infographic (see right), developed by Jenn Lonzer at nuviun which analyses and illustrates the make-up of the 2014 Global Digital Health 100 winners and highlights some of the key trends from the data. Due to the success of the Awards we will be running the Global Digital Health 100 Awards again in 2015. If you would like to nominate a company for consideration, or for your chance to partner with us as a sponsor of this high-profile global event then please do get in touch at enquiries@simedics.org.

Audio Port Connectivity Platform by LGTmedical is an mHealth Game Changer Canadian company’s unique universal interface enables inexpensive medical sensors to easily connect to mobile devices through the audio port. There are a lot of challenges facing the global mHealth sector today, not the least of which is the development and production of low-cost, cross-platform solutions that are both accurate and affordable. LionsGate Technologies (LGTmedical) has taken on that challenge with the goal of overcoming health inequities in the developed world and helping to save lives in the developing world. It’s a tall order but combined with its groundbreaking technology, it’s the reason why the Canadian company was a Finalist for the Global Digital Health 100 Award. “With this first-annual Award, The Journal of mHealth recognises the rapidly growing importance of mobile technologies and digital solutions in the healthcare sector. We’re honoured to be recognised for our innovation in mHealth and join other international healthcare trailblazers in accepting this Award,” said Tom Walker, President and CEO of LGTmedical.

February 2015

In Depth with the Global Digital Health 100 “With our unique audio-based connectivity platform called Kenek Core™, we have developed softwaredefined app-devices that drive medical sensors," he explained. “Our universal interface enables standard medical sensors to easily connect to mobile devices through the audio port. This means the sensor is driven entirely by the app in the smartphone or tablet. Since there are no batteries, processors, or wireless configuration required, these app-devices can be used anywhere, by anyone.” “This novel, audio-based interface also dramatically lowers the cost of vital signs monitoring so that accurate medical devices can be produced for a fraction of the price of current products,” added Walker. "This means manufacturers can also benefit as our proprietary connectivity platform enables them to cost-effectively incorporate into their products the most innovative and powerful sensor technology available today." A pulse oximeter is currently available for integration; a blood pressure monitor and a thermometer are targeted for release in Q2 2015. The app-devices are compatible with select iOS and Android mobile devices. Pulse oximetry is LGTmedical’s initial application to be commercialised because of its significant impact on saving lives in the developing world: specifically children with pneumonia, people with sepsis, women with preeclampsia, and critically ill newborns. “Developing clinically validated software-defined medical devices requires a team of clinical experts, software engineers, hardware engineers, regulatory agents, and researchers including physician specialists. Our team has completed years of intensive R&D, as evidenced by our audio-based interface,” said Loki Jörgenson, LGTmedical’s CTO. Since its launch in 2012, LGTmedical has leveraged the synergies of award-winning interdisciplinary research, the support of global foundations such as Grand Challenges Canada, and business expertise to establish the innovative core technologies, infrastructure, and partnerships and become a leading mHealth company. LGTmedical is focused on product and channel development to achieve the most scalable and clinically impactful mobile health solutions. The company is ISO 13485:2003 certified. n

The Journal of mHealth

In Depth with the Global Digital Health 100

Smartphone Apps Just as Accurate as Wearable Devices A new study has highlighted just how good apps like dacadoo can be for encouraging you to hit your health and fitness goals. According to a research team from Perelman School of Medicine and the Center for Health Incentives and Behavioral Economics at the University of Pennsylvania, most smartphone apps are just as accurate as wearable devices when it comes to tracking your physical activity. The study looked at the ten best-selling smartphone apps and devices and had 14 participants take part to test them. All of them were asked to walk on a treadmill for 500 and 1,500 steps, each twice, while the researchers clocked their step count. It acts as a follow-up to a recent report from the Journal of the American Medical Association (JAMA), suggesting that there was limited evidence that just using wearable devices by themselves can improve health or change behaviour for people in the highest need of it. Lead author of the study Meredith Case, a medical student at the University, said they wanted to address one of the challenges with using wearable devices: they must be accurate. "After all, if a device is going to be effective at monitoring — and potentially changing — behaviour, individuals have to be able to trust the data," she said. "We found that smartphone apps are just as accurate as wearable devices for tracking physical activity." "Since step counts are such an important part of how these devices and apps measure physi-

February 2015

cal activity, including calculating distance or calories burned, their accuracy is key," said senior author Dr Mitesh Patel, assistant professor of Medicine and Health Care Management at Penn and an attending physician at the Philadelphia VA Medical Center. He added that, with the high uptake of smartphones, they could be a more "widely accessible and affordable way of tracking health behaviours". dacadoo was recognised in the Global Digital Health 100 Awards 2014 for its pioneering development of its lifestyle navigation platform designed to calculate a person's Health Score. The score, a number from 1 to 1000, represents a person's health status from poor to excellent and aims to represent a directional relative indicator of a user's current health

and well-being status in real-time. Using a combination of smartphone technology, social networking, motivation techniques from the gaming industry, and big data analytics, the company’s technology focuses on active prevention and encouraging healthier lifestyles aimed at tackling health problems before they become chronic. On dacadoo’s inclusion as one of the Top 100 companies in the Global Digital Health 100 Awards 2014, Founder and CEO Peter Ohnemus commented proudly: “Mobile and digital health is still in the early days, and we’re very honored to get this prestigious award and be recognised as one of the innovators in this growing space”. The infographic below illustrates the core components of the dacadoo platform. n

5G and the Implication for Digital Healthcare

5G and the Implication for Digital Healthcare At last year’s Mobile World Congress in Barcelona, one of the hottest topics of discussion was the future of 5G — a nextgeneration mobile communications network that would offer exponential gains in both speed and capacity over existing 4G networks. Speaking at the event, Vice President of the EU Commission Neelie Kroes suggested that mHealth could emerge as one of the biggest applications of new 5G networks. As wearable device use increases, it will lead to new types of “sentient” health devices that are aware of real-time changes in your health — and are capable of relaying that information to health providers and loved ones. It might also lead to innovations like “remote surgery.” What is 5G? When asked to answer that question in Barcelona, the heads of Europe’s top mobile operators — the likes of Ericsson, AlcatelLucent, Orange and Nokia – couldn’t even define what 5G was, but were nonetheless committed to spending billions of dollars to make 5G a reality in Europe. The same timetable exists in Asia, where Japan and South Korea also plan to invest billions to build the next 5G networks by 2020. "I have no idea what 5G is,” began Hossein Moiin, CTO of Nokia Solutions and Networks, one of the five founding companies behind the European 5G Infrastructure Public-Private Partnership. But that’s not a concern, as the massive investment will fund a project to define it.” If 2G networks were for voice, 3G networks for voice and data, and 4G networks for broadband Internet connectivity, what exactly do you get when you deliver a 5G network? Marcus Weldon, president of Alcatel-Lucent’s research arm Bell Labs, offered a number of characteristics that 5G networks should have. “They should be dynamically configured, dynamically scalable, and distributed not centralised,” he said. “And rather than making a best effort at delivering all traffic, they should offer best efforts only for traffic that needs it. Where the first four generations of mobile networks were distinguished, at least when introduced, by the frequencies in which they operated, 5G networks should operate in any spectrum—high frequencies or low, licensed or unlicensed, shared or dedicated”. He also suggested that they should not be limited to just one type of waveform but should instead be a blend of formats, rather than a pure standard. He concluded by saying that 5G networks should be peoplecentric and should harvest energy from their environment in order to operate. Neelie Kroes, speaking at the event, called for bold steps towards

the adoption of 5G, "Let's find a global consensus on the scope of 5G, its main technological constituents, and the timetable for putting it in place. Let's work this out together. And let's work it out soon: by the end of 2015, so all our citizens can get the 5G boost as early as possible.” By 2020 there will be more than thirty times as much mobile internet traffic as there was in 2010. But this will not be the same type of traffic as currently exists - Internet usage will not only have grown thanks to the number of smartphones & tablets in use, but also because of the massive growth in machines and sensors using the Internet to communicate, which require more efficient and ubiquitous technology to carry the data traffic. Communications specialist Cisco predicts that much of that traffic will be driven by billions of devices talking to other devices wirelessly. To make that M2M (machine-to-machine) communication possible you need fast, high-capacity networks. The 5G network technology and infrastructure will bring the capacities needed to cope with this increased growth in the use of communication - especially wireless - technologies by humans and by machines, promising speeds that are 100x faster than anything that exists today. Just one of the many benefits that 5G could bring to healthcare is in the advanced area of telesurgery. Telesurgery made international news in 2001 when the first transatlantic surgical procedure took place between New York City and Strasbourg. This remote surgery experiment required extremely expensive high capacity leased lines. Commands triggered in the US controlled surgical devices in France, with some small delay. 5G could potentially make this scenario easier, mobile, and reduce the command-response time to nearly zero. As well as providing the practitioner with greater operational comfort, accuracy, and near real-time feedback. The technology would mean a patient who needs an urgent or specialist operation could be operated by a practitioner from virtually any remote location in the world. We’re now entering an age where real-time health data from Continued on page 34

The Journal of mHealth

U.S. FCC to Look into New-Generation Wireless Networks Continued from page 33

mobile devices is becoming the norm rather than the exception. 5G won't just be faster, it will bring new functions and applications with high social and economic value. Global Investment The European Commission is investing €700 million to kickstart a 5G research project, part of a broader 10-year initiative to bolster competitiveness of European industry. Also announced in 2014 were details of the 5G-InfrastructurePPP. A 1.4 Billion Euro joint initiative between the European ICT industry and the European Commission this project is aimed at rethinking the infrastructure in order to create the next generation of communication networks and services that will provide super-fast connections and seamless service delivery in all circumstances. Similar, investment initiatives are also in place around the world. Mike Murphy, Nokia Networks' head of technology for North America recently suggested that the upcoming Olympic Games-specifically the 2018 winter event in South Korea and 2020 summer event in Japan--will likely drive those Asian nations, whose wireless networks are already among the world's most advanced, to shine the spotlight on their respective 5G prowess while they hold the world's attention. Because those nations will want to prove they are still on the cutting edge, Murphy predicts

that we will actually see early 5G trials during 2018 in South Korea, followed by broader commercialisation starting in 2020. The European Commission and South Korea recently agreed to work towards a global definition of 5G and to cooperate in 5G research. They similarly agreed on the need for harmonised radio spectrum to ensure global interoperability and on the preparation of global standards for 5G. Both sides have signed a Joint Declaration on Strategic Cooperation in Information Communications Technology (ICT) and 5G, agreeing to deepen discussions in the area of Net Futures (network and communications, 5G, cloud computing), an element of on-going relations on ICT topics. Both sides will also work towards a coordinated call for research project proposals, to be launched in 2016. An industry memorandum of understanding will be signed between the EU’s 5G Infrastructure Association (whose members include Alcatel-Lucent, Atos, Deutsche Telekom, Ericsson, Nokia, Orange, Telecom Italia, Telenor and Telefonica) and South Korea’s 5G Forum. Speaking of the agreement in 2014 Neelie Kroes stated, "5G will become the new lifeblood of the digital economy and digital society once it is established. Both Europe and South Korea recognise this. This is the first time ever that public authorities have joined together in this way, with the support of private industry, to push forward the process of standardisation. Today’s declaration signals our commitment to being global digital leaders.” n

U.S. FCC to Look Into NewGeneration Wireless Networks U.S. regulators will look "to infinity and beyond" to harness new technology that can help build a new generation of mobile wireless connections. The FCC, during a meeting in October 2014, voted unanimously to open a socalled "notice of inquiry" into what it and the technology industry can do to turn a new swath of very high-frequency airwaves, previously deemed unusable for mobile networks, into mobilefriendly frequencies. The FCC's examination would serve as a regulatory backdrop for research into the next generation of wireless technology, sometimes referred to as 5G and which may allow wireless connections to carry a thousand times more traffic. In question are frequencies above 24 gigahertz (GHz), sometimes called millimetre waves that have previously been deemed technically unwieldy for mobile

February 2015

connections, though have the potential to carry large amounts of data and give the promise of lightning-fast speeds. Millimetre waves work best over short distances and have required a direct lineof-sight connection to a receiver. They are now largely used for point-to-point microwave connections. The FCC said it will study what technologies could help get around the technological and practical obstacles and what kind of regulatory regime could help a variety of technologies to flourish on those airwaves, including the potential for services other than mobile. The U.S. wireless industry continues to work on deploying the 4G connections, though some equipment manufacturers, are already testing data transmission on the higher frequencies. "While we will always work to locate

more cleared licensed spectrum under 3 GHz, we also need to expand our search to find other complementary spectrum bands, and this Notice is an important step in that effort," Meredith Attwell Baker, head of CTIA-The Wireless Association, said in a statement. Google has recently asked the FCC for permission to conduct tests on some of the extremely high-frequency airwaves, which experts say may provide the foundation for a wireless version of its highspeed fibre-internet service. Rosenworcel said growing data demand made it necessary for next-generation wireless networks to carry heavy traffic, quickly and without draining the phones' batteries. “How do we meet these demands? We look up. Way, way, up. To infinity and beyond,” she said at the meeting. Source: Reuters n

Samsung 5G Development Could Benefit Mobile Health Applications

Samsung 5G Development Could Benefit Mobile Health Applications In a step toward the 5G era, Samsung Electronics announced during 2014 that it had successfully developed the world’s first adaptive array transceiver technology operating in the millimeter-wave Ka bands for cellular communications. The new technology sits at the core of 5G mobile communications system and will provide data transmission up to several hundred times faster than current 4G networks. Predicted to debut in 2020, the wireless standard could be used in medical devices that enable physicians to see high-resolution images remotely, Samsung explained in a statement. The 5G format will also enable real-time streaming of ultra highdefinition content "practically without limitation." The speed is so fast that the network could be used to download a two hour movie in one second. 5G mobile communications technology is the next generation of the existing 4G Long Term Evolution (LTE) network technology. 5G will be capable of providing a ubiquitous Gigabyte per second (Gbps) experience to subscribers anywhere and offers data transmission speeds of up to several tens of Gbps per base station. The implementation of a high-speed 5G cellular network requires a broad band of frequencies; much like an increased water flow requires a wider pipe. While it was a recognised option, it has been long believed that the millimeter-wave bands had limitations in transmitting data over long distances due to its unfavourable propagation characteristics. However, Samsung’s new adaptive array transceiver technology has proved itself as a successful solution. Supporting the 5G breakthrough is an advance in adaptive array transceiver technology. In tests, the millimeter-wave band proved capable of transmitting at speeds as high as 1.056 Gbps over distances up to two kilometres. The millimeter range has historically been difficult

to work with because of the difficulty of transmitting the signals over distances and into buildings. In a statement, Samsung explained that adaptive array transceiver technology using 64 antenna elements “can be a viable solution for overcoming the radio propagation loss at millimeter-wave bands, much higher than the conventional frequency bands ranging from several hundred MHz to several GHz.” Samsung plans to accelerate the research and development of 5G mobile communication technologies, including adaptive array transceiver at the millimeter-wave bands, and hopes to commercialise those technologies by 2020. Once commercialised, 5G mobile communications technology will be capable of ultra-highspeed data transmission up to several hundred times faster than even the 4G LTE-Advanced technology, currently available. Samsung’s new technology will allow users to transmit massive data files including high quality digital movies practically without limitation. As a result, subscribers will be able to enjoy a wide range of services such as 3D movies and games, real-time streaming of ultra highdefinition (UHD) content, and remote medical services. This latest innovation is expected to invigorate research into 5G cellular communications across the world; triggering the creation of international alliances and the timely commercialisation of related mobile broadband services.

The competition for technology leadership in next-generation mobile communications development is becoming increasingly fierce. China established a government-led “IMT-2020 (5G) Promotion Group” for 5G research in February 2012, while the European Commission has also committed large investments designed to bring 5G services to the market by 2020. Samsung has been gradually increasing its presence in the medical technology and health-tracking niches. In 2010, it acquired Medison, a Korean maker of ultrasonic equipment. The company also has a presence in healthcare IT; and health tracking applications via its smartphone technology, which it is in the process of trying to build into a global healthcare business. n

Have a project you want us to cover? Let us know the details of any projects that you would like us to cover in upcoming editions of The Journal. Send the details to thejournalofmhealth@ simedics.org The

Journal of mHealth The Global Voice of mHealth

The Journal of mHealth

Upcoming Events

Upcoming Events 24-26 February

26 February

20-21 March

ePharma Summit

Royal Society of Medicine: Recent Developments in Digital Health

HIMSS Turkey

New York, NY, USA For more information visit www.iirusa.com/epharmasummit

London, UK For more information visit www.rsm.ac.uk

Antalya, Turkey For more information visit www.himssturkey.org

2-5 May

11-12 May

11-13 May

20th Annual Telemedicine Meeting & Trade Show

mHealth Summit Europe

Europe eHealth Week

Riga, Latvia For more information visit www.mhealthsummit.eu

Riga, Latvia For more information visit www.worldofhealthit.org

27-28 May

June

17-18 September

Wearables Europe

Connected Health 2015

The Health Festival

Los Angeles, CA, USA For more information visit www.ATA2015.org

London, UK For more information visit www.wearables-europe.com

San Diego, CA, USA For more information visit www.openmobilemedia.com/ connected-healthcare-mhealth-usa/

London, UK For more information visit www.informa-ls.com/event/ healthfestival

Advertisers Index To advertise in Consultation Plus

dacadoo 29

Infield Health

Pass Group

February 2015

The

Journal of mHealth The Global Voice of mHealth

Contact Matthew Driver matthew@simedics.org +44 (0)1756 709605

Consult…..connect…..engage……respond……improve In today’s fast changing health landscape understanding and responding to patient needs is becoming ever more critical. Designing healthcare services to match more closely the profile and lifestyle of your local population can bring benefits for patients and the efficiency of the health system. Consultation Plus is an online system tool that helps organisations improve their consultation exercises and encourage customer and user engagement. Designed by communications and engagement experts the system is simple to use and provides meaningful feedback to aid improved decision making via meaningful engagement. »» »» »» »» »» »» »» »» »» »» »»

Easy to use with simple ‘wizard’ menu to guide all users though the consultation and engagement process Low cost – multiple users can access the system via PCs and mobile devices to provide ongoing feedback and up to the minute information about user and customer views and experiences Feedback can be analysed demographically and geographically to give a clear picture of emerging themes and key issues Ability to manage multiple consultation exercises Upload data from meetings, web sites, or community outlets such as GP surgeries, town halls and schools Provides a clear ‘audit trail’ of activity to ensure ‘good practice’ and the meeting of legal requirements such as the ‘duty to consult’ Mapping feature shows ‘hot spots’ to identify areas where greater engagement is needed Analysis of feedback creates presentations for management and public meetings Our team can set up the system and upload an organisation’s existing databases for use in the consultation processes We can also set up and embed a new forward looking engagement approach in your organisation to improve customer and user experiences and enhance service delivery Bespoke solutions – building on the basic system we can add and tailor additional features to match customer’s exact requirements

For further information and a free demonstration email: info@consultation-plus.com

Advertising & Marketing Opportunities We have a full range of advertising, marketing, and content publishing programs available for companies engage with our extensive audience of mobile and digital health professionals.

Global Reach

Our readers come from all around the world, although the majority are based in the UK, North American and European markets.

Targeted Professional Audience

Our current subscriber base is representative of the whole mHealth and Digital Health industries with readers including: Doctors, Healthcare professionals, Government, Business professionals, NGO's and many others.

Advertising

Marketing Opportunities Let us help you to deliver information on your product and solutions to a global audience of digital healthcare professionals.

We have a whole range of advertising formats available across our publications and online channels, with prices to suit all budgets. Please contact us for more information.

Content Publishing Program We can publish your educational white papers, case studies, and research reports in The Journal of mHealth. We can work with you to develop engaging, creative, and informative content that will help promote the results of your work, to a targeted audience of industry professionals. Our readers appreciate thought-provoking white papers that educate and inform in order to expedite their decision-making process. Publishing credible, quality white papers in The Journal of mHealth will ensure that your potential clients will refer to them frequently as valued resources. Our publishing programs all include an integrated marketing plan to ensure that your content gets high exposure. Please contact us for more information.

We regularly work with digital health solution providers to develop marketing packages that can help significantly raise awareness of a solution and provide targeted industry coverage. To discuss how we can help you, please get in touch.

Report Sponsorship We aim to provide a variety of library resources for our readers, and our report program is very well respected and followed within the industry. We publish a range of reports throughout the year on topics relating to many different aspects of the mHealth and Digital Health sectors. We often collaborate with commercial partners on these reports, to gain additional insight and expertise. A number of our reports are available for sponsorship. Please contact us for more information.

The

Journal of mHealth The Global Voice of mHealth