The Journal of mHealth Vol 1 Issue 2 (Apr 2014) by The Journal of mHealth

WHAT’S INSIDE

NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

The

Journal of mHealth The Global Voice of mHealth April 2014 | Volume 1 Issue 2

mHealth... What Does it Really Mean?

ARTICLES

REVIEWS WS

INTERVIEW

‘Bionic Eye’ Treatment Paving the Way for Artificial Sight

Google Glass: Gl Transformative Technology for Healthcare?

With Peter Ohnemus at dacadoo

Editor's Comments

Welcome I would like to take this opportunity to thank all our readers for the overwhelming response that we have received following the publication of our inaugural issue. We greatly appreciate everyone who got in touch following the publication of the inaugural edition and for all of the positive comments, letters and feedback that we have received. We are getting fantastic support and assistance from all areas of the Digital Health professional community from around World and we are confident that with this backing we can continue to provide you with an informative and engaging publication as we go forward. In this issue we aim to bring you an in-depth analysis of the scope of mHealth, to consider the wide variety of topics and technologies that the subject encompasses, and to evaluate how, or if, the term mHealth can be defined. mHealth has different meanings for different people. At The Journal of mHealth we perceive the term in the widest possible context. Thus, viewing it more as a principle synonymous with the transformative possibilities that technology and digital solutions, can have upon the way and manner in which healthcare is delivered, namely: Increased patient choice; Integrated patient engagement and personalised healthcare; Connected care pathways; Increased connectivity and mobility; Changes in care delivery and healthcare settings; Digital enhancement and facilitation of working practices; Connected workforces; Data collection and analysis; and Mobile health monitoring. We acknowledge this wide reaching remit by bringing you articles from a variety of different sub-sectors of the industry, all of which are showing significant potential for the delivery of care, both now and in the future. We hope that this will begin to set the agenda for future content and help guide submissions. We are also very pleased to announce the launch of the Global Digital Health 500. This prestigious award, which is being researched and compiled by the team here at The Journal of mHealth, will comprise a list of the most innovative companies and solution providers, from around the World, operating in the field of digital health today. A significant number of companies have already been shortlisted for inclusion on the Global Digital Health 500 and we will begin to contact these shortly. There is still time to suggest a company or apply to be considered for the list, and if you would like to be considered please do get in touch.

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.simedics.org 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 final Global Digital Health 500 will be published later this year and will be available online and to readers of The Journal of mHealth.

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 excercise 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.

Enjoy reading!

ISSN 2055-270X ÂŠ 2014 Simedics Limited

Matthew Driver Editor

1 The Journal of mHealth

Table of Contents

In This Issue 4

mHealth...What Does it Really Mean? In this issue we aim to bring you an in-depth analysis of the scope of mHealth, to consider the wide variety of topics and technologies that the subject encompasses, and to evaluate how, or if, the term mHealth can be defined.

Google Glass: Transformative Technology for Healthcare? Google Glass and wearable computers have the potential to drive radical innovations in healthcare, through the application of augmented reality. This article assesses the changes that Google Glass may bring.

Interview with Peter Ohnemus at dacadoo As part of our investigation into the â&#x20AC;&#x2DC;Definitions of mHealthâ&#x20AC;&#x2122;, we talk to Peter Ohnemus founder and CEO at dacadoo, a company pioneering the delivery of digital-prevention and lifestyle-navigation platforms.

2 April 2014

Table of Contents

Industry News

Putting the ‘m’ into Health: How Mobile Technology is Defining the Future of Healthcare

dacadoo Health Score Application Now Available for New Samsung Gear 2

‘Bionic Eye’ Treatment for Retinitis Pigmentosa Paving the Way for Artificial Sight

Johnson & Johnson Innovation Establishes Network of Partnering Offices in UK

Bio-Telemetry and the Next Generation of Bio-Engineered Health Sensor

HealthSpot Teams with MedAvail Technologies to Offer Comprehensive Telehealth Platform for Consumers

3-D Printer Creates Transformative Device for Heart Treatment

NHS Health and Care Innovation Expo 2014

Pilot Health Tech NYC 2014 Launches!

Philips Healthcare Innovation Summit 2014

European 5G and the Prospects for Connected Health

Who Put the ‘m’ in Health?

Telehealth Case Study: Airedale Telehealth Hub

Quality Assurance in the Age of Mobile Healthcare

Using mHealth to Support Ageing Populations

Mobile Phone Camera Turned into a Mini-Microscope New US Bill Seeks to Remove the FDA from the Digital Health Equation

7 More European Regions Tackle Care Integration

Obamacare Paper Cut Leaves Patients Hemorrhaging from EMR Band-Aids

MEDSEEK Goes Mobile by Partnering with Tactio Health Group

UK’s MHRA Issues Guidance on Medical Device Stand-Alone Software and Apps

New Smartphone App Can Help Study X-Rays

Digital Health and Care Alliance Opens for Registration

The UK NHS Needs to Embrace the “Technology Revolution”

Upcoming Events

Advertisers Index

3 The Journal of mHealth

mHealth...What Does it Really Mean?

mHealth... What Does it Really Mean? Mobile digital solutions have revolutionised the way in which consumers engage with many industries, e.g. banking, retail, and travel. The provision of access to data and services through relevant, timely, mobile systems helps promote informed consumers, and improve the working business practices of those industries, ultimately, resulting in cost efficiencies and improvements to service provision. The benefits have been widely accepted and the technology has become entrenched within the daily activities of those industry providers and the way in which they interact with their customers and conversely the methods by which those customers can access information, products, and services. The ‘digital health’ revolution has been long-awaited. For many years now, there has been a considerable amount of discussion and planning for fully-integrated and mobile care solutions that should have the potential to change the composition of the traditional care continuum. However, the reality has often been significantly less successful than the rhetoric. Many of the promises of digital healthcare and mhealth have yet to be witnessed, particularly at scale. Many view the ultimate goal for the integration of digital into healthcare as being the tool that will allow the complete system to reach a symbolic ‘tipping point’. By which it is suggested that the system of healthcare delivery would be ‘flipped’ from the current status quo of care delivery

April 2014

dictated by care providers in primary (doctors) or secondary (hospital) led treatment environments, to a situation of personalised care provision, where ‘you’ the patient and ‘your’ individual care requirements dictate the care pathway. Digital is obviously not the only factor in reaching such a radical change in the way healthcare is delivered, but is most likely to be the tool that facilitates the process. What we are finally beginning to see is an institutional change in perceptions across the healthcare ecosystem, leading to wider adoption of modern mobile and digital solutions, that have the potential to significantly change the way in which modern healthcare is delivered. We still have a long way to go before this type of care model becomes the reality, and there are many barriers to overcome, not least in terms of policy, data and protocol standards, compliance, and strategy, all of which will need to become standardised across the health sector and ideally across

geographical regions, in order to facilitate the exchange of information and data between systems. The likelihood of this happening in the short-term is improbable, however, that is not to say that technology is not already beginning to radically and systematically alter the way in which care is delivered. Current technology has started to provide this personalised level of care across a number of health sectors, and as these systems become more widely available and entrenched within working practice and clinical procedure, then the possibilities for providing treatment characterised by the individual become much more likely. It is in this realm of personalised care where the subject of mobile health or mhealth has become synonymous. The term itself, however, can be extremely difficult to define and its scope problematic to determine. mHealth has different meanings for different people. Many patients, health consumers, and to a large extent health-

mHealth...What Does it Really Mean? care professionals still perceive mhealth simply as mobile applications and the use of mobile phones or smartphones. Others view it as a new medium for the delivery of more established technology services, such as telehealth and telecare, whilst some see the term as a distraction from what should really be just considered health in the 21st century.

This list is by no means exhaustive, and will likely grow as new technologies emerge that have the potential to change the working practices of healthcare professionals, through the delivery of greater integration of technology and mobility within care environments. We believe there are six key factors that characterise the concept of mhealth:

facilitating the flow of information between care providers to help ensure that they have solutions which can assist in the delivery of treatment or care provision when and where it is needed. It is about having connected devices, solutions, software, and hardware that can all be untethered and made available in a wide variety of different situations.

At The Journal of mHealth we perceive the term in its widest possible context. Thus, viewing it more as a principle tantamount to the transformative possibilities that technology and digital solutions, can have upon the way and manner in which healthcare is delivered, namely:

MOBILITY

RELEVANCE

Technological solutions, whatever they may be and however they are delivered should be able to change the interaction between data, information and service provision for the stakeholders involved. Mobility and mobile in rela-

Relevance is a vital factor in the mhealth equation and one which can sometimes be overlooked. Doctors, Consultants, Nurses, and other Medical professionals work in extremely difficult circumstances, where they are

We believe there are six key factors that characterise mHealth: Mobility, Relevance, DataDriven, Intuitive, Connected, Cost-Eﬀective »

Increased patient choice

Integrated patient engagement and personalised healthcare

Connected care pathways

Increased connectivity and mobility

Changes in care delivery and healthcare settings

Digital enhancement and facilitation of working practices

Connected workforces

Data collection and analysis

Mobile health monitoring

The delivery of services that can be easily scaled to improve efficiency, and drive cost reductions.

tion to mhealth should not be narrowly viewed in terms of just smartphones or tablets; these are merely examples of the many tools that facilitate the integration of mobility into work flows, clinical procedure, or patient care. Instead mobility should be considered in the sense of allowing freedom of access to the technology, wherever it may be required and in whatever situation is relevant. For a patient, this may mean transferring the foundation of their health monitoring, treatment, or medical consultations away from the traditional environments of the doctor’s surgery or hospital to environments more convenient to them. It may mean providing them with personalised solutions that empower them to manage their condition, whenever and wherever they may be. In a clinical sense mobility is all about

expected to work long hours under extremely stressful conditions, meaning that any technology that they use must integrate easily into their clinical duties, and not place additional burdens upon them. Data, information, or analytical solutions in whatever format must be provided in a timely, relevant manner, ensuring that the right person can access the necessary information at the required time. Failure to ensure relevance can lead to ‘technology fatigue’, and ‘beep avoidance’ whereby professionals simply ignore the updates from the solutions. Similarly, solutions that target patient involvement must be carefully crafted to ensure that the user interface presents only the information or data that is relevant to them. Complex analytics, and convoluted ‘settings’ or ‘options’, should all be shielded from the user, so Continued on page 6

5 The Journal of mHealth

mHealth...What Does it Really Mean? Continued from page 5

as to promote the patient’s understanding of the overall system.

DATA-DRIVEN Any system that operates in the healthcare sector needs to be underlined by a foundation of quality, proven data that is appropriate to drive the technological solution. Data in healthcare is growing at an exponential rate, and with every

new system comes more information that needs to be processed, referenced and catalogued. Providing access to this information in a relevant manner, or processing the data to determine quantified insights, should be paramount in the delivery of mhealth solutions.

ical and care structures. Intuitive systems help to ensure that only the most effective solutions are implemented, and that once deployed they do not require significant levels of supervision nor input from the operator, thereby not placing additional administrative burdens upon healthcare professionals. Equally, for a patient an mhealth solution needs to be suitably ‘smart’ in order to carry out the required tasks with minimal intervention from the user.

INTUITIVE (SMART) mHealth and digital health solutions need to perform tasks in a way that it easily assimilated with the existing med-

Digital Living Augmented Reality Wearables

3D Printing

Big Data

Remote Monitoring

mHealth

Patient Perspectives Telehealth

Telecare Patient Care Bio Sensors Health 3.0

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mHealth...What Does it Really Mean? CONNECTED

Augmented reality

Integration of information helps ensure that systems collaborate and that relevant data is made available across different care scenarios. This means connected devices, systems, solutions, and platforms should all be able to share information, and update in real time from a variety of different inputs. Stakeholders should also be able to easily connect to systems from different locations or situations, using a whole range of different devices.

Patient perspectives

Bio-engineering and sensors

Health 3.0 (Mobile enabled software solutions)

Medical 3D printing

COST EFFECTIVE We all know that healthcare on a global scale faces significant financial and resource limitations. With populations increasing and the occurrence of chronic ‘lifestyle’ associated illness rising, healthcare providers are persistently being asked to do more with less. It is here that mhealth can potentially be most disruptive. Solutions should deliver quantifiable returns on investment across a range of elements, including: Reductions in capital equipment expenditure, reduction in the number of doctor’s visits and hospital admissions, decreases in readmissions, and improved patient health, leading to the need for fewer interventions. By defining mhealth using these criteria, it instantly highlights the breadth of technologies and solutions which can potentially fall beneath the overall purview of the sector. These include, but are not limited to: »

Digital living

Telehealth & telecare

» Remote patient monitoring »

Wearables

» Big data » Patient orchestrated care

lised in countries and regions that have remote and disparate populations, with little or no medical care coverage.

The benefits of using mhealth are already widely accepted, across many medical disciplines.

In a similar fashion the ability to interact personally with an individual or group of patients by communicating with them on issues relating to health using devices that are integral to their daily lives, provides interesting possibilities for educating and manging the general health of a population, as well as providing improved management of individual needs. The health information that you receive becomes much more specific and tailored to your requirements, there and then. For example, providing an expectant mother with relevant information relating to prenatal care, in a manner that fits with her every day activities, is much more effective than simply handing out a series of information brochures during checkups. It means that the patient becomes more informed and ultimately able to manage elements of their own health in an efficient manner.

The technology can personalise healthcare treatment and condition management for individual patients. Ultimately, making intervention more effective, as it is driven by the patient rather than external stakeholders. It can also empower those patients, providing them with the necessary information and tools to actively manage their individual conditions.

It would seem that mhealth, by its very nature, should perhaps be seen more as an ecosystem within health and medical practice. By combining the array of technological solutions that fall within the wider definition of the term, and combining it with traditional, skilled, medical expertise it becomes possible to radically alter the way in which care is delivered and health is perceived.

For healthcare practitioners mhealth delivers innovative ways of working, new options for treatment and monitoring of conditions, as well as providing tools that actively promote efficiency and collaboration throughout an organisation.

By its very nature the term mhealth remains subjective and we are not suggesting that our interpretation will suit all. As part of this issue we present a range of case studies, articles, and reports that consider many of these areas, as well as proposing different viewpoints on the scope of mhealth from a range of industry thought-leaders. 

Again this list is by no means definitive we are seeing new concepts for different technologies evolving on a regular basis, and many meet the criteria set out previously. What is clear is that mhealth when defined in this way, really does have the potential to radically change the way in which healthcare is delivered, to the point whereby we could reach the ‘tipping-point’ in the healthcare system.

From a social perspective, mhealth has provided methods that can allow universal healthcare access to parts of the population that would previously have had limited or no recourse to healthcare services. This type of mobile health delivery has been particularly well uti-

7 The Journal of mHealth

INDUSTRY NEWS News and Information for Digital Health Professionals

dacadoo Health Score Application Now Available for New Samsung Gear 2 ‘dacadoo’ have announced that their innovative and award winning Health Score Platform is now available for the new Samsung Gear 2. Launched at the Mobile World Congress in Barcelona, the next generation Samsung Gear 2 will come pre-installed with the dacadoo Health Score application. The dacadoo application is optimised for the Samsung Gear 2 as a mini version of its comprehensive dacadoo health and wellbeing platform. With the dacadoo app, users will be able to see their personalised Health Score, an overall measure of health and well-being, based on their body metrics, lifestyle and activity. Peter Ohnemus, President and CEO of dacadoo AG, shared: “dacadoo is very proud to announce this major partnership with Samsung Electronics, the leading worldwide producer of mobile wireless devices. Bringing the dacadoo mini-application onto the new Samsung Gear 2, we expect to increase the visibility of the dacadoo Health Score concept worldwide”. The dacadoo Health Score web platform and the dacadoo mobile applications enable people to track, document and benchmark their health and wellbeing in real-time in an easy and fun way. dacadoo gives users a personal Health Score from 1 (low) to 1,000 (high), which moves up or down depending on how the body, emotional wellbeing, and activ-

8 April 2014

ities (exercise, nutrition, stress and sleep) change. The Health Score is based on “big data” with several tens of millions of personyears of clinical data and incorporates many of the well-known cardio cerebrovascular risk studies and quality of life assessment tools. dacadoo systematically applies techniques from the gaming industry, group dynamics from social networks and provides relevant lifestyle feedback to users to engage and motivate them to use the Health Score Platform regularly and thereby adopt a healthier lifestyle. More information can be found at: www.dacadoo.com 

Industry News

Johnson & Johnson Innovation Establishes Network of Partnering Oﬃces in UK Johnson & Johnson Innovation, London, have announced the formation of a network of partnering offices across UK life science clusters. The offices function as extensions of its London Innovation Centre to work with academics and entrepreneurs throughout the UK to identify early stage innovation and support the translation of research into new products for patients. While the London Innovation Centre continues to be the primary hub for interactions with the academic and entrepreneurial community in the

greater London area, these new partnering offices are part of a broader strategy to interact more directly with life science “hotspots” throughout the UK and Europe. Johnson & Johnson Innovation is establishing partnering offices in the following locations that will function as a base for interactions throughout the regions: »

Babraham Research Campus for the wider Cambridge area

How healthy is your

workforce?

» University of Oxford Old Road Campus for the wider Oxford area » The University of Manchester Innovation Centre (UMIC) for the North and Midlands » Edinburgh BioQuarter for Scotland and Northern Ireland » Life Sciences Hub Wales in Cardiff for Wales and the South West.

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

Re p r e s e n t a t ive s from the Johnson & Johnson Innovation Centre in London will establish a regular presence in each of the part-

nering offices that are expected to be fully operational in early 2014. “Establishing these partnering offices reflects our commitment to collaborative innovation and our belief that being close to the source of innovation drives our ability to create strong networks of people who can combine ideas, resources and technologies in a new way to tackle urgent unmet medical needs,” commented Patrick Verheyen, head of the Johnson & Johnson Innovation Centre, London. “Opening these new partnering offices extends the approach we piloted with Stevenage Bioscience Catalyst (SBC) earlier this year,” commented Dr. Kurt Hertogs, Incubator Strategy Leader for the Johnson & Johnson Innovation, London. “Our continuing experience with SBC confirms this model as an effective way for our scientific teams to interact with innovators and entrepreneurs, and advance promising healthcare solutions. Given the number and diversity of research campuses, incubators, and life science parks throughout the UK and Europe, we believe the establishing of these regional partnering offices will enable us to reach out and more effectively collaborate with innovators across the UK and Europe.” Johnson & Johnson Innovation provides scientists; entrepreneurs and emerging companies focused on early stage opportunities a one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and diagnostics and consumer companies of Johnson & Johnson. 

9 The Journal of mHealth

Industry News

HealthSpot Teams with MedAvail Technologies to Oﬀer Comprehensive Telehealth Platform for Consumers HealthSpot™, a pioneer in patient and provider driven healthcare technology, have announced a strategic partnership with MedAvail Technologies Inc., an innovative company that created the MedAvail MedCenter™ telepharmacy kiosk. This collaboration will enable HealthSpot station locations to provide high-quality, accessible pharmacy services in addition to acute care telehealth services, in locations where there is no retail pharmacy, such as employer sites and community locations. As HealthSpot stations deploy in convenient locations across the country, consumers will have more immediate options to receive quality healthcare and have their pharmaceutical needs met quickly and efficiently. The HealthSpot station - a private, walk-in kiosk that enables patients’ immediate access to medical diagnostics from board-certified doctors via high-defini-

tion videoconferencing and interactive, digital telehealth tools, could now be co-located with a MedAvail MedCenter telepharmacy kiosk, which is currently in pilot phase at locations in Illinois. The MedCenter could support the dispensing of prescription drugs and over-the-counter medications through live, two-way conferencing with a pharmacist after a visit with a provider inside the HealthSpot station. At the completion of the Healthspot visit, the provider has the ability to send an e-prescription to the MedAvail MedCenter for fulfilment. This combination of services becomes a comprehensive telehealth platform that offers the ultimate in convenience and accessibility for consumers. “HealthSpot is dedicated to increasing accessibility while creating a truly integrated healthcare experience for the

consumer. This experience means being able to receive care from a provider and then easily be able to fill the prescribed meds after the visit and consult with a pharmacist if needed. MedAvail allows consumers to get pharmacy services in non-pharmacy locations and is the perfect addition to HealthSpot’s platform for extended reach of convenient, affordable healthcare across the country,” said Steve Cashman, founder and CEO, HealthSpot. “The cooperation we have with HealthSpot will have a significant positive impact on accessibility and health outcomes for consumers,” said Ed Kilroy, CEO of MedAvail Technologies. “We believe innovative telehealth solutions like HealthSpot have a consumercentric edge that pairs well with our vision to bridge the gap for consumers needing pharmacy services.” 

Pilot Health Tech NYC 2014 Launches! The New York City Economic Development Corporation, in partnership with Health 2.0, have announced the launch of Pilot Health Tech NYC 2014, a program that provides $1,000,000 in funding to innovative projects that pilot new health technologies in New York City. The program seeks to match earlystage health or healthcare technology companies (‘innovators’) with

10 April 2014

key NYC healthcare service organisations and stakeholders (‘hosts’), including hospitals, physician clinics, payers, pharma companies, nursing associations, foundations, major employers, and retailers. The 2013 program was a tremendous success, with participation from 25 provider organisations, over 250 inno-

vator companies, 200 matchmaking meetings, 41 joint applications, and finally, 10 pilot winners. Since the ‘Pilot Day’ 2013, an event during which last year’s winners were announced, the inaugural class of Pilot companies has raised more than $14 million in private investment, including $4.5 million in the last six months and their pilots have enrolled more than 1,000 patients. 

Industry News

European 5G and the Prospects for Connected Health Despite being some way off, 5G mobile networks are gaining considerable ground, particularly in Europe. This infograph published by the European Commission, illustrates the benefits that these advanced networks could bring to connected care. On 17 December 2013, VicePresident of the European Commission Neelie Kroes signed an agreement with the ‘5G Infrastructure Partnership’ to usher in a new era in mobile network development. The Partnership is an industry association comprising publicprivate partners (the so-called 5G-PPP) and was represented at the signing by Hossein Moiin, Executive Vice-President of Technology and Innovation at Nokia Solutions and Networks, and Markus Weldon, President of Alcatel Lucent’s Bell Labs. The Commission has set aside up to €700 million in public funding to develop the next generation of ubiquitous 5G communication systems during its seven-year Horizon 2020 programme. For its part, the private sector has agreed an ambitious set of key performance indicators (KPIs) to leverage this public stake – seeking a five-fold return on investment – and will support the Commission in analysing the effectiveness of the resulting research effort. Key to the success of the 5G-PPP will be its ability to

integrate various technologies and stakeholder groups. The 5G-PPP receives valuable support from the Net!Works European Technology Platform (ETP), a research thinktank with around 1,000 members. It is predicted that by 2020 there will be more than 30 times as much mobile internet traffic as there was in 2010. This will not be the same type of traffic as now - 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, and which require more efficient and ubiquitous technology to carry the data traffic. 5G is a new network technology and infrastructure that will bring the capacities needed to cope with this increased growth in the use of communication - especially wireless - technologies by humans and by machines. 5G will not just mean faster networks, it will bring new functionalities and applications with high social and economic value. We will be looking in more detail at the future of 5G and the work of the European Commission in future issues. Please visit www.ec.europa.eu/ digital-agenda for more information from the European Commission. 

11 The Journal of mHealth

Industry News

Mobile Phone Camera Turned into a Mini-Microscope of the optics. The resolution of such mini-microscopes was dependent on the pixel size of the sensor, but sufficient for identification of several pathogenic parasites.

Microscopy, being relatively easy to perform at low cost, is the universal diagnostic method for detection of most globally important parasitic infections. Methods developed in well-equipped laboratories are, however, difficult to maintain at the basic levels of the health care system due to lack of adequately trained personnel and resources. Modified mobile devices could provide a novel solution to this issue. Researchers at the Institute for Molecular Medicine Finland, FIMM, Univer-

sity of Helsinki and Karolinska Institutet, Sweden, have now shown that novel techniques for high-resolution imaging and image transfer over data networks may be utilised to solve these diagnostic problems. The team led by Dr. Johan Lundin and Dr. Ewert Linder modified inexpensive imaging devices, such as a webcam and a mobile phone camera, into a mini-microscope. The test sample was placed directly on the exposed surface of the image sensor chip after removal

In their study published in PLOS Neglected Tropical Diseases the researchers were able to use the minimicroscopes they constructed to yield images of parasitic worm eggs present in urine and stools of infected individuals. They first utilised this novel approach to detect urinary schistosomiasis, a severely under diagnosed infection affecting hundreds of millions, primarily in sub-Saharan Africa. For diagnostics at the point-of-care they developed a highly specific pattern recognition algorithm that analyses the image from the mini-microscope and automatically detects the parasite eggs. “The results can be exploited for constructing simple imaging devices for low-cost diagnostics of urogenital schistosomiasis and other neglected tropical infectious diseases,” says Dr. Lundin. “With the proliferation of mobile phones, data transfer networks and digital microscopy applications the stage is set for alternatives to conventional microscopy in endemic areas.” 

Digital Health 500 500 Companies Worldwide Leading the Way in Digital Health To suggest a company or to apply to be considered for the list please contact journalofmhealth@simedics.org

The

Journal of mHealth The Global Voice of mHealth

12 April 2014

Industry News

New US Bill Seeks to Remove the FDA from the Digital Health Equation Controversial legislation to reduce the regulatory burden for healthtech entrepreneurs has been recently introduced in the Senate. The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014 was proposed by Senators Angus King (I-Maine) and Deb Fischer (R-Nebraska). In a similar manner to the SOFTWARE Act from October of 2013, the bill proposes removing authority from the Washington D.C. regulators who currently oversee health IT, notably via the Food and Drug Administration (FDA). Supporters of the bill have suggested that it would free up the FDA to focus on medical devices that represent a higher risk to patient safety rather than “low risk” health IT or “digital health” technologies. At a time when we have finally seen the

FDA begin to clarify their position on digital health (with the publication of their final guidance on Mobile Applications and Guidance), this proposed bill will surely generate new debate and questions over the way in which the sector can be best regulated. The proposed legislation references the FDA guidance stating that The Food and Drug Administration has: “...sought to expand its enforcement discretion by regulating the dynamic mobile health and mobile application market through the sub-regulatory guidance, ‘Final Guidance on Mobile Medical Applications’, issued by the Food and Drug Administration on September 25, 2013. In so doing, the Food and Drug Administration has set aside economic impact analysis and failed to defer to Congress’ stated preference under the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) that

the agency make recommendations to Congress about a new risk-based, regulatory framework.” The bill further extends this argument in claims that: “The current Food and Drug Administration structure for regulating health care technology was conceived in an era of discreet devices and wired connections that ill-suit the new environment of nimble applications that often are run wirelessly and hosted on the Internet. The role that the Food and Drug Administration has taken in regulating such technology exceeds the role Congress expected the agency to take.” The text continues to state that: “Consumers and innovators need a new framework for the oversight of clinical and health software that Continued on page 14

7 More European Regions Tackle Care Integration Seven more European regions turn to the challenge of providing better joined-up support to their older population, by bringing social care and healthcare services closer together. The BeyondSilos initiative is an EU co-funded pilot project that allows providers in seven European regions to implement and pilot integrated

care services. Up to 10,000 people in Northern Ireland, Bulgaria, Spain, Italy, Portugal and Germany are expected to receive improved services by 2015. The services will be piloted and evaluated for a period of two years. A key role in the services will be played by different ICT tools (from

home health monitoring to shared data records) that will be utilised to enable better cooperation between care professionals, family members and those receiving care. For more information visit the European Commission website: https:// ec.europa.eu/digital-agenda/en/news/7more-regions-tackle-care-integration 

13 The Journal of mHealth

Industry News

MEDSEEK Goes Mobile by Partnering with Tactio Health Group Tactio Health Group, a provider of science-based mobile apps for healthcare consumers to track their health and physical activity, and MEDSEEK, the only provider of a strategic patient influence platform, have announced that they will partner to help healthcare providers better engage patients in keeping track of their health anywhere and anytime using their personal smartphones and tablets, along with popular off-the-shelf connected health devices. As healthcare moves away from almost exclusively physical to numerous virtual online and mobile touch points, hospitals today are facing a challenging transition in the way they interact with consumers. MEDSEEK is bridging the gap by helping hospitals and health systems better predict the needs of individuals, convert high value prospects into loyal patients, and empower patients to make better health-related choices so they can live longer, healthier lives. “By reaching patients on their smartphones and tablets, MEDSEEK gives healthcare organisations a new way to engage with patients, deliver just-in-time health coaching and further influence decisions that positively affect patient outcomes and costs,” states Kyra Hagan, Senior Vice President of ProdContinued from page 13

improves on the framework of the Food and Drug Administration.” The bill proposes that the burden of regulation should be reduced, suggesting that the responsibility of establishing a risk-based regulatory framework should lie with The National Institute of Standards and Technology. This has been seen by many as a first step towards the introduction of standards based regulations that will essentially require a certification process for digital health solutions, potentially a costly and prohibitive option for start-ups and small-scale suppliers. The proposed bill has already

14 April 2014

uct Management and Marketing for MEDSEEK. “Partnering with Tactio provides an additional avenue to help healthcare organisations embrace and reinforce patients in their efforts to better self-manage, which is the silver bullet for improving population health. Our partnership will provide a cost-effective and consumer-friendly way to bridge the information gap that exists today between physical encounters, enabling providers to have more meaningful, data-informed conversations with patients about how they are doing between visits and to help reinforce healthy behaviours that are important for them to achieve their personal goals.” “Together with MEDSEEK, patients can now enjoy tracking their health and active lifestyle on their iPhone, iPad and Android devices, while receiving the just-in- time coaching they need to live a healthier, more active lifestyle or to keep control of their chronic diseases such as obesity, hypertension, diabetes, atherosclerosis and COPD,” states Michel Nadeau, P.Eng., President, CEO and Founder of Tactio. “With consistent branding between the organisation’s website, patient portal and mobile health tracking apps, patients are able to carry the provider brand they trust with them every day, everywhere.” 

been met with significant controversy and is likely to be a contentious issue going forward. Patient groups and technology lobbyists have already begun to rally against the PROTECT Act. In a letter to Senator Tom Harkin (D-Iowa), Chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), a coalition of influential patient groups expressed their concerns about the proposed legislation that would limit the U.S. Food and Drug Administration’s regulatory authority.

ing so-called ‘health software’ and ‘clinical software’ devices from FDA oversight,” states the letter signed by 12 organizations, including the American Medical Women’s Association, the Jacobs Institute of Women’s Health, National Consumers League, National Physicians Alliance, National Research Center for Women & Families and the National Women’s Health Network.

“As members of the Patient, Consumer and Public Health Coalition, we strongly oppose the PROTECT Act of 2014. The Act, as drafted, would have the harmful consequence of exempt-

You can read the proposed bill here: www.fischer.senate.gov/public/_cache/ files/7b25f3a3-2d8b-4638-aba9b12cc68fde0d/tam14031.pdf 

The FDA has stated that they are unwilling to comment on proposed or pending legislation.

Industry News

New Smartphone App Can Help Study X-Rays Doctors in Northern Ireland have developed a new smartphone application that can help in the study of x-rays. The app, which is still in testing, can specifically identify where a doctor is going wrong when interpreting an X-ray, and is designed to helps medics develop their skills. According to the team behind the training tool it is the first of its kind in the world. Dr Tom Lynch, one of the app’s creators and head of nuclear medicine at the Northern Ireland Cancer Centre, in an interview with the UK’s BBC, states, “This is the medical and IT worlds coming together in Northern Ireland and producing something which is really unique.” The app provides quick feedback and the more it is used by a doctor, the “...more targeted and personalised the feedback becomes”, according to Lynch. The app, which is being called ‘Experior’, will mainly be used in accident and emergency and cancer departments. However, there are plans to see it rolled out across all health specialities and even into education, industry and financial services. On the app’s screen there are 30 different X-ray images each displaying a particular condition - the doctor’s task is to identify the diagnosis, submit their answer and have it marked. Lynch says: “Some [X-rays] are obvious some aren’t. But [most] are typical X-rays that a junior doctor - and one who’s been qualified a long time - would see in an emergency department.” In an interview Kevin Donaghy, who provides the IT expertise for the app, said, “When Tom first approached me with the idea of improving the skills of doctors with X-rays, I

thought ‘How do we build a solution that can be utilised by doctors and training organisations around the globe? How can we harness the best medical brains in the world to the benefit of all doctors and ultimately, all of their patients?’” “That’s the bottom line - we wanted to develop a device that improves diagnosis and health care for everyone. With that in mind we used the ‘lean start-up model’ to prove that we can do this, and lead the way with the best medical and IT expertise in Northern Ireland to deliver a world-class solution. We really believe that Northern Ireland can lead the way in the development of innovative health solutions.” It is understood that the Northern Ireland Health Board may be interested in testing the app for a year before making a longer-term decision on its broader use across health trusts. For more information visit www.experiormedical.com Original article published by BBC News 10th February 2014 

Are you interested in the design and application of new technologies that support improvements in the care of people with long-term conditions, or other health and social care needs? This highly-acclaimed two-day conference brings together international researchers, policy makers, practitioners and innovators to share experiences and showcase new ideas. Discover worldwide research and innovations in digital health, mobile health, telehealth and telecare. To find out more and book online, visit The King’s Fund website at http://www. kingsfund.org.uk/events/international-digital-health-and-care-congress

15 The Journal of mHealth

Industry News

The UK NHS Needs to Embrace the “Technology Revolution” The NHS needs to follow banking and shopping and embrace a “technology revolution,” which will allow far more tailored and personal patient care, the UK’s Health Secretary has said. Jeremy Hunt said the health service has “barely scratched” the surface of potential advances, and fallen far behind major industries. Speaking at a conference in Manchester, he said the NHS needed to learn from retail, banking and travel industries which had drastically cut their costs while improving customer service. Mr Hunt told delegates: “I believe that we have only barely scratched the technology revolution that is about to hit everything we do in healthcare and particularly everything that happens inside the NHS.” He said he believed the health service was on the “cusp of one of the most exciting changes in delivery of heal care that will ever happen in our lifetimes”. The Health Secretary said the NHS needed to learn from other sectors, such as retail, with one in five Christmas presents now bought online, and 500 per cent increase in the number of people who bought Christmas presents on tablets last year. “If you look at banking, half of people do their banking online, that rises to three quarters of under 35s,” Mr Hunt said. “The retail banks have actually cut a third of their costs by persuading us to do all the work that they used to do.” He said a revolution in the budget air industry had been possible because of technology, with 70 per cent of ticket sales now made online.

we face we inevitably have to accept that our care will become less personal and less high quality than we have been used to.” “Technology will help us do exactly the opposite, it will help make care more personal, more tailored, more in tune with our demands as an increasingly affluent and demanding population,” he said.

“You look at those changes and you think of what is possible in our NHS, and I think we are on the cusp of one of the most exciting changes in delivery of healthcare that will ever happen in our lifetimes,” Mr Hunt said.

Speaking at the Health and Care Innovation Expo, the Health Secretary said technology would mean increasing use of apps to help those with long-term conditions manage their care, with more use of online booking of appointments, as well as medical consultations online.

“The biggest myth that technology can help us to bust is this idea that because of financial pressure, because of the ageing population, because of the huge challenges

Read the full article here: http://www.telegraph.co.uk/health/ healthnews/10676615/Jeremy-Hunt-NHS-needs-to-learn-fromonline-banking.html 

16 April 2014

Putting the 'm' into Health: How Mobile Technology is Defining...

Putting the â&#x20AC;&#x2DC;mâ&#x20AC;&#x2122; into Health: How Mobile Technology is Defining the Future of Healthcare By Mark Brincat, Director of Product Strategy, Exco InTouch

Around the globe, the cost of healthcare is rising. It is estimated that chronic conditions account for more than 75% of healthcare costs in the USA1, whilst in the UK non-adherence to medications is said to cost the NHS over ÂŁ500M per year2. Payers recognise that, in order to address the increasing financial burden of healthcare, steps must be taken to approach the treatment of chronic conditions in different ways. Taking diabetes as an example; in the US alone, there are around 24 million diabetes sufferers. While 18 million of those are diagnosed, only 15 million actually receive treatment. Of that number, as little as 6 million patients are well controlled. It is estimated that increased adherence could decrease care costs of the US diabetes patients from as much as $8,867 to $4,570 per year, resulting in $4,297 savings per patient3. Mobile technology is ideally placed to help meet this challenge. Access to mobile and digital technology has seen huge growth in recent years, there are estimated to be 6.9bn mobile subscriptions globally and 96% of the world population is now said to have access to mobile technology. Alongside this growth, the use of mobile technology has changed dramatically across the globe; from checking bus timetables through to highly regulatory activities such as mobile banking, we expect to use phones to find information and complete transactions as part of everyday life, and healthcare is no exception! As a result, mobile technology is being implemented across the world to provide value based health solu-

18 April 2014

tions that help patients manage their conditions, with the mHealth market estimated to have grown to $4.5 billion in 20134.

GOING BEYOND THE APP The term mHealth is often used to describe the rapidly growing market for health and wellbeing apps. This market is predominantly consumer facing, and typically consists of relatively basic services with a singular focus; activity tracking, diet monitoring or providing condition specific information. As a result, these limited scope apps can often be static and research has found that user attention span is relatively short-lived with an average of only 3.7 uses per week, and less than a third of users are retained for 90 days5. To change healthcare models and impact health expenditure in the long term, mHealth services must go beyond apps with such narrow focus and create integrated solutions that bring together multiple facets into a user-friendly interface that helps patients, and their caregivers, self-manage their conditions. Through this approach, patients can be empowered to take back control in their lives, helping them remain engaged over time and ultimately leading to improved health outcomes. At Exco InTouch, we have created a platform approach that leverages mobile and digital technology to create multi-level, intelligent disease management programs that help patients, as well as those providing their care, to manage their conditions and improve health outcomes. To successfully

engage patients, these services must be adaptive solutions that incorporate a range of complementary technologies used across the mHealth spectrum. The key lies in integrated solutions and a personalized approach, combined with aggregation and analysis of data to provide relevant reporting that is specifically tailored to each stakeholder group, ranging from patients and caregivers, through to healthcare professionals (HCPs) and payers. The range of tools which can be utilized in order to create a seamless multilevel program is illustrated through the mHealth Interventions Wheel shown on page 19. This modular approach enables each program to be uniquely adapted in order to address the primary issues and challenges facing the patient population, as well as ensuring effective integration into defined care pathways. Accurate measures of patient well-being are achieved through a range of assessments combined with integration of medical devices such as blood glucose meters and spirometers or lifestyle technology like activity trackers or weighing scales. Patient support is an essential element alongside data capture; using alerts, treatment management content, and timely provision of relevant information linked to the progress of each patient. Using this approach, patients are also able to personalize the service through goal setting, for example limiting days off work and sleeping comfortably through the night. This module can also be used to build reward through community Continued on page 20

mHealth /ŶƚĞƌǀĞŶƟŽŶƐ Wheel

Assessment Set up any form of information capture

Clinician

Patient Data

Providing required level of support & integration to healthcare providers

Capture data directly from medical & healthcare devices

Caregiver

Alerts

Helping carers to support & monitor relatives

Intelligent monitoring for patients, carers & HCPs

Treatment Management

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

Helping manage treatments, clinical visits, tests & vaccinations

Content

Goals Management

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

Setting and managing pre-defined & personalized goals

Reward Acknowledging patient progress & achievement

Exco InTouch’s health solutions are patient centric self-care models that allow patients, carers and healthcare professionals to interact, support and be involved in patient care remotely. The system is built on a modular platform of functionality that can be combined with individual workflows, rules and content to create a highly specialized therapeutic product. These functions, part of a larger library, are built as generic modules that can be configured and adapted to deliver specific programs, as well as being presented with a look and feel that reflects patient and customer needs. These programs and platforms are built on the background of systems that have supported hundreds of thousands of patients in clinical trials.

Putting the 'm' into Health: How Mobile Technology is Defining... Continued from page 18

activity, such as patients working together to walk the distance from Paris to Rome, often a more rewarding achievement than simply setting a personal goal of taking 10,000 steps a day. In the context of clinicians, it is essential that mHealth solutions provide valuable information, in a format that enhances the HCPs experience without increasing workload. Here the use of a single platform to collate data from a variety of inputs enables the use of algorithms to generate effective dashboards and reports to support patient review as well as alerts should patients venture outside of pre-determined limits, using agreed pathways to contact the patient and determine appropriate interventions. Having recognized the opportunity to enhance the traditional role of the pharmaceutical industry, AstraZeneca are pioneering the development of these ground-breaking integrated health programs having announced their strategic initiative ‘Intelligent Pharmaceuticals’, which will be implemented across a number of key therapeutic areas globally. The first program to be announced publicly is ‘Me&MyCOPD’ which is initially being rolled out in the UK to support COPD (Chronic Obstructive Pulmonary Disease) patients. ‘Me&MyCOPD’ is an integrated health solution designed to support each individual patient towards better medication and lifestyle management, providing personalized selfmanagement tools for the patient which responds to the individuals needs in the right way, at the right time. The program uses a mobile and internet based platform to capture information, manage medication and support the patient’s existing COPD care-plan, integrating HCPs into the end-to-end process. Ultimately

20 April 2014

‘Me&MyCOPD’ empowers patients to take control of their condition and self-manage to improve their health outcomes.

BRINGING PAYERS ON BOARD Return on Investment (RoI) is of crucial importance to the payer and will determine the future direction of mHealth services. Historically telehealth programs were implemented to monitor patients suffering from chronic conditions remotely. Whilst these programs have provided compelling evidence of the value of supporting patients in their own homes, for example the UK Dept. of Health Whole System Demonstrator*, the investment required for equipment purchase, installation and maintenance has been a barrier to entry. Mobile health provides a more holistic patient-centered approach, linking solutions together to provide an integrated picture, tailored to each stakeholder, through the use of the patient’s own devices, thus removing device management costs associated with telehealth programs. It is this clear RoI with minimal upfront investment that will drive healthcare payers to adopt mHealth solutions as part of their careplans in order to create healthcare of the future.

DEFINING THE FUTURE OF HEALTHCARE The emerging market for mHealth services holds within it the potential to revolutionize how the world will manage health and wellness in the 21st century. Patients need access to information, they need to feel connected, to better understand their condition, be empowered and ultimately to enjoy better health outcomes. Advances in mobile technology, and the growth of access to it around the world, now enable the development of programs to sup-

port patients using their own devices. As a result, patients have access to the information they need when and where they want it, data can be captured simply and easily, and analyzed to provide valuable feedback and alerts to the patient, their caregivers and their HCPs. This adaptive combination of remote monitoring, motivation, education and reward empowers patients to take control of their health conditions, reducing the burden of healthcare for payers, improving health outcomes and ultimately leading to improved quality of life for patients. Footnote* Whole System Demonstrator (WSD) is the largest randomized control trial of telehealth in the world to date. The purpose of the program included measurement of cost effectiveness and clinical effectiveness for three conditions; diabetes, Chronic Obstructive Pulmonary Disease (COPD) and coronary heart disease. Results showed a 45% reduction in mortality rates as well as significant reductions in condition related events and hospitalizations. References 1. Centers for Disease Control and Prevention http://www.cdc.gov/chronicdisease/ 2. Pharmatimes “Drug non-adherence costing NHS £500M+ a year” http:// www.pharmatimes.com/mobile/13-02-19/ Drug_non-adherence_costing_ NHS_%C2%A3500M_a_year.aspx 3. World Health Organization (2010), “Global status report on non-communicable diseases” 4. GSMA & PWC (2012), “Touching lives through mobile health report” 5. App Engagement: The Matrix Reloaded http://blog.flurry.com 

'Bionic Eye' Treatment Paving the Way for Artificial Sight

‘Bionic Eye’ Treatment for Retinitis Pigmentosa Paving the Way for Artificial Sight In January 2014, Second Sight Medical Products Inc. (Second Sight)1 announced that their Argus II Retinal Prosthesis System had been implanted in patients with Retinitis Pigmentosa (RP) for the first time in the United States. This is a major step forward for the treatment technology as it is the first time that the system has been used on patients with Retinitis Pigmentosa (RP) in the U.S. since it was approved by the U.S. Food and Drug Administration (FDA) in 2013. The procedure which was carried out at the University of Michigan’s Kellogg Eye Centre by K. Thiran Jayasundera, MD, FRCSC, and David N. Zacks, MD, PhD, follows the first ever commercial implant of Argus II which took place in Italy in 2011. There have been 18 reimbursed procedures in Germany and 12 in Italy since then. Retinitis Pigmentosa (RP) is a rare, hereditary disease that causes a progressive degeneration of the lightsensitive cells of the retina, leading to significant visual impairment and ultimately blindness. Difficulties with night vision and peripheral vision are the first things that are noticed. Later, reading vision (detailed vision), colour vision, and central vision are affected. The age at which symptoms start is variable and the rate of deterioration often differs between patients - for example with the different genetic types - but is generally very slow with changes occurring over years rather than months. In approximately half of all cases there are other family members with RP.

There are three main inheritance patterns: autosomal recessive, autosomal dominant and X-linked inheritance; depending on the genetic cause, with RP affecting approximately 1 in 3,000 to 4,000 people. There are an estimated 1.2 million people worldwide with RP.

HOW CAN ARGUS II REINSTATE SIGHT? In a healthy eye, the photoreceptors (rods and cones) in the retina convert light into tiny electrochemical impulses that are sent through the optic nerve and into the brain, where they are decoded into images. If the photoreceptors no longer function correctly—due to conditions such as retinitis pigmentosa—the first step in this process is disrupted, and the visual system cannot transform light into images. The Argus II Retinal Prosthesis System is designed to bypass the damaged photoreceptors altogether. A miniature video camera housed in the patient’s glasses captures a scene. The video is sent to a small patient-worn

computer (i.e., the video processing unit – VPU) where it is processed and transformed into instructions that are sent back to the glasses via a cable. These instructions are transmitted wirelessly to an antenna in the implant. The signals are then sent to the electrode array, which emits small pulses of electricity. These pulses are intended to bypass the damaged photoreceptors and stimulate the retina’s remaining cells, which transmit the visual information along the optic nerve to the brain. This process is intended to create the perception of patterns of light which patients can learn to interpret as visual patterns. Second Sight gained European approval (CE Mark) for the system in 2011 and FDA approval in 2013. It is the first approved retinal prosthesis anywhere in the world, and the only such device approved in the USA. The majority of blind subjects fitted with the Argus II consistently identify letters and words using the retinal implant, according to a study published in the British Journal of Continued on page 22

21 The Journal of mHealth

'Bionic Eye' Treatment Paving the Way for Artificial Sight Continued from page 21

Opthalmology (BJO)2, indicating reproducible spatial resolution. This, in combination with the proven, stable, long-term function of the device, represents significant progress in the evolution of artificial sight. According to another study published in the Opthamology3, two types of real-world orientation and mobility (O&M) tests were performed: a door test where subjects were asked to find a door across a room and a line test where subjects were asked to follow a white line on the floor. Subjects performed statistically better with the Argus II system ‘on’ versus ‘off ’ in the visual tasks: » 96% of subjects improved in object localisation » 57% of subjects improved in motion discrimination » 23% of subjects improved in the discrimination of oriented gratings In addition, significant improvements in the O&M tasks were noted and the safety profile of Argus II was found to be comparable to other ophthalmic devices and procedures. Although there are several research efforts in retinal prostheses worldwide, none has demonstrated the reliability and efficacy of such a device in a multi-centered, longterm, controlled clinical trial involving 30 subjects, as was demonstrated by the Argus II in this study. Lyndon da Cruz, MD PhD Consultant Retinal Surgeon at Moorfields Eye Hospital in London , UK “ The fact that nearly all patients had a stable, safe and functioning system and that a majority of patients could recognise large letters, locate the position of objects and the best could read short words impressed us beyond our most optimistic expectations.”

22 April 2014

“This ‘artificial retina’ brings hope to thousands of people with advanced retinal diseases” added David Head, Chief Executive of the British Retinitis Pigmentosa Society. “The restoration of an element of vision may bring with it the restoration of independence and mobility that would greatly improve a patient’s quality of life.”

PROCEDURES IN THE USA In February 2013, after more than 20 years of research and development, Argus II received FDA approval making it the first and only approved longterm therapy for people with advanced RP in the U.S. In August 2013, the Centres for Medicare & Medicaid Services (CMS) authorized both a new technology add-on payment (inpatient setting of care) and a transitional pass-through payment (outpatient setting of care) for the Argus II. These temporary payments are intended to facilitate access to new technologies for Medicare beneficiaries. Dr. Stanislao Rizzo, Director of the University Hospital Ophthalmic Department in Pisa, Italy, who first implanted the Argus II in Europe, provided guidance throughout the first procedure conducted in the USA. Dr. Rizzo has performed the largest number of implants on patients worldwide since receiving the CE Mark in 2011. Ultimate outcomes will not be known for some period of time until the patients go through a period of rehab to train them on using the Argus II. The Kellogg Eye Centre has been selected by Second Sight as a “Centre of Excellence” for its cutting-edge approach to medicine and unparalleled commitment to patient care. It is one of 12 centres in the US that are currently accepting consultations for patients. “This is a tremendous milestone, not only for the Kellogg Eye Centre and Second Sight, but also for those affected by RP in the United States,” stated Rob-

ert Greenberg, MD, PhD, President and CEO of Second Sight. “We are pleased to have the first implants take place at such a nationally recognised and respected institution. This device is going to positively impact the lives of those suffering from RP by providing renewed visual capabilities, which can help improve daily functioning and activities.” “Until now, we’ve had no treatment options to offer our patients with advanced RP,” said Kellogg’s Thiran Jayasundera, MD. “We hope the implant will bring light back into our patients’ worlds, allowing them to detect shapes of people and objects in their environment. It could allow them to gain more independence and the ability to go about their daily lives with more confidence.” The Kellogg Eye Centre has already selected further patients to receive the Argus II, while several other centres of excellence are also preparing for their first implants. Second Sight is actively partnering with additional hospitals throughout the U.S. to make the therapy more readily available.

NHS ENGLAND TO CONSIDER REIMBURSEMENT FOR THE PROCEDURE There are currently over 25,000 people in the UK diagnosed with RP4 and it is hoped that the £100,000 procedure will soon be more widely available via the NHS. The NHS’s Prescribed Specialised Services Advisory Group (PSSAG) considers whether to include treatments which are intended for fewer than 500 cases per year in England within the definition of specialised services. PSSAG considered Argus II at its meeting in September 2013. The outcome of those discussions is still pending, but once a decision has been made the

'Bionic Eye' Treatment Paving the Way for Artificial Sight

PSSAG will make a recommendation to UK Ministers, who will then need to consider the recommendations and consult on them with NHS England. If the treatment is included in the specialised services definition, it will be commissioned by NHS England rather than individual Clinical Commissioning Groups (CCGs). In this case, NHS England will develop a service specification and agree on a process for selecting providers. NHS England will be considering a number of proposals for new services and these will be prioritised at a meeting of NHS England’s Clinical Priorities Advisory Group (CPAG) later in the year. Robert Greenberg, MD PhD, President and Chief Executive Officer at Second Sight, says: “We very much hope that patients in England will soon be able to experience the life changing benefits from our prosthesis already enjoyed by RP patients elsewhere in Europe and in the USA. The UK has been instrumental in the clinical research of the Argus II.” “The Argus II has been available and reimbursed for patients in Germany and Italy for the past two years, and has just become reimbursed for patients in the

USA. The reimbursement approval for Argus II proves how important this technology is for the patients affected with blindness from the untreatable orphan disease - retinitis pigmentosa.”

LIFE-CHANGING RESULTS In 2009 Keith Hayman was one of the first patients in the UK to receive an Argus II Retinal implant at Manchester Royal Eye hospital, the procedure undertaken by Professor Paulo Stanga, was conducted as part of a clinical trial system, due to the lack of current NHS funding for the technology. Keith had, prior to the procedure, been totally blind owing to inherited RP, his original diagnosis being made when he was in his twenties. He was registered blind in 1981. Keith says, “I was blind for 30 years and got no real help – RP was a thing that couldn’t be cured.” “The Argus II implant is life changing, uplifting, an absolutely wonderful invention. It stops you feeling in the dark, you do suddenly realise there is a whole world around you. I get a lump in my throat just talking about what that means to me–to see the world around you, it helps you to come out of yourself, and to communicate with other

people who can see. Otherwise you can become very immersed in your own world of blindness, that is not good for your health or your relationships.” “The first thing I really remember seeing when my Argus II implant was switched on in October of that year, was that we went to a bonfire night party with the grandchildren on November 5, and I was more excited than the kids. When they let the fireworks off I could see flashing lights and rockets and big fireworks going off in the night sky – it’s the first thing I had seen for 25 years. It was a new world. It was wonderful. I had a few tears that day.” “Having this implant is simply the difference between sitting in the dark and having the light on. When I go out now, I can discern that there are people around me - you know there’s somebody there – so you can talk with them. Otherwise you’d be totally isolated because you wouldn’t want to start talking to yourself.” “What you actually see is a series of flashes – which you can see is not the shape of objects, but you can learn to discern what the flash actually is – it’s like standing in a pitch dark street and Continued on page 27

The Journal of mHealth

The Next Generation of Bio-engineered Health Sensor

Bio-Telemetry and the Next Generation of Bio-Engineered Health Sensor Telemetry has long been used in industry for a wide range of uses, from measuring the performance of machinery, to transmitting data from the engines of race cars, but until now the possibility of having sensors, embedded and transmitting data from inside a patient’s body has been the stuff of science fiction. That is until now. In recent months a number of announcements from the growing field of bio-sensing research, have opened up the possibility of having biologically embedded sensors placed directly inside the human body, streaming data to the patient, and their doctors on factors such as organ condition, vital signs, chemical balances, and tissue damage. As well as transmitting data to other devices, and applications allowing them to conduct real-time analysis of bodily and biological function. The prospect for these types of sensors is intriguing. In the relatively near future we could potentially see microscopic cameras, chemical sensors, vital sign monitors all incorporated into human tissue and embedded in vital organs, or key parts of the body. Skin tissue could be grafted with electrical sensors to monitor UV levels, or exposure to particular pathogens; tiny cameras could be embedded in intestinal tissue to monitor for digestive complications; or, sensors could be grafted to bone as a means of monitoring wear in arthritic patients. Whilst many of these possibilities are still merely concepts, and likely decades away, we are beginning to see

24 April 2014

advancements in this field that can give us an insight into what may be possible in the future. One of the most talked about digital health stories of recent months has been the announcement from Google (http://issuu.com/journalofmhealth/docs/ the_journal_of_mhealth_volume_1_iss) that they had been involved in the creation of a bio-enhanced ‘smart’ contact lens that has the potential to continually monitor a patients insulin levels. Data is streamed directly from the lens to a user’s Smartphone allowing instant monitoring and real-time analysis, by patients and their care providers. Our article in this issue on the work of Second Sight, equally demonstrates how the implantation of augmented camera sensing technology within the eye, to provide a ‘Retinal Prosthesis System’ designed to bypass damaged photoreceptors, is delivering the possibility of recovered sight to patients suffering from Retinitis Pigmentosa (RP). Researchers at the School of Engineering & Applied Science of Washington University in St. Louis and an international team of biomedical engineers and materials scientists have created a 3-D elastic membrane made of a soft, flexible, silicon material that is precisely shaped to match the heart’s epicardium, or the outer layer of the wall of the heart. This custom-fitted, implantable device has sensors that could transform treatment and prediction of cardiac disorders. The unique elements of this type of device have become a reality as a result of research and development to min-

iaturise the necessary sensory, power source and data transmission components. 3D medical printing and the augmentation of synthetic bio-elements are providing the theoretical potential to develop organ grafts; augments; implantable tissues; and, bone grafts all of which could be enhanced with sensors and applied to a range of different parts of the body. In addition to the miniaturisation of the technology and the advancement of synthetic tissue structures, the ability to transmit data from within the body provides very interesting possibilities for future developments. Smartphones and low energy Bluetooth connections mean that the data only has to be transmitted over a short distance and can be monitored full-time without being a significant drain on a devices battery. This opens the door to real-time biotelemetry transmission and analysis. The rise in recent years in the availability, range, and sophistication of wearable health monitoring devices demonstrates that there is a desire among consumers to monitor their health, and to have systems in place that can help them analyse and modify their lifestyle depending upon the data received. Whether people, on a wider scale, would be comfortable with the idea of having sensors embedded inside their body transmitting telemetry remains to be seen. There are likely to be a number of key markets and early adopters that would be open to these types of sensors and the unique monitoring possibilities that they could provide.

The Next Generation of Bio-engineered Health Sensor Athletes and sports professionals could conceivably be given the ability to monitor key vital signs; chemical build ups that could suggest fatigue or stress; or, bio-sensors could be embedded in muscle tissue to monitor signs of strain, damage, and rates of repair. The telemetry from these embedded devices could then be transmitted and reviewed by the athlete and their trainers, allowing them to identify health related issues, well before they would otherwise be observed. Google’s contact lens (one might call this a hybrid bio-wearable falling somewhere between the wearable sensors available today and the implantable sensor of the future) and the research from Washington University’s School of Engineering & Applied Science shows how this type of sensor could be amalgamated into everyday life for the more effective monitoring of chronic disease conditions, and it is conceivable that ultimately this could be applied to all manner of other chronic conditions. For example, sensors could be embedded into grafts on the wall of the kidney to monitor renal function and predict deterioration or failure. In 2013 scientists at the EPFL (Ecole Polytechnique Federale De Lausanne) announced that they had developed a tiny, portable personal blood testing laboratory: a minuscule device implanted just under the skin provides an immediate analysis of substances in the body, and a radio module transmits the results to a doctor over the cellular phone network. This feat of miniaturisation has many potential applications, including monitoring patients undergoing chemotherapy. There are likely many defence and industrial uses for the technology as well. Workers in hazardous environments could be alerted to bio-hazards via implantable sensors in the surface of the skin; soldiers could be continually monitored for signs of injury or reduction in performance.

The telemetry data itself also heralds a new era in bio-analytics. Wearable technology has allowed this field to grow significantly in recent years and this looks set to continue with the advent of bio-sensing and bio-telemetry. The ability to stream data from vital organs such as the heart could yield many future options for real-time analysis and evaluation of serious medical conditions.

Many of these devices are still in the early stages of research and require significant work and clinical testing before they would be patient ready.

Activity levels and dietary intake could all be monitored from sensors embedded at a number of the points in the body, feeding data to lifestyle and health monitoring applications. Take a service like dacadoo’s Health Score, which already works with many of the wearable technologies currently available. It is conceivable that internal sensing could transmit data directly to a Smartphone or smart watch solution like this, so that the solution could provide the user with instant feedback and suggestions on their health and lifestyle.

For more information on the research from the School of Engineering & Applied Science of Washington University in St. Louis see our article in this edition of The Journal titled: “3-D Printer Creates Transformative Device for Heart Treatment” on page 26. For more information on the work of Second Sight see the article in this edition of the Journal titled: “‘Bionic Eye’ Treatment for Retinitis Pigmentosa Paving the Way for Artificial Sight” on page 21. 

Whether we are looking at a future where technology becomes integrated within our bodies is indisputable, some examples such as pace-makers have been improving the lives of patients for years. The real question is whether people will be open to the greater integration of technology within their own body? When sensors are printed onto the surface of synthetic or laboratory grown tissues and directly incorporated into a part of the human body, then the distinction between technology and biology becomes much harder to make.

Have a project you want us to cover?

This is a pioneering area of medical research and holds many possibilities for mHealth in the future. There are, however, significant hurdles for this type of medical technology to overcome before it becomes widely available. Not least, greater testing is required to consider the effects that electrical sensors and transmitters embedded within tissues, may have upon other functions within the body.

That said a future where we all have a small piece of technology working away inside us and transmitting data from within, is conceivably becoming less of a science fiction prediction and more of a real possibility.

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

25 The Journal of mHealth

3-D Printer Creates Transformative Device for Heart Treatment

3-D Printer Creates Transformative Device for Heart Treatment Using an inexpensive 3-D printer, biomedical engineers have developed a custom-fitted, implantable device with embedded sensors that could transform treatment and prediction of cardiac disorders. Igor Efimov, PhD, at the School of Engineering & Applied Science at Washington University in St. Louis and an international team of biomedical engineers and materials scientists have created a 3-D elastic membrane made of a soft, flexible, silicon material that is precisely shaped to match the heart’s epicardium, or the outer layer of the wall of the heart. Current technology is two-dimensional and cannot cover the full surface of the epicardium or maintain reliable contact for continual use without sutures or adhesives. The team can then print tiny sensors onto the membrane that can precisely measure temperature, mechanical strain and pH, among other markers, or deliver a pulse of electricity in cases of arrhythmia. Those sensors could assist physicians with determining the health of the heart, deliver treatment or predict an impending heart attack before a patient exhibits any physical signs. “Each heart is a different shape, and current devices are one-size-fits-all and don’t at all conform to the geometry of a patient’s heart,” says Efimov, the Lucy & Stanley Lopata Distinguished Professor of Biomedical Engineering. “With this application, we image the patient’s heart through MRI or CT scan, then computationally extract the image to build

26 April 2014

a 3-D model that we can print on a 3-D printer. We then mold the shape of the membrane that will constitute the base of the device deployed on the surface of the heart.” Ultimately, the membrane could be used to treat diseases of the ventricles in the lower chambers of the heart or could be inserted inside the heart to treat a variety of disorders, including atrial fibrillation, which affects 3 million to 5 million patients in the United States. “Currently, medical devices to treat heart rhythm diseases are essentially based on two electrodes inserted through the veins and deployed inside the chambers,” says Efimov, also a professor of radiology and of cell biology and physiology at the School of Medicine. “Contact with the tissue is only at one or two points, and it is at a very low resolution. What we want to create is an approach that will allow you to have

numerous points of contact and to correct the problem with high-definition diagnostics and high-definition therapy.” Co-leading the team with Efimov is John Rogers, PhD, the Swanlund Chair and professor of materials science and engineering and director of the F. Seitz Materials Research Laboratory at the University of Illinois at Urbana-Champaign. Rogers, who developed the transfer printing technique, developed the sensors using semiconductor materials including silicon, gallium arsenide and gallium nitride, along with metals, metal oxides and polymers. Recently, Google announced its scientists had developed a type of contact lens embedded with sensors that could monitor glucose levels in patients with diabetes. Efimov says the membrane his team has developed is a similar idea, though much more sophisticated.

3-D Printer Creates Transformative Device for Heart Treatment “Because this is implantable, it will allow physicians to monitor vital functions in different organs and intervene when necessary to provide therapy,” he says. “In the case of heart rhythm disorders, it could be used to stimulate cardiac muscle or the brain, or in renal disorders, it would monitor ionic concentrations of calcium, potassium and sodium.”

cells and a hallmark of a heart attack. Analysis for troponin is standard of care for patients with suspected heart attacks due to a test developed by Jack Ladenson, PhD, the Oree M. Carroll and Lillian B. Ladenson Professor of Clinical Chemistry in Pathology and Immunology and professor of clinical chemistry in medicine at the School of Medicine.

Efimov says the membrane could even hold a sensor to measure troponin, a protein expressed in heart

Ultimately, such devices will be combined with ventricular assist devices, Efimov says.

“This is just the beginning,” he says. “Previous devices have shown huge promise and have saved millions of lives. Now we can take the next step and tackle some arrhythmia issues that we don’t know how to treat.” The findings were published online in Nature Communications on February 25, 2014. http://www.nature.com/ ncomms/2014/140225/ncomms4329/ full/ncomms4329.html 

Continued from page 23

FUTURE POTENTIAL

someone turns on a series of lampposts – you see that is a post – you can discern the shape with the light flashes.”

Second Sight is already working on research and development that will enhance the quality, clarity, and representative ‘sense’ feedback that the prosthetic system can deliver.

“I can look at a car and see it is a car, but usually there has to be a colour contrast – a white car on a black street. Then you have got to work out the shape of the object.”

The way the device system has been designed means that once the implant has been undertaken, the recipient patient can still benefit from software, hardware, and firmware updates as they become available. This means that in the case of Keith, his system could be potentially updated in the future, to allow him to continue to benefit from technological developments. This could mean better camera technology used in the capture system, thereby improving image quality. It can also allow for software and firmware updates that improve the efficiency of the overall system. As previously discussed, the system can currently only deliver limited visual restoration, however, it is predicted that future versions of the device will be able deliver higher quality images to the recipient, as well as improved feedback latency. The company ultimately hopes to be able to deliver colour images using the system. This is a rather unique proposition for a surgical procedure, as it is one that potentially adapts to technological advancement during the lifetime of the patient, thus further improving the relative return on investment. 1. www.2-sight.com 2. British Journal of Opthalmology http://bjo.bmj.com/content/early/2013/02/19/bjopthalmol-2012-301525.short 3. Opthalmology- http://www.ncbi.nlm.nih.gov/ pubmed/22244176 4. www.rpfightingblindness.org.uk 

27 The Journal of mHealth

CONFERENCE NEWS NHS Health and Care Innovation Expo 2014 This yearâ&#x20AC;&#x2122;s Expo, hosted by NHS England, was designed to give everyone the tools and inspiration to make positive changes in health and care. Hundreds of speakers delivered a comprehensive programme across the two days. The Community stage shared the latest insights from the health and care sectors, from voluntary services and from overseas. The Living Room stage brought together some surprising people to discuss and debate the issues of the moment in the Expo Uncut sessions. To find out more about both programmes, click on Speakers. The sharing continued in Camp Expo, a democratic unconference area where delegates set their own agenda. Camp Expo leaders shared the challenges they had overcome and recipes for successful innovation in their organisation.

28 April 2014

Other participants shared lived experience across the various zones such as the Community space. This was a genuinely open and inclusive area where the energy and engagement was electric. People added their voice, perspective and feedback through conversation, pledges and art. The participation and enthusiasm from everyone was exceptional and was felt across the whole event, truly putting patients and people at the heart of Expo. Delegates were transported into a lively, engaged and participative environ-

ment right across the exhibition floor. Whether becoming a dementia friend in the dementia cafĂŠ, picking up new digital health skills in the digital zone or making a pledge for NHS Change Day, everyone attending experienced diverse opportunities to be inspired, make lots of new contacts from across the health and care system and move the dial on their professional ambitions. Everyone attending Expo could create their own programme of learning as a student at the Pop-up University, choosing their course from more than 80 seminars and tutorials across a range of themes including the immersive Leadership Academy experience. Rich learning was available for everyone from commissioning for outcomes to how social media can improve patient care. ď Ž

Conference News

Philips Healthcare Innovation Summit 2014 This year’s Philips Healthcare Innovation Event marked the company’s 100th anniversary of involvement in healthcare technology research. To celebrate, the event, hosted at The King’s Fund in London, showcased some of the company’s most recent developments and innovations for the healthcare sector. Drawing from projects that Philips has in development from around the World the company was keen to demonstrate technologies that look set to continue this rich heritage of healthcare innovation well into the future. Philips has come a long way since the days of developing early x-ray tubes. On show were technologies dedicated to meeting the company’s ambitions of delivering health technologies that can revolutionise health and wellbeing across the ‘complete care continuum’ of: Prevention; Diagnosis; Treatment; Recovery; and Wellness. A number of interesting digital and mHealth solutions were on show.

REMOTE MONITORING TO SUPPORT PATIENTS DURING CHEMOTHERAPY Around 20% of cancer patients suffer from adverse events, leading to emergency admissions and lengthy hospital stays. Philips is developing a Home Clinical Monitoring service that will enable the cancer patient to self-test their white blood cells via a simple finger-prick and have the results sent to the managing oncologist who follows the progress of the cancer treatment and monitors any progression towards adverse events. Timely clinical intervention will then either prevent or ameliorate the severity of these adverse events thereby improving patient outcomes, supporting cost containment in acute hospitals, and improving the efficiency and effectiveness of care, and overall, reducing the emotional stress on cancer patients. Trials of this technology have already been undertaken at St James’s Hospital Leeds, as well as at a number of other UK hospitals and have so far shown significant potential for improving clinical outcomes.

eICU AND SELF-CARE OF LONG TERM CONDITIONS Healthcare organisations are beginning to see the need for a truly holistic approach to care, which necessitates managing a patient’s journey through the whole care system, irrespective of their entry point. Realistically, this requires planning an integrated care approach to the complete patient journey

and anticipating and managing transitions between the different elements. Philips is involved in a number of projects in the UK in which technology, content and innovative service models are developed in collaboration with partners. This approach helps to develop multi-disciplinary teams who can utilise telehealth and telecare practices to manage the complete care remit between hospital and home environments.

UNOBTRUSIVE CARDIO AND MOTION MONITORING TECHNOLOGY The Company has developed a technology that allows accurate and robust measurement of heart rate, body motion, as well as other cardio-vascular parameters by means of a small unobtrusive sensor that can be, for example, integrated into a watch. The technology uses light reflected by the skin to detect small changes in blood volume and sophisticated software can compensate for body motion during the measurement. The technology with its Heart-Rate measurement function has already been brought to the sports market (e.g. Alpha by MIO, Adidas Smart Run). The devices functions are being extended with additional measurements (e.g. heart-rate variability, breathing rate, energy expenditures, cardio-fitness estimate, motion, etc) with the goal to enable applications in the field of preventative healthcare, early diagnostics, monitoring of (chronically) ill patients at home or at the hospital. Philips also had on show a proof-of-concept demonstration focusing on cases for using Google Glass. You can read more about this in our assessment of Google Glass on page 32. For more information on any of these innovations and more from the event visit: www.philips.co.uk/innovationandyou 

29 The Journal of mHealth

Who Put the 'm' in Health?

Who Put the ‘m’ in Health? 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 when he has been providing consultancy services to businesses.

mHealth is currently the topic of much discussion. The problem is nobody really knows what it is, and nobody’s defined what it is - everybody’s interpretation is different. So when you talk about mHealth services people immediately put it into a box according to their interpretation. To some it involves electronic health records, to others it is something you do on a mobile phone. The problem I have with this is where do you draw the line? Does a standalone fitness app that records how many steps you take in a day count? How does that differ from an application that monitors a serious condition? Others take a wider view, including anything health related that isn’t a traditional approach, something other than having an old fashioned face to face conversation with your doctor, for example a remote consultation with a doctor over Skype would be mHealth. It’s all very confusing. All of the above probably are mHealth in the widest interpretation, but to me it’s just health. Take the ‘m’ off the front. We’re simply delivering health care in a different way.

THE EVOLUTION OF HEALTHCARE The concept of delivering health support to a patient outside of a healthcare setting has gone through a journey. It started with the telephone, enabling patients to speak to someone when they had concerns. That took a step forward and became

30 April 2014

telemonitoring, which we now see as clunky, unfashionable, bespoke pieces of kit, hard-wired into a monitor the size of an old school tv. We connected blood pressure monitors but they were hard wired through USB and provided very basic information back to whoever was monitoring you at other end. This was large, intrusive equipment for patients and it was also hugely expensive for health payers, not just in providing the equipment, but also managing installation, maintenance, logistics and support. In the last year or 2 this has started to move forward and we have seen the introduction of much slicker, more manoeuvrable devices - tablets, mobile phones, laptops - that allow people to have more flexibility to move. But these programs have mainly provisioned devices, still require hard wiring in terms of broadband, and as a result hold similar expense for the payer.

THE REMOTE CONTROL TO OUR LIVES The real win-win for both health payers and for patients as I see it is to get to a place where you can use the patient’s own communication, health and lifestyle devices. Not only is the patient already familiar with it, payers are not required to purchase, provision and install the kit, and you scale back the level of support required. Initially this means mostly manual entry of data from external devices, glucometers, pulse-oximeters etc., but

over time many of these devices will come with Bluetooth (or the next generation of connectivity). This will be truly advantageous to the payer because the upfront system is as minimal as can be, and will bring huge benefit to patients because they can be being monitored and supported, but don’t have to have extra devices. I find this personally if have a work phone and my own phone – charge 2 phones, bring them with me – it’s just a matter of time before I forget one, or it becomes a hassle. Someone said to me recently the mobile phone is becoming the remote control to our lives – but you want that on a single device, how did we live before the universal remote! mHealth solutions deployed on patients own devices empower them to better understand and to make more informed decisions about their conditions in a light and easy way, removing the need for costly provisioning and expensive set ups. I believe this model will bring phenomenal results for payers, but the benefit is only going to be seen if these solutions have low entry costs, and more importantly, the patient actually uses them – if the patient does not use them there will never be a return on investment (RoI).

ARE PATIENTS READY? There is a big misnomer being bandied around, that patients do not want to or cannot use technology.

Who Put the 'm' in Health? This is nonsense, society is becoming increasingly tech savvy with a basic level of functionality – I do not know how a computer works, and I certainly do not know how to take it apart, but I don’t need to. I think this is wonderfully summed up by the study conducted using iPads for cardiac surgery. The patients were ‘70-year olds on morphine’ and yet achieved 98% engagement using the iPad – this gives hope to us all! (http://mobihealthnews. com/28015/mayos-ipad-studyhad-98-percent-engagementamong-seniors)

the information they want, when and where they need it, rather than seeing a doctor every 4 months and walking away 6 minutes later realising they did not ask anything they had wanted to. Allow patients to access that information and empower them to share it with caregivers, relatives or whoever might be in their circle of care. Put that to a patient, explain the only downside is to punch the blood sugar reading they already take each day into a phone, and the phone will remind you to do that, and it will tell you when you need to take your medication.

Take the ‘m’ oﬀ the front. We’re simply delivering healthcare in a diﬀerent way.

To me the critical piece is ensuring the patient understands what the benefit is to them. If you ask them to use a new device, and put in readings they already take every day just because you’ll get some nice data out of it, the instinct of patient is “what’s in it for me?”. But provide a solution that will show patients’ results, help them manage their care and better understand their condition. It will give

The market is still in its infancy, however there are some great examples out there to draw from. The Dept. of Veterans Affairs in the US is probably the biggest in terms of patient numbers, providing excellent accredited data. In the UK the Dept. of Health Whole System Demonstrator (WSD), which ran for over a year with over 10,000

patients, gave compelling evidence in terms of lowering of mortality and lowering of hospitalisation. So there is reputable early evidence that these kinds of remote patient monitoring programs provide RoI for patients and payers. I am also extremely excited by the prospect of the COPD (Chronic Obstructive Pulmonary Disease) program being rolled out in the UK by AstraZeneca and Exco InTouch. This is the first time I have seen full scale deployment of the truly mobile approach which I believe is the future. The program uses a light touch, connecting information across the patient’s own devices to monitor, support and empower them to take control of their condition. It seems to be the right model that will provide clear benefits to patients with the low cost of entry that will give RoI to payers. The secret is to make the system link up, not by owning it, but taking existing pieces and linking them together to provide an integrated picture, tailored to each stakeholder. This will be the health model of the future. 

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

The Journal of mHealth

Google Glass: Transformative Technology for Healthcare?

Google Glass: Transformative Technology for Healthcare? There are currently a whole range of projects underway around the world to explore the unique potential that Google Glass and other augmentedreality wearable systems may bring to medical and healthcare environments. The delivery of timely data to doctors and medical professionals within the care environment has already become fairly common-place. Tablets and Smartphones are enabling data-driven services to help assist with patient consults and the delivery of healthcare directly when it is needed. The unique proposition of augmented reality is that it has the ability to deliver real-time relevant information to doctors and surgeons directly at the point of care, with hands-free operation. This is particularly relevant in medical procedures and surgical environments where doctors cannot directly interact with technology interfaces that require touch input. The benefits of a head-up display providing an augmented visual perception, is that it can allow doctors to access and interact with key patient information or vital sign data remotely, using, for example, voice commands or physical gestures to scroll through data. The premise of augmented reality displays and wearable computer devices presents new opportunities for data driven clinical and surgical procedures. Philips Healthcare is currently assessing the options that Google Glass may bring to advance clinical excellence and efficient care. They have developed an early-stage ‘proof-of-concept’ demonstration that is being used to research different ways to improve the effectiveness and efficiency of performing surgical procedures. Their demonstrator connects Google Glass to

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Philips proprietary Intellivue Solution and proves the concept of seamless transfer of patient vital signs into Google Glass, potentially providing physicians with hands-free access to critical clinical information. Developed in collaboration with Accenture, the new concept demonstration depicts how a doctor wearing the display could simultaneously monitor a patient’s vital signs and react to surgical procedural developments without having to turn away from the patient during a procedure. This ultimately means that they can focus on providing more efficient and effective patient care. A physician could also monitor a patient’s vital signs remotely or enlist assistance from doctors in other locations. A spokesperson for Philips speaking at their recent Healthcare Innovation Event in London suggested that there were many opportunities for the technology going forward, but that the hype surrounding Google Glass must be tempered with caution to ensure that the technology is integrated in ways that actually add value or improve care methodologies. They also suggested that whilst the technology shows significant promise across many aspects of healthcare and medical provision, that there are still barriers that must be overcome in order to allow for wider adoption. Battery life is one particular hindrance, with the Google Glass test units only getting about an hour and a half of practical use time. Another element that must be taken into account is access to wifi networks. For critical transfer of data it is essential that there

is minimal latency between the point of collection and the subsequent presentation to the Google Glass display, for this latency to be negligible the surgical unit must be able to ensure high-speed access to dedicated wifi networks. This can be fairly easily implemented onsite, however, when you begin to look at options for using the system for offsite monitoring (or multiple site monitoring) then speed of network transfer will become more of an issue. Another demonstrator in this area has been implemented by the company SAP. In their ‘proof-of concept’ trials they have successful used Google Glass to showcase a number of options for use in healthcare settings. These concept elements include, allowing healthcare professionals to check the augmented display for pre-planned patient rounds, for clinical consults or for medication dispensing. Upon interaction with a patient, the doctor or nurse can use the device to scan a bar code that instantly prompts delivery of information and chart data to the display. If there are any questions, then the device can be used to collaborate with other responsible care givers. The device can also be used to generate spoken and visual notes during the course of a working day. SAP has successfully demonstrated

Google Glass: Transformative Technology for Healthcare? how the Google Glass system can be directly linked to their proprietary SAP HANA data services. At Beth Israel Deaconess Medical Center in Boston they have been testing Google Glass with four of their emergency room doctors over a three month period. Using Glass, the doctors have been able to access the medical centre’s internal web-based emergency room dashboard while ensuring that all patient data stayed securely within the centre’s firewall. This means that the clinicians were able to speak with and examine patients at the same time as viewing data from the dashboard. Dr. John Halamka the Centre’s Chief Information Officer suggests that the wearable device has proven helpful for accessing summarised real-time information. “We believe the ability to access and confirm clinical information at the bedside is one of the strongest features of Google Glass” writes Halamka in a recent blog post. “I believe wearable computing will replace tablet-based computing for many clinicians who need their hands free and instant access to information.” An area that is receiving strong support for the use of Google Glass technology is for recording and live streaming surgical procedures for use as a real-time teaching tool. The ability to record live surgeries from the unique perspective of the performing surgeon gives students and trainee doctors the opportunity to view surgeries close-up, and gain an informative visual demonstration of the surgical elements. Cardiothoracic surgeon Pierre Theodore, MD and Associate Professor at UCSF School of Medicine, has gone one step further by using Google Glass to pre-load CT and X-ray images relevant to the procedure. He can then have the system display the necessary image during surgery, and use this to

directly compare the medical scan with the surgical site. “Often one will remove a tumour that may be deeply hidden inside an organ – the liver, for example,” reveals Theodore. “To be able to have those X-rays directly in your field without having to leave the operating room or to log-on to another system elsewhere, or to turn yourself away from the patient in order to divert your attention, is very helpful in terms of maintaining your attention where it should be, which is on the patient 100 percent of the time.” The key benefit with wearable technology like the Google Glass, according to Theodore, is to make information more accessible to physicians to help them constantly make critical decisions. “Poor decision-making is a chief source of poor outcomes among patients” he said. “So I think that’s one way the Google Glass can truly help, by providing data when we need the data.”

is the ability to breakdown geographical barriers. By providing wearable augmented-reality systems to surgeons in remote areas of the world, it becomes possible to teach them modern surgical techniques through live feedback and direction during surgery. It is becoming obvious that Google Glass and similar systems from companies like Vuzix, are going to play an important role in healthcare provision of the future. How far these systems will penetrate into the care environment will depend upon the acceptance among healthcare professionals and patients. That said, the data produced from trials already shows that delivering data in this way is considered less intrusive than the technologies already used, suggesting that wearable head up displays could become widely adopted in the near-term future. 

For instance, physicians can easily call-up electronic medical records, a systematic collection of electronic health information about patients that allows clinicians to accurately assess the patient’s medical condition at all times without the need to track down volumes of actual medical record files. The other benefit of this type of device

33 The Journal of mHealth

Telehealth Case Study: Airedale Telehealth Hub

Telehealth Case Study: Airedale Telehealth Hub Telehealth and telecare is a well proven example of the potential that digital health provision can provide. Despite having been around, in principle, for many years, it has only been in recent years that the services have finally begun to match the expectations for the sector. Innovative changes to the way in which care is delivered are finally beginning to emerge and deliver real results, in a wide range of care situations. The recent successes of telehealth and telecare also signal the potential for mHealth services in the future. By adding the extra dimension of mobility to the already established protocols of connected care services, it becomes possible to truly begin to integrate care into patientâ&#x20AC;&#x2122;s lives and deliver effective treatment beyond traditional primary and secondary care environments. This personalisation of care, through the creation of integrated connections that deliver treatment, provide medical advice, and enable condition monitoring wherever the patient may be, heralds new possibilities for the management of chronic conditions. There are many successful deployments of telehealth and telecare services worldwide providing many innovative solutions for the management of a whole variety of medical and health needs. For this case study we take an indepth look at a scheme that has demonstrated a proven record for delivering practical benefits. UK based Airedale Telehealth Hub established and operated by the Airedale NHS Foundation Trust in Yorkshire, England has been in operation since 2011, and in that time has managed to deliver both quantitative and qualitative results for patients across a number of care situations.

34 April 2014

The Hub, which builds upon the Trustâ&#x20AC;&#x2122;s long history of implementing pioneering digital health solutions via its Digital Health Centre, has successfully developed a range of digital solutions to provide remote care, including: Telemedicine; Telecoaching; and, Telemonitoring. By partnering with a number of strategic technology and solution providers the Hub has been able to deliver a model that can be deployed across a range of care pathways, as well as easily commissioned by other institutions and care providers. Rather than use a typical call centre approach, where call handlers are used to triage cases to other, clinically qualified, team members, the Trust took the view that it would be better for

patients and, ultimately, more effective if the first person receiving the call was a highly trained nurse with advanced assessment skills and a broad clinical experience. The nurses are able to deal with all kinds of clinical issues, as well as having the support of hospital consultants by day and the on-call resident medical team overnight [1]. In order to meet the strategic requirements of this type of deployment, the service uses a teleconsultation approach to try to ensure that patients are provided with the right care, by the right person at the right time. It also means that given the nature of teleconsultation large numbers of people can be supported in a safe and clinically effective way.

Telehealth Case Study: Airedale Telehealth Hub The Hub is used to deliver remote services across multiple care pathways, with new additional use cases being introduced on a regular basis. The scope of the deployment has become self-perpetuating with existing services fuelling innovation, pilot studies, and research that is then used to guide future digital service models. Strategic industry partners provide the technological infrastructure for the service, which helps ensure a stable, highquality, and effective deployment. Considerable work has been undertaken by technology partner Red Embedded to deliver the set-top boxes which are installed onsite, either within individual patient’s homes or within care-home environments. The system allows the delivery of video and content to a range of devices including the patient’s TV at home. The service also integrates into clinical workflows facilitating improved access to care and development of new pathways. Red Embedded has also developed a range of complementary video enabled technologies including: phone handsets and multimedia tablets. Another external partner Technomed provides remote cardiac monitoring infrastructure that is used by The ECG Cardiology Telemedicine Service to provide remote cardiology services to, Clinical Commissioning Groups, GPwSI, GPs, Prisons or private healthcare providers, allowing Airedale NHS Foundation Trust to remotely provide cardiology outpatient services to any GP practice within the UK. This system facilitates a workflow that can significantly improve patient experience and care efficiency. By taking remote data collected onsite at a primary care location e.g. the GP’s surgery, the data can be securely transmitted to the Cardiology Telemedicine Service along with the relevant patient history data file. The service staff can then return delivery after interpretation of a recommended action plan together with the diagnostic result,

and if required suggest escalation to a Consultant Cardiologist to allow for a remote video consultation to take place with the Cardiologist and the patient as well as enabling detailed management to be agreed with the GP. One particular care setting managed by the Hub is residential care homes for the elderly. The Hub uses video conferencing equipment to directly interact with care home residents, as well as key stakeholders related to the patient e.g. care home support staff, family and friends, as well as hospital doctors and consultants. Rebecca Malin, head of business development and investment at Airedale NHS Trust says: “It costs around £200,

per month, per patient or care home to setup and look after them through telemedicine. Given that one hospital admission costs about £2,500, the service virtually pays for itself if just one admission is avoided per year. These cost reductions are significant and highlight the level of interest that healthcare providers are beginning to place upon digital care solutions. The Airedale Telehealth Hub has delivered tangible cost reductions in a relatively short period of time. The Trust believes that it has reduced the need for emergency admissions by 50%, relative

to comparable care homes in the area that do not yet have access to the service. Accident and Emergency department attendances have also dropped dramatically from the ‘teleconsultation – equipped’ care homes; these have decreased by 47% and relative to the non-teleconsultation homes by 74%. These early results have encouraged both local and out-of-area clinical commissioning groups to commission services from Airedale, doubling the number of homes the Trust will be working with in the near future [2]. Staff at Airedale have also pioneered the similar use of teleconsultation services to help treat prison populations. Teleconferencing services are being used to help deliver care to inmates

without necessitating onsite consultations or prisoner transfers in order for them to be seen by a care professional. This helps reduce the costs associated with providing healthcare to this problematic sector, whilst concurrently limiting the safety concerns that would normally be associated with the occasions when consultants are required to visit inmates in prison, or similarly when prisoners are admitted to hospital wards. There are a number of services that the Airedale Telehealth Hub provides using these methods, from Continued on page 36

35 The Journal of mHealth

Telehealth Case Study: Airedale Telehealth Hub Continued from page 35

chronic illness management, to dietary advice. Obesity and malnutrition are two extremes of dietary related problems that Airedale’s specialist dieticians regularly encounter when helping prisoners. They have been using telemedicine to give on-screen advice and healthcare to offenders throughout the country for the past two years. Currently they have telemedicine consultations with up to three prisoners a month which could increase as Airedale bids to provide health services for more prisons. It involves using secure video conferencing equipment located both in the prison’s healthcare centre and the hospital so that clinicians can carry out ‘virtual’ consultations, talking face- to-face with the patient and occasionally carrying out examinations using close up handheld cameras if necessary [3]. “Airedale NHS Foundation Trust has rolled out this pioneering project to provide 20 prisons throughout the country with immediate medical advice using telemedicine. This covers a range of health problems including serious situations dealt with by skilled Accident and Emergency consultants to second opinions on other medical conditions via scheduled appointments with consultants. All prisoners who have had consultations by this method would otherwise have been taken out of prison to a local hospital which can mean an increase in both costs and the time taken to deliver medical advice, particularly as many prisons have a remote location. Telemedicine consultations reduce the risk of removing prisoners from the prison and they restore the patients’ dignity as there is no need for escorts or handcuffs” [3]. The Hub is also piloting schemes which utilise the same process in the management of other conditions. A pilot is currently underway to assess the potential for using teleconsultations to help children with Type 1 diabetes

36 April 2014

and their families manage their condition. Television set-top boxes were installed in the homes of 10 families, including those in rural areas, so that young patients can see an Airedale consultant, nurse or dietician specialising in paediatric diabetes, without leaving their own home. Richard Pope, diabetes consultant, said: “We have learnt that this approach benefits families who need intensive specialist support. This may only be

needed for short periods of time and we are looking in the future at moving the equipment around to benefit more families. When a problem has been resolved, perhaps with a newly diagnosed child, we could move the equipment to be used by another child and look at using it for teaching sessions for groups of families.” The service is similarly using the technology to deliver speech therapy sessions to sufferers of Parkinson’s Disease. LSVT Loud is a speech treatment for Parkinson Disease and neurological conditions, developed in America and promoted by the National Institute of Health, to help improve the quality and loudness of the voice [4]. By creating therapy sessions that can be run via the teleconference medium, it can save time, and significantly improve the patient experience by allowing them to undertake treatment in the comfort of

their own home. The benefits of an inclusive telehealth service like the one championed by Airedale are obviously not solely limited to the care provider, the patient’s care experience can be greatly improved by the implementation and use of the system. Airedale provides treatment to an area of Yorkshire, England that has many remote rural communities making travel to and from the hospital problematic and time consuming.

This is of particular inconvenience to those suffering from chronic illnesses. The availability of the Telehealth Hub means that the need for many of these hospital visits can be eliminated. Patients know that they can directly converse with a trained medical professional prior to making any unscheduled visit to the hospital, and in a number of cases arrange for scheduled consultations to be undertaken using the system. This means that in cases of nonemergency the patient can be treated without the need for admission, thus reducing the stress placed upon the patient and reducing the cost implications of treatment for the provider. 1. Pope R, 2013. The Electronic Age: Using Teleconsultation. Nursing & Residential Care, Vol. 15, Iss. 8, 01 Aug 2013, pp 561 – 563 2. Airedale NHS Foundation Trust, 2013 3. Airedale Hospital, 2013. Telemedicine’s Help for Prisoners. Telehealth Talk, Spring 2013, Issue 2 4. www.lsvtglobal.com 

Interview with Peter Ohnemus at dacadoo

Interview with Peter Ohnemus at dacadoo This issue sees the first in a series of interviews with leading figures from the world of mHealth. As Digital Healthcare evolves we ask leading CEOs, Clinicians, Industry Innovators, and Developers to share their insight and opinions of the mHealth industry. We ask what it takes to develop, deploy, and integrate successful digital health solutions that have the potential to revolutionise the way in which healthcare is delivered. As part of our investigation into the ‘Definitions of mHealth’, in this edition, we talk to Peter Ohnemus founder and CEO at dacadoo, a company pioneering the delivery of digital-prevention and lifestyle-navigation platforms. We ask him to share his experience of developing and bringing to market a leading mobile digital health solution and to provide his thoughts on how the dacadoo model could potentially alter the way in which we all perceive health.

into business process re-engineering, and satellite communications… the last company I built, was Asset4 where we developed a very significant algorithm that was used to rate and benchmark companies based on their water usage, energy usage, legal claims, etc., so really looking for ‘quality’ data on the World’s 4,000 largest public quoted companies. This taught me a lot about real time information and how to value and rate real time information.”

A serial entrepreneur and leading figure in the field of data-analytics, Peter Ohnemus, founder and CEO at Swissbased dacadoo has made a career developing innovative solutions that collate and analyse large datasets in real time, in order to extract meaningful insight and realise tangible outcomes. Speaking to The Journal of mHealth from the dacadoo headquarters in Zurich Switzerland, Peter shares some of the insights and philosophy that has led to the creation of his latest company.

After selling Asset4 to Thompson Reuters in 2009, Peter chose to apply his considerable knowledge and expertise of real-time data analytics to the growing sector of mhealth and related lifestyle management, the result of which has been dacadoo.

“I have been in high-tech all my life having been involved with four [different] companies that went public, and always dealing with big data.” Peter tells us. “I originally sold IBM mainframes, before moving to build Sybase, a database company, in Europe. I then went

“After I sold Asset4 to Thompson Reuters I started thinking about what I would like to do next? I have five daughters myself and I was concerned about people not moving. When I mean moving, [I mean] keeping an overall active lifestyle and so I began to wonder that if there could be a way where you can show people their health in an easy, understandable, way then you would have something that people can navigate within their life. If you then combine that with what we call “SoLoMo”

(Social, Local, and Mobile), then you have something very powerful, because you can follow people’s lives in real time on a smartphone.” “… We have more people dying now of sitting than of smoking. Obesity in America is clearly defined as a disease by the American Medical Association (AMA) and in an article published by The New England Journal of Medicine it has been suggested that one of the most important parts of ‘Obamacare’ is the provision under paragraph 2705 of the Patient Protection and Affordable Care Act (ACA) where companies can reserve 30% of their overall healthcare spending for digital prevention and lifestyle navigation… Being an entrepreneur all my life I believe instead of just watching and complaining, that you do something about it!” Staying true to those original convictions, in a relatively short period of time Peter has managed, along with the team at dacadoo, to develop, and deploy an extremely innovative platform that has already proven itself to have the potential to significantly alter the way in which we perceive and manage our individual health. The result of this Continued on page 38

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Interview with Peter Ohnemus at dacadoo Continued from page 37

innovation is an easy-to-use, wireless, secure and fun way to manage personal health and fitness from a lifestyle and wellness perspective called the ‘dacadoo Health Score Platform’. The platform calculates an individual’s personal dacadoo Health Score, a number from 1 (poor) to 1,000 (excellent), and this becomes a directional relative indicator of your current health and fitness sta-

tus in real time. By integrating gaming and social networking principles, dacadoo motivates users to be active in an easy way by automatically tracking and comparing their personal health, fitness and lifestyle. The platform is available across a whole range of devices, allowing it to be fully integrated into an individual’s daily life. Peter describes the foundation for the Health Score, “For 500 years medicine has been based on what we call Da Vinci’s lifestyle model, which consists of who you are, how you feel, and how you live, and that is how we have created the Health Score” This concept has been directly incorporated into the system so that an individual can input hard data such as age, gender, weight, height, body dimensions, blood values and blood pressure. They can then also record emotions, using a quality of life questionnaire, and finally, they can capture activity data such as physical activity, nutrition/ food, stress, sleep and daily steps. The company have collated over 80 million people years of clinical data that has been used to define and construct the Health Score Platform, and upon which the complex algorithm

38 April 2014

for calculating the score is based. This has been done with numerous strategic partners from around the world, such as Nuffield Health in England, and AOK in Germany. Peter tells us, “We have created something called ‘Instant Health Scoring’, where instead of [users] completing a lot of complicated questionnaires and filling out who knows what, if you provide your gender, your height,

some fresh air!” “The whole idea is of course that we want to keep you fit and happy and we have invented something we are proud of that we think is a good terminology which we call the ‘REF factor’. This stands for ‘Relevant’ to your life, ‘Easy’ to understand, and ‘Fun’. The more REF factor, the more successful the overall m-health platform!” All of these factors help to keep users engaged and interested in investing time to work with their individual score. Users can share their outcomes via social media channels, or compete against friends and family, who can in turn make suggestions to help them meet specific goals.

your weight, and your age, we can provide an instant Health Score using the underlying 80 million people years of clinical data. We can give you a Health Score “on the fly” and then you can invite your friends [to share your health activity], or you can compete with your work colleagues based upon your Health Score. Basically, your Health Score becomes a real time proxy of your effective health and wellbeing.” “We have normalised the Health Score for age and gender, so that everyone can relate to it and compare the same way, which basically means that my 12-yearold daughter can actually benchmark herself against my 78-year-old father.” Peter describes how these features have been incorporated into the system and the plans for the future, “Our core business is the Health Score and then the second part of our business is based upon lifestyle navigation. We have built what we call the “Feedback Loop”, which is our own avatar called ‘Q’, which of course comes from James Bond. Let’s say that you normally walk 5,000 to 10,000 steps a day and then there are 3 days when you have not walked, then suddenly your smartphone will talk to you and say “hello, haven’t you been out walking? I need

The corporate health and wellness market offers significant opportunities for the dacadoo platform, and the company is rapidly gaining recognition and acceptance within this sector. The unique nature of the Health Score allows companies to track employee activity and encourage competition between different groups within an organisation. This enables corporate users to easily monitor the overall health of their staff, and identify any areas for concern. Peter describes how this works in practise, “We sell mostly into corporations, so let’s say that you have a big British pharmaceutical company, they could have different groups [set up] so that the marketing department would be competing against the sales department or the manufacturing [department] against the R&D department. We have over 115 different activity styles supported by the system, and we measure in real time the amount of energy you burn in METs, the metabolic equivalent of a task. Afterwards we then work that into calories by adding your weight information.” By providing an ecosystem for monitoring health within an organisation and across departments, not only can

Interview with Peter Ohnemus at dacadoo employers monitor the overall general health and wellbeing of the employees, using a quantifiable method of analysis, they can also begin to extract meaningful insights from the data. By incorporating a social aspect then it becomes engaging for those involved and helps encourage positive lifestyle management. Peter describes how this is a phenomena that is becoming widely accepted across the medical arena. “…If you look at the healthcare sector generally there is something called the Hawthorne Effect. Hawthorne was a town in America where they put 1,500 people on diets and asked them to share their daily activity and their daily nutrition consumption. They then took 1,500 people and told them to do exactly the same but that they didn’t have to share with anyone. To keep a long story short, the ones that had to share what they were doing, about what they were eating, where they were walking, etc. lost the weight three times faster than the people that were doing the exercise with no social interaction.” “You can punish people, you can put pictures of dead people on tobacco packages and they will still smoke. If somebody wants to smoke they will smoke! If somebody wants to be an alcoholic then they will be an alcoholic! I personally believe that you need to work with happiness and relevance like the REF factor and then of course also give people economic incentives.” This concept of personal motivation is definitely something that underlies the dacadoo philosophy. Without an individual wanting to undertake physical activity or take steps to lead a healthier lifestyle then there is little chance of them actually achieving any significant progress. By integrating health into everyday life, making it something that can be fun, rewarding achievement and encouraging engagement via social interaction and financial incentive, then it becomes more likely that an individual will take greater personal respon-

sibility for their own health and wellbeing. In order to make the platform integrate easily with people’s lifestyles the company has gone to great lengths to ensure that the system can be used with a wide variety of monitoring devices. “We have integrated over 35 different vendors of bio-sensors, e.g. Jawbone, Fitbit, etc.” tells Peter. “But, at the end of the day it is not about the device, it is really about building in a fun factor. That you create challenges, that you provide prizes that people can win, or that you give them achievements, and personal recognition… we have levels, you have personal activity achievements, or you have ‘Q’ serving in on personal lifestyle issues.” Peter and his team are themselves proof of the benefits that the system can deliver. “I use the Health Score every day! I have stopped smoking! Our CTO has lost 80 pounds using the platform.” The simplicity of the execution that is the Health Score is testament to the power of the concept that the dacadoo team have created. Beneath the customer facing ‘outcome’ is an extremely complex set of data driven algorithms and an integrated data analysis engine, the potential for which is far reaching. By monitoring and analysing health data in real time dacadoo has managed to create a quantifiable method of benchmarking health. The Health Score changes in real time depending upon a variety of factors from levels of activity to your dietary intake, providing the user with actionable data on their immediate relative health. Peter states that, “What we have built mathematically is definitely state of the art.”

As the company takes on more users, who generate data, then this is anonymised and used to feedback into the system, thus over time making it more intuitive. “We are going to have millions of users. Users give us feedback so at the end of the day the social graph and the distribution of the system just make the system more and more powerful.” The Health Score has potential far beyond the individual consumer, and the company is rapidly building a range of business models that all rely upon a benchmarked outcome. Peter explains how this works, “We have done something that we call ‘Health Score Indexing’ where we can actually create a zip code based Health Score. There is a huge difference between health in different regions across a country or across the EU. We are currently in talks with government organisations, talking about how we could improve the overall average health across regions such as Europe and how we could have an outcome that is benchmark-able.” “If you think about it, if you cannot measure something, then how can you manage it? So we give it an outcome! Let’s say that the Health Score in Leeds (England) was 521 but that the Health Score in central London was 610 then you have a very clear evidence of the Continued on page 40

The Journal of mHealth

Interview with Peter Ohnemus at dacadoo Continued from page 39

fact that there are worse health outcomes in Leeds than in London.” “We can also create Health Scores on the fly. We can receive complete medical histories and anonymously create a Health Score for 10,000, or 100,000, or millions of users… this becomes very powerful because you can create a departmental Health Score, or a zip code Health Score which does not only give you the score but it actually also tells you where are the related issues without mentioning any employees [or individuals], because everything is done anonymously.” dacadoo has seen significant global growth in the short time the Health Score product has been available. The company has a number of high-value, high-growth markets that they are looking to target with the Health Score, not least the possibilities for revolutionising the way in which we value health in association with insurance. “I think that people really see that the Health Score [as something that]: First, gives you a hardware, software, and content agnostic profiling and real time scoring system; Second, mixes this with the fun factor of gamification: and, Third, which is very significant, we are working with some of the world’s leading insurance companies as they start integrating the Health Score into their overall pricing, so if your Health Score improves over time you will actually have a lower health insurance premium”. This proposition has very significant possibilities for the future ways in which insurance policies are valued. We have already seen ‘driver behaviour models’ incorporated into motoring insurance policies, whereby the insurance provider can analyse the manner in which you drive, and then make adjustments to your policy based upon the results. To apply a similar model to health insurance poli-

April 2014

cies, using the dacadoo Health Score as the benchmark for analysing health and well-being is fairly ground-breaking. Peter believes that this will be the way we can expect to value health insurance in the not so distant future, “In the future I believe if someone is living healthy and moving around then they will actually get a better price for their insurance.” Discussing the company’s wider business model, it becomes apparent that the Health Score has the potential to be disruptive across a significant number of large markets. Peter describes how in a relatively short period of time dacadoo has already made a substantial impression on many of these target industries. “We see very strong interest from large employers. That is definitely our core market. All large companies must check the health of their employees once a year, maybe they buy them a fitness program or something similar, but with dacadoo you actually see the health of the employees in real time. Of course

all the data is anonymised so that the employer cannot see that Mr. Smith has a Health Score of 200 or 800, but you can see the average Health Score of all marketing employees, or the average Health Score of all the people in the factory, etc.” “Our key strategy is to work with what I would call the industry highways for our distribution... Around our industry you have an ecosystem of 3-4 key industries and we are pushing those and supporting those very dynamically with the Health Score.” This business model seems to be working extremely effectively, with the company seeing rapid market penetration despite being at a relatively early stage of its evolution. This is reflected in the significant number of subscribers that the company has amassed from around the world. “In England we work very closely with Nuffield Health who have a large number of corporate clients, they also have hundreds of thousands of fitness club members. In Germany we work with

Interview with Peter Ohnemus at dacadoo AOK. America is the biggest market for us. We work with a very large health organisation, which has not been announced yet, but is a very significant organisation with over 80 million clients. We work with partners in Russia, we just signed a deal with a health provider in Brazil, and we are also in Australia. Last year we finished the year with about 100,000 paying users which make us ones of the largest mhealth operators in the world, and I would say that within the next 24 months we will have over a million paying users alone in the corporate world.” The infrastructure behind dacadoo is state-of-the-art, with the company aiming to protect personal health data with the strongest possible security and encryption techniques. To this end they have built their security protocols from the ground up. Where many digital health providers have relatively weak security infrastructure, Peter believes that health data should be protected in a similar manner to financial and banking data. “You can hack any health app within half an hour, trust me and get all the data that you want and that is not the business we want to be in. We did not build security as an accident or afterwards said, ‘Oh we also need this’ we really designed dacadoo from the ground up using our 25 years of deep data experience. Hiring four of the world’s leading professors we have a very strong academic advisory board challenging the Health Score every quarter. It has cost us a fortune to do everything but we have done it, in the most professional way.” “We have a huge data centre run on HP blade servers so that we can calculate everything in real time. That is based in Switzerland, in a nuclear-safe data centre, in the middle of the Alps. We encrypt all data, we segregate all data, meaning that the physical blood pressure of Mr. Smith is data segregated so that if someone were to run into our data centre and steal an HP server they

would come home with a server where it would say 80-120, 90-130, but you wouldn’t have a name from any individual because the affected blood pressure would be segregated from the person’s identity”. “Your health data is one of the highest value assets that you have and I am a big believer in privacy and providing people with a level of privacy. If you are sick or healthy I think your private data is your private data. [Which is why] we don’t do any advertising on the platform, we don’t license any data to anyone, it is solely used in anonymous ways to improve the overall algorithm.” For Peter the wider topic of mHealth is one that is close to his heart and he is regularly asked to provide commentary on the state of the industry: “For me, the definition of mHealth is: That firstly, your health doesn’t become static, and secondly that you can benchmark and track your health wherever you are.” “In today’s world, which is still the analog world for most people, the first place [for healthcare] is the doctor, the second place is the hospital, and the third place is your private home or where you happen to be. And in today’s world, if you go to the doctor you create expenses anywhere from $200 to $500, or Euros, or if you go to the hospital you create expenses per day, which can be from $2,000 to $3,000, or Euros, or more, per day in the hospital. Now if we can provide a way to have your healthcare follow you, where you happen to be (meaning the third place) and at the same time take out 50% of the expense, then I think that we will have a very successful industry.” “There are two examples I can give: Number one is for ECG. If you buy a 2/4/8-channel ECG in a hospital, that equipment could very easily cost anywhere from $5,000 to $10,000 dollars. Today you can buy a 2-channel ECG that you can attach to the cover of your

smartphone for just $100. Now [if you can] take that down to less than $25 by having a Wi-Fi enabled patch that you put next to your heart to get complete 24/7 observation of your heart, then that for me is an incredible breakthrough.” “Another example would be in skin cancer areas, where I can take a picture with my iPhone and upload it to the doctor instead of going to the hospital where they would need to take photos and have specialist consultations. There are now platforms, who have trained dermatologists that will evaluate the picture of your skin, and they will charge something like 30 Euros instead of the 300-400 Euros that you would normally pay to visit the doctor.” “These are just two concrete examples where with very little pain you can gain up to 90% savings. Going forward this is just the beginning; being an entrepreneur I personally believe we have seen nothing in mobile health! I think mobile health means that it is with me 24 hours a day, wherever I want to be and that it is convenient.” The unique nature of the dacadoo Health Score has meant that the company has won or been nominated for a considerable number of industry awards. In the UK the company have produced the Nuffield Health Score as a white label platform and this has now been nominated for Health Innovation of the Year 2014. The company have also won the German Health Media Award in 2013, the Swiss ICT Award, and have recently been announced as one of the winners of the Red Herring Top 100 Europe Awards 2014 as well. These successes are likely to continue as the dacadoo platform grows in global popularity and application. May we take this opportunity to thank Peter Ohnemus for his time and for sharing his thoughts and opinions with The Journal of mHealth. For more information about the dacadoo platform, please visit: www.dacadoo.com. 

The Journal of mHealth

Quality Assurance in the Age of Mobile Healthcare

Quality Assurance in the Age of Mobile Healthcare The Journal of mHealth, Vol 01 Issue 02 (2014) pp 42-46 Received: 10 February 2014

Dieter Speidel, Mithun Sridharan PASS Switzerland, Dufourstrasse 91, CH-8008, Zurich, Switzerland Keywords: Evidence-Based Testing, Apps, Crowd Testing, Healthcare IT, mHealth, Mobile, Models, Outsourcing, Patients, Provider, Quality, Requirements, Service, Software, Testing, Stakeholders, Consumer Centricity, On-demand, Flexibility, Cost savings, Efficiency

ABSTRACT The increasing adoption and use of mobile technologies is disrupting the Healthcare industry. This phenomenon has created innovative ways, channels and tools to deliver healthcare cost-effectively even in the remotest of places. Among the material issues that existing mHealth Applications (Apps) face are quality, accuracy and reliability. Most mHealth Apps aren’t downloaded that often and physicians are generally hesitant to recommend applications because they don’t trust them. One of the biggest challenges is in getting mHealth Apps tested and validated under real-world conditions with a large and constantly growing variety of mobile devices and operating system versions, which need to be supported by such Apps. It could be easily inferred that traditional in-house or outsourced verification and validation methods can no longer cope with the challenges given by today’s exploding world of mobile devices and the global user landscape. Software applications with a high Defect Exposure Factor (DEF) i.e. criticality as a measure of immediate customer exposure post release such as mHealth Apps, are excellent candidates for ‘crowdtesting’.

MOBILE APPLICATIONS (APPS) IN HEALTHCARE IT A quick search for “health” on Apple iTunes store returns over 43,000 Apps, demonstrating a high demand for such applications. According to the US Food and Drug Administration (FDA), mobile healthcare (mHealth) Apps were downloaded an estimated 660 million times as of June 2013. By 2015, 500 million smartphone users worldwide are expected to regularly use some healthcare application; by 2018, industry experts expect 1.7 billion mobile users to use mHealth Apps on a fairly regularly basis. These users include general consumers, patients, doctors and other healthcare professionals. Realising this growing interest, independent App developers and companies, such as Nike and Walgreens, alike have released several Apps around weight loss and general physical fitness. Besides these lifestyle Apps, the number of Healthcare Apps supporting serious use cases, such as: Patient diagnosis; remote patient and health information monitoring; patient therapy management; epidemic alerts, etc; and productivity Apps for doctors, physicians, healthcare professionals, hospitals and other healthcare institutions is also exponentially growing.

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DIY TOOLS DISRUPTING THE HEALTHCARE INDUSTRY These developments mark a turning point in the history of the healthcare industry. Mobile Apps are radically changing the way doctors and patients interact and approach health care. Using a smartphone, a mobile application and an additional portable device, it is now possible for anyone to instantly get an electro-cardiogram (EKG) reading, giving patients a simple and easy means to keep track of their heart conditions. Wall Street Journal cites a case experienced by Dr. Eric Topol, cardiologist and Director of the Scripps Translational Science Institute in La Jolla, California. Dr. Topol’s patients started E-Mailing him the results of do-it-yourself (DIY) electrocardiograms:

am getting emails from people saying, “I’m in atrial fibrillation—what do I do?” The first time I saw that in the subject line of an email, I said, the world has really changed.

Doctors regard such developments as real time savers with tremendous potential to eliminate inefficiencies, reduce costs, increase transparency and make health care more affordable by speeding diagnosis, improving monitoring and reducing unnecessary visits to a physician or hospital. Many Apps have been designed in consultation with the doctors themselves and these range from information databases about drugs and diseases to sophisticated monitors that read patients’ symptoms and diagnostic data.

CHALLENGES FACING mHEALTH APPS Though it is widely agreed that mHealth Apps have the potential to revolutionise healthcare, these trends are not without challenges. Among the material issues that existing mHealth Apps face are quality, accuracy and reliability. Despite the number of mHealth applications available for download from App stores, only a small number of those applications have

Quality Assurance in the Age of Mobile Healthcare actually been through proper evidence-based software testing. According to Shivani Goyal, a researcher at the Centre for Global eHealth Innovation in Toronto:

eople have to be cognizant of the fact that there are a mixture of people who are making these Apps. I would caution people going onto the app store to do research to see where the Apps are coming from, who is designing them, and read reviews about their functions. According to a recent report1 by the MS Institute for Healthcare Informatics, “Patient Apps for Improved Healthcare: From Novelty to Mainstream”, a vast majority of the mHealth applications have limited function. The study also indicates that most applications aren’t downloaded that often and physicians are generally hesitant to recommend applications because they don’t trust them.

security breaches or infringements. Thus, it could easily be recognised that healthcare is a sector that requires superior user experience and buy-in from all stakeholders – doctors, healthcare professionals and patients alike, while abstracting much of the intricate and complex details typical of the healthcare industry. In other words, both form and substance are material in developing mHealth applications for them to be of any value to their intended users. It is, therefore, obligatory that mHealth applications perform exceedingly well along all of these dimensions: mHealth Apps should comply with regulatory and legal standards prescribed under HIPAA, FDA, etc., if users transform a mobile platform into a regulated medical device, or they connect to such device mHealth Apps should have easy-to-use and intuitive interfaces that are usable by medical professionals and patients alike. mHealth Apps should meet the highest quality, reliability and precision requirements. Such applications should be able to suppress false alarms, while automatically sensing and detecting symptoms based on users’ health patterns and vital parameters.

QUALITY MANAGEMENT STRATEGIES FOR mHEALTH APPS mHealth applications require extensive, time-consuming, and costly testing efforts to validate their efficacy, quality and safety, before they can be safely delivered to users and health care providers. According to Roderic Pettigrew, Director of the National Institute of Health’s National Institute of Biomedical Imaging and Bioengineering:

In particular, mobile applications catering to these stakeholders should be easy to operate, intuitive and require minimal learning effort. Complex functions and confusing technical implementations should be completely abstracted from the user interface to facilitate adoption. The App should permit easy access to critical information with an absolutely minimal number of user inputs and a high tolerance to any erroneous inputs. Regulatory requirements mandate strict compliance, not only with local data protection and privacy laws, but also with international standards and best practices for quality assurance and quality management. Security requirements mandate advanced encryption techniques to process sensitive information. The Apps should be resilient to sophisticated attacks and permit quick reaction to any actual or intended

his smartphone-enabled technology is superior technology [to standard diagnostic procedures] and is an example of the type of rigorous evaluation that we need to establish the real value for these mobile and wireless tools. As the mHealth technology is relatively new, most software development companies are still struggling to develop and implement effective software or system verification and validation strategies. One of the biggest challenges is in getting mHealth Apps tested and validated under real-world conditions with a large and constantly growing variety of mobile devices and operating system versions, which need to be supported by such Apps. It could be easily inferred that traditional in-house or outsourced verification and validation methods can no longer cope with the challenges given by Continued on page 44

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Quality Assurance in the Age of Mobile Healthcare Continued from page 43

today’s exploding world of mobile devices and global user landscape. But, the situation does not appear all that bleak and highly effective solutions could be crafted by combining in-house and outsourced software testing activities with crowd-sourced testing (‘crowdtesting’) approaches.

scenarios, loads and user paths, which cannot be replicated by an internal testing team; many technical issues and bottlenecks, only come to light only when the product is tested “in the wild”. Knowing how well an application performs under real-world conditions in advance makes refactoring much easier and cheaper. Crowdtesting is also a quick and flexible way of scaling up the number of test personnel, while simultaneously keeping the costs under control. Furthermore, crowdtesting is several times faster in identifying standard defects than conventional testing as the following representation demonstrates. Crowd-sourced software testing is a recent innovation driven by product and service innovations in mobile and cloud computing technologies. Software applications with a high Defect Exposure Factor (DEF) i.e. criticality as a measure of immediate customer exposure, post release, are excellent candidates for crowdtesting. mHealth Apps are particularly suitable for crowdtesting due to the dangers and risks they pose to the lives or property of their users in case of device or software failures.

Crowd testing has proven to detect a large number of bugs and issues which passed internal QA, verification and validation as the real-world experiential case by Passbrains demonstrates.

Crowdtesting is a software testing methodology that leverages a “community” of carefully curated external professional software testers and App users with specific demographic and health profiles, across the globe. Here, software testing is carried out by a larger number of testers, from different locations rather than by a handful of local testing professionals. Crowdtesting subjects the application under a set of realistic Crowdtesting offers a particularly easy and scalable way to engage all stakeholders in addressing the various considerations that are captured in such applications. For instance, usability experts with specialised know-how in the healthcare domain could be sought to propose various recommendations that facilitate adoption and usage. Similarly, healthcare practitioners and legal experts could easily contribute insights and consultation that help application developers meet the technical, functional and compliance requirements. Through crowdtesting, it is also possible to target mobile

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Quality Assurance in the Age of Mobile Healthcare

healthcare applications to a specific subset of testers and gather their views and opinions on the fitness for purpose (utility) and use (warranty) considerations. Expert software testers conduct a battery of tests under the most unforgiving of situations and device configurations to ensure that the application works correctly, requires the absolutely minimal system requirements, and is resilient to user errors, etc. Business and Process integrators could critically evaluate the adequacy of functions and processes for mission critical applications that deal with emergency situations.

Through a mix of in-house, outsourced and crowd-sourced testing, several best practices could be properly combined to maximise efficiency in terms of both, resources and costs. Inhouse staff and outsourced teams deliver value by focusing on technological, regulatory and business challenges requiring immediate attention due to its proximity to the development team. Crowdtesting team’s laser focus, single-minded efforts, inherent motivation and scalability deliver tremendous value by detecting further issues before the software is released. The crowd’s knowledge is diffused among its tester base, but the collective testing knowledge base is larger than that within any company. Given the complexities of the modern IT landscape, an optimum testing scenario should include elements of in-house, outsourced and crowd-sourced testing teams in the right proportion.

mHEALTH AND CROWDTESTING

CHOOSING A SOFTWARE TESTING SERVICE PROVIDER

Despite the various models at a company’s disposal, crowdtesting demands some special attention, especially in the mHealth context. Given the complex nature of mHealth Apps and the need to include as many stakeholders as possible to articulate a coherent mHealth adoption strategy, crowdtesting offers a particularly easy and scalable way to engage all stakeholders capturing their expectations from mHealth applications. The following graphic represents how crowdtesting could help mHealth companies at various stages of their software development life-cycle (SDLC):

Choosing the right software testing service provider is by and far one of the most important decisions for companies developing mHealth Apps. It is mandatory that the company performs extensive due diligence and evaluate service providers’ offerings, client base, capabilities, resources scalability, and in case of crowdtesting service providers, the community size, skill-sets and expertise, demographics, and device configurations coverage, as well as their crowdtesting platform technology and processes.

Similarly, healthcare practitioners and legal experts could easily contribute insights and consultation that help application developers meet the technical, functional and compliance requirements. As previously discussed through crowdtesting, it is also possible to target mHealth applications to a specific subset of testers and gather their views and opinions on the fitness for purpose (utility) and use (warranty) considerations.

In general, selecting a proven and experienced software testing vendor with crowdtesting offerings makes the operational activities much easier, as there is usually less maintenance and governance required during the strategy development and execution stages because the service provider has already addressed many of the relevant aspects of engagement from Continued on page 46

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Quality Assurance in the Age of Mobile Healthcare Continued from page 45

past experiences with other clients. Regardless of the service provider chosen, an assiduous review of the Terms & Conditions, Non-disclosure Agreements (NDA), Escrow arrangements, Service Portfolio and Service Level Agreements (SLA) must be conducted. A Sourcing Hierarchy of Constraints & Criteria document could be used for evaluating platform operators for every major crowd testing project. The client company could use this document to evaluate the various software testing vendors based on diverse criteria.

CASE STUDY PASS Technologies regularly helps mHealth App development and Healthcare IT companies with their specialised software testing requirements through hybrid combinations of onshore, offshore and crowd delivery models. By bringing in complementary skills, aligning the development efforts on design thinking principles and placing usersâ&#x20AC;&#x2122; needs at the core of software development by engaging in conversations with the community, PASS helps customers to successfully verify, validate and deploy mHealth applications, thereby improving care for patients as they transition throughout the continuum of care.

SUMMARY It is easy to envision how crowdtesting could be a valuable asset to companies developing software and mobile applications for the healthcare industry. It is an absolutely indispensable tool for companies and developers aspiring to disrupt the healthcare industry through their innovations. By seeking the vested knowledge and professional expertise distributed among the diverse members of a crowdtesting community, the power of the crowd could be easily leveraged to benefit all stakeholders and in delivering superior healthcare where and when it is the most required.

46 April 2014

AUTHORS Dieter Speidel is the Founder & CEO of PASS Group, a leading Swiss provider of software and system testing services. PASS Group owns passbrains.com, a global platform for on-demand crowdtesting services, with offices in Zurich, Berlin, Boston, Belgrade, Bangalore and Mumbai. An entrepreneur in the Software Development and Testing domain for more than 30 years with strong focus areas within the Healthcare & Life Sciences industry, Dieter Speidel founded and successfully expanded PASS Group, offering managed QA and testing services through global delivery, including near-/offshoring and crowdsourcing. In 2011, he developed the Passbrains platform and global community for crowdtesting and knowledge services. Within a very short time, Passbrains has become a leading vendor of crowdtesting services, engaging thousands of software testers in more than 100 countries. Mithun Sridharan is a Business Development Manager with Passbrains, based in Eschborn, Germany. He brings over ten years of International experience in Business development, Marketing, Global Delivery and Consulting. He holds a Master of Business Administration (MBA) and Master of Science (M.Sc). He is a Project Management Professional (PMP) and a Certified Information Systems Auditor (CISA). He also serves as the Communication Chair for the German Outsourcing Association. References Patient Apps for Improved Healthcare: From Novelty to Mainstream, IMS Institute for Healthcare Informatics, October 2013 ď Ž

Using mHealth to Support Ageing Populations

Using mHealth to Support Ageing Populations mHealth and Digital Health services have long been championed for their potential to help healthcare organisations deal with the issues arising from ageing populations, and the growing need for the provision of effective (and crucially) affordable wide-scale elderly care. There have been many small-scale projects introduced in this field that have varied in results. As we see digital health beginning to become integral in the delivery of services, we are likely to see both a rise in the number of these schemes and hopefully a resulting increase in the beneficial outcomes. One element that always needs to be assessed in these cases is the patient opinion of digital services and the benefits they feel may be delivered. Digital services have the potential to be extremely engaging and increase patient confidence. The support that can be provided through the effective delivery of connected services can help people to become more in control, and to feel supported with their health and care requirements. However, technology can equally be isolating, particularly where there is a lack of understanding, knowledge or competency when it comes to interacting with the relevant solutions. Solutions that utilise digital delivery must therefore be inclusive, engaging and above all open to all. This can be a hard balance to get right. That said there is a growing demand for these digital services. We see in the US with the introduction of the ACA (Affordable Care Act) the desire among healthcare consumers of all ages to have the option of using or engaging with connected health provision. In the UK, a recent study by Carers UK, examined

public attitudes to using technology to support caring for older and disabled family members and found many people to be open to propositions, providing that the necessary support and engagement can be delivered.

relatives on Skype to booking a lastminute.com holiday, buying insurance on comparison websites and using online banking services – technology is often a normal and essential part of daily living.

The report uncovers a number of very interesting results. Not least the fact that many people surveyed are unaware, uneducated, or just not interested in technology solutions as a means of managing their personal health or care needs as well as those of family and friends, particularly when compared with their use of technology in other aspects of their life. This highlights the need for education, and engagement when it comes to the introduction and delivery of digital health services.

Our polling showed that:

Are people closed off to the idea of digital health provision, or do they simply require a better means of finding out about the potential of the solutions on offer? The results of this report can be seen below. Reproduced with permission from Carers UK.

POTENTIAL FOR CHANGE – TRANSFORMING PUBLIC AWARENESS AND DEMAND FOR HEALTH AND CARE TECHNOLOGY In July 2013, Carers UK commissioned YouGov to examine public attitudes to using technology to support caring for older and disabled loved ones. Technology enables shopping, chatting and leisure. But not caring. For many people, technology is fully embedded in their lives. From burglar alarms to sat-navs, from chatting with

More than 7 in 10 people in the UK use technology to either bank, pay bills, shop or communicate

6 in 10 use technology in leisure activities (61%) or travel (58%)

62% now use social networking such as Facebook or Twitter

Only 2% of the population say that technology doesn’t feature in their lives

Yet when we asked the public about the different ways in which they used technology in their lives, health and care came in last place. »

Fewer than 1 in 3 (30%) people use technology to support health and care

Coming behind banking, shopping, communicating, social networking, leisure, travel, work, learning and education – health and care was the area in which the fewest people used technology.

AN ISSUE FOR ALL GENERATIONS Managing health conditions and needing care are often seen primarily as issues associated with ageing. Continued on page 48

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Using mHealth to Support Ageing Populations Continued from page 47

An easy assumption might be that there is an inverse correlation between needing care and being comfortable using technology. However, our polling showed that a lack of access to technology to support health and caring counts across the generations. »

28% of 18-24 year olds use technology for health and care – the same percentage as use it amongst 35-44 year olds and 45-54 year olds A higher percentage, 31%, of both those aged 55-64 and those over 65 said they used technology to support health and care

However our polling showed that low usage of health and care technology isn’t simply a case of care and health needs being ‘out of sight and out of mind’. Families weren’t using the technology now, but even when asked what they would do if caring affected them in the future, few mentioned technology. Hardly any of the respondents named health and care technologies such as telecare, health monitoring and health-related smartphone apps as a top choice on where they would seek support. We asked where families would look for support if they did need help with caring for an older parent or a disabled loved one. »

Public services were the top choice – the majority (55%) would look to their local council and 39% would think of the NHS

Even the tech-savvy and middle classes are not getting their hands on technology to help manage their health or support caring.

Family and friends were a top choice for a third of the public (32%), while 27% would look to the benefits system

» 30% of the general population were using technology to support health and care, but this only rose to 32% for Facebook users and 40% of Twitter users

Around one in ten would expect to buy in care services privately and 7% would think about asking their workplace for support like flexible working

Current use of technology in supporting health and care was higher amongst the middle classes (35%) than working class families (25%), but was still only just over a third

Again, technology came last, with just 4 in every 100 members of the public saying that technology like telecare, health monitoring and smartphone apps would be one of their top choices for help if they needed to provide care and support for a loved one.

The highest usage (35% of the age group) was amongst 25-34 year olds

NOT NOW, BUT IN THE FUTURE? It is perhaps unsurprising that most people are not using technology to help with health conditions or care needs, as this kind of technology often only gets used when families are hit by a health crisis or someone starts to need care and support.

48 April 2014

No more than 5% in any age group said they would look to technology as a top choice for support if caring affected them in the future

43% of all respondents said that technology was the last thing they’d consider as a source of support if caring affected them

With only a minority (30%) of families currently using health and care technology, not many more would consider using technology even if their family were to be affected by poor health or caring. Even groups which we might expect to be more likely to look to technological solutions would not think about technological support if they were caring. Facebook and Twitter users and those aged 18-34 were just as unlikely to look to care and health technologies if caring affected them in the future. It seems clear that, despite families’ enthusiasm for technology across most other aspects of their life, they simply do not think about how they could use it now or in the future for their own health and care support, or to help them care for an older or disabled loved one.

TELECARE AND OTHER ESTABLISHED CARE AND HEALTH TECHNOLOGIES Smartphone apps have shown exponential growth in the past five years, as has the number of users of social networks and internet communications software like Skype and Facetime. However, these are relatively new innovations compared to other technologies in health and care. It may be that these technologies have not yet moved beyond social interactions to become fully integrated into all aspects of family life. Telecare monitoring systems have been used for decades in the UK, and alerts and monitors linked to support services are one of the more familiar forms of health and care technologies. So to what extent has awareness and readiness to use these technologies reached a broader public understanding and acceptance? We asked the public whether they would use telecare – without giving a definition of what it was.

Using mHealth to Support Ageing Populations »

Only 1 in 8 (12%) of all respondents said they would use telecare, dropping to only 7% of for over65s

Less than 1 in 10 (8%) responded that they would not use telecare

80% admitted they weren’t sure what telecare was

The results held across age brackets with small variations amongst older people – with 85% of over 65s saying they weren’t sure what telecare was. This was not markedly different from the most aware group, 35-44 year olds, where still 77% of respondents did not know what telecare was.

RESISTANCE OR LACK OF AWARENESS? We then defined telecare for respondents, in plain English: “Telecare is a system of monitors and sensors which can include a basic alarm service, able to respond 24/7, e.g. if someone has a fall. It can include sensors such as motion or fall detectors and fire and gas alarms that trigger an alert to a response centre staffed 24 hours a day, 365 days a year. It can include location devices that can find someone, e.g. if someone with dementia wanders outside the home.” We asked if, knowing what it was, they would consider using it: »

79% said they would use it (so long as it was affordable), with a third (32%) saying they definitely would and 47% saying they probably would Only 1 in 8 said they would not consider using it with only 5% (1 in 20) saying they definitely would not

So based on their existing knowledge, only 12% of the population would use telecare but when the term was explained to them this shot up to 79%.

Surprisingly the youngest respondents were least likely, though still very likely, to consider using telecare – with 74% of 18-24s saying they would consider it. However, this is also likely to demonstrate that issues of ageing and poor health are less likely to be preying on the minds of younger respondents. The group most likely to use it were, in fact, the over 65s, with 85% saying they would consider using telecare once it had been defined. This is amongst a group of whom only 7% said they would use telecare when initially asked; the explanation triggered a rise of 78%.

APPETITE FOR HEALTH AND CARE TECHNOLOGY It is hardly surprising then, that the potential for technology in health and care has not been realised when you consider the level of public awareness: Despite heavy usage across the generations of technology in daily life, less than a third of people say they use technology in health and care. Most individuals would not consider technology to be an important source of support when caring for health conditions affecting them and their family. In fact, many say it would be the last place they would look. Most people have no idea what even established health and care technologies are. However, when people are informed about what health and care technologies are, the vast majority would consider using the services. Only 1 in 8 say they wouldn’t use this kind of support. This enthusiasm extended well beyond telecare when respondents were given a menu of options on how technology could help: »

Two thirds (65%) said they thought technology would play a bigger role in supporting families to care for

older or disabled loved ones »

Almost two thirds (61%) would use online information and alarms, sensors and health monitoring equipment

Almost 6 in 10 would access online services like banking and shopping (58%) or would like to book hospital appointments or organise care services (57%) online

Only 3% said they would not use any of the technological options listed to help with caring

The results also discredit the myth that older people are Luddites when it comes to technology. Respondents over 65 were more likely than average to say they or their families would use the internet for information and communication, for alarms, monitors and sensors and for online services such as banking and shopping.

OPPORTUNITIES AND VISION Opportunities for Health and Care As health and social care continue to operate under severe financial pressures resulting from steep demographic challenges combined with tough public spending settlements, new technologies can drive productivity, reduce avoidable demand and play a key role in prevention. Technology must be key to the Government’s renewed focus on integration of health and social care roles, transforming and integrating services, streamlining processes and providing information and training. It has already been shown to deliver significant outcomes for health and care services, helping to substantially Continued on page 50

49 The Journal of mHealth

Using mHealth to Support Ageing Populations Continued from page 49

reduce mortality, reducing the need for admissions to hospital, lowering the number of bed days spent in hospital and reducing time spent in A&E, with clear gains in terms of service and cost effectiveness.

Opportunities for Families and Carers Technology presents huge opportunities for families, particularly as demographic shifts result in childcare, work and eldercare overlapping for greater numbers of families and a rapidly rising number of carers take on more intensive caring responsibilities. Across the trends in carer demographics, from rapidly rising numbers of older carers, pressured ‘sandwich generation’ families and even greater numbers juggling work and care, technology can play a vital role in improving access to support and information, giving peace of mind and reducing stress. We already know that assistive technology can give both carers and the people they care for greater independence and reassurance. Carers UK research in 2013 showed that almost three quarters (72%) of carers using technology said that it had given them greater peace of mind. Over 10% said that using health and care technologies had either helped them to get a job or stay in work alongside caring. Despite this, we are only now starting to realise the opportunities for practical and online technology to help families to co-ordinate a better work-life-care balance, access peer-to-peer support and save time.

of a failure to support families to combine caring and work. Business forum Employers for Carers continues to highlight the costs in staff productivity, absence, absenteeism and workplace stress of families’ struggle to combine work and care. When they reach crisis point and end up having to leave work not only do families often face financial crisis but employers face huge costs in recruitment, retraining and a loss of skills, knowledge and expertise – often from employees at the peak of their careers who suddenly find that ageing parents need support. Employers should be looking to see how technology can help them to be better employers for the 3 million people who juggle work and caring. Not just through new models of remoteworking, but through smartphone apps which tells a staff member that a care worker has arrived on time, co-ordination tools for them to organise care between them and their families, online carer support networks in workplaces or alarms and monitors at home which give carers peace of mind at work.

Opportunities for the Economy With millions giving up work or reducing working hours the economy is paying the price. The earn-back effect of helping families to stay in work could net the Treasury millions in additional tax revenues and reduced spending on benefits and social care.

Opportunities for Employers

With rapidly growing demand for health and care services, providers and workers need to work smarter and technology can help deliver for a sector that is being asked to drive up workforce skills, and service efficiency and quality on tightening budgets.

With an estimated 2.3 million people having given up work to care, and a further 3 million having cut their hours, businesses are bearing the costs

The market for health and care technologies is underdeveloped and remains focused on delivering block contracts for statutory health and care agencies.

50 April 2014

A stimulated private purchase market which drives consumer purchasing of health and care technologies, alongside increased and more varied use in the public sector, could be amongst the innovations which the Treasury’s Plan for Growth identifies as long-term drivers of economic growth for the UK.

OUR VISION FOR TECHNOLOGY AND CARING »

A step-change in public and professional awareness of health and care technologies so that use and purchase of technology to support caring becomes a normal part of life and of professional practice

Cross-Government action to identify and realise the potential of health and care technologies to support health and wellbeing, business growth and productivity, labour market participation, care workforce development and the sustainability of health and social care services

A vibrant, accessible health and care technologies market focused on consumers, which delivers attractive, affordable products and services which reflect how families live and work

METHODOLOGY Fieldwork was undertaken by YouGov between 26th July and 29th July 2013 as part of an online omnibus survey. Total sample size was 2069 UK adults aged 18+. The figures have been weighted and are representative of all UK adults (aged 18+). Report commissioned and published by Carers UK, 20 Great Dover Street, London, SE1 4LX. For more information on the work of Carers UK visit: www.carersuk.org 

Obamacare: Electronic Medical Records

Obamacare Paper Cut Leaves Patients Hemorrhaging from EMR Band-Aids By Thanh Tran

Whether driven by simple technological advancements or Obamacare, the digitisation of medical records and data is a necessity. Almost 80 percent of U.S. hospitals currently use some type of electronic records software, according to the U.S. Department of Health and Human Services. Approximately $2.05 trillion is spent on these systems yearly, reports the Healthcare Information and Management Systems Society. What is still being debated is how to mesh the almost daily mobile technology shifts, mixed with social media and security concerns to enable medical professionals and patients to unite in ending needless medical errors. These errors cause 200,000 patients deaths yearly, 40 percent of which are directly related to information omissions and miscommunications. If the Center for Disease Control reported a category for erroneous medical deaths, it would rank 6th in the U.S. These unnecessary deaths, along with reducing duplicative tests and procedures, waste billions needlessly on costs that drive up insurance premiums that are passed on to consumers.

PROLIFERATION OF REDUNDANT ELECTRONIC MEDICAL RECORDS There are hundreds of Electronic Medical Records (EMR) software tools in existence today. Most hospitals, because of medical mergers and

acquisitions, have multiple EMRs in place. Unfortunately, most of these programs do not connect and they all present the data they store differently, often in proprietary databases with HIPAA creating a secondary set of data in many cases. The expectation was of EMR data sharing through open architecture, but instead hospital IT departments were burdened with systems lacking interoperability. To address these challenges, it is being suggested that Health Information Exchanges (HIE) use an additional consolidated database on top of the existing EMR software. However, the HIE database not only causes data duplication, but also requires additional database synchronisation and data privacy. These requirements only add an additional layer of difficulty rather than solving the actual data sharing that was intended to support patient care.

INFORMATION RICH, BUT DATA POOR The focus on being data rich, but information poor also creates gaps. Differing sets of data between a current care environment and the previous care environment, such as existing emergency room data and new data at an outpatient facility, easily causes miscommunications. EMR tools need collaboration between caregivers, and caregivers and patients. There is also a lack of real time medical information over geographical distances. When you add the lack of access to the original records by the family

physician and the inability of EMR systems to offer an analysis of the impact of new medicine on a patient, we are almost back to square one. EMRs, as passive components, fail the basic purpose of having paperless records. If the data is not moved into the active environment, how can care providers deliver on the promise of better patient outcomes in 2014? How many more patients will wind up like Bill White who almost died because an order to check his potassium level was never received by his night physician after a shift change? How about 12 year old Rory Stauton who did die from lack of timely medical record communications between a hospital and his family physician?

ITâ&#x20AC;&#x2122;S NOT THE BOOM OF THE BEEP, BUT THE SUCCESS OF THE SIGNAL EMRs also often fall short in patient tracking by medical professionals suffering from beep fatigue who turn off their devices. Often the beeps are not even going to the appropriate provider. What is critical is not the beep, even though many times coming from hand held devices, but the signal. How accurate and timely is the beeped information and does it correspond with other current data? Another form of fatigue is the additional time now needed for training on new, unfamiliar systems that nursesâ&#x20AC;&#x2122; must use rather than deliverContinued on page 52

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Obamacare: Electronic Medical Records Continued from page 51

ing the patient care they were originally trained for. These environments easily lead to misdiagnosis, negative impact on productivity, and time taken away from patients, contrary to the goals of Obamacare.

TIME FOR BAND-AID TO BE CHANGED Obamacare’s emphasis on quality care also impacts the method of reimbursement, from pay-perprocedure to pay-per-performance, non-reimbursement for readmission within 30 days of discharge, and quality guidelines. These enforcements dramatically change the need for care quality, efficiency and productivity for care providers from nice-to-have to must haves. With Obamacare’s paperless records mandate beginning this year, 2014 is the time to finally fulfill the original promise of ending medical deaths and needless spending. This is the year to resolve these issues and go beyond the EMR band-aid approach.

BRIDGING THE DATA GAP What the medical industry needs to finally bridge the gap between medical records and improved patient care is technology that works the way medical professionals work. A system to align medical professionals with data that needs to be collaborative, not passive, and include analysis. The right data also needs to be delivered to those who need it, when they need it, with all the data in one place. A true electronic replacement for the all encompassing and universally deployed nurses’ chart. Provide an open architecture so third-party developers can save on development costs when creating new, innovative solutions.

April 2014

A cloud-based data network that connects to multiple databases and legacy systems instead of proprietary databases. Systems that make the data smart through collaborative platforms that can analyse and interpret the data.

costly, resource wasting practice of replacing old systems with new. This scrap and build IT practice at many medical facilities is one of the leading causes of high hospital costs that are passed onto insurance companies and ultimately consumers.

Add voice to text capability to save valuable physician and nurse time and help end miscommunications. Replace the nurses’ sheet with a single screen that can compare and analyse all the necessary data with all medical professionals using the same device.

MEDICAL RECORD HUBS FOR 2014 While EMR software can still be used for more limited point-to-point solutions, there needs to be a paradigm shift with a patient centric approach that connects all the points. Smart collaborative hubs need to be How healthy developed that enable hospital IT administrators to differentiate between these new data hubs and traditional EMR services.

Thanh Tran is CEO of Zoeticx, Inc., a medical software company located in San Jose, CA. He is a 20 year veteran of Silicon Valley’s IT industry and has held executive positions at many leading software companies. 

is your

workforce?

However, developers must ensure that present EMR tools can connect and share data with these new overarching hub systems, side lining yet another set of tools and further implementing the

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

UK's MHRA Issues Guidance on Stand-Alone Software and Apps

UK’s MHRA Issues Guidance on Medical Device Stand-Alone Software and Apps The UK’s Medicines and Healthcare Products Regulatory Agency (MHPR) has recently issued new guidance covering the regulation of software and applications which qualify as stand-alone medical devices. This follows the issuance of similar guidance by the FDA at the end of last year. Manufacturers, software developers, academics, clinicians and organisations are all increasingly using software for both healthcare delivery and social care needs. The MHPR guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device), as opposed to software which is integrated into a medical device. The full guidance text is reproduced here. The following guidance is for healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device.

INTRODUCTION Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs. This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this is seen to be part of the device, e.g. software that controls a CT scanner.

KEY POINTS AND EXISTING GUIDANCE Stand-alone Software Software which has a medical purpose, which at the time of it being placed onto the market, is not incorporated into a medical device.

Intended Purpose Regulation of medical devices is limited by the intended purpose as defined by the manufacturer. This will include claims given in promotional materials for the device, e.g. brochures and WebPages.

Medical Purpose Software that has a medical purpose could be a medical device. A medical device is defined in the medical device Directive (MDD) as: “software… intended by the manufacturer to be used for human beings for the purpose of: » diagnosis, prevention, monitoring, treatment or alleviation of disease, » diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, » investigation, replacement or modification of the anatomy or of a physiological process, » control of conception….” The other directive where this guidance is applicable is the active implantable medical device directive. Continued on page 54

We want to hear from you The thoughts and ideas of our readers and subscribers are essential to us at The Journal of mHealth. We want to hear your opinions on the mHealth industry. Contact us at thejournalofmhealth@simedics.org

The

Journal of mHealth The Global Voice of mHealth

53 The Journal of mHealth

UK's MHRA Issues Guidance on Stand-Alone Software and Apps Continued from page 53

Systems There is no definition of a system in the directive but there are specific requirements for products placed on the market that combine CE marked devices and non-CE marked products, e.g. a combination of laptop (not a medical device), software (a medical device) and heart monitoring hardware (an accessory) is considered to be a ‘system’ if these are placed on the market together.

Existing Guidance In January 2012, the European Commission (EC) published a set of guidelines in MEDDEV 2.1/6 - Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices. These guidelines will help you decide if your software is a medical device or an in-vitro diagnostic. The following documents provide useful information to help software developers understand regulations for medical device software: » European Commission MEDDEV 2.1/1 Definitions of “medical devices”, “accessory” and “manufacturer” » European Commission Manual on borderline and classification in the Community Regulatory framework for medical devices » Team NB FAQ on Implementation of EN 62304:2006 with respect to MDD 93/42/EEC. » MHRA Borderlines with medical devices.

Software Applications (apps) Mobile devices have unique qualities because they store personal data, are generally always switched on, have a light source and a camera that can capture high quality images and can provide information such as orientation through in-built sensors. There has been an increase to use the software on these devices for medical purpose. If these software applications meet the definition of a medical device, it will be regulated by MHRA as a medical device and will have to undergo a conformity assessment. The words and phrases listed below are all likely to contribute to a determination by the MHRA that the app they were associated with is a medical device: » amplify » analysis » interpret » alarms » calculates » controls » converts

54 April 2014

» » » »

detects diagnose measures monitors

There are a number of different types of apps and these could be categorised by function such as: » Decision-support or decision-making software that applies some form of automated reasoning, such as a simple calculation, a decision-support algorithm or a more complex series of calculations, e.g. dose calculations, symptom tracking, clinicians guides. These are the types of software most likely to fall within the scope of the medical devices directives. This includes software which provides personalised guidance based on information it has about a specific individual and makes use of data entered by them, provided by point of care devices or obtained via health records. » Apps acting as accessories to medical devices such as in the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device as are programmers for prosthetics. » Software that monitors a patient and collects information entered by the user, measured automatically by the app or collected by a point of care device may qualify as a medical device if the output affects the treatment of an individual. » Software that provides general information but does not provide personalised advice, although it may be targeted to a particular user group, is unlikely to be considered a medical device. » Software that is used to book an appointment, request a prescription or have a virtual consultation is also unlikely to be considered a medical device if it only has an administrative function. Some decision-support software may not be considered to be a medical device if it exists only to provide information to enable a healthcare professional to make a clinical decision as they ultimately rely on their knowledge. However, if the software or app performs a calculation or interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device. Increasingly apps are being used by clinicians who will rely on the outputs from this software and may not review the source/raw data.

Telehealth and Telecare Telehealth is the delivery of health services or information using telecommunication technologies. It uses devices to monitor people’s health in their own home including monitoring vital signs (blood pressure, blood oxygen levels or weight). The data can then be transmitted to a healthcare professional who can observe health status without the patient leaving

UK's MHRA Issues Guidance on Stand-Alone Software and Apps home. Increasingly, this latter function could be placed on a server and software could be used to interpret the patient data. This could be considered a medical device. However, consideration should be given to the interface between social care, well-being and health, which can become blurred. For instance an app that uses an accelerometer or gyroscope as a falls detector in epileptic patients is likely to be regulated as a medical device but the same app or device could alert as to whether an elderly person has got up from a chair or bed in a social care context. As a detector of falls of a medical condition the app will qualify under the MDD and be regulated as a medical device but in the latter case it will not meet the definition of a medical device and the medical device regulation would not apply.

Home Telehealth Systems with Connected Monitoring Devices MHRA requires individual devices to be CE marked as medical devices but does not require a system to be CE marked as a medical device unless it is placed on the market as a single product. Items such as the hub and possibly the motion detector (depending on the claims of the manufacturer) are not likely to be CE marked medical devices as they do not have a medical purpose. However, the software that runs on the server and interprets or interpolates the patient data is likely to be a medical device and would be regulated as such.

GENERAL REQUIREMENTS For all software and apps that meet the definition of a medical device, the following guidance will be applicable.

Classification Advice on classification is given for general medical devices but for software, an active device, the following existing classification rules are most applicable: » Implementing rule 2.3 - Software, which drives a device or influences the use of a device automatically falls into the classification of that device. » Rule 9 - Active therapeutical devices are generally Class IIa – however if potentially hazardous then Class IIb. » Rule 10 - Active devices intended for diagnosis are generally Class IIa – however if potentially hazardous then Class IIb. » Rule 12 - All other Active Devices are class I. » Rules 14 - All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb. While compliance class I devices are based on self-declaration by the manufacturer, all other devices require use of a notified body to assess compliance.

Manufacturers of Class I devices, must also register with MHRA. Clinical data is required for all medical devices and for some novel software clinical investigations may be needed.

Post Market Surveillance Manufacturers have a responsibility to implement an effective post-market surveillance system to ensure that any problems or risks associated with the use of their device once freely marketed are identified early, reported to competent authorities, and acted upon. This is known as the medical devices vigilance system. For software, a system of registration / activation may aid the manufacturer trace devices that have been distributed by third party distributors or by app stores. This is important when undertaking any corrective action such as a recall.

Instructions for Use (IFU) These are not needed for Class I and IIa devices if they can be used safely without any such instructions. If instructions are needed, they can be provided electronically if the device is intended for ‘professional users’ and the electronic instructions for use of medical devices regulations apply. Otherwise, the paper IFU shall be provided with the device. This could be supplied at activation of the software. The IFU should contain all the information needed to verify whether the device is properly installed and can operate correctly and safely.

Validation Software devices must be “validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.”

Supplier/Distributer Unlike the MDD, the UK’s medical device Regulations and amendments place requirements on suppliers of medical devices. UK suppliers/app stores should be aware of their responsibilities under the regulations.

Adverse Incident Reporting Manufacturers should follow the guidance for reporting adverse incidents and field safety corrective actions to MHRA.

SPECIFIC SOFTWARE CONSIDERATIONS: Software for Sports or Leisure In general, products for sport or leisure purposes are not considered to be medical devices. However, in some cases, products aimed at sports people may be considered to be medical devices. Contact MHRA for more details. Continued on page 56

55 The Journal of mHealth

UK's MHRA Issues Guidance on Stand-Alone Software and Apps Continued from page 55

products that have been “placed on the market” rather than sold.

Viruses and Antivirus Protection Currently only a small number of smart phones are protected by security software. Any virus that attacks the mobile phone operating systems may also affect the medical device app and this may not work as the manufacturer intended and the user may be unaware of this. Incorrect use of antivirus software is also known to affect performance of medical devices.

Software that Makes Recommendations Based on Patient Entered Data Software intended to carry out further calculations, enhancements or interpretations of patient images or data, is a medical device. It’s also a medical device if it carries out complex calculations, which replaces the clinician’s own calculation.

Software that Replaces Existing Paper Charts

Software which Uses A Physical Accessory If the app has a medical purpose and relies on a physical accessory to obtain data to function, e.g. a device to position a smartphone’s camera, it will be a medical device and the device that positions the camera could be viewed as an accessory to the software. Accessories are classified in their own right separately from the device with which they are used.

Software that Utilises A Patient’s Genetic Information Together with Other Data from A Patient Record for A Medical Purpose The guidance document MEDDEV 2.1/6 gives the example of “software that integrates genotype of multiple genes to predict risk of developing a disease or medical condition” and considers the software to be an in-vitro diagnostic.

These are not usually considered to be a medical device; however, the addition of complex functions to the product can make it a medical device.

Software for in-House Use Only

Software Combined with Non-Medical Products

Disclaimers

A system can comprise medical devices that need to be CE marked for a medical purpose as well as other devices that could be used in a social care context but will not be regulated as a medical device. In cases where the system incorporates devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system will be treated as a device in its own right and as such be subjected to the relevant conformity assessment. The MDD requires the whole system to be safe. This is particularly pertinent to stand alone software, where the manufacturer must demonstrate compatibility with the recommended hardware platforms.

Other Software Types that May be Medical Devices The following types of software may be medical devices if the manufacturer has assigned to them a medical purpose: » spread sheets – particularly if they provide complex functionality that is beyond that of existing paper charts » documents with macro or script enabled functions – complex medical applications can be written with languages such as visual basic » interactive web pages – these can utilise programming languages such as JavaScript to produce medical applications » un-compiled software – if all of the information is provided to install the software then the MDD may apply » freeware/open-source software – the MDD will apply to both methods of software distribution, it applies to

56 April 2014

Guidance on in-house manufacture may be applicable.

A number of apps have a disclaimer saying “for information only” or “for research use only” or other statements that try and reduce the responsibilities of the manufacturer. However, if an app qualifies as a medical device and is placed on the market for a medical purpose it will still need to comply with the MDD. General disclaimers (for example ‘this product is not a medical device’) are not acceptable if medical claims are made or implied elsewhere in the product labeling or associated promotional literature. Anecdotal quotes and testimonials are considered to be implied claims by the manufacturer if they are repeated in product literature.

Software that is not a medical device Other legislation may apply such as the General Product Safety Regulations.

CONTACTS Contact MHRA for any further enquiries at www.mhra.gov.uk

FURTHER READING European commission guidance on medical devices European commission guidance on Borderline and classification of medical devices The published guidance and more information can be found via the MHRA website: http://www.mhra.gov.uk/Howweregulate/ Devices/Software/index.htm 

Digital Health and Care Alliance Opens for Registration

Digital Health and Care Alliance Opens for Registration DHACA the newly established Digital Health and Care Alliance is now open for registration in the UK. Set up by the ‘i-focus’ team, and led by ADI (Advanced Digital Institute), the Alliance is one of four projects under the UK Government’s £23m ‘Dallas’ programme. DHACA’s objective is to identify appropriate resources and facilitate fruitful collaborations between the public sector, industry and the third sector, to expedite the development of new ways of delivering health & care that benefit all parties. Organisations in health and social care are battling challenging financial targets and increasing demand. They need tools to enable transformation, business models that demonstrate the cost

effectiveness of new systems, new ways to procure and contract services, help navigating information governance regulations and vitally systems that improve outcomes, care and value for money. DHACA provides a trusted structure, expertise, knowledge and a process for collaboration across its membership to: »

Define and share best practice service designs, technologies and business models that improve outcomes

Define and share business requirements for future procurements and road-maps

Leverage existing investments, assets and infrastructure

Ensure quality, interoperability with other systems and future-proofing.

DHACA has been established as a community for NHS Community Care Pro-

vider Trusts, Foundation Trusts, Local Authorities, Clinical Commissioning Groups, Health and Wellbeing Boards, 3rd sector not-for-profit and commercial health and care service providers. The Alliance is also for supplier-side organisations include technology providers, software infrastructure providers, application providers and developers, training providers, communications providers, installers, and technical support service providers. Until June 2014, organisations are being offered the first year’s membership of DHACA free and without obligation. There is no commitment to contribute resources, and members are free to select which DHACA activities or areas of interest they engage in actively. Subsequent years’ membership will be subject to a small fee to cover administrative costs and membership rates for commercial organisations vary depending upon the size of the organisation. To find out more and to join visit: www.dhaca.org.uk 

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 educate and 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 your content gets high exposure. Contact us for more information on our Content Publishing Programs

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Upcoming Events 6-8 May 2014

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Washington, DC, USA For more information visit www.healthdatapalooza.org

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The Th T he Eu European E uro rop pe ea an n Future Futur uttur u ure HealthHe H e ealthcare cca arre e Forum Fo orru um m, D Du Dublin, ub bllin liin n, Ireland. Irre ellan laan nd. For For or

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