The Journal of mHealth Vol 1 Issue 5 (October 2014) by The Journal of mHealth

WHATâ&#x20AC;&#x2122;S INSIDE

NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

The

Journal of mHealth The Global Voice of mHealth

October 2014 | Volume 1 Issue 5

mHealth: The Engagement Issue

SPECIAL REPORT EBOLA: The Role of Technology in Managing an Outbreak ARTICLES

INTERVIEW

NEWS

Health Application Enables Citizen Superheroes

Philips Delivering Change Through Innovation

Full Round Up of Industry News

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

Global Digital Health 100 The most innovative companies in the field of digital health For more information please contact us at thejournalofmhealth@simedics.org

Editor's Comments

Welcome In the digital health industry the issues of ‘patient engagement’ and ‘engaging users’ are regularly debated. In this issue we seek to consider what we actually mean when we refer to these terms, and whether digital solutions really are beginning to successfully ‘engage’ with patients and users. As an observer and reporter on the digital health industry, it is easy to see that this is a multi-faceted issue and one where a variety of questions need to be asked. In terms of how technology can deliver meaningful relationships for the many stakeholders involved in the care continuum, and, essentially, in what ways can we use technology to encourage people to take greater responsibility, and a more active role, in the way they manage their health and medical conditions. We accept that managed self-care and proactive community driven health provision are some of the many ways that modern healthcare systems need to evolve, and that technology can be a major enabler of this process. The question that persistently needs to be asked, is how we can best use the technology to ensure that it works for, and benefits the patient? In this edition, we include a number of articles that consider the ‘engagement issue’ from a variety of different perspectives. We are also very pleased to be able to bring you an interview with Alan Davies, Director of Home Healthcare for UK and Ireland at Philips, and Dr Cees van Berkel, Principal Scientist at Philips Research UK in which they share their insight into the ways in which Philips, as a major global healthcare brand, is using collaboration, and meaningful innovation in both technology and service redesign, to help the UK healthcare system provide long-term effective and affordable care. Finally, we have all seen the terrifying rate at which the Ebola outbreak has engulfed Western Africa, and it seems that at the moment there is little sign of this spread slowing. Emergency response teams, medical charities and non-governmental organisations are all struggling to contain the virus and consequently Europe and the US are on high alert as they begin implementing screening at some airports. In this issue we include a special report that considers the role that technology is playing in the fight against the spread of the disease. Data analysis, digital mapping techniques, digital location analysis, and mobile technologies are all being used in a variety of ways to help with the outbreak, and we discuss how effective these techniques are in assisting in the response to Ebola and other similar disease outbreaks.

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

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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.

Matthew Driver

Editor

The Journal of mHealth

Table of Contents

In This Issue 4

mHealth: The Engagement Issue When it comes to digital healthcare one of the most frequently asked questions relates to whether a solution can deliver and demonstrate ‘Patient Engagement’. In this article we consider what is actually meant by the term ‘engagement’.

Philips: Transforming Healthcare Through Innovation and Service Design In an interview with Alan Davies, Director of Home Healthcare for UK and Ireland at Philips, and Dr Cees van Berkel, Principal Scientist at Philips Research UK we consider how collaboration, and meaningful innovation in both technology and service redesign, can help the UK healthcare system provide long-term effective and affordable care.

SPECIAL REPORT: Ebola and the Role of Technology in Managing an Outbreak We feature a number of articles which focus on the role that mobile and digital technologies are playing in the response to Ebola. From public health mobile communications to advanced mapping algorithms, technology has the ability to help in the fight against the spread of the virus.

October 2014

Table of Contents

Industry News 14

Parkinsonâ&#x20AC;&#x2122;s Disease Monitoring Technology to be Made Available in US Clinics

Technology Funds Look to Healthcare in Search of Next Windfall

16 17

Webcam Used to Detect Abnormal Heart Rhythm Two Apple Medical Trials Shed Light on how HealthKit will Work

SPECIAL

REPORT 40

Ebola: The Role of Technology in Managing an Outbreak

Medical Researchers Call for Technology to Help Fight Ebola

Cell-Phone Data Might Help Predict Ebolaâ&#x20AC;&#x2122;s Spread

Health Map Algorithm Detected Ebola Outbreak a Week Before it Spread

Wearable Technology UX: New Event is Dedicated to the User Experience

Remote Access to Medical Images Fuelling Demand for Digital Medical Imaging in the Cloud

mHealth Solution Provider Making Quality a Priority

Graphene Turns Rubber Bands into Stretchable Body Sensors

Defibrillator Garment Detects and Corrects Abnormal Heartbeat

HealthXL: Driving Innovation through Collaboration

Lightweight Sensor Measures Heart Rate and Body Movement

Digital Health Days 2014: A Glimpse into the Future

Smart Glasses Offer Spatial Awareness to the Visually Impaired

International Digital Health and Care Congress

Intel Edison Designed to Power the Internet of Health Things

The Evolving US mHealth Regulatory Landscape

Global Report Suggests Many Mobile Applications are Failing on Privacy

Technical Considerations for Vetting mHealth Applications

Tackling Respiratory Disease with Home-Based Services and Solutions

Upcoming Events

Advertisers Index

21 22 23 23 24

Heart Energy May be Enough to Drive Pacemaker

Patient Engagement in the Digital Era

Health Application Enables Citizen Superheroes

Delivering Effective Patient Engagement

The Journal of mHealth

mHealth: The Engagement Issue

mHealth:

The Engagement Issue When considering whether digital health solutions actually deliver measurable outcomes and tangible benefits, one of the most frequently asked questions relates to whether a solution can deliver and demonstrate ‘Patient Engagement’.

What is Engagement?

One question which is often NOT asked, is, what is actually meant by the term ‘engagement’? When it comes to the range of different digital solutions available in the healthcare, social care and personal health & wellbeing markets, there are many different interpretations as to what engagement actually means. Is it a patient using the solution on a daily basis? Is it the solution delivering some measurable impact on a patient or user’s life or medical condition? Is it someone feeling that they have the ability to more effectively self-manage their condition? Or, is it simply having a wide audience of users?

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In a wider healthcare perspective ‘patient engagement’ can be defined as ‘a patient accepting greater responsibility for the management of their own health and care, through positive activity to deliver individual health goals’. But, in digital healthcare the issue of engagement also considers the ways in which technology can help increase this idea of personal patient accountability as well as the ways other stakeholders engage. If engagement is considered purely in terms of frequency of interaction and prolonged frequency of interaction, then by its nature the more complex a system, the greater number of interactions required. But does this really demonstrate engagement? For example a patient may be extremely diligent in taking vital sign data, and recording that data within a solution. But, if the solution then fails to interpret and use that data in a meaningful way, to encourage the patient to take steps that will have a positive impact on their health or condition, or to understand the

mHealth: The Engagement Issue type of behaviours that may lead to negative impacts, then the solution is failing to deliver real health benefits, and therefore failing to engage. Without clearly defining ‘engagement’ in each specific case then it is difficult to truly determine whether a solution has proven successful in ‘engaging’ with the user. It is, therefore, important to ask what the purpose of the solution is and what are the desired outcomes, for all stakeholders? Even within a single solution there will likely be different user groups who will have different desired outcomes. Take, for example, a personal medication adherence device like a wireless pill bottle. Designed to assist people in remembering to take their medication, and to help ensure that they adhere to their own personal medication routine, the bottle is able to alert the owner (via a variety of means) when it is time to take their medication, or when they have forgotten a dose. The inherent nature of this device requires it to discretely become a part of everyday life, only interacting with the owner when necessary. On the other end of the scale, the solution also allows prescribing doctors to monitor real-time metrics relating to levels of medication adherence among their patients. This element of the system requires greater integration in order to adopt the solution into existing work-flows. From an engagement perspective, it is easy to see, from this example, that there are two well defined user groups, each of which will need different consideration to ensure systematic and effective use. To go back to the earlier questions of what is the

The change that this new model of delivery brings is significant. It requires major cultural shifts to the way that healthcare professionals and providers design and implement services, and to the intrinsic approaches that are taken in day-to-day care provision. This means that any technology that is introduced into the equation needs to have been developed with an inherent understanding of the need to deliver a multi-dimensional and multidisciplinary tool that not only integrates with the needs of all the various stakeholders, but which also forges lasting relationships. The types of relationship that influence engagement include: »» »» »» »» »» »»

Healthcare Professional (HCP) – Patient HCP – HCP Patient – Patient Patient – Technology HCP – Technology, and Technology – Technology.

There are different ways of incorporating all of these relationships and connections within a system, but in each case it is essential to consider these factors from the beginning. This means that rather than simply designing technology, it is necessary to actually develop services, with engagement as the core tenant around which a solution is built. Digital solutions that assist or enable healthcare provision cannot be merely technology layers stacked upon existing services, as this will likely result in problems with integration, use, and acceptance by both healthcare professionals and patients.

A patient with a chronic condition is much more likely to engage with a solution if it is designed to fit their needs… by understanding what they hope to achieve by using a solution and tailoring the specifics to help them attain those goals, then you begin to connect with the patient on an emotional level, which in turn means that they are more likely to adopt the technology into their daily activities. purpose of the solution and what are the desired outcomes, for all stakeholders? Then it is easy to see that these change between stakeholder groups.

Engagement Built on Relationships Technology, and the ability to deliver care remotely as well as the introduction of digital personalised self-care, is transforming the traditional paradigm of care provision. No longer does healthcare have to be a reactive industry that responds to patients in established locations or during set appointments, instead healthcare can go beyond conventional pathways of care delivery and begin integrating directly with the lives of the various stakeholders. This means that care can be delivered in a more proactive way, that encourages prevention, reduces the need for intervention, and hopefully, leads to overall improved health and wellbeing.

Instead, at the start of a project developers should begin by mapping stakeholder networks, in order to gain an understanding of who are the intended users of the system. There should also be a clear framework outlining the desired outcomes and benefits that the service hopes to achieve. It is also necessary to identify the user profile, in terms of specific conditions, different elements of the population, or from particular demographics. In a clinical setting, the care pathway design and the manner in which patients will be encouraged to use a solution - and then managed as they progress along that pathway - will need to be assessed and given maximum priority. Different use cases will require different levels and methods to engage users. Some will only have minimal stakeholder networks, and others will need to meet the needs of a complex netContinued on page 6

The Journal of mHealth

mHealth: The Engagement Issue Continued from page 5

work of users, spread across a variety of healthcare disciplines. By understanding where a solution fits into this equation and how it will impact users is an important step in ensuring that the design can work effectively for all involved.

Patient First A patient with a chronic condition is much more likely to engage with a solution if it is designed to fit their needs, this requires knowing about the patient before connecting them with the care program. By understanding what they hope to achieve by using a solution and tailoring the specifics to help them attain those goals, then you begin to connect with the patient on an emotional level, which in turn means that they are more likely to adopt the technology into their daily activities. Support, for patients using digital solutions is also a key aspect. Making sure that they are well equipped with an understanding of what the solution is designed to do, how it can help them and their condition, and then taking them through the relevant processes and steps, will help people transition more easily. This is something that should be maintained throughout the experience, so that as data is collected, results and the impact of those results are presented or discussed in such a way that it adds to the understanding of the overall process. This type of reflective learning helps to reinforce the user’s knowledge of both the solution and of themselves and their condition. If, through the technology, a patient can develop a symbiotic relationship with their own body and medical conditions, then they become empowered to more effectively manage their own care, and are more likely to continue to engage in different ways with the technology.

using a solution were inclined to do so. In addition to measuring the level of interactive engagement, a user satisfaction score or a wellbeing survey may also help to determine to what extent a patient or user has benefitted from the solution. Other measures are less reliable in that they can give a skewed picture on reality. Take for example, user uptake or download statistics for a digital health application. Measuring downloads can indicate popularity and awareness of a solution, but, by itself the figure does little to provide any meaningful indication of regular, systematic, and critically beneficial use. This is why it is important to focus on not just interactive engagement but also quality of engagement i.e. are the users gaining continual benefit through their interactions with the system?

Meaningful Relationships with Technology The issue of how to embed digital healthcare technology and services within the everyday lives of patients and their doctors and healthcare providers is leading the industry to rethink the way in which they approach and target solutions. It is also generating some extremely interesting cross-industry collaborations, as healthcare technology companies seek to draw upon the techniques and methods used in other consumer based industries.

One example of this type of collaboration can be seen from the recent announcement of a strategic business alliance between Philips and salesforce.com which aims to deliver an open, cloudbased healthcare platform, leveraging Philips’ leading positions in medical technology, clinical applications and clinical informatics and salesforce.com’s leadership in enterprise cloud computing, innovation and customer engagement. Patient relationship Where there is a complex level of interaction required, management will be at the centre of the envisioned platform, e.g. through a therapeutic digital solution, allowing caregivers to collaborate closely in support that is designed to be a substitute for of their patients. The platform will enable medical medication or some other form of device and data interoperability – the collection treatment, then the investment in Introducing of data and subsequent analysis to enhance terms of: time required to learn proven business clinical decision making by professionals and how the solution works; to enabling patients to take a more active role understand what it can and concepts like customer in managing their personal health. cannot do; and, to articulate relationship management what is expected of the user, Through this alliance, Philips hopes to requires a far greater level into healthcare has the draw upon salesforce’s expertise in deliverof interaction in order to potential to emulate the ing enterprise cloud computing solutions achieve the desired results. that focus on customer engagement and But, in the longer term is success these systems apply these concepts to healthcare services. likely to lead to much more have had in other Using techniques that have proven successful significant outcomes, and more in other commercial environments to drive digieffective engagement. industries. tal healthcare engagement.

Measuring Engagement In terms of physically collecting information and analysing whether there is engagement with a specific solution, then there are certain measures that can be considered. For example, longevity of use i.e. how many people use the service/solution on a regular basis, and how many continue to do so after a given period of time. Although, a measure like this would need to take into account the reasons why any users who have stopped

October 2014

This is an interesting approach that should remind us that modern patients need to be considered as health consumers. This means providing services and solutions that include features and elements that consumers expect across other aspects of their lives. By using common interfaces found in other consumer experiences, then patients can instantly begin to identify with a solution more quickly. Consumers are leading the demand for digital services, so it is

mHealth: The Engagement Issue important for solution providers to engage with them in order to understand underlying problems and the issues that they are seeking help with. It could be argued that patients are the most valuable resource for the healthcare industry. They have the knowledge of what does and doesn’t work for them, and they can determine which parts of a solution or service are the ones that of most benefit. Technologists have a habit of sometimes getting caught up with the actual technology, whereas often it is very simple things that can actually deliver the most value and benefit. Digital healthcare solution providers and developers should be looking to implement processes that directly involve consultation with patient communities and advocacy groups to help deliver better patient engagement. Introducing proven business concepts like customer relationship management into healthcare has the potential to emulate the success these systems have had in other industries, by providing better customer experiences. Using inspiration from other industries and creating meaningful relationships with technology is something that is starting to emerge across other areas of digital healthcare solutions. One very successful example is gamification. Companies such as Ayogo Health have demonstrated how game psychology can be successfully used to encourage patient self-care. This means creating serious games that nurture human connection, motivate, educate, and promote health and wellness and develop new ways of leveraging technology for performance improvement and producing behavioural change. Many digital healthcare companies are beginning to understand this need to create meaningful relationships between users of technology, as well as the need to present information and data in ways that embed themselves more deeply within the consciousness of users. Another example, is the company Biobeats, who have taken a unique approach to presenting heartbeat data through music. Their solution engages users by providing a multi-sensory interpretation of the data, which instantly creates a meaningful relationship with the technology. Within healthcare organisations, themselves, there is also an opportunity to bring together groups who have different opinions when it comes to technology. Traditionally, you tend to have three distinct groups in every healthcare organisation: There are those who are technology-led; those who are patient-led; and those in management who are tasked with facilitating strategic interventions designed to bring those two groups together. By fostering relationships between these groups it is possible to increase understanding and adoption across the organisation. It also means that IT staff gain an insight into how the technology can actually benefit patients, and clinicians are able to see how the back-end technology can advance quality of care.

lack of Interoperability hindering engagement One of main difficulties still facing the digital healthcare industry is the lack of interoperability between solutions. An ideal ‘engaged patient’ is one who can use a variety of technologies, and different solutions to manage the range of aspects of their care and treatment. For example, a patient may wish to use a

monitoring device to record vital signs, they may also be referred by their doctor to use a patient management system, on top of this they could have a separate medication adherence solution, and finally, they may want to use a consumer digital activity tracker to monitor their fitness. All of this screams ‘engaged patient’ - it is someone who wants to take an active role in their self-care and use technology to help guide them in their activities, as well as benefit from new ways of interacting with their healthcare professionals. What often lets this scenario down is the lack of interoperability between those systems. Many solutions use different data formats, different operating standards, and they fail to communicate with each other. Because of this patients are often left having to duplicate data across multiple solutions, or access different solutions to manage each aspect of their self-care regime. This can quickly lead to technology fatigue and frustrated users. Firstly, it is important to say that having separate systems for these different aspects of health is good for the patient. Solutions that try to be everything to everyone, often fail on many levels. It is important for the industry to have solution providers in different niches, providing innovation and delivering technology and services that work. What is necessary though is for these systems to communicate with each other, in a way that is easy for the patients to implement and follow. This means having all of the data available in an open standard that can easily be exchanged across systems and solutions. There has already been considerable work undertaken in this field, and the landscape is evolving rapidly, but until there is true data and solution interoperability, then this will continue to be a pinchpoint in the engagement issue.

Best Practice Digital health services that wish to demonstrate engagement need to clearly outline initially what engagement actually means in relation to their specific solution. They then need to ask the questions: Who does the service target? What are the conditions that the service can help with? What are the outcomes that the service hopes to achieve, from the point of view of the many different stakeholders involved? And, how will the benefits and outcomes be measured? Finally, technology-led services need to be supportive of patient users, making adoption and engagement a deliberate step that is then reinforced by creating meaningful long-term relationships. All of this should be underscored by systems that are easy to navigate, simple to understand, and intuitive to patient/users needs. That collect and analyse data, and deliver information using open standards that supports interoperability between different solutions and systems. Only by having a clear understanding of all of these elements, can you begin to understand whether a solution has had meaningful impact, produced desired outcomes, and ultimately engaged patients and users. This edition of The Journal of mHealth includes a variety of articles that consider the ‘Engagement Issue’ from a number of different perspectives. n

The Journal of mHealth

Philips: Transforming Healthcare Through Innovation and Service Design

Philips: Transforming Healthcare Through Innovation and Service Design In this interview with Alan Davies, Director of Home Healthcare for UK and Ireland at Philips, and Dr Cees van Berkel, Principal Scientist at Philips Research UK we consider how collaboration, and meaningful innovation in both technology and service redesign, can help UK healthcare system provide long-term effective and affordable care. Designing technology enabled services for healthcare in the UK that is capable of delivering positive outcomes requires a multi-disciplinary approach, that demands input from all stakeholders in the equation. In reality, one of the best ways of approaching this is through the creation of strategic partnerships between healthcare organisations and technology and solution providers that bring together the expertise and knowledge of those partners, allowing meaningful and effective services to be developed and deployed. Speaking to Philips Home Healthcare Director Alan Davies and Dr Cees van Berkel, we sought to gain an insight into the way that Philips collaborates with healthcare partners, to not only deliver the technical aspects of care service provision, but also to become involved at the strategic level, through the design and development of care pathways and even on to shared responsibility for delivery of community based supported self-care programs.

The opportunities to innovate beyond conventional methods of healthcare delivery, through the use of technology are well documented. However, what is proving to be significant is that in order to deliver successful projects capable of providing real benefits to all stakeholders in the healthcare economy it is necessary to innovate, from not just a technical perspective but also critically from a service delivery point-of-view.

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Compounded by the many pressures that are facing modern healthcare providers, this means that healthcare technology companies are no longer seen as merely technical solution providers. Instead, they are increasingly becoming more entrenched within the wider care continuum, and through collaboration helping to drive the adoption of broader technology enabled services. At Philips, this type of socially responsible approach is seen as the best way to help effect change within modern healthcare delivery. It also represents a significant change in culture, from the way in which Philips and other healthcare technology providers have operated in the past, and this is proving to be positive for healthcare providers, their suppliers, and most importantly for the end users – the patients. Alan describes in greater detail what this has meant for Philips. “If you look at what is happening to our healthcare economy from the demographics of people living longer, the prevalence of co-morbidities, and the pinch-points occurring around Accident and Emergency departments and centralised secondary care facilities, it is obvious that we have to be driving care into the community, and from a Philips point of view we want to be a part of that.” There are, however, certain factors that can hold this back. Alan suggests that “part of what is holding this up is invest-

ment and the other part is innovation. Therefore, if we can play a role in changing that, then effectively we are helping our own ecosystem.” In the UK this has meant taking significant steps to get involved at all levels of service design and implementation. “We accept that there has to be a degree of investment and it has to be [based upon] a risk reward. What we are doing is continuing to provide technology to the marketplace, and we will certainly continue to innovate, as we have a strong and proud history of research and because of that we will continue to develop and come up with new solutions, but we recognise that rather than waiting for the ‘soil’ to be ripe for those innovations we actually have to get out there and work in the ‘garden’ ourselves.” says Alan. “We understand that we are going to have to help the NHS [UK] and the independent sector and certainly help the patients to get this technology, and to get it in a form where it is useful. That

Philips: Transforming Healthcare Through Innovation and Service Design means care pathway transformation, and it means getting our sleeves rolled up and really being involved in that change. Of course hopefully then we would also be able to provide at least some of the underlying technology to enable and support this. However, if you are really into transformational change and you want to deliver new ways of providing care, then I think that you have to have that as your objective, and that as your focus. This in turn, logically, takes you down a path which says that you are actually going to be providing services, albeit technology-enabled services, but services all the same.” Dr Cees van Berkel, Principal Scientist at Philips Research UK echoes this sentiment by describing how this change of approach is as much about internal transformation within Philips. “There is a huge amount of knowledge within Philips around healthcare and around the potential for care transformation using technology. What is changing is that traditionally we would only share this expertise through the purchase of a product up front, increasingly we are now engaging with customers around helping them define their programme objectives and desired patient outcomes using our knowledge and expertise and then looking to help them put in place the right technology at the right point to underpin the achievement of these goals. We [have the potential to] provide huge value in getting people through the journey and our challenge is to take that value and expertise within Philips and make it work for our customers.” Philips has already seen significant success with telehealth and telecare deployments in the US marketplace, and they are now beginning to gain similar traction through digitally-based services in the UK. Alan suggests that the UK NHS presents its own unique set of operational and delivery challenges. “The UK is a fascinating telehealth market, on the one hand we have arguably considerable experience through the Whole System Demonstrator, DALLAS (Delivering Assisted Living Lifestyles at Scale), and the 3 Million Lives initiative; and there is a huge potential market, but on the other hand it has been slower than the likes of the US to adopt on a widespread basis where the services are paid for by healthcare insurance providers in the main.”

“From a global perspective the UK significant technology enabled services and the US are both of top priority [to in the areas of community, supportive Philips]” continues Alan. “The UK has care, condition management, and digihuge potential but it does take time and tally enabled self-care through projects investment to unlock it. Although, we with a growing number of NHS organhave NHS England as a governing body, isations. providing policy and structure, we still effectively have 211 separate commisConsidering these successful deploysioning organisations (CCGs)... because ments, “Top of the list for me” says Alan of this you cannot think of the NHS as “would be Liverpool CCG where we are one creature. Instead, you have to think delighted to be a partner with the DALof each CCG as a separate organism in LAS initiative that they have there, which a collective. The collective has multiis branded as ‘More Independent’. cells, and although there is a This is a partnership with commonality in terms of a number of other the fact that each of organisations, so it “There are them has a populais great because financial benefits tion responsibilit links up ity and those industry but there are also some populations with clinical real patient outcome benare made of capability people like and with efits that you can get by the you and I, social care risk stratified use of telehealth, capability. with their various conIt is breakas opposed to previous more ditions, there ing new general deployments that are slight differground in ences in terms of terms of serwe think are really emphasis around vice delivery and quite powerful” the particular stratecoming up with gic objectives they are new innovations in, trying to achieve. Therefore for example-delivering a when you talk about changing the NHS patient health record.” what you are actually talking about is all of those CCGs picking up particular “In Liverpool, we have introduced ideas and beginning to implement those something that is probably unique in the through their provider community and UK” adds Cees. “This has meant introthen through to the patient themselves, ducing telehealth directly into primary and that takes time.” care pathways... Traditionally telehealth has been offered around a hospital dis“On the one hand there is a degree of charge management type solution but to fragmentation and certainly a degree make it work with a primary care soluof inefficiency in the UK market” adds tion you have to strike a balance, by sayCees. “At the same time there are over ing [to GPs] we are not going to take 200 CCGs working in the health econopatient responsibility from you, you will mies and that actually means there is a remain clinically responsible for everylarge market which allows early adopters thing about the patient, but at the same to innovate without having to be worried time this service shouldn’t be adding about late followers holding them back. additional burdens to you.” So it does drive innovation... The market will change because it has to change The way that Philips has achieved this and because the financial pressures on balance in Liverpool is by allowing all the system will mean that commissioners of the day-to-day monitoring of the and providers will have to look at where patients, the installation, the talking the biggest costs are and how they can to the patients, and the training of the commission and operate in such a way patients to be handled or coordinated that reduces those costs whilst maintainby the multidisciplinary team (MDT) ing quality, safety and maximising patient at the telehealth hub. At the hub, there outcomes”. are both clinical and technical personnel. So that the technical personnel are Despite some of the inherent difficulties, Philips has already helped to deliver Continued on page 10

The Journal of mHealth

Philips: Transforming Healthcare Through Innovation and Service Design Continued from page 9

well equipped to deal with all the support issues relating to hardware, software and connections, etc. Whereas, the clinical personnel are available to identify when there is a genuine health concern with a patient and alert clinicians only when needed based on a smart alert warning on a threshold breach. Often patients worry that through the introduction of technological monitoring and self guided care that they will be unable to access their GP when needed. However, in reality the service is designed in such a way that instead of losing connection with their GP patients actually gain from having a targeted service that will focus better informed clinical engagement when and where it is most needed. Other similar such partnerships for Philips include the work with NHS24 on their DALLAS initiative for the Scottish population. Looking more exclusively at the secondary care area and in particular, critial care for the moment, one particular digital solution that has proven very successful for Philips in the US is the deployment of eICU programs. More than 400+ hospitals in the United States have implemented the eICU approach, and so far this includes more than 2M patient stays monitored. Seen as ‘an air traffic control tower’ for healthcare it consists of a range of cutting-edge technology, including two-way audio and video, which allows intensivist consultants to care for patients remotely. At the heart of the system is sophisticated smart alert software that collates and analyses the data flowing from bedside monitors, in real time. If a potential problem emerges with one of the patients, the system immediately flags it up on a central monitoring system for further analysis and intervention. Philips is now hoping to replicate the success of eICUs in the UK. Alan suggests that this type of solution also lends itself to collaborative use between healthcare organisations which offers additional cost and benefit practicalities. “We are just beginning to focus in the UK on introducing eICUs and we can already see there are 6 major trusts in serious conversations with us about implementing it. One of the organisations we are talking to which has a

October 2014

very large ICU is already looking to provide overspill or out of hours support for smaller hospitals and we have seen in the US that, that model can work quite well.” One interesting partnership announced early in 2014 was the rather intriguing tie-up between Philips and Salesforce. com. Designed to develop and introduce an open, cloud-based healthcare platform, leveraging Philips’ leading positions in medical technology, clinical applications and clinical informatics and Salesforce.com’s leadership in enterprise cloud computing, innovation and customer engagement. Patient relationship management will be at the centre of the envisioned platform, allowing caregivers to collaborate closely in support of their patients. The platform will enable medical device and data interoperability -- the collection of data and subsequent analysis to enhance clinical decision making by professionals and enabling patients to take a more active role in managing their personal health. Both companies envision that apps will cover the continuum of care: from selfcare and prevention, to diagnosis and treatment through recovery and wellness. It is hoped that the platform, based on the Salesforce1 Platform, will enable collaboration and workflow, as well as integration of data from multiple sources worldwide, including electronic medical records, diagnostic and treatment information obtained through Philips’ imaging equipment, monitoring equipment, personal devices and technologies like Apple’s HealthKit. Moreover, the cloud-based platform is designed to be highly scalable with built-in privacy and data security. By combining the data, the platform will allow for analysis that will enhance decision making by professionals and engage patients. Both Philips and Salesforce.com foresee that the platform, will utilise Philips’ clinical data stores and medical device interoperability. It is intended to be open to developers and is expected to result in a vibrant ecosystem of partners creating applications. As a result, the envisioned platform has the potential to transform both professional healthcare delivery and continuous personal health management. In discussing this type of partnership Alan believes that this will become an

important organisational distinction for Philips in the future. “Increasingly we do not want to be boxed into being just a technology provider. I think in the past this is what we have done well, and that is great, but I don’t think that should necessarily restrict us in future. Now, what we talk about is additionally providing the option of a partnered service, so that it is a joint risk-return service where we invest and they [the partner] invest. That investment could be as simple as providing technology or it can be as complex as providing technology, IP, and our own people.” Changing perspectives and cultures within operational healthcare delivery are part of the challenge when it comes to the issue of digital adoption. Alan continues, “I think some of the past negativity is changing and I think it is changing because of the pressures on the healthcare economy... which are forcing healthcare professionals, and even those who are deeply sceptical or cynical, to start looking again at using technology to help solve some of the problems that we have with the demographics and with the cost.” Cees suggests how the image of telehealth and digitally-enabled services is also beginning to change. “From an international perspective there has been, in the past, an unfortunate conversation around telehealth being an intervention that will just work regardless of implementation, technology and service design. The UK is probably leading (along with other countries like the US and Germany) the national debate as to what is the right service design for an intervention like this. I think that the UK is uniquely enabled because of the way the conversation is moving, and at Philips this is also where we see ourselves. It is not simply about technology it is about service design and working with people to make the technology work rather than saying ‘here it is - it will work’.” The way in which patients and healthcare professionals engage with technology enabled services are also changing and Philips has been proactive in taking innovative steps when approaching and building these relationships. “The solution nowadays includes a distinct patient activation step” says Alan.

Philips: Transforming Healthcare Through Innovation and Service Design

Digital revolution in healthcare

Professional care Home healthcare

Patient relationship management

Personal health

“It perhaps could be accused of being not given enough emphasis in the past, but today, it is a very deliberate step. You have to select the people, you have to educate them in advance, and the people have to understand what a service is all about... The patient awareness and understanding of what this can do for them and what it can’t do for them, as well as the work they will need to do is much more important nowadays, and more of our focus.” Philips takes a similar approach in order to encourage adoption amongst the various stakeholder healthcare professionals. “In terms of the HCPs we work to train them and demystify care plan design” says Alan. “This should not be a dark art. For technology to work it has got to be something that the nurses and the people in the triage area within the multidisciplinary team understand, both from a planning and an operational perspective. We get involved in making sure that the whole process works by physically being there and working with the people on the

ground. This is a big change from the old days where effectively technology providers were neither wanted nor required to get involved in an integrated fashion.” “We work to encourage patient and HCP engagement in the solution. Unless you have that, whatever you provide in terms of technology and systems won’t deliver the benefits required. So what we do now is very much about service design and the joint delivery of a program as engagement rather than the delivery of boxes and other given fixed solutions.” adds Cees. As a result of these changes both Alan and Cees believe that we are beginning to see significant shifts in the way that many health services are delivered. “The intention that we follow, nowadays, is to try to help the patient self-manage much more and that is a different philosophy and it is a different way of working” says Alan. “It is about educating the patient, helping them to understand where they are with their condition and what their options

are and then setting some parameters around it where they can manage themselves. But, in addition there is a point where alerts can be sent back to the GP or monitoring hub who can then provide additional support. I think it is a really exciting area that not only Philips but other organisations are trying to move forward so that healthcare partners help people to properly self-manage and to then use telehealth as a supporting and enabling technology around that.” This is a change in the way patients perceive care as well and for Cees this means services need to be packaged in such a way that patients are made to feel comfortable with using the technology. “You don’t have to put self-management right there in front of people and say ‘you have to learn this’ and present it as a big scary thing. Simple things like showing patients what their readings are so that they understand a little bit more about themselves, can really work. This is called Continued on page 12

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Philips: Transforming Healthcare Through Innovation and Service Design

Continued from page 11

reflective learning. Self-management is not a black box, it is not a dark art, it is something very practical. It is a little bit of help for people that gives them some responsibility, empowers them, and provides them with knowledge so that they can self-manage [their condition].” In a similar fashion to the opportunities presented by increasing self-management, digitally-enabled solutions can be similarly tailored to meet the needs and requirements of specific groups of patients, parts of a population, or individuals something which is very attractive to providers. “We believe that it is possible to customise a care plan, to provide individualised care” states Alan. The technology is flexible enough, but it is often the financial or human aspects of care provision that are the constraints. In other words we haven’t got enough time, or money, or people to be able to sit down and do this. We therefore tend to work with commissioning authorities and providers to focus on a deliberate cohort of patients, we then work with the referring GP through the self-care hub multidisciplinary team to train them in the art of what is possible, given the technology, to customise the care plans down to an individual level. We believe that if these things are done correctly it is not only possible but obviously very beneficial to provide individualised

October 2014

care in the way that we do.” Both Alan and Cees believe that the range of benefits that this collaborative approach to technology and service design can deliver is significant. “I think the benefits are for all three parties, that is the healthcare provider, the patient, and the solution provider” begins Cees. “The fundamental benefits are related to cost pressures and that is what really drives change in the healthcare system and the need to look at the way we deliver long-term care for long-term conditions. Because people experience healthcare at their GP practice, through their community provider, and at the hospital, as well as via social services, you have to look at the benefits of cost, and unfortunately you cannot simply go to your community provider and say we are going to change how you deal with longterm conditions and all the benefits and the advances will be for your staff, your patients, and for your business. What we have to deal with, and engage with is the entire health economy.”

solutions that Philips has available is significant, spanning a wide variety of health and social care disciplines. One of the difficulties for a company with such a large product portfolio is ensuring that those technologies can integrate and deliver connected health benefits. For Alan the key point is that, “we are looking at a very big brand who really wants to bring the full capability of itself to the market in a partnership mould... The future that we see is very much one of interoperability and partnerships. Let’s not try and reinvent the wheel, let’s not try to be all things to all people, instead let’s try to do what we do really well and integrate with others that can help us do likewise.” When asked what they feel the future holds for healthcare innovation, digital delivery, and specifically for Philips, both Alan and Cees have some insightful predictions.

“There are financial benefits but there are also some real patient outcome benefits that you can get by the risk stratified use of telehealth, as opposed to previous more general deployments that we think are really quite powerful” adds Alan.

“I see wearables and patient mobile sensors becoming the norm in the future” says Alan. “I think that integration of devices and data will become a must rather than something that is nice to have. I also think that we will see greater patient empowerment which means patients will be better informed and take charge of their own health using better information and education.”

The range of different products and

“We will also see data collection and

Philips: Transforming Healthcare Through Innovation and Service Design analysis becoming more important, where we can collect together information on personal genomes, we can take vital sign data, and personal health information and combine all that together to give us even greater drug and technology individualisation. Because of this we should see customisation and individualisation of treatment and ways of living becoming much more normal than they are now.” Alan continues. “The interesting bit on the data side is that I am beginning to believe that this will happen with or without healthcare practitioner consent. With some of the new ecosystems, for example those developed around wearables, we are going to see data stored outside of the NHS increase rapidly and when that data

reaches a critical mass it is going to be difficult to stop the demand for personal information because you almost end up with more information on the outside than you do on the inside, and that is quite a startling new development.” “Home in vitro diagnostics will grow and Philips will be leading that very soon through our Minicare home blood cell count solution” suggests Cees. It will initially be used to monitor the blood cell count of people that are undergoing chemotherapy, as the blood cell count of people with that type of problem drops when their immune system is comprised. This is the biggest danger for people when they undergo chemotherapy in terms of fatalities and hospital admissions. If you can monitor immune-

suppression through a simple test like a blood glucose test, and those tests are something that Philips is developing very seriously, then that will change the landscape of digital home care.” “Lastly” says Alan “there will be more public private partnerships. I think that we will always need our providers, I think they do a great job, but what we want to do is focus the right care needs on the scarce resources we have in the centralised secondary care facilities and I think we will increasingly look to use publicprivate partnerships to help us deal with some of the other pathways outside of that, where maybe we can manage the cost and patient outcomes on a better basis.” n

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INDUSTRY NEWS News and Information for Digital Health Professionals

Parkinson’s Disease Monitoring Technology to be Made Available in US Clinics Australian technology company Global Kinetics Corporation have announced that they have secured US regulatory clearance for their Parkinson's KinetiGraph™ (PKG™) movement recording device, a tool that Doctors can use as part of their treatment and management program for Patients with movement disorders, such as Parkinson’s Disease. The Personal KinetiGraph, “offers comprehensive, automated reporting of a Parkinson’s disease patient’s movements so that neurologists and other physicians can more easily identify changes in movement symptoms to assist in decisions to optimise therapy,” according to the company. The wrist-worn device is already in use in Australia, but has previously not been cleared for sale in the United States. The device can be prescribed to a Parkinson’s patient by their physician; the patient then takes the device and wears it at home. It can collect and store up to 10 days of movement data. That data is then downloaded by the physician, who can use it to obtain a more accurate assessment of the patient’s mobility than they could get from an office visit. The device can also serve as a medication adherence tool in conjunction with the Parkinson’s symptom management medication levodopa. The wearable can be set to vibrate at preset times to remind patients to take the medication.

ing scales such as the UPDRS, and modified AIMS are also traditionally used. There are well-known limitations with these assessment methods including: No assessment during activities of daily living; poor visibility of compliance with medications; inadequate reporting of symptoms; lack of or poor quality control data and inter-rater variability.

The PKG™ Data Logger uses a precision digital accelerometer to collect movement data and a unique mathematical algorithm to process the data to provide information useful for clinical evaluation.

The PKG™ movement recording seeks to address these limitations by providing an objective continuous automated quantification of movement disorder symptoms experienced in the home environment during the activities of daily living. This enables the assessment of Bradykinesia and Dyskinesia severity (relative to controls) presented in the context of medication timing and compliance.

Traditionally, in routine clinical care the severity of movement disorders was assessed by clinical impression and patient selfreporting of symptoms. In clinical trials, diaries and rat-

Announcing the FDA determintation, GKC Managing Director Andrew Maxwell said the company was now moving to ensure that the technology is available to over one million people living

October 2014

Industry News with Parkinson's in the USA. “To date we have made this life changing technology accessible to more than 50,000 people living with Parkinson's disease across Europe, Australia and Asia.”

Steve Ford, Chief Executive of Parkinson’s UK commented “This is a new way of managing Parkinson’s and we eagerly await the outcome of this important evaluation program.” “Mobile health technologies provide a new opportunity to monitor and manage this debilitating movement disorder affecting an estimated 127,000 people in the UK alone.” “Tools that are able to provide more objective information about how symptoms actually affect people in their everyday lives can assist clinicians in planning more suitable medication regimes. Our aim is for people living with the condition to receive the best possible treatment that best manages the symptoms that affect their quality of life.” Mr Maxwell said Parkinson’s UK is a highly influential patient focused organisation, committed to helping people with Parkinson’s live the best possible quality of life. He said he was confident that technologies such as the PKG would become a routine management tool throughout the United Kingdom.

Collaboration to Provide Parkinson’s mHealth Technology Throughout the UK

“We know this technology is highly effective at monitoring the key movement disorder symptoms of Parkinson’s, dyskinesia and bradykinesia,” he said.

Lead Parkinson’s research and support charity Parkinson’s UK have also recently announced that they will be enabling access to the Parkinson’s KinetiGraph (PKG), for up to 200 people living with Parkinson’s throughout the UK, as part of a 12-month pilot project.

“When clinicians have this information they can tailor medication regimes for optimal symptom management and ultimately enable improved quality of life. We look forward, in time, to making this important PKG technology available and accessible throughout the UK.”

As part of the pilot program, patients will wear the technology for 10 days prior to consultation with their specialists to allow information about their symptoms and their impact on daily life to be tracked.

For more information on the Parkinson’s KinetiGraph please go to www.globalkineticscorporation.com.au n

Technology Funds Look to Healthcare in Search of Next Windfall Venture capital firms and portfolio managers of large mutual funds are among those investing in companies that gather and analyse healthcare data, all in hopes of tapping into the shift to electronic record keeping and consumer acceptance of personal health tracking devices. Unlike biotechnology firms, which are often hit-or-miss based on the success of drugs under development, investors say these health technology firms tend to have a reliable path to profits by selling services and data to insurance companies, doctors and hospitals. Overall, venture capital funding for healthcare technology firms is up 176 percent so far this year, at $2.3 billion, versus the same period last year, according to Rock Health, a San Francisco–

based seed funding firm. Most of the funds have gone to companies focused on payment management and data analytics. In contrast, funding for biotechs, a sector whose rally this year has prompted the Federal Reserve to warn about a potential bubble, has increased just 28 percent over the year through June 30, compared with the same period in 2013. Andreessen Horowitz, Qualcomm Ventures and Google Ventures are among the venture capital firms that have invested in healthcare technology firms this year, according to Rock Health, Continued on page 16

The Journal of mHealth

Industry News Continued from page 15

while Intel Corp, General Electric Co and Medtronic Inc have all acquired digital health companies. Mutual funds are moving in the same direction. Among all growth funds, healthcare investments have increased 14 percent over the last three years, to make up 16 percent of portfolios, according to Lipper, a Thomson Reuters company. The average actively managed technology mutual fund has doubled the portion of its portfolio in healthcare companies over the last three years. Fund managers are finding health technology a reason to like even industry leaders such as Apple Inc. Over the last year, Apple has hired several senior medical technology executives who focus on sensor technology that can monitor health, ranging from blood-sugar levels to sleep quality. “The line between what is healthcare and what is technology has become blurred,” said Robert Stimpson, the lead portfolio manager of the Black Oak Emerging Technology fund.

companies because he expects growth in U.S. healthcare spending. He recently bet on drug distributor McKesson Corp largely because of its division that provides IT services to hospitals and physician offices, and has higher profit margins than those of the entire company, he said. Other well-known technology funds are taking large bets on healthcare. The $3.7 billion Waddell and Reed Science and Technology A Fund and the $5.6 billion Ivy Science and Technology fund each have about 14 percent of their portfolios in healthcare funds. Zachary Shafran, the lead portfolio manager of both funds, holds companies such as health insurer UnitedHealth Group Inc, device maker Boston Scientific Corp and generic drug maker Teva Pharmaceuticals Ltd. “Medical technology, biotechnology, medical records and pharmaceuticals are among the greatest innovators and early adopters of new science and technology, so we are paying particularly close attention to companies in those areas,” Shafran wrote in a recent note to investors.

Healthcare technology can be just as risky as other areas in the rapidly changing tech sector. Yet fund investors say that aging populations in the United States and Europe, along with the transition to digital health records mandated by the U.S. Affordable Care Act, should provide a growth catalyst for the industry.

Kevin Spain, a general partner at Emergence Capital Partners, said he has invested about $40 million in health tech startups, including Augmedix, which is developing applications that would allow a doctor wearing Google Glass to access a patient’s health records on demand. He expects more startups to focus on health technology in the future, largely because of the potential to disrupt established companies.

Skip Aylesworth, manager of the Hennessy Technology fund, now devotes a quarter of his portfolio to health technology

Reproduced from an original article by Reuters.com n

Webcam Used to Detect Abnormal Heart Rhythm With a regular laptop camera and sophisticated software, researchers may be able to detect atrial fibrillation about as accurately as with a standard electrocardiogram (ECG), according to a new pilot study. The technology records and analyses video footage of a person’s face and detects subtle shifts in skin colour that indicate changes in blood flow. “Existing ECG-based technologies are used only for patients who had symptoms,” comments Jean-Phillipe Couderc of the University of Rochester Medical Center in New York, who led the study. “But there are approximately 3.2 million people with Atrial Fibrillation (AF) in the U.S., and an estimated 30 million people in the world,” and currently there’s no way to diagnose the condition without consulting a doctor.

October 2014

In AF, the upper and lower chambers of the heart beat out of sync with each other. Although that can cause symptoms like heart palpitations or dizziness,

often the condition has no obvious outward signs. An estimated 30 percent of people with

Industry News AF do not know they have it, according to past research. The long-term implications are serious, as AF is progressive and can lead to stroke or heart failure. Couderc said the video-based system, developed with colleagues at Xerox Research Center in Webster, New York, is the first diagnostic tool to measure the electrical activity of the heart without physical contact with skin. He envisions the face scan being used one day to diagnose patients without symptoms and monitor their progress as they receive treatment. For the pilot study, Couderc and his team enrolled 11 patients with diagnosed atrial fibrillation who were scheduled to undergo an ECG at the university’s hospital. The researchers set up a standard web camera to capture video of the person’s face in 15-second increments at the same time as the ECG was being performed.

The scan focuses on the face because its skin is particularly thin, making blood running through the veins more easily visible. In particular, the program looks for the colour of the blood as it reflects or absorbs green light. The experiment demonstrated that the observed colour changes corresponded with the subject’s heart rate, the study team reports in the journal Heart Rhythm. The scan correctly identified the presence or absence of atrial fibrillation 80 percent of the time, with an error rate of 20 percent. That was similar to the automated ECG measurements, which were wrong between 17 percent and 29 percent of the time. This new technology could one day be used by anyone with a tablet or laptop, Couderc said, though he cautioned that the small study is only a proof of concept and “we need to evaluate the technology in a large prospective clinical trial,” to test how accurately it works and

how easy it is to use. Dr. Steven Swiryn of Northwestern University in Chicago, who studies atrial fibrillation, agreed that the small study is “quite preliminary, and though interesting, has a number of major limitations.” One, is that patients need to be absolutely still for the scan, an issue that excluded one participant in the study. Another participant was excluded because she was wearing makeup, which obstructed the camera’s ability to see blood flow. Finally, Swiryn noted, the study only included Caucasians and the technology needs to be tested on people of colour as well. However, Swiryn added, if the new technique’s methods were refined and applied to a larger and more diverse group, it would be worth pursuing with more research and “might prove a useful and inexpensive screening method.” Source: Reuters Health n

Two Apple Medical Trials Shed Light on how HealthKit will Work Two prominent U.S. hospitals are preparing to launch trials with diabetics and chronic disease patients using Apple Inc’s HealthKit, offering a glimpse of how the iPhone maker’s ambitious take on healthcare will work in practice. HealthKit is the centre of a new healthcare system by Apple. Regulated medical devices, such as glucose monitors with accompanying iPhone apps, can send information to HealthKit. With a patient’s consent, Apple’s service gathers data from various health apps so that it can be viewed by doctors in one place. Stanford University Hospital doctors said they are working with Apple to let physicians track blood sugar levels for children with diabetes. Duke University is developing a pilot to track blood pressure, weight and other measurements for patients with cancer or heart disease. The goal is to improve the accuracy and speed of reporting data, which often is done by phone and fax now. Potentially doctors would be able to warn patients of an impending problem. The pilot programs will be rolled out in the coming weeks. Apple aims eventually to work with health care providers across the United States, including hospitals which are experimenting with using technology to improve preventative care to lower

healthcare cost and make patients healthier. Stanford Children’s Chief Medical Information Officer Christopher Longhurst said that in the first Stanford trial, young patients with Type 1 diabetes will be sent home with an iPod touch to monitor blood sugar levels between doctor’s visits. HealthKit makes a critical link between measuring devices, including those used at home by patients, and medical information services relied on by doctors, such as Epic Systems Corp, a partner already announced by Apple. Medical device makers are taking part in the Stanford and Duke trials. DexCom Inc, which makes blood sugar monitoring equipment, is in talks with Apple, Stanford, and the U.S. Food and Drug Administration about integrating with HealthKit, said company Chief Technical Officer Jorge Valdes. DexCom’s device measures glucose levels through a tiny sensor inserted under the skin of the abdomen. That data is transmitted every five minutes to a hand-held receiver, which works Continued on page 18

The Journal of mHealth

Industry News with a blood glucose meter. The glucose measuring system then sends the information to DexCom’s mobile app, on an iPhone, for instance.

sentatives said they are building integrations with HealthKit and working with Apple. As mentioned previously Apple already has a partnership with rival electronic health record company Epic Systems.

Under the new system, HealthKit can scoop up the data from DexCom, as well as other app and device makers. Data can be uploaded from HealthKit into Epic’s “MyChart” application, where it can be viewed by clinicians in Epic’s electronic health record.

The goal is to help doctors monitor patients with chronic conditions from home and identify health risks. HealthKit gathers data from various applications and devices, including blood pressure cuffs, accelerometers and glucose measurement systems, and makes it easier for doctors to view it all in one place.

Privacy Matters

Across the United States, hospitals are rolling out pilots using HealthKit to improve preventative care, and potentially cut costs.

Continued from page 17

While HealthKit promises to enhance the process of data-sharing between physicians and those under their care, observers have noted the potential for sensitive data to be abused. Others are wary of having all their private information stored in one location, susceptible to hackers for instance. To ensure patient privacy, Apple is considering creating a “HealthKit Certification” for third party developers, with conditions stipulating how data must be stored securely on devices and forbidding sale of data to advertisers, according to people familiar with Apple’s plans. Apple recently updated its developer guidelines with data sharing rules for health apps.

Cerner, Epic and Athenahealth are central to these plans, as the patient-generated data is ultimately stored in the electronic health record. Both Athenahealth and Cerner have developed mobile applications targeted at patients. HealthKit-compatible versions of these apps will be available on the App Store.

Stanford’s Longhurst said he expects the pilot to be expanded quickly if there are no problems.

Athenahealth vice president Abbe Don said the company will use HealthKit to help patients with chronic conditions like diabetes. Cerner senior director Brian Carter said care teams, including doctors and nurses, will be able to access data from HealthKit with patients’ consent.

Rajiv Kumar, the physician leading Stanford’s pilot and a pediatric endocrinologist at Stanford Children’s Health, said his team may soon be able to set up alerts, so they can notify patients via Epic MyChart when their blood sugar spikes or falls.

Carter said they will work closely with “focused smaller organisations” to prove the value of the service. He said the initial integration will focus on wellness and preventing the onset of chronic conditions.

Kumar said two young patients with diabetes have been chosen to participate in the initial trial and he hopes to extend the pilot to teens and infants.

Athenahealth’s Don said the company will test its “proof of concept” application with one client, Hudson Headwaters Health Network, a non-profit health centre based in New York. Don said medical device makers are also working on HealthKit integrations for use in early trials.

Duke University’s Ricky Bloomfield, an internal medicine pediatrician and director of mobile strategy, hopes the pilot will help doctors access the data they need to better monitor sick patients living at home. “This could eliminate the hassle of getting data from patients, who want to give it to us,” said Bloomfield. “HealthKit removes some of the error from patients’ manually entering their data.” The HealthKit Ecosystem In a sign of the growing ecosystem that is stemming from Apple’s Healthkit Cerner Corp and Athenahealth Inc, two leading U.S. electronic health record providers, have also announced that they are working with Apple Inc to develop applications that leverage Apple’s mobile health service HealthKit.

Cerner and Athenahealth repre-

October 2014

Source: Reuters Health n

Industry News

Remote Access to Medical Images Fuelling Demand for Digital Medical Imaging in the Cloud DICOM Grid, makers of the cloud-based platform for medical image management and exchange, have announced a $6 million inside funding round fuelled by the increased demand for image management and exchange strategy among top healthcare organisations. The investment will drive product development and open up additional strategic integration opportunities with the industry’s leading EHR and RIS providers. Dozens of healthcare organisations, in pursuit of a cloud-based platform that safely shares and stores information, now rely on DG Suite, DICOM Grid’s product line, for managing diagnostic imaging and related health data. DICOM Grid’s customers include Mayo Clinic, Rush University Medical Center, Greater Houston Healthconnect, Baptist Health South Florida, Memorial Hermann Health System, Frederick Memorial Hospital, and some of the world’s largest clinical trial research organisations. “Leading healthcare institutions in the U.S. are adopting our technology to improve the lives of patients,” said Morris Panner, CEO of DICOM Grid. “There is a huge demand for an easy workflow that moves imaging data between locations and across disparate systems, all under HIPAA compliance. DG Suite eliminates traditional costs and hassles associated with moving data, which translates to a smoother experience for the patient.” Current estimates show that imaging has been one of the fastest growing components of medical costs, and constitutes between 7.5 and 10% of total healthcare expenditures. Even though costs of imaging amount to more than $100 billion per year, 10% of these exams—$10 billion worth—are duplicates or unnecessary. With DG Suite, healthcare organisations can break down financial and operational barriers by eliminating traditional hassles

associated with sharing, exchanging and storing diagnostic imaging. Greater Houston Healthconnect, one of the largest health information exchanges in the nation, serves 20 counties in Southeast Texas and is collaborating with DICOM Grid to create community-wide access to diagnostic imaging. “DICOM Grid’s technology is being made available to 15,000 physicians and 130 hospitals in the region, to deliver immediate access to imaging at the point of care, says Phil Beckett, PhD, Healthconnect’s Acting CEO and Chief Technology Officer. “Being able to electronically retrieve prior imaging will mean providers can make more informed treatment decisions and help to eliminate unnecessary duplication of tests, which are often not reimbursable. We believe this will save dollars and reduce radiation exposure for patients.” DICOM Grid manages over 1.2 billion images for users worldwide, who use its secure, HIPAA compliant imaging software to facilitate CD ingestion, image sharing, patient transfers, remote reads, and disaster recovery. n

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Industry News

mHealth Solution Provider Making Quality a Priority Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has announced that it has been approved to ISO9001:2008 by Lloyd’s Register Quality Assurance (LRQA), the world’s leading provider of independent assessment services.

Tim Davis, CEO and founder of Exco InTouch commented: “We are delighted to have received this important certification. The capability underlines our commitment to quality and our ability to provide best in class services for our customers whilst marking us out as a gold standard provider in our field”.

The certification has been awarded to the company in recognition of their quality management system built around processes of the highest standards and which meets or exceeds its customers’ requirements, whilst maximising continual improvement.

Mark Wright, Head of Quality Assurance at Exco InTouch commented; “Quality of service is a key driver for us at Exco InTouch and we are very pleased to have been approved to ISO9001:2008 in recognition of the very high standard of products and services that we provide in mobile and digital technology data capture and patient engagement solutions. We are achieving ever increasing customer service levels to meet the needs of our clients head on and we are proud to have been formally recognised in this regard.”

The ISO9001:2008 certification is designed to underwrite the quality of service delivery processes, making the company the only electronic Clinical Outcomes Assessment (eCOA) provider to comply with ISO9001:2008 as well as the data privacy and security standards: Safe Harbor, EU Data Protection and HIPAA, which are essential when using a BYOD (Bring Your Own Device) approach in clinical and healthcare settings.

Quality assurance and standardisation in the mobile and digital health sectors are key considerations and the need for solution providers to demonstrate their adoption of these principles is becoming critical to the delivery of successful

deployments. In another recent announcement Exco InTouch also highlighted the fact that their solution is now the only electronic Clinical Outcomes Assessment (eCOA) provider to have had publicfacing apps published on all three of the major mobile operating platforms (iOS, Android and Windows8). Dale Jessop, CTO at Exco InTouch comments on the importance of native apps over other commonly used standards: “We’re thrilled to have reached this milestone, and even more so having used native apps, as this provides the user with device specific natural controls - driving familiarity and ease of use. Currently the most common approach is to use HTML5, which wraps a web app into mobile operating controls, however, this does not enable the layout to be optimised for the device in use, or incorporate natural button configurations and so does not present the best experience for patients.” For more information please visit: www.excointouch.com n

Graphene Turns Rubber Bands into Stretchable Body Sensors Researchers have found a way to turn rubber bands into cheap, flexible body monitoring sensors by infusing them with graphene. A team from Surrey University in the UK and Trinity College Dublin said their method could be used to create low-cost strain sensors that work by measuring the changing flow of electricity through them as they move and stretch. This could allow them to accurately monitor bodily movements, breathing and heart rate, either as a stand-alone device or by being woven into

October 2014

clothes. They could even be used to measure changes in buildings, particular where rubber is already used as a construction material, for example in some bridge cables. ‘You can easily produce similar types of devices but the advantage of this system is it’s extraordinarily easy to make,’ said Dr Alan Dalton, who led the Surrey team. ‘We’re using shop-bought rubber bands and such a small amount of graphene that the cost is in pennies, but it performs as well as any commercial sensor.’

Industry News The researchers created the sensors by infusing conventional rubber bands with molecules of graphene (the single atomic layer form of carbon), enabling them to conduct electricity. When the bands are stretched, the conductive pathways between the infused graphene molecules change, reducing the flow of electricity. Measuring this change can be used to work out how much the band has stretched and, if the band is worn on the body, this can indicate how the user is moving in real-time. ’We can stretch it to 800 per cent of its original length and still see measurable and quantifiable changes in conductivity,’ said Dalton. ‘Because the response is so good we can do it very quickly, we can see how fast we’re straining it, so for applications such as measuring pulse or breathing it can give you a very accurate measurement.’

Graphene exhibits exceptional strength and provides an electromechanical response to movement when deformed. The researchers used these properties to convert a cheap but highly elastic material, a rubber band, into a high performance strain sensor, called the G-band. Strain sensors have existed and been used for physiological measurement for decades. However, the G-band strain sensor is unique in that it is the most extensible strain sensor ever demonstrated. This property facilitates the monitoring of dynamic strain, which is key to the rubber bands’ use as alternative velocity or acceleration sensors. The G-band sensors also performed well at frequencies of 160Hz which is more than sufficient for common body sensing applications. To create the sensors, the researchers used a process developed by Prof Jonathan Coleman from Trinity College in which a solvent dissolves a sample of

graphite into single-layer molecules of graphene. The rubber is then swollen with toluene to create pores between its polymer threads. Another solvent made from water and NMP (N-methyl-pyrrolidone) was then used to disperse the graphene molecules into the pores – thereby solving the problem that rubber molecules naturally dislike being mixed with carbon. The researchers are now looking for a way to scale up the process in order to be able to manufacture large amounts of graphene-infused rubber. Since its creation in a University of Manchester lab in 2004, graphene has rapidly found applications in the fields of medical sensing, imaging, and a variety of other non-medical fields due to its versatility and unique structural and electrical characteristics. n

Defibrillator Garment Detects and Corrects Abnormal Heartbeat Johns Hopkins biomedical engineering students have designed a lightweight, easy-to-conceal shirt-like garment to deliver lifesaving shocks to patients experiencing serious heart problems. The students say their design improves upon a wearable defibrillator system that is already in use and should help persuade patients at risk for sudden cardiac arrest to wear the system around the clock. “In two studies, up to 20 percent of patients who received the defibrillator garment that’s already available did not keep it on all the time because of comfort and appearance issues, problems sleeping in it, and frequent ‘maintenance alarms,’ which occur when the device does not get a good signal from sensors on the patient’s skin,” says Sandya Subramanian, who led the undergraduate team that built the new prototype. “We set out to address these issues and design a device that heart patients would be more likely to wear for longer periods of time— because their lives may depend on it.” Wearable defibrillators, which rest against the skin, are designed to detect arrhythmia, an irregular heart rhythm that can cause death in minutes if it is not stopped by controlled jolts of electricity. People who face this higher risk of sudden cardiac arrest include patients who have undergone open-heart surgery and those who have recently survived a heart attack. The long-term treatment for these patients is to surgically implant a small defibrillator, similar to a pacemaker, in the chest. The operation, the students say, costs roughly $150,000 and

generally takes three months of testing and insurance review before being approved. During this waiting period, insurance providers usually pay for the rental of an external defibrillator garment to protect the patient. More than 100,000 devices have been prescribed in the United States in the past eight years or so that it has been available. The students’ defibrillator prototype emerged from the undergraduate design team program offered by the Department of Biomedical Engineering, which is shared by the university’s schools of Medicine and Engineering. Continued on page 22

The Journal of mHealth

Industry News

Lightweight Sensor Measures Heart Rate and Body Movement The Holst Centre and Imec have unveiled a prototype flexible health-monitoring patch that at 10g is claimed to be half the weight of other products currently available.

link provides a standardised communication channel to mobile devices, including smart phones and tablets. Researchers from Imec used Shinko’s SiP technology to integrate this function into a module measuring 17.4mm x 17.4mm, which represents a PCB area reduction of 52 percent compared to previous generations of the module.

In use, the patch employs tissue-contact impedance, a real-time electrocardiogram (ECG), and an accelerometer to monitor physical activity. The electronics module measures less than two by two centimetres, thanks to advanced system in package (SiP) technology from Japan’s Shinko Electric Industries. It is further claimed that high accuracy algorithms, low power consumption, and small size and weight make the patch suited to consumer applications. A number of activity monitors exist that can count the number of steps a person takes, or calories they’ve burned. Heart rate is a key input in determining activity levels, so monitors that can be worn comfortably on the chest offer the greatest accuracy. This, in turn, increases the demand for small, lightweight monitors that can flex and move with a person’s body.

Imec and Holst Centre claim their patch makes such applications possible because it combines ultra-low power electronics and flexible electrode technology to provide the end user with a 1-lead ECG, a tissue-contact impedance sensor and a 3D accelerometer. Data is processed and analysed locally, and relevant information is transmitted via Bluetooth Smart (BLS). According to Imec, the patch acquires, processes and communicates data with minimal energy, allowing extended use with smaller batteries. Moreover, the Bluetooth Smart

Continued from page 21

The team’s assignment—to develop a system that would lead to greater compliance among patients—was sponsored and mentored by Todd J. Cohen, who earned his undergraduate and medical degrees at Johns Hopkins and is now director of electrophysiology at Winthrop University Hospital in Mineola, N.Y. “Our JHU design team students were able to survey electrophysiologists and their patients who wore the currently approved wearable cardioverter defibrillator,” Cohen says. “The students’ research confirmed my personal findings, namely that the current device has several components that could be improved. The students took this information and with my guidance designed a better mousetrap. The new device incorporates features that should improve patient compliance, ease of use, and overall functionality.” In particular, the students replaced the existing chest harness– style garment with a more comfortable vestlike design made of thin, breathable, and stretchable fabric that can be worn unobtrusively beneath clothing. Its electrical components, capable of delivering a 200-joule shock to stop a deadly arrhythmia, are encased in thin pockets on the sides. A bulky control box

October 2014

The module was then integrated into a flexible and stretchable patch designed by Eindhoven-based Holst Centre. The design is said to combine system in foil technology with stretchable, integrated electrodes to create a lightweight patch that can be worn comfortably on the chest for extended periods. The module’s small size and the flexibility of the patch reduce motion artefacts, thereby providing accurate and reliable monitoring. The patch was developed in the framework of Imec’s and Holst Centre’s Human++ program, which aims to address the need for better, more efficient healthcare monitoring systems. Imec and Holst Centre say they are now looking for partners interested in commerialising the concept. n

hanging from the patient’s waist was replaced with a smaller wireless system worn on the wrist. This controller gives the wearer a 30-second warning to stop an impending shock if the system has been activated by a false alarm. “We did not change any of the science involving how a wearable defibrillator works,” team member Melinda Chen says. “We just changed the form of the device. We pursued a ‘slip on and forget’ approach to minimise the user’s need to maintain and interact with the device.” The prototype has already garnered some attention. It recently won a $10,000 first prize in a competition sponsored by the North American Professionals and Entrepreneurs Council. Electrophysiologist Cohen, the team’s mentor, says that the prototype was also well-received recently by physicians, medical researchers, and device makers at the noncompetitive Stanford Biodesign Conference. At the annual Johns Hopkins Biomedical Engineering Design Day event, organised by the university’s Centre for Bioengineering Innovation and Design, the project won the Most Innovative Design honour and took first place in the People’s Choice Award contest. n

Industry News

Smart Glasses Offer Spatial Awareness to the Visually Impaired People with visual impairment could regain a level of spatial awareness with smart glasses developed at Oxford University. According to the University, the glasses don’t replace lost vision but assist with spatial awareness. Anyone using the glasses looks through them to make the most of their existing sight, with additional images appearing in their line of sight to give extra information about who or what is in front of them. In some cases, details such as facial features can become easier to see – making social interaction more natural. The glasses work particularly well in low-light and can be used to cope with night blindness. “The idea of the smart glasses is to give people with poor vision an aid that boosts their awareness of what’s around them – allowing greater freedom, independence and confidence to get about, and a much improved quality of life,” said Dr

Stephen Hicks of the Nuffield Department of Clinical Neurosciences at the University of Oxford, who is leading the development of the glasses. “We eventually want to have a product that will look like a regular pair of glasses and cost no more than a few hundred pounds - about the same as a smart phone.” Lyn Oliver, 70, of Faringdon, Oxfordshire was diagnosed with retinitis pigmentosa in her early 20s, an eye disease which gradually leads to loss of vision and blindness. “If Jess [Lyn’s guide dog] stops, the glasses can tell me if she’s stopped because there’s a kerb, there’s something on the floor or it’s roadworks, and it’ll give me a sense of which way she may go around the obstacle,” she said in a statement. Dr Hicks’ team has set up testing venues in Oxford and Cambridge where they can control the lighting and introduce obstacles to avoid. Participants are tracked as they navigate

through obstacle courses, with and without smart glasses. The study will involve 30 volunteers with poor vision. The group is also beginning to see how people respond with the glasses in indoor spaces like shopping centres. The Oxford University researchers carried out preliminary tests last year of an earlier prototype with 20 volunteers having a range of eye conditions and levels of vision. They found that people could quickly get used to the glasses, and it was the people with the lowest vision that really found benefits in using the glasses to

get around and avoid obstacles. There are roughly 100,000 people in the UK alone with this low level of vision and who could potentially benefit. The research and development of the glasses is funded by the National Institute for Health Research (NIHR). The trials are being carried out with the support of the Royal National Institute of Blind People (RNIB). The group has been awarded further funding from the Royal Society to look at introducing more features into the glasses, such as face, object or text recognition. n

Intel Edison Designed to Power the Internet of Health Things Intel is the latest global computing company to see the value in mobile and wearable health technologies. The company announced a number of health related initiatives at its developer conference in September.

wirelessly-enabled, general purpose compute environment, designed for developers and consumer product designers who create small or wearable devices to be sold through commercial channels to individuals.

the ability to shrink the size of microprocessors, including Intel Edison, which relies on very little power, has allowed Intel and the industry to rethink where – and in what situations – computing is possible and desirable.

Slightly Larger than a Postage Stamp, Intel Edison Powers Small and Worn Devices

The announcement was made by Intel CEO Brian Krzanich at the Intel Developer Forum. During a Mega Session led by Mike Bell, Vice-President of Intel’s New Devices Group, he described how

This new line of microprocessor highlights the growing demand for product ready wireless-enabled computing

The Intel Edison is a product-ready,

Continued on page 25

The Journal of mHealth

Industry News

Heart Energy May be Enough to Drive Pacemaker Following our Special Report on the methods of Powering Future Medical Devices in the last edition of The Journal of mHealth, Swiss researchers have recently announced a battery-less pacemaker, powered using energy from the heart and based on 200-year-old selfwinding wristwatch technology. In a feasibility study, Adrian Zurbuchen, MS, from the University of Bern in Switzerland, and colleagues demonstrated that their prototype device could harvest heart energy to power a pacemaker, using the same technology as an automatic wristwatch. Zurbuchen, who is a PhD candidate in cardiovascular engineering, presented his group’s findings at the European Society of Cardiology (ESC) meeting. Batteries are a limiting factor in medical implants, and once they reach a critically low-energy level, physicians may find themselves having to replace a correctly functioning medical device via a surgical intervention, Zurbuchen explained. This increases the risk of complications for the patient as well as the costs of the intervention, he added. In addition, “the battery in a pacemaker takes up about 50% of the size of the device,” Zurbuchen said. “The heart is a convenient energy source. The conversion of heart motion into electrical energy is feasible. The harvesting device provided enough energy to power a cardiac pacemaker.” A traditional clockwork wristwatch is automatically wound because the rotor inside is turned whenever the watch accelerates due to the movement of the wearer’s arm. This rotation progressively winds a mechanical spring that, once fully charged, unwinds again and spins an electrical micro-generator. To develop a pacemaker that operated in a similar way, the researchers copied the wristwatch mechanism, removing unnecessary parts to reduce weight and size and developing a custom-made housing with eyelets so it could be stitched

October 2014

directly onto the heart muscle tissue. “The heart seems to be a very promising energy source because its contractions are repetitive and present for 24-hours a day, 7 days a week,” said Zurbuchen. “Furthermore the automatic clockwork, invented in the year 1777, has a good reputation as a reliable technology to scavenge energy from motion.” The device first harvests energy from the heart, then stores the energy temporarily in the buffer capacity. The buffered energy is then taken up by the packer to apply very small stimuli to the heart. Zurbuchen and colleagues tested the device in vivo in a pig’s heart and achieved a battery-less overdrive-pacing at 130 beats per minute. The mean harvested power was 52 microwatts, the group reported. The next phase with this experimental device -- Zurbuchen said he does not have any industry relationships associated with the prototype -- will be to integrate the electronic circuit for energy storage and the custom-made pacemaker directly into the harvesting device, and eliminate the need for leads. In commenting on the work, ESC press conference co-moderator Ken Dickstein, MD, of the University of Bergen in Norway, pointed out that “the

device we saw today is not going to be implanted in patients. The devices that will eventually be implanted are going to be inserted through catheter-based systems, not through major surgeries.” Co-moderator Frank Ruschitzka, MD, head of the Heart Failure and Transplantation Clinic at the University Hospital in Zürich, stated that “the idea is that we can use the energy of the heart, which beats 100,000 times a day, and transform it into energy that can provide us a way to replace batteries in these heart devices ... if you can use the motion of the heart to replace the batteries, it would be a neat idea.” “We know that it is clinically relevant that these batteries wear out,” explained Athena Poppas, MD, head of echocardiography at Rhode Island Hospital in Providence. “Re-operations carry costs and the risk of infection, and it is not an easy procedure to do because of these factors. It is really exciting to use the concept of an [automatic] watch. The proof of concept is fantastic. It’s a long way from there to input, but the fact that someone is thinking about this is clinically important and very exciting.” *Please note that this study was published as an abstract and presented at a conference. The data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. n

Industry News Continued from page 23

modules, that is fuelling development in the Internet of Things (IoT) industry. Developers and innovators are seeking to connect growing numbers of devices, items, and products, in new, non-traditional, computing contexts. The Internet of Health Things (IoHT) is something that is also rapidly developing. Wearable monitors, health and activity trackers have been the first stage in this revolution, but we can expect to see a whole new range of different connected products, devices, and items across the spectrum of health related environments, in the not-so-distant future. The move by Intel to introduce the Edison reflects the recent success of other module based computing components, that have opened up a vast market for integrating wireless computing into situations that were previously unachievable. The module uses a 22-nm Intel® SoC that includes a dual-core,dual-threaded Intel® AtomTM CPU at 500 MHz and a

32-bit Intel®QuarkTM microcontroller at 100 MHz. It supports 40 GPIOs and includes 1GB LPDDR3, 4 GB EMMC, and dual-band Wi-Fi and BTLE on a module slighter larger than a postage stamp. The device will initially support development with Arduino and C/C++, followed by Node.JS*, Python*, RTOS and visual programming support in the near future. The announcement also includes details of a device-to-device and device-tocloud connective framework to enable cross-device communication and a cloud-based, multi-tenant, time-series analytics service. This is not the first offering from Intel in the IoHT and Wearable Health markets. The company has been working on a number of product and component lines that they hope will power this growing ecosystem of connected devices. At the event in California, the company also announced an update to their own wearable activity tracking smartwatch the Basis Peak which is the latest iteration

of the companies device following the acquisition of Basis earlier in the year. They also introduced their first SDK and API for wearable devices, which allows developers building fitness and wellness applications for iOS and Android to leverage Intel’s heart rate sensing technology embedded in future Intel-powered headphones, such as the recently announced SMS Audio BioSport In-Ear Headphones. n

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The Journal of mHealth

Patient Engagement in the Digital Era

Patient Engagement in the Digital Era By Dr Alexander Graham Dr Alex Graham is a medical doctor by background, having trained in London before entering the business world. He is currently a founding partner at AbedGraham, a research and strategy consultancy which assists global IT corporates to navigate the clinical, organisational and commercial complexities of the UK’s National Health Service (NHS). He is also medical director of EMEA for Imprivata. If you were to play healthcare buzzword bingo, the phrase ‘patient engagement’ would be right up there with ‘integrated care’ and ‘innovation’. For many years now, the belief has existed that involving patients more in their care from the symptoms and signs they exhibit through to the management plans they engage in will revolutionise the practice of healthcare, improving outcomes and cutting costs. In an increasingly digital world, technology, it is claimed, has the ability to expedite this process. But what is actually happening now and what needs to happen for this to truly work? One of the main issues surrounding patient engagement is that there is no clear consensus on what the concept actually entails. It has been applied to everything from telemedicine programs to medication adherence to the thousands of apps that catalogue disease, diet and exercise information. A huge issue here is that the majority of all these patient engagement solutions are often stand-alone solutions with no interoperability and no tie to existing healthcare infrastructure. Many have advocated a patient-centric model of healthcare in which patients produce data from a number of sources (online portals, remote monitoring and diagnostics for example) and this leads to a proactive healthcare response (from their healthcare providers and their staff) rather than a reactive one (in response to what may be delayed symptoms). The market is now abound with trackers and monitors such that patients can now record the majority of their vital signs and metrics relevant to their conditions 24 hours a day. I personally have issues with how this will manifest itself and pan out, and it’s not to do with the idea of technol-

October 2014

ogy being used to engage and motivate patients. I have no doubt that technology will eventually play a huge part in driving the treatment of, for example, chronic disease forward and reducing admissions to both primary and secondary care, thus relieving huge time and cost pressures. My issue is that if one stakeholder in healthcare (in this case patients) adopts technologies without the others being involved in any way, the maximum benefits the technology espouses will not be realised. This is because, like the vast majority of healthcare initiatives, the concept of patient engagement is change management in essence and if each of the stakeholders involved in that process are not appreciated, then the initiative will fail before it has started. Take for example, a general practitioner in the UK currently. The constraints he or she has to work under now are huge and they will be expected to see upwards of 30-40 patients daily with no more than 10 minutes for each one. In that 10 minutes, they will commonly have to take a history, perform an examination, establish a diagnosis, construct a management plan, discuss it with the patient and then document everything in that consultation, plus there is the potential for referrals and additional paperwork. Now if a patient came in with a personally tailored and specific set of data relevant to them (such as blood sugar levels in the last month for a diabetic) that would be invaluable for a clinician. But if a patient came in with 24 hour or weekly recordings of blood pressure, heart rate, ECGs and a dozen other metrics from disparate sources that couldn’t be integrated into the GP’s engine without any analytics then what is the GP going to do in that 10 minute window? The chance of even looking at that information is

minimal which opens up questions about relevance of data and even legal issues if things are missed from the huge amount of data that is generated. Because of this, three things stand out for me that must be present in any patient engagement strategy: Full stakeholder engagement As with any change program, anyone affected by the technology, product or service change must have their input into the initiative. If a particular stakeholder is left out or ignored, there will always be the potential for a single point of failure in the system. Interoperability and data sharing is key As one of the keys to patient engagement is data capture and sharing, there needs to be a systematic attempt to set up data transfer between patients’ devices and primary and secondary care infrastructure. Only then will the efficiencies and benefits be start to be realised in full. Working patient engagement into robust business plans Patient engagement programs have often concentrated on the benefits to the patient alone, which is admirable but ignores the scale of the benefits to both healthcare professionals and institutions as well. Working patient engagement concepts into workflow and financial plans will reduce a lot of the barriers to adoption and diffusion from all affected. As I mentioned, I have no doubt that patient engagement led by technology will change how healthcare is delivered in the future, and there are many issues and areas I haven’t touched on. But like any healthcare initiative, it must go beyond a single stakeholder and empower the system as a whole before we truly realise the benefits of patient engagement as a concept. n

Health Application Enables Citizen Superheroes

Health Application Enables Citizen Superheroes Imagine that you are in a restaurant having lunch with a few friends. You hear a siren in the distance and think to yourself, “I wonder where they are going?” The siren gets louder and closer, and then you actually see a fire engine approaching in the distance. Suddenly, surprisingly, the engine turns into the parking lot and parks right in front of the crowded restaurant where you’re eating. That’s when you learn that right next door, someone is unconscious after suffering a cardiac arrest. If you only knew, maybe you could have made a difference. This scenario could become a thing of the past as US based application PulsePoint begins to gain widespread adoption. PulsePoint Respond is a location-aware phone application that empowers everyday citizens to provide life-saving assistance to victims of Sudden Cardiac Arrest. Communities can now use the application to dispatch CPR-trained citizens to major cardiac emergencies where the potential need for bystander CPR is high. The free app connects to local 911 call centers and alerts users when there is someone nearby in need of CPR. PulsePoint users get an alert the same time as local emergency responders. Notifications are made simultaneously with the dispatch of paramedics to anyone within the area that is CPR-trained and has indicated their willingness and ability to assist during an SCA emergency. These notifications are only made if the victim is in a public place and only to potential rescuers that are in the immediate vicinity of the emergency. When notifications do occur they intend to target potential citizen rescuers that are primarily within walking distance of the event. At the time of need, users that have opted-in receive a push notification accompanied by a distinctive alert tone. The notification is followed by a map display showing the dispatched location of the emergency along with the precise location of the citizen rescuer – providing for easy navigation between the two. The map display also shows the exact location of the nearest AEDs (Automated External Defibrillator). In many cases across the United States, nearby AEDs have not been used when they may have made a big difference. The application aims to address this type of failure by informing citizen rescuers where the near-

est AED is located – in real-time and in context of their current location. Crowdsourcing has been used for everything from political campaigns to potato salad, but PulsePoint’s app represents the first time it has been used on a wide-scale to help save dying people in cardiac arrest. Victims have very little time – generally ten minutes or under – to receive CPR before they either lose brain functions or die. Cardiac arrest is a leading cause of death, killing more than 1,000 people a day in the United States. The system also aggregates information on community located AEDs using crowdsourced collaboration. Users of PulsePoint Respond and subscribing local emergency responders all get updated information about the AEDs available in their communities, and precise instructions on their location. The application has three primary components – the mobile application, a middle tier web service, and a dispatch system interface. The application is provided and maintained by the PulsePoint Foundation a non-profit foundation based in the San Francisco Bay Area. Deployments of the system have been introduced in collaboration with partner emergency agencies, which have allowed the project to grow rapidly in a short period of time. Development of the application began in June, 2009 as a partnership between the San Ramon Valley Fire Protection District (SRVFPD) and the College of Informatics at Northern Kentucky University (NKU). It now services 700 local communities in 20 states which have connected the technology to their 911 call centres, and around another 200 communities are in the process of adding the service. For more information visit: www. pulsepoint.org n

The Journal of mHealth

Patient Engagement

Delivering Effective Patient Engagement By Keith Nurcombe Keith Nurcombe has worked in healthcare for over twenty years spending the last few years working with businesses in the health and technology space, most recently building O2 Health where he was Managing Director until the end of 2012, since then he has been providing consultancy services to businesses. For me the secret of any successful health program is about how the patient engages with and immerses themselves in the solution that is being provided to them or possibly just being offered to them. Without engagement from the patient it doesn’t matter how high tech or low tech the solution is it will fail - the patient must see the benefits of engagement clearly and easily to take part and to truly get involved. For some time now the worlds of wellness and fitness has been out and about producing devices and integrating into our smart phones and our lives with all kinds of physical information about our ways of working, exercise, diet and even sleep patterns. This works well for a while, but most have struggled to get long term engagement with the patient as they seem to become ‘tired’ with the system and inputting or even viewing results. I think because the user starts to stop seeing the reason to engage with the system and the information it produces. So what’s going on out there in the digital healthcare world that is really engaging patients and also allowing healthcare professionals to engage with their patients differently and how can we make sure we

don’t go the way of the wellness and fitness market. In healthcare this is even harder, but there are some really interesting programs that are delivering healthcare in novel and interesting ways. Take some of the work that has been done with access to primary care in the UK with the new venture fund provided by the government. This was about driving patients and GPs to work together to provide better access, more timely appointments and for GPs to be able to provide a more holistic approach to patient care by using digital technology to engage patients. A number of these programs have started by offering Skype consultations, online or centralised appointment systems for patients and more recently care records for the patients that they can share with their carers, loved ones and their GPs. This has led to better delivery of care, which is also quicker, meaning more time for the GPs to spend with the patients that need that time. This is really simple stuff, done well, which proves to me that if we look at the fundamentals of the system and say “we can do that differently it doesn’t have to

be the same and it doesn’t have to use lots of expensive and hard to manage technology” it can work. These are not the only examples of where this is done well, there are lots of other ones but I think what is also interesting is where healthcare professionals are driving their patients to get engaged and use their healthcare systems differently to get the best output for both. Take uMotif and their Parkinson’s disease work - engaging with neurologists to help get their patients to communicate with them so that they can help to manage the day to day life of living with a very difficult to manage condition. This to me shows how industry and developers can work with a specific condition, really identify how they can help, and then work with patients, patient charities and support groups and importantly healthcare professionals to deliver a world class healthcare solution fit for the digital age. These types of simple but effective solutions give me hope that the digital healthcare age is upon us and really delivering improvements in patient care and most importantly is engaging patients to take part in managing their condition for the better. n

EXECUTIVE HEALTHCARE CONSULTING Nurcombe Consulting delivers interim senior management support, strategic business analysis, change management as well as development of plans and capability for entry into the healthcare market in the UK and globally. Experience at end to end business reviews and then implementing required changes to deliver strategic goals and change of direction for businesses. Management support at senior level within organisations to deliver change as well as day to day management of the running of the business. Support in delivering new business opportunities into new markets in the healthcare space with considerable experience in: • • • • • • •

Pharmaceuticals OTC and Consumer brands Healthcare delivery to patients in their home Tele-health and tele-care provision Provision of staff and care for patients in their home and also in NHS and private care settings Development of private healthcare opportunities working with the NHS and other state providers Digital Health and the use and deployment of technology to support patient and health outcomes With over twenty years experience in healthcare locally, regionally and globally this consultancy has the experience to deliver value to your business. For more information please visit www.nurcombeconsulting.com or email nurcombeconsulting@gmail.com

October 2014

Conference News Wearable Technology UX: New Event is Dedicated to the User Experience

Creating a compelling user experience for digital and mobile health applications and devices requires a subtle blend of intuitive design and innovative technology in order to succeed. The many considerations that impact this relationship were the basis for the recent Wearable Technology UX event held in London. This new event organised by Apex Smithers and hosted at the renowned Central Saint Martins College of Art and Design in London, offered a unique programme of speakers assembled around the concepts of Wearable Technology and the factors that are driving the design of user experiences in this growing market. Presentations were made across a broad range of relevant topics to encompass, the evolution of wearables; moving from a technology focus â&#x20AC;&#x201C; and the risks of using technology as the starting point for new designs; privacy considerations; and, behavioural economics. Represented in the programme were speakers from companies including: Google, Flextronic, Biobeats, Virgin Innovation, and Microsoft Research.

Although the event was not unique

October 2014

to healthcare, the presentations and discussions delivered did provide useful insights into the many elements required to deliver superior user experiences. Topics discussed included: sensory perspectives; the combination of form and function; and, the economics of human behaviour.

James Deakin, Technology Director at Fjord London presented on the new types of interactions that we as humans are beginning to experience as a result of using these technologies. Focussing particularly on the relationship we develop with wearable technology and the novel connections that this technology presents, he presented an interesting narrative as to the way in which these interactions are already evolving as technologies become more discrete, intuitive, and embedded.

The conference approached the themes from an intriguing range of perspectives, which was reflected in the eclectic mix of speakers.

Other speakers included: Hong Z. Tan, Senior Researcher & Research Manager at HCI Group, and Microsoft Research Asia who discussed the role of haptics and the sensory possibilities of touch to communicate information to and from devices; and, Morten Just, User Experience designer for Android Wear, Google who provided an insightful presentation on the lessons learnt from developing a user experience for Google Glass and how the longer term aim for the technology will be to take base sensory experiences of the world and deliver it in a better, more livable way. So that we donâ&#x20AC;&#x2122;t have to fight with the user interface, we simply forget that they are there and become aware of them only in their absence i.e. they just work.

Included in the line-up was Adam Montandon Associate Professor of Innovation at E.A.L Denmark who described his rather radical work with augmenting the human experience. Adam presented his experiences of developing Eyeborg, a project based around body modification apparatus designed to allow people to perceive colour through sound waves. It works with a head-mounted antenna that senses the colours directly in front of a person, and converts them in real-time into sound waves through bone conduction. The project which has been running for nearly 10-years made an interesting demonstration as to the ability to change an individualâ&#x20AC;&#x2122;s perspective on reality through the integration and use of technology.

The Journal of mHealth was pleased to be a supporting partner of the Wearable Technology UX Conference 2014. For more information visit www.wearabletechnologyux.com n

Conference News

HealthXL: Driving Innovation through Collaboration Launched earlier this year HealthXL is a collaboration between eleven of the largest healthcare corporations in the world. Designed to link leading innovators developing digital and mobile health solutions and healthcare companies seeking to develop meaningful commercial projects, the central goal is to connect prominent brands with cutting edge technology providers in order to help drive global innovation and adoption of mHealth. A mixture of strategic network, accelerator and development programme, the collaboration is an interesting approach to the healthcare technology paradigm. Established to encourage strategic alignment between industry partners, the HealthXL programme aims to develop projects that can provide solutions to some of the big digital issues and opportunities facing modern healthcare delivery. Using insight from the eleven partners Bupa, Cleveland Clinic, GSK, IBM, ICON, ResMed, Janssen Healthcare Innovation, Linde Healthcare, Novartis, Partners HealthCare and Silicon Valley Bank, the HealthXL team determined common technological issues that all of these organisations are seeking to address. The results led to the establishment of a series of major aims for the project which have been categorised as:

“Moonshots”. These “Moonshots” include: »» To improve life expectancy and quality of life through big data. »» To be able to monitor the health of every patient from birth to death: anytime, in any location. »» To have millions of hearts beating younger, stronger and longer through increased patient engagement. The wider programme aims to find innovators in digital health that can collaborate to work with the HealthXL partners to implement technology projects that have the potential to achieve these “Moonshots”. The process is designed to help create business partnerships and facilitate relationships that will lead to the rapid adoption of new technologies, as well as bringing together innovative digital health entrepreneurs with strategic industry partners. The HealthXL programme originally assessed some 300 different digital and mobile health companies from around the world, before reducing this number to just 150 companies who were then invited to submit project proposals. Using an online platform the partners

were then able to vote for the projects that they felt offered a particular strategic fit. Finally, this shortlist of 40 companies was screened to produce a final group of 21 technology developers.

The Silicon Valley Gathering 2014 A cornerstone of the HealthXL programme has been the organisation of a series of unique events designed to bring together partners, to hear presentations and speeches from a wide variety of health technology innovators. These events also operate as strategic networking opportunities to provide participants with the chance to forge partnerships, and to collaborate on exploratory projects that will introduce and adopt potentially ‘game-changing’ mobile and digital health technologies into healthcare delivery. At the September gathering CEOs from the group of 21 companies were invited to meet with senior executives from the eleven strategic partners to select projects that they were interested in developing in tandem. Among those companies invited to attend and present were 4D Healthware, AccelDX, Alivecor, Apervita, ApolloDX, Bjond Health, Cellscope, Evinance, Excointouch, Gepetto Avatars, Ginger.io, Glooko, Health Beacon,Healthloop, Lark, Lindacare, Luminacare, Medisafe, Patients Like Me, Welldoc, and, Zephyr Health. Tim Davies CEO, and founder, of Exco InTouch commented on the opportunity, “We are delighted to have the opportunity to present our experience and expertise as a company at the forefront of mHealth innovation. Indeed, we look forward to discussing the full impact that mHealth services, uniquely tailored to the primary issues Continued on page 32

The Journal of mHealth

Conference News Continued from page 31

and challenges facing patient populations, can offer to address the rising cost burden of chronic health conditions.” He continued: “We are always keen to forge ever stronger links with leading companies in the healthcare sector, to further expand the use and benefits

of our innovative mHealth solutions throughout the healthcare market.” In comments to The Journal of mHealth Tom Parsons, co-founder of HealthXL commented, “We were delighted to have a very broad group of individuals involved. These are really the individuals who are driving digital health inno-

vation, and we want to connect them with other [industry] leaders who see the opportunity to partner in new ways, to help address the major healthcare opportunities we all face. This will, however, require new ways of sharing and collaborating that we are just starting to understand. In addition we need to create a sense of urgency if we stand a chance of driving meaningful innovation in healthcare.”

Next Steps One of the founding concepts of HealthXL is to increase the speed with which technology is adopted by creating commercial opportunities that can bring projects to market rapidly. A regular series of gatherings that bring together programme participants is one of the major methods of ensuring that projects stay on track. The next of these gatherings will be held in Cleveland on the 28th of October to coincide with the Medical Innovation Summit. At this event progress from the partnerships developed at the Silicon Valley Gathering will be reviewed. For more information on the HealthXL programme visit www.healthxl.co n

Digital Health Days 2014: A Glimpse into the Future Patient-centric care. Patient empowerment. Consumer-driven digital health. Personalised medicine. We’ve heard the words. But what do they really mean for individuals and society and for healthcare professionals and organisations in life science, wellness and ICT? These were just some of the questions debated at this year’s Digital Health Days event in Stockholm. The two day event was packed with knowledge and insights into the rapidly developing world of digital health, and how it is beginning to transform people’s everyday lives. Rethinking healthcare with the patient in focus, both as an active participant and contributor, was one of the main themes. It opened up with a fantastic example from none other than the legendary E-patient Dave. Also in the spotlight was the theme of data mining and the many opportunities that it presents, and how it is not what you know, but what you do with that knowledge that really matters. Ethical questions of ownership and privacy were discussed and cases of successfully transforming health with data were shared, including some amazing examples from South Asia and Sub-Saharan Africa, which pose

October 2014

the question; will the developing world take the lead in digital health? Health Hack Academy is connected to the conference Digital Health Days, and the winners were announced on the second day of the conference. This year’s winner was Experentia a team focused on the challenge of “Life-long living”, and the enormous potential that elderly people comprise. The concept behind Experentia is a

Conference News portal where elderly people are connected with people who may need their help. The idea is that retired people shall be able to find both activities and shorter consultancy assignments – sort of a mix between a social forum and a job centre. The team will now continue the development of Experentia during a pre-incubator program at STING (Stockholm Innovation and Growth), and hope to see the concept mature from idea to reality. Health Hack Academy is a collaborative think tank for corpo-

rations, entrepreneurs, developers, researchers, designers, students, patients, health care professionals, caregivers and others who are looking to transform the future of health care. HHA’s goal is to support and accelerate the creation of digital health start-ups. The conference attracted over 500 delegates from all over the world bringing together representatives from life sciences, ICT, and healthcare to meet, explore and shape the future of digital health. n

International Digital Health and Care Congress This three-day event brought together researchers, policy makers, practitioners and innovators to explore how the innovative use of technology is supporting improvements in the care of people with long-term conditions and other health and social care needs. This was the fourth annual congress and attracted more than 500 international delegates who came to hear about the design and application of new technologies; to share experiences; and to showcase new ideas, new research and new innovations in digital health, mobile health, telehealth and telecare. The Congress considered topics including: Sustaining independence as people age; preventing and managing chronic illness effectively; supporting people with mental health issues; digitally enabling service transformation; and, innovations in technology. Among the speakers were Dr Ali Parsa, Founder and CEO of Babylon who outlined how babylon’s new app is changing the way people access health care services. He explained how the app lets you book virtual GP consultations with professional clinicians; monitor symptoms and receive prescriptions; and what apps like this mean for the future of health care delivery.

Dr Kathleen Frisbee Co-Director of Connected Health, for The United States Department of Veterans Affairs, spoke about the work that the organisation has done in assessing the impact of mobile health apps and predicting mobile health app use, and how they are successfully implementing digital technology within their wider service provision. On a similar topic, Paul Rice the Head of Technology Strategy for NHS England also discussed how the NHS is embracing technology, by drawing upon projects that are already underway including, the Open Source Programme which is delivering digital solutions, such as Electronic Health Records, to the care community, and the Integrated Digital Care Fund, which is supporting the effective delivery of digital health projects. The conference was closed by Ray Hammond a renowned futurologist and author of ‘The World in 2030’. His inspirational presentation took delegates on a journey into the future of healthcare, where he considered the impact that technology will have as we go forward. The Journal of mHealth was pleased to be a supporting partner of the International Digital Health and Care Congress. For more information visit www.kingsfund.org.uk. n

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 at journalofmhealth@simedics.org.

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Journal of mHealth The Global Voice of mHealth

The Journal of mHealth

The Evolving US mHealth Regulatory Landscape

The Evolving US mHealth Regulatory Landscape By Bradley Merrill Thompson, Kim Tyrrell-Knott and Matthew Driver The explosion of mobile apps and digital health technologies has left regulators struggling to provide timely and adequate guidance to industry participants. In the United States, some have proposed legislation to limit the FDA’s regulation of health IT. At the same time, the FDA has taken a number of steps that signal an intention to take a risk-based, even de-regulatory, approach to Healthcare. In this, the second-part of our series of articles written in collaboration with the mHealth Regulatory Coalition we consider some of the major developments to the mHealth regulatory landscape in the USA, from the last year. Final MMA Guidance In the Final MMA Guidance, the FDA divided apps into three categories, and set out how they intend to regulate applications falling into each class: 1. Higher risk apps that involve medical device function will continue to be regulated by the FDA. ‘Medical device function’ involves apps that are intended to be used for diagnosis, cure, mitigation, treatment or prevention of disease or condition. This would include, for example, apps that analyse an EKG to identify irregularities or perform a urinalysis to evaluate hyperglycemia. 2. Apps that are used in the healthcare setting but do not meet the definition of a medical device. Applications in this category will not be regulated by the FDA. 3. Apps that may meet the definition of medical device but are so low risk that the FDA has decided to exercise enforcement discretion. Enforcement discretion means the FDA will not require companies that develop these apps to comply with FDA regulations. The FDA does, however, strongly recommend they follow the FDA quality system requirements. Apps in this category include those

October 2014

that trend and track health information, simple reminder tools that help patients manage their health in their day to day environment or allow patients to document and communicate with the healthcare providers about potential conditions. Enforcement discretion is not necessarily permanent. It is subject to change if, for example, there are adverse events or safety issues with a particular app. Overall, the Final MMA Guidance was deregulatory in nature and reflected the FDA’s intention to focus its regulatory oversight on higher risk apps. FDASIA Report In July 2012, Congress directed the FDA in collaboration with the Federal Communication Commission (FCC) and the Office of the National Coordinator of Health IT (ONC) (collectively referred to as “Agencies”[1]) to develop a comprehensive and risk-based strategy for the oversight of all health IT, including mobile apps. In April 2014, the Agencies released a report proposing 3 categories of health IT subject to the following levels of oversight: »» Administrative IT that will not be subject to regulation or oversight. »» Health management health IT that will be primarily overseen by ONC. This oversight will include creating voluntary standards, certification and other tools in partnership with the private sector. It also includes establishing a Health IT Safety Center. The report made clear that the FDA will not regulate products that fall within this category even if they meet the medical device definition. »» Medical device function will continue to be subject to FDA regulation. The report also discussed clinical decision support (CDS) software. It proposed that most CDS would fall within the middle category. However, higher

risk CDS (e.g. computer aided diagnostic or radiation treatment planning software) would be subject to continued regulation by FDA. The question of if and how the FDA should regulate CDS depends on a range of factors, including issues of risk and whether the user is substantially dependent on the software or output. The regulation of CDS requires additional discussion and a more detailed framework addressing the unique characteristics of CDS. The Agencies specifically requested feedback on the regulation of CDS software and FDA is expected to release draft guidance on CDS in the near future. Many commented, including the mHealth Regulatory Coalition (MRC), that the definition of health management health IT versus medical device needs to be more clearly articulated. The framework also needs to take a more nuanced approach to considering the risks in determining whether a specific function is regulated or not. Dividing all health IT into 3 categories does not fully take into account the complexity of many health IT systems today. It will be critical for the Agencies to address these comments in the final report and the CDS guidance. MMDS Draft Guidance In June 2014, the FDA released a draft guidance proposing that medical device data systems (MDDS), and medical image storage and communication devices be subject to enforcement discretion. MDDS are those devices that transmit, store, display and convert in a limited manner medical device data. FDA just created the MDDS classification in 2011. It is significant that FDA is proposing to deregulate MDDS for 2 reasons. First, many mhealth apps are considered MDDS today. Under the draft guidance, those apps would now be subject to enforcement discretion. Second, the fact that the FDA is revisiting MDDS, after only 3 years, reflects a progression in FDA’s approach to low

The Evolving US mHealth Regulatory Landscape risk products. If finalised, these changes will have significant impact on mhealth developers. 510(k) Exempt Devices Draft Guidance On August 1, 2014, the FDA issued other draft guidance exempting certain devices from pre-marketing notification requirements, commonly referred to as a 510(K). There are a number of products that fall into the mHealth category. For example, thermometers, stetho-

claims. Today, we have a better understanding of how lifestyle decisions can impact our health and certain disease and conditions. We also have access to a lot more information about health status through the use of wearable devices and mobile technologies. This is empowering individuals to more proactively manage their health. But it is also blurring the line between those regulated products that are intended to diagnosis and manage diseases and conditions and those intended to help manage health and wellness.

The regulatory framework for the mHealth market and broader health IT industry is dynamic and continues to evolve....Many mHealth and health IT products are part of complex, interconnected systems which require a refined regulatory approach. scopes, talking first-aid kits, hearing aids, and exercise equipment were included. The FDA indicated that the proposed devices were sufficiently well understood and did not pose risks that require 510(k) review to assure their safety and effectiveness. While these devices are still subject to other regulatory requirements, the FDA is not requiring manufacturers to comply with 510(k) requirements for these devices while the guidance is being finalised. Other Guidance The mhealth industry eagerly awaits guidance on two other crucial issues: The accessory rule and wellness products. Historically, the FDA has regulated accessories to medical devices in the same manner as the medical device. So if you have a USB plug connected to a class II glucometer the USB plug would be regulated as a class II device. This does not work well in the current environment where mobile apps and devices are interconnected and data is shared among various systems. The wellness issue requires a clear distinction between unregulated wellness claims and regulated disease–related

The FDA is expected to publish draft guidance addressing both the accessory rule and wellness claims in the coming months. Clarity on these two issues is critical for mhealth developers. The Software Act and Protect Act There has also been recent legislation proposed aimed at limiting the scope of the FDA jurisdiction over software products. The FDA’s seemingly targeted approach at regulating mobile medical apps has instigated Congress to question the appropriateness of FDA oversight of mobile medical apps. In October 2013, The Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 (the “Software Act”) was introduced in the House of Representatives. The Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (the “PROTECT Act”) was introduced in the Senate in the Spring of 2014. The Software Act is focused on differentiating between “health software,” “clinical software” and “medical software.” If passed, the Software Act would limit FDA oversight to medical software

which would be defined as software that is intended to be marketed: to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider and which, if followed, would change the structure or any function of the body of man or other animals. For clinical and health software, the Software Act would require the President and Congress to work together to develop a regulatory framework for addressing appropriate oversight of these markets. Additionally, during Spring 2014 the US Senate introduced a bill named the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (the “PROTECT Act”). By amending Section 201(h) of the Federal Food, Drug and Cosmetic Act, it clarifies that the term “device” does not include clinical software or health software thereby stripping the FDA of its authority over clinical and health software. If passed, the PROTECT Act would nullify the FDA’s recently published final guidance as well as the FDA’s efforts to regulate medical devices as they relate to digital health. Commentators have expressed concern that all mobile medical apps will be unregulated if the PROTECT Act is passed because the proposed bill passes the oversight authority to the National Institute of Standards and Technology (NIST). Currently, NIST is a non-regulatory federal agency that works with U.S. industries to promote innovation and industrial competitiveness by advancing measurement science, standards and technology. Because it is not a regulatory body, NIST does not have the power to investigate wrongdoing. Both bills were introduced prematurely, in that Congress was still awaiting the FDASIA Report. Neither of these bills have passed to date and their status is unclear given the release of the FDASIA Report. At this time it is unclear whether either of these pieces of legislation will become Continued on page 36

The Journal of mHealth

The Evolving US mHealth Regulatory Landscape Continued from page 35

law in the United States, but they demonstrate the evolving nature of the regulatory landscape. Similar developments can be expected in the near-term in Europe. In the meantime, the general consensus is that companies in the clinical software and mobile medical apps industry should follow the final guidance recently published by the FDA with respect to regulation of their products. Conclusion The regulatory framework for the mHealth market and broader health IT industry is dynamic and continues to evolve. So does technology. Many mHealth and health IT products are part of complex, interconnected systems which require a refined regulatory approach. Companies in or close to the health IT space should closely monitor the final FDASIA Report and the draft guidance, as well as the release of additional guidance from the FDA. Having a thorough understanding of the current environment is essential to developing

The mHealth Regulatory Coalition was formed in 2010 with the purpose of ensuring that the regulatory environment for mHealth technologies allows for innovation while at the same time protecting patient safety. The coalition serves as a thought-leader in the mHealth ecosystem to provide expertise on which mHealth technologies should be regulated and how they should be regulated.

lation, including the agency’s reach into: Apps used for wellness; Low risk generic IT accessories; Pharmaceutical-related apps; and, Generic software modules used as parts of medical software programs. »» Improving the regulatory environment for those apps subject to FDA oversight, including: Moderating the quality system requirements for app development; identifying a clear pathway for FDA clearance; creating a hassle-free way to keep software up-to-date. »» Expanding these frameworks to coordinate with other regions around the world.

The coalition focuses on a number of issues relevant to the mHealth regulatory framework, including:

For more information on the mHealth Regulatory Coalition please visit www. mhealthregulatorycoalition.org.

»» Participating in the legislative process to tackle the big picture question of which agency or organisation should regulate mobile medical apps. »» Tackling the tougher questions associated with the scope of FDA regu-

The first article in this series can be read online at: http://joom.ag/Xclb/p28 (MMA Roadshow: 10 Lessons for Developers).

business and regulatory strategies that support the successful launch of your new mHealth products. The mHealth Regulatory Coalition

Want to learn about the benefits of Field Testing for Health apps & systems? Visit www.pass.ch/fieldtesting

October 2014

[1] ONC is not an agency but is an office of the Department of Health and Human Services. n

Global Report Suggests Many Mobile Applications are Failing on Privacy

Global Report Suggests Many Mobile Applications are Failing on Privacy The vast majority of popular applications are guilty of basic failings over user privacy, a report has warned. The Global Privacy Enforcement Network (GPEN) looked at 1,211 apps during 2014 and found 85% were not clearly explaining what data was being collected, and for what reason. Almost one in three apps were requesting an excessive amount of personal information, the report said. The UK’s Information Commissioner’s Office (ICO) has backed the findings. “The results show that many app developers are still failing to provide this information in a way that is clear and understandable to the average consumer,” said the ICO’s group manager for technology, Simon Rice. “The ICO and the other GPEN members will be writing to those developers where there is clear room for improvement.

tion in too small a print, or by hiding the information in lengthy privacy policies that required scrolling or clicking through multiple pages

“We will also be publishing guidance to explain the steps people can take to help protect their information when using mobile apps.”

Dr Steven Murdoch, a researcher at University College London, said the findings on data privacy were “sadly not surprising”. He argued that often the use of third-party advertising platforms within apps is particularly troubling.

The second Global Privacy Enforcement Network (GPEN) Privacy Sweep demonstrates the ongoing commitment of privacy enforcement authorities to work together to promote privacy protection around the world.

“Often privacy leaks from mobile apps don’t come from the app itself, but from the advertisements which are added, quite frequently the people who are writing the application don’t understand themselves what they advertisement code is doing.”

Some 26 privacy enforcement authorities in 19 countries participated in the 2014 Sweep, which took place May 12-18. Over the course of the week, participants downloaded 1,211 popular mobile apps in a bid to assess the transparency of their privacy practices.

The problem is further exacerbated by platform-dependent behavior. For example, iOS allows users to revoke an application’s access to certain data after installation, but Android has no such mechanism, forcing users to choose between granting apps any permission they request or not using them at all.

The report’s results suggest:

Lessons for Healthcare

»» 85% of the apps surveyed failed to clearly explain how they were collecting, using and disclosing personal information. »» More than half (59%) of the apps left users struggling to find basic privacy information. »» Almost 1 in 3 apps appeared to request an excessive number of permissions to access additional personal information. »» 43% of the apps failed to tailor privacy communications to the small screen, either by providing informa-

Many of the apps considered for this report were mainstream consumer products, as opposed to healthcare solutions, however, the findings are a useful reminder of the importance that privacy and security must be given. When it comes to personal health data the standard of care that needs to be taken in order to protect information, is even higher. Measures to protect security and privacy should not be considered as an afterthought, but should be designed intrinsically from the early stages, and quality measures should be implemented to ensure that these factors remain a priority as products and services are developed. Continued on page 39

The Journal of mHealth

Technical Considerations for Vetting mHealth Applications

Technical Considerations for Vetting mHealth Applications As the demand and use for mobile applications in healthcare settings grows organisations increasingly need to assess the security and reliability of solutions, in order to determine whether they are acceptable for use. A recent document published by the United States’ National Institute of Standards and Technology aims to provide technical guidance on the systems and methods that organisations can use to assess applications. The demand for this type of assessment is critical in mobile health applications due to the unique privacy and data security issues that arise when applications are used in these environments. The purpose of the document is to provide guidance for vetting third-party software applications (apps) for mobile devices. The document has not been designed to be a step-by-step guide for performing software vetting, but rather highlights elements that are of particular importance, and which should be considered prior to mobile apps being approved as ‘fit-for-use’. The document has been published in order to inform an audience, of individuals or organisations that will be vetting, assessing, and acquiring mobile applications, as well as those with responsibilities for setting app vetting policies and practices. It is advised that organisations should develop or adopt requirements that they expect mobile software applications to meet. These requirements should reflect the organisation’s unique mission requirements, understanding of their IT infrastructure, choice of mobile devices and configurations, and the organisation’s acceptable levels of risk. The process of verifying that a software application meets those requirements is known as vetting. Understand the security and privacy risks mobile applications present and have a strategy for mitigating them

When deploying a new technol-

October 2014

ogy, organisations should be aware of the security and privacy impact these technologies may have on the organisation’s IT resources, data, and users. New technologies may offer the promise of productivity gains and new capabilities, but if these new technologies present new risks, the organisation’s IT professional users, and business owners should be fully aware of these new risks and develop plans to mitigate them, or be fully informed before accepting the consequences of them. Administrators should consult with the organisation’s privacy officer or legal counsel to ensure the collection and sharing of data collected using mobile devices is legal. Provide mobile application and privacy training for employees Employers should ensure that their employees understand the organisation’s mobile device use policies and how mobile apps may compromise the organisation’s security and the user’s privacy. Users should be educated about Personally Identifiable Information (PII), how PII can be accessed and shared, how the privacy- and security-relevant capabilities of a mobile device relate to PII, as well as how an organisation’s resources can be protected or put at risk by the user’s actions and inactions. Training programs should describe how mobile devices can collect information about the user and how that information can be shared with third parties through apps running on the mobile device. Provide long-term assurance of the software throughout its lifecycle, all mobile apps, as well as their updates, should go through a mobile app vetting process Each new version of a software application can potentially introduce new, unintentional weaknesses or unreliable code into an existing mobile app. New versions of mobile apps should be treated as new mobile apps and should go through an app vetting process. For many organisations this software assurance step does not currently take place for mobile

apps. This is in contrast to new releases of desktop or server enterprise software, which are typically tested in a controlled enterprise software assurance model. This, however, does not scale well to meet user demands for the wide array of apps for medical devices. Mobile apps developed in-house should also be tested and analysed for security and reliability before being released to the community of users within the organisation. The purpose of these tests and the analysis is to validate that an app adheres to a predefined acceptable level of security risk and to identify whether the developers have introduced any latent weaknesses that could make the IT infrastructure vulnerable or expose the user’s confidential data. The mobile app update can help mitigate risks when used properly. Security administrators should establish a process for quickly vetting security-related app updates Mobile app update notifications can be sent directly to the user’s device and downloaded from an app store or marketplace and bypass the traditional IT testing, staging, approval, and deployment process. This model offers the promise of pushing critical security updates faster to the end user, but it also introduces the risk of having unvetted code installed on a user’s device with unknown consequences and security implications. The first release of a mobile app may be free of any malware, but malicious code may be introduced in subsequent updates. Security administrators should establish a process for quickly vetting securityrelated app updates. Stakeholders should be made aware of what the mobile app vetting process does and does not provide in terms of secure behaviour applications A mobile apps vetting system is comprised of a set of tools and methodologies for addressing specified app vetting requirements. Each mobile app vetting tool or methodology generates results

Technical Considerations for Vetting mHealth Applications that identify security, privacy, reliability, accessibility, and performance issues with the mobile app. Any vetting approach should be repeatable, efficient, consistent, and limit errors (e.g. false positives, false negatives). As with any software assurance process, there is no guarantee that even the most thorough vetting processes will uncover all vulnerabilities. Stakeholders should be made aware that although app security assessments should generally improve the security posture of an organisation, the degree to which it does so may not be easily or immediately ascertained. Stakeholders should also be educated on the value of humans in security assessment processes. Security analysis is primarily a human-driven process that can be highly augmented and aided by automated tools, but the tool results themselves need to be evaluated in the context of the intended mission/ business use of the app and the capabili-

ties and configuration of the mobile platform and networking setup. There is a residual risk associated with any capability, including mobile apps. App security assessments are intended to reduce that level of risk by identifying and mitigating vulnerabilities. The collection and analysis of metrics can indicate the level of risk reduction, but it is impossible to completely nullify all risk. Mobile applications are part of a larger system; mobile application testing results should be reviewed by a software analyst within the context of an organisation’s mission objectives, security posture, and risk tolerance End user’s mobile devices, data, and network resources face multiple threats that can originate from many places and that depend on the sophistication of

the adversary. Some risks can be mitigated through the use of technical countermeasures. Mobile app deficiencies detected through the mobile app vetting process may be mitigated by technical countermeasures that are part of a larger system. Mobile apps that meet minimum technical requirements may not be suitable for an organisation to use because they do not meet acceptable use policies. Automated testing is necessary for the vetting process to scale and keep up with the demands of the user base, but the manual review of the test results by a human analyst will best serve an organisation’s software assurance goals. The full document can be downloaded from the National Institute of Standards and Technology website at: www.csrc.nist. gov/publications n

Continued from page 37

A number of general best practices are suggested by the report: »» Many popular apps are embracing the potential to build user trust by providing clear, easy-to-read and timely explanations about exactly what information will be collected; and, how it will be used pursuant to each permission. »» Sweepers found many positive examples of apps properly tailoring privacy communications to the small screen through pop-ups, layered information and justin-time notifications. »» Some apps didn’t just tell users what they would do with their personal information, but also clearly articulated what they would not do with the information. Some apps even provided links to the privacy policies of their advertising partners. Others gave users the option to “opt-out” of the “help us with analytics” feature, which uses software to collect user information to improve the performance of the app. »» Sweepers noted a number of best practices in the area of children’s privacy and parental consent. One international partner highlighted, for example, an app that required parents to complete a consent form before their child could register. The Global Privacy Enforcement Network was established in 2010 upon recommendation by the Organisation for Economic Co-operation and Development. Its aim is to foster cross-border cooperation among privacy regulators in an increasingly global market in which commerce and consumer activity relies on the seamless flow of personal information across borders.

Its members seek to work together to strengthen personal privacy protections in this global context. The informal network is comprised of 51 privacy enforcement authorities in 39 jurisdictions around the world. For more information on the report visit: www.priv.gc.ca/media/ nr-c/2014/bg_140910_e.asp n

The Journal of mHealth

SPECIAL REPORT: Ebola-The Role of Technology in Managing the Outbreak

SPECIAL REPORT Ebola: The Role of Technology in Managing an Outbreak The number of new Ebola cases is growing faster than the ability of health officials to handle them, the head of the World Health Organisation stated at the end of September.

Ebola-specific treatment centres,” said Margaret Chan, the WHO director-general. “Today, there is not one single bed available for the treatment of an Ebola patient in the entire country of Liberia.”

“In the three hardest hit countries, Guinea, Liberia and Sierra Leone, the number of new cases is moving far faster than the capacity to manage them in the

More than 4,000 people have died in Guinea, Liberia and Sierra Leone, where the outbreak has been concentrated, Chan said. Cases have also been reported

in nearby Nigeria and Senegal. Here we feature a number of articles which focus on the role that mobile and digital technologies are playing in the response to Ebola. From public health mobile communications to advanced mapping algorithms, technology has the ability to help in the fight against the spread of the virus.

Medical Researchers Call for Technology to Help Fight Ebola Africa is fighting Ebola not just with policy and humanitarian aid but also with accessible technology and social media. From the #FactsOnEbola hashtag to the international call to action issued by doctors in Sierra Leone, Africans are calling for technology to help combat the spread of the disease. In their appeal, which featured in the Lancet[1], medical researchers based in Sierra Leone demanded that governments and public health agencies around the world begin using mobile

October 2014

technology that is widely available on the Continent to prevent more loss of life from the highly contagious illness. “Emerging technologies can help early warning systems, outbreak response, and communication between health-care providers, wildlife and veterinary professionals, local and national health authorities, and international health agencies,” the team explained. The doctors advocated the use of opensource software applications that receive and send bulk SMS messages to com-

municate with local health centres, and to ensure uninfected citizens remain healthy & informed. The group has also called for infectious disease surveillance systems to be strengthened by adopting new data-sharing technologies. Laboratories in the region have shown that routine syndromic surveillance systems can be designed to rely on mobile phones which have become ubiquitous in West Africa. Open-source software

SPECIAL REPORT: Ebola-The Role of Technology in Managing the Outbreak programs that receive and send bulk SMS messages can be used for communication with populations and peripheral health centres. Digitised maps can be created from satellite images, and distinctions between residential and unoccupied buildings can be added to opensource geographic information systems (GIS) to improve the accuracy of case mapping. Mapping has been shown to be an effective tool in the fight against Ebola. Already in Guinea back in April, Medecins sans Frontiers (Doctors without Borders) partnered with Humanitarian

OpenStreetMap Team (HOT), a digital mapping organisation, to build a map of Guéckédou, a city of around 250,000 people in southern Guinea, where an outbreak was believed to be concentrated. At the time MSF made the request there were only two roads on their digital map. In less than 12 hours, with the help of volunteers from around the world, the digital map of Guéckédou grew to include 100,000 buildings – including two other nearby villages – based on satellite imagery of the area. The MSF team was able to begin using the map immediately to attempt to pinpoint the origin

of infected persons, investigate rumored infection sites and navigate through unfamiliar areas. As the research team in Sierra Leone wrote, this outbreak “serves as a call to ensure access to needed diagnostic technologies and health-care resources, to accelerate the implementation of smartphone-based health applications in developing countries, and to improve regional and global surveillance and health communication.” 1 http://www.thelancet.com/journals/lancet/article/ PIIS0140-6736%2814%2961119-3/fulltext n

Cell-Phone Data Might Help Predict Ebola’s Spread A West African mobile carrier has given researchers access to data gleaned from cell phones in Senegal, providing an insight into regional population movements that could help predict the spread of Ebola. Orange Telecom made “an exceptional authorisation in support of Ebola control efforts,” according to Flowminder, the Swedish nonprofit that analysed the data. “If there are outbreaks in other countries, this might tell what places connected to the outbreak location might be at increased risk of new outbreaks,” says Linus Bengtsson, a medical doctor and cofounder of Flowminder, which builds models of population movements using cell-phone data and other sources. The data from Senegal was gathered

in 2013 from 150,000 phones before being anonymised and aggregated. This information had already been given to a number of researchers as part of a data analysis challenge planned for 2015, and the carrier chose to authorise its release to Flowminder as well to help meet the Ebola crisis. The new model helped Flowminder build a picture of the overall travel patterns of people across West Africa. In addition to using data from Senegal, researchers used an earlier data set from Ivory Coast, which Orange had released two years ago as part of a similar conference. The model also includes data about population movements from more conventional sources, including surveys. The model created using the data is not

meant to lead to travel restrictions, but rather to offer clues about where to focus preventive measures and health care. Bengtsson cautions that the model is essentially a first draft, and that it is based on historical movements, so it does not take into account how people may have changed their behavior in response to the recent crisis. Ideally, he adds, it would include real-time data. But “in countries that already have epidemics,” he says, “this is the best estimate we can do of what mobility will look like. This can give the sense of the radius people tend to travel around.” Ebola is transmissible via bodily fluids during an incubation period of between Continued on page 42

The Journal of mHealth

SPECIAL REPORT: Ebola-The Role of Technology in Managing the Outbreak Continued from page 41

2 and 21 days, during which victims may not know they are infected. That makes it particularly important to know where people are going and where they’ve been. Mobile phones—which are ubiquitous even in poor countries—can play a key role. All cell phones “ping” nearby towers with a unique ID number to announce their presence. In this way, mobile carriers amass huge databases containing fine-grained information on population movements and social patterns. The application to public health is compelling. Caroline Buckee, a Harvard epidemiologist who also worked with Flowminder to develop the West African model, has demonstrated how such data

can show where people have gone after leaving a hot spot, suggesting where a disease cluster will crop up next. Last year Buckee demonstrated how cellphone data could aid in fighting malaria by revealing where to focus mosquito eradication efforts. Previously, researchers trying to model mobility relied on techniques like counting heads at bus stations and asking sick people where they’d been traveling. While public health agencies are interested in the topic, Bengtsson says that agencies such as the World Health Organisation didn’t ask the researchers to develop the model or work with them to do so. At this time there is no indication that health officials are using this

particular model. Emmanuel Letouzé, cofounder and director of Data-Pop Alliance, which is working on similar projects, says the approach holds promise. “If mobile carriers provide all the data at a very granular level, the value you can extract is huge,” says Letouzé, a visiting scholar at MIT’s Media Lab. “Nevertheless,” he says, “the privacy concerns are even more salient.” That is because such data reveals detailed social and business connections and location information, which can often be linked back to individuals. Source: MIT Technology Review n

Health Map Algorithm Detected Ebola Outbreak a Week Before it Spread An algorithm on HealthMap, an international mapping tool that detects and tracks diseases, found Ebola, called a “mystery hemorrhagic fever,” just over a week before it spread, though the founders didn’t initially realise the importance of what they had discovered. Eight people reported the mysterious disease in March and it caught the HealthMap team’s attention, but they didn’t call out a massive issue until it was confirmed as Ebola on March 22. “That was concerning, but still oftentimes these events tend to be smaller in nature, and this is much more substantial than what we’ve seen in the past as far as the time it’s taken to spread. It’s unusual as far as what we’ve seen,” said John Brownstein, co-founder of HealthMap and an epidemiologist. Once the HealthMap team realised the seriousness of the situation they created a dedicated HealthMap visualisation. This can be found at: www.healthmap. org/ebola. The tool shows the full timeline of events, including locations, case counts (suspected, confirmed, deaths), and original source documentation. There are few other places to find comprehensive, easy-to-understand details on the full scope and progression of the Ebola outbreak. Traffic to the

October 2014

HealthMap site has skyrocketed as citizens and professionals seek out clear information, said Clark Freifeld, cofounder of HealthMap. According to the World Health Organisation, as of October 14th, these are the stats of the Ebola outbreak in Africa, which emerged in March 2014: Guinea: 1,350 cases, 778 deaths Liberia: 4,076 cases, 2,316 deaths Nigeria: 20 cases, 8 deaths Sierra Leone: 2,950 cases, 930 deaths Senegal: 1 case “The situation was something we were keeping close tabs on as it evolved at the time, but there was still a small number of initial cases, and Ebola outbreaks have been successfully contained in the past,” said Freifeld. “The real concern arose when cases kept increasing this summer, especially given the high fatality rate of the strain [60%].” Brownstein states that the data they collect is a real time view of what’s happening. The Ebola outbreak reminds him of what HealthMap showed when the H1N1 (swine flu) virus spread -- they had many reports from local news media early on, which were eventually confirmed. So this instance is not unfamiliar. “This instance with Ebola is some of

the most usage we’ve ever had at the site, and it’s raising awareness for infectious disease,” Brownstein said. In addition to the structured information they capture about locations and case counts, HealthMap also captures narratives of case situations, such as patients leaving their containment areas, civil unrest, and other impacts of the outbreak. “These factors are key for fully understanding the situation and how to address it,” Freifeld said. The web crawler on HealthMap collects information from hundreds of thousands of sources across the internet, based mostly on keyword searches for disease-related terms. Of course, it filters out things such as “outbreak of home runs” or “Justin Bieber fever.” It sifts through RSS feeds and APIs and analyses the text and geographic location of the information and removes the noise. The automated process is repeated every hour, 24 hours a day. The algorithm is 90% accurate at filtering out the junk, Freifeld said, and it is continually improving through feedback from analysts. This is a machine-learning algorithm. It looks for example articles that have been categorised by HealthMap analysts and searches for patterns

SPECIAL REPORT: Ebola-The Role of Technology in Managing the Outbreak

of how new articles match up with the history of relevant and irrelevant content. The value of HealthMap, Brownstein said, was initially for disease surveillance, but it has moved onto something better. He suggests that it now plays a more important role in, “Getting case information and data of very specific epidemiology, of outbreaks, and fitting that to disease models, where it might spread, how bad it might be, by then integrating it with climate data or transportation data, all of a sudden it’s data you wouldn’t necessarily have access to,” Brownstein said. “For me personally, it combines two passions of mine, computer science and public health. Our work gives us a chance to apply advanced artificial intelligence algorithms to problems that matter in global health,” Freifeld said. Freifeld had the idea for HealthMap as a way of organising the large amounts of outbreak data that, he said, at the time were widely available on the internet but

scattered and difficult to use. Brownstein’s background is in epidemiology, specifically infectious disease mapping, and he especially focuses on emerging diseases and how to use technology to map and track them.

users. HealthMap accepts reports from anyone via the web or mobile devices. “We are seeing the role of the public as ‘citizen epidemiologists’ rather than just passive consumers of information,” Freifeld said.

HealthMap started in 2006 as a side project on nights and weekends outside of work. However, the website, which is now based at the Boston Children’s Hospital, rapidly became a full-time project as it started to take off.

Part of the importance of HealthMap is its usefulness to epidemiologists and other experts, to engage them and have them report back to the team, but it’s also to engage communities around the world, and HealthMap has projects focused on that concept as well.

Since its conception, HealthMap has evolved in three main ways. First, it is continually incorporating more and more sources of data. It has expanded into 15 languages and uses social media sources, looking at drivers of disease such as attitudes towards vaccines and animal health. Second, they have greatly expanded how they categorise outbreaks. Disease and location are obviously key, but they now look at setting (e.g., hospital, military base), nature of the disease (e.g., antibiotic resistance), case counts, and location mapping. And third, they are consistently engaging more with

“We’re trying to build better tools to provide data and have them return information to fill out the map,” he said. “What’s exciting about HealthMap is that we are capturing all this information and making it available and accessible,” Freifeld said. “Our users include public health professionals, but actually the vast majority come from the general public. You don’t need to be an expert to benefit from the service.” Source: www.techrepublic.com n

The Journal of mHealth

Tackling Respiratory Disease with Home-Based Services and Solutions

Tackling Respiratory Disease with Home-Based Services and Solutions Respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD), Bronchiectasis and severe Asthma affect one in five of us. Now Portsmouth Hospitals NHS Trust (PHT) in the UK, the University of Portsmouth (UoP) and UK-based Aseptika Ltd have come together to develop, trial and evaluate new ways to help people with respiratory disease learn about ways to maintain their health. The study aims to provide a tailored suite of simple medical devices, internet connected iPads and training in how to use them to 30 volunteer patients from the Portsmouth area. In the study, volunteers will measure their own parameters of health such as: lung function, levels of physical activity, oxygen levels in the blood and even their weight, using devices which then automatically send the information to a secure dedicated website. Volunteers will also provide samples of sputum, which will be analyzed later at PHT using a new test developed by Aseptika that measures the level of activity of certain bacteria. The three collaborators have come together to test the idea that this information when combined, can be used to predict flareups of infection (called exacerbations) 10-15 days before hospitalisation is eventually required. The hope is that the study may help lead to future services including, self-care plans in which patients are educated to monitor and interpret their own signs of impending exacerbation. The emphasis of the solution being developed and trialed is patient empowerment, self-management and giving greater control to the patient and their family members who care for them, and as such the technology is being developed to be simple enough for everyone to use correctly - with only a minimal amount of education, training and support from their clinical care team. With the digitised information recorded and made accessible to the diverse range of professionals involved in supporting these patients, the system can also be used to provide remote support, monitoring, advice and health coaching during weekends and evenings, providing a continuum of care at home, which cannot be delivered through face-to-face contact owing to the rising demand that is fast outpacing available clinical resources. SElf-management checks to predict exacerbatioNs of Pseudomonas aeruginosa in patients with long-term reSpiratORy conditions or SENSOR, is funded through Aseptika, via a pre-procurement contract with NHS England’s Small Business Research Initiative Healthcare (SBRI Healthcare) managed by Health Enterprise East on behalf of the Eastern Academic Health and Sci-

October 2014

ences Network (EAHSN). Aseptika is working closely with the clinical research team at PHT and the NHS South Central Research Design Service as well as academic staff from the School of Health Sciences and Social Work (SHSSW), at UoP. Aseptika is funding positions for a research nurse and a laboratory technician based at PHT, the research by UoP and is providing its Activ8rlives products to volunteer patients – with an iPad. The three teams are also collaborating to develop a dedicated App to meet the specific needs of the people of Portsmouth who take part in the SENSOR study programme. Commenting on the goals of the collaboration, Professor Anoop Chauhan, Research Director and Chief Investigator at PHT said: “Everyone in healthcare knows the challenges that lie ahead – an ageing population, lifestyle-related ill health, increasing demand for services and constrained budgets. We have pioneered the use of self-care plans in Portsmouth and these are very popular with patients because following them reduces the number of visits they have to make to the hospital. We have also researched the impact of providing 24/7 care at home in the surrounding area and this has been proven to help patients stay healthy and reduce the number of emergency admissions, but it is very expensive to provide through face-to-face contact with the patient.” “In the past there have not been the simple technologies and tools to enable the patient and their families to help themselves when they need it. Ideally, we want these same tools to also communicate this information to us at the same time. This means that we can share our skills and knowledge with the family carers and patient, but with the benefit of the technology, we can give support sooner. What we all want is to provide the right

Tackling Respiratory Disease with Home-Based Services and Solutions care before a problem, which could be managed safely at home, becomes a real emergency” – the right care at the right time in the right place. Ben Green, Consultant Respiratory Physician at the Queen Alexandra Hospital described the challenges he and his team face in caring for patients with severe respiratory disease: “A number of patients with severe airways disease are chronically infected with a bacterium called Pseudomonas aeruginosa (PA) and in these patients, despite attempts to treat these infections, complete eradication is difficult. Flare ups of the infection are common, leading to deterioration in symptoms which can lead to prolonged hospital admission. Hospital admission for this type of disease reduces quality of life and can be associated with increased mortality. This work is important because it is helping to develop a tool for the early detection of flare ups which will mean patients can be treated earlier at home, improving quality of life and reducing the costs to the NHS of hospital admission.” Emergency admissions for COPD are the second highest of any disease area in the UK, with one in three people with the disease being readmitted within 28 days[2]. Early intervention and better self-management at home could together, reduce the number and severity of admissions and increase life quality by slowing the rate at which the disease progresses.

“While these diseases are complex, there are predictable patterns. The changes that can be seen in the lead-up to the next exacerbation can be measured with very simple devices that everyone can be taught how to use. If we learn from the information we gather about ourselves, we can adopt new behaviours and see how best to implement the self-care plans and the advice about medication, exercise, lifestyle and diet that our doctors give us.” “With education, support and a bit of encouragement, we can slow the rate at which these diseases progress. All it takes is to make a few quick health measurements at home each day using our simple devices.” “We have seen in previous clinical trials that the pattern of these complex changes can be easily identified. Eventually, we want to transfer this skill to the patient. In doing so, we want to help them reduce the number of their infections, decrease emergency hospital admissions and improve their quality of life and that of their carers. These are the unpaid army of health care providers - often family members - who may also have jobs and perhaps children to also take care of.” We were very impressed with the initiatives for “hospital at home” that have been trialed by the clinical researchers in Portsmouth. We hope that our technology will enable their vision to be realised.” Dr Jeannette Bartholomew, Head of the University of Portsmouth’s School of Health Sciences and Social Work, said:

Dr. Kevin Auton, Founder and inventor of the test being developed at Aseptika, commented:

“We are very pleased to be working with Aseptika and PHT, to help build a sound evidence base for the SENSOR project. Being part of the team and involved from the outset means that the University has the opportunity to be influential during the research and innovation phase. Patients, both in Portsmouth and the wider health community, will have more complex health problems in the future and therefore will increasingly need services and products like these.”

“Whatever the cause, respiratory disease predisposes us to repeated lung infections, which damage the lungs irreparably, leading to more infections in a downward spiral.”

[1] All Parties Parliamentary Respiratory Report, June 2014 [2] Consultation on a strategy for services for chronic obstructive pulmonary disease (CPD) in England. Sourced at http://www.dh.gov.uk. n

Professor Chauhan and his clinical team have a strong track record of research at PHT and have previously demonstrated leadership in establishing self-care plans for patients with respiratory conditions to improve care in a sustainable healthcare model.

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