The Journal of mHealth Vol 1 Issue 3 (June 2014)

WHAT’S INSIDE NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

Deploying mHealth: Overcoming Barriers to Adoption

INSIGHT

June 2014 | Volume 1 Issue 3

Lab Quality Testing in the Palm of Your Hand

The Valueof Videoin ModernHealth and Social Care

ARTICLES

Full Round Up of Industry News

NEWS

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Journal of mHealthThe Global Voice of mHealth

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Editor's Comments

1The Journal of mHealth

The proliferation of digital and mobile technologies within healthcare is becoming more and more widespread as the industry moves to ac-cept these solutions as part of everyday working practice. Despite this, however, there remains a considerable number of barriers that seem to continue to prevent the wider scale adoption and deployment of digital solutions.

As our regular readers will know, we frequently publish reports and news articles that detail the successes of different digital health trials, from which it is easy to see the benefits of solutions in those particular cir-cumstances. What we currently rarely seem to see, however, is reports of these types of solutions being adopted at scale.

There are numerous reasons for this. Integration with IT (and other solu-tions) is often problematic, the need to accept new methods of working can sometimes be resisted by staff, or cultural change within organisa-tions is often slow to happen.

We must accept that technology should not just be implemented for technologies sake. There must be tangible benefits to the way care is pro-vided in order for a solution to be used. Equally, that solution should fa-cilitate the care process and the working practices of care providers with-out introducing additional burdens. The way this should be achieved is to develop flexible, integrated, intelligent, solutions that can empower the end user. In patient solutions this may mean giving them the ability to take a greater responsibility for the monitoring and management of their condition, whilst also providing them with new ways of interacting with the different stakeholders involved with their care. For healthcare professionals it should mean providing them with solutions that compli-ment care provision, and which allow them new ways of working, so that they are supported by the technology, meaning they can do more with less, or provide services in improved or different ways.

Considering some of these barriers to adoption from a variety of differ-ent perspectives, we include in this issue thought-leadership articles from clinicians, digital solution providers, and industry leaders - eHealth: Accelerating Towards a Healthy Future (by Neelie Kroes Vice-President of the European Commission for Digital Agenda). As well as featuring case studies that consider the digital adoption question in the context of par-ticular system deployments.

We hope you enjoy reading!

Matthew DriverEditor

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2

Table of Contents

June 2014

As part of the theme for the issue, we assess the range of different challenges and barriers that can influence adoption and deployment of mobile and digital health solutions.

We are very pleased to include this article written for The Journal of mHealth by Neelie Kroes Vice-President of the European Commission responsible for Digital Agenda.

Embedding video within health and social care provision has been shown to produce significant health economic and quality benefits. This report developed with the help of healthcare video specialist v-connect considers the implications of incorporating video within modern clinical work flows.

In This Issue

4 Deploying mHealth: Overcoming Barriers to Adoption

20 The Value of Video in Modern Health and Social Care

33 eHealth: Accelerating Towards a Healthy Future

Table of Contents


Industry News

8 Samsung Launches Major Digital Health Initiative

9 AbedGraham leads US IT Expansion towards the NHS

10 Innovative Timepiece for the Blind and Visually-Impaired

10 FDA Approval of First Mobile Plat-form for Real-Time Estimation of Surgical Blood Loss

11 New Diagnostic Device Aims to Deliver Lab-Quality Results at Patient Bedside

12 New US Study Shows 70% of People Tracking Their Health and Fitness Daily Using Apps

13 Global Mobile Subscriptions Reach 7 Billion

14 $150 Smartphone Spectrometer Can Determine the Number of Calories in Your Food

15 Low-cost Motion Controller Pro-vides a Unique Approach to Physi-cal Therapy

16 Global mHealth Market Expected to Reach $49 Billion by 2020

17 App Offers Interesting New Way for Doctors to Learn

17 New Method for Lowering Blood Pressure Without Side Effects

18 'Grip Chips' Let Hand Prostheses Think for Themselves

18 Proteus Raises $120M to Scale Smart Pills

27 Social Networking and Alerts Tech-nology ‘Transforms’ How Health-care Teams Work

28 ATA Plans to Launch Telehealth Accreditation Program

28 Medical Devices Summit West 2014

29 Wearable Technologies Conference 2014 – San Francisco

29 Healthcare Revolutions: Big Data and Smart Analytics

31 Health Datapalooza Review

32 mHealth + Telehealth World 2014

32 International Digital Health and Care Congress: Improving Health Through the Use of Technology

34 Can We Really Deploy mHealth at Scale?

35 Engaging Patients Using mHealth

38 Understanding Stress and Post-traumatic Growth

40 A Clinician’s Guide: How to Enhance Adoption and Diffusion of Technol-ogy in Healthcare

41 Lab Quality Testing in the Palm of Your Hand

45 The Changing Face Of Healthcare: Quality in Medical Applications

47 US and UK Working to Strengthen Use of Health IT for Better Patient Care

48 China: A Market for mHealth?

50 Upcoming Events

50 Advertisers Index

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June 2014

It is now widely accepted, amongst the wider healthcare profession, that the so-called ‘Digital Revolution of Healthcare’ is, and will continue to be, an essential mechanism, necessary to help overcome some of the many challenges facing modern medical provision.

Every democratic society has to address practical questions about the availability and distribution of medical services. Life expectancy is projected to increase from an estimated global average of 72.6 years in 2012 to 73.7 years by 2017, bringing the number of people over age 65 to around 560 million worldwide, or more than 10 percent of the population. In Western Europe this proportion will hit 20 percent, and in Japan 27 percent[1].

With ageing populations comes an increase in those afflicted with chronic ailments, that require increases in health care spending. When this is combined with heavy government debt and con-straints on tax revenue, it is forcing health providers to make difficult deci-sions, in order to provide more services with fewer resources.

Across the world, healthcare systems have recognised the need for innovation, yet, despite the promise and potential of mobile and digital health solutions, as a means of changing the ways in which care is delivered, there remains a signifi-cant number of ‘barriers’ that continue to hinder adoption and dissemination of technology. This edition of The Journal

of mHealth considers some of these issues from a range of relevant perspec-tives. In this article we briefly consider some of those barriers and challenges.

PRIVACY AND DATA OWNERSHIP

A technology-enabled healthcare system produces immense volumes of informa-tion and data, and with the collation of data comes a complex series of consider-ations for each stakeholder in the supply chain. Solution developers and provider organisations must determine what data is stored and then implement the nec-essary steps to ensure that, that data is subject to the necessary levels of control and oversight.




Many medical disciplines are now under-scored by the use of data-driven systems, yet the data, itself, can be the source of problems. New care and insurance mod-els, electronic information transmission, and inter-connected boundaries among industry participants increases the com-plexity of managing protected health information. The consequences of digi-tising healthcare means that there are an ever-increasing number of networked connections within the system, which in turn is increasing the chance of data breaches, malware infections, and vul-nerability to unauthorised access.

As technology disseminates beyond the confines of the hospital or GP practice the challenges of maintaining data integ-rity become even more difficult. Intro-ducing mobile and digital solutions to a range of stakeholders, using different technology providers, decentralises the role of data management, which can in turn result in greater opportunity for breach. Similarly, where organisations use ‘bring-your-own-device (BYOD)’

methods to deploy mobile technologies then it becomes necessary to implement robust models for asset management, policy enforcement, and distributing profiles, apps and content.

Potential patient safety, economic, and reputational damage may arise if organ-isations lack appropriate security and pri-vacy controls.

INTEGRATION

The ability to effectively integrate mobile and digital health solutions within exist-ing infrastructure is critical. Integration encompasses both the technological and the human factors of care delivery.

Applications must be able to commu-nicate, which means developers and system providers need to use interna-tionally accepted standards, in order to ensure that they can be easily adopted. These standards become even more vital when organisations begin to demand and implement a multi-system solution, and require those solutions to inter-connect.

In order to be effective, technology must also integrate within work flows. Health-care professionals are unlikely to use a system that places unnecessary, addi-tional, burdens on their time or working practices. Careful strategic management is needed to ensure that a solution does what it is designed to do; that in doing so it does not add additional compli-cation to existing care packages; and that the necessary support structures are instigated to help deliver seamless deployment. This may mean using small trails to test deployment, and determine implementation strategies. It may also mean ensuring that the necessary train-ing and assistance is in place, to help

users adapt to the technology.

DATA SILOS

The current rise of data-driven solutions in healthcare is resulting in the creation of large volumes of clinical, personal, operational, and institutional data that is growing at a rapid pace. As more digital solutions are deployed then consequently the amounts of data will continue to rise. Data can obviously have very significant and beneficial outcomes on health, how-ever, it can also be problematic. As we discussed earlier there are the issues of data management, but one must also consider the challenges of cross network data connections. At present much of the data collected via digital systems is

considered proprietary and is held within compartmentalised silos, all of which have different ownership, management and processing protocols.

It is recognised, that for a true digital revolution of healthcare, it is neces-sary for the many different IT, mobile/digital systems, and networks to interact, and exchange data, with one another. In doing so this delivers systems that are able to analyse, and utilise, data in order to derive useful insight. This exchange of data across networks is something that has traditionally been problematic, and despite some changes for the better, remains a major barrier to deployment.

ADOPTION AT SCALE

The ability to deploy mobile and digital health solutions across a small number of users, is relatively straight-forward. Difficulties arise when trying to deliver those same solutions at scale, to a much larger user base. Increasing users, raises the amount of data produced, as well

as the required number of connec-tions involved. It also means that there are greater burdens on networks, an increased potential for security breaches, as well as difficulties integrating with other care provision. Each issue grows exponentially with the addition of users. When you consider how many potential users there are for these systems, then it becomes possible to foresee some of the problems facing a scaled-approach. Whilst developers can individually man-age their own system usage, the respon-sibility for efficacy ultimately falls with the care provider. Leaving them a con-siderable management task, in order to coordinate the control, maintenance, and

Despite the promise and potential of mobile and digital health solutions...there remains a significant number of ‘barriers’ that continue to hinder adoption and dissemination of technology

Continued on page 6

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June 2014

oversight of multiple systems.

EASE OF USE

The manner and style in which a user interacts with the technology is a sig-nificant factor in terms of adoption. It is critical that a solution can be easily integrated into existing care pathways without necessitating additional burden or complication to the user.

Usability factors are a major obstacle to health information technology adoption. While health IT such as mHealth tools can offer potential benefits, they can also interrupt workflow, cause delays, and introduce errors[2][3]. Lack of attention to health IT evaluation may result in dissat-isfied users, decreased effectiveness, and increases in error costs. While the prom-ise of mobile health is that we can lever-age the power and ubiquity of mobile and cloud technologies to monitor and manage side effects and treatment out-side the clinical setting, it is essential to be attentive to usability, keeping in mind its intended users, task and environment.

User interface design can be even more contentious when dealing with patients as the end user. In a professional envi-ronment there is often technical support available should it be required, however, a patient at home is often unlikely to have access to similar resources. Therefore, the solution must be designed so that it can be easily understood, and so that it performs the task required without the need for unnecessary intervention from the user. Intuitive systems, that can per-form complex monitoring and analysis, should be built into back-end elements of the solution, leaving the user-facing aspects to be simple and user-friendly. Designers also need to accept that users will have different social and technologi-cal intelligence, meaning that a solution needs to be designed so that it will per-form, as desired, for different users.

Small text, poor colour contrast, overly complex menu systems, confusing set-tings, extended load times, and connec-tion problems, can all cause difficulties. As a result, research must be undertaken in order to ensure that mobile health technologies are appropriately designed and targeted to the end-users’ needs,

before they are used as health inter-

ventions[3].

QUALITY

Increasing numbers of healthcare pro-fessionals are using smartphones and their associated applications in daily clin-ical care. While these medical applica-tions hold great potential for improving clinical practice, little is known about the possible dangers associated with their use. Breaches of patient confidentiality, conflicts of interests and malfunction-ing clinical decision-making tools could all negatively impact on care. A signifi-cant number of medical applications lack authenticity details; authors, manu-facturers and distributors are not listed, and references are unavailable or out-of-date[4].

It has been proposed that medical appli-cations should be peer-reviewed by clini-cal experts and that regulatory measures should be increased in order to safeguard quality of care. This would allow health-care professionals to be made aware which digital solutions lack evidence and professional involvement in their design and development[5]. (See article: “The Changing Face Of Healthcare: Quality in Medical Applications” on page 45).

ENGAGEMENT

Maintaining engagement with digital solutions is essential to ensure that they continue to be useful. Among patients in particular, the initial enthusiasm for using digital health applications to man-age their own health, tends to wane fairly quickly. Developers and solution provid-ers must therefore design systems in ways that continue to engage with users, and

to encourage long-term adherence. This is an area that a number of companies are successfully beginning to navigate, by developing a whole range of ways to incentivise and encourage active engage-ment (See article: “Engaging Patients Using mHealth” on page 35).

CONSUMERISATION OF HEALTHCARE

The changing demands on healthcare systems are forcing providers to begin to consider patients as consumers. Tech-savvy patients are used to managing so many aspects of their lives, with the assistance of technology, that they are beginning to demand to do the same with their health. As a result providers need to consider new ways of engaging and providing access to services, which means laterally diversify into offering technology to support their core com-petencies.

As we have already discussed many diffi-culties can arise when you begin to scale these types of technologies. As a result healthcare professionals and care organ-isations should not have to be distracted from their main care priorities, by issues of technical management. In order to prevent this from happening care organ-isations need to enter into strategic part-nerships with technology and digital solution providers, who can handle the technical aspects of deployment. Part-nership strategies can work very effec-tively, but, they do still require significant oversight and central management, by the care organisation, in order to ensure that a coherent package of services is delivered. Commissioning partnerships also requires service level agreements,

Continued from page 5



technical/maintenance contracts, train-ing provision, and regulatory adherence, all of which further complicate deploy-ment and lead to additional management tasks within the organisation. That said by implementing a digital commission-ing strategy, much of the bureaucracy can be standardised, and the overall process streamlined to encourage more rapid adoption.

LIABILITY AND LEGAL IMPLICATIONS

The legal and regulatory landscape sur-rounding digital and mobile health solutions is still very much in its infancy, leaving considerable uncertainty for care p r o v i d -ers and solution d e v e l -o p e r s . At pres-ent this means many solutions are potentially being deployed without the necessary regulatory oversight to ensure that they are fully fit for purpose.

Where a solution has been designed to deliver clinical monitoring, analy-sis, and/or insights then it is vital that the technology is reliable and effective. This necessitates a robust testing and quality control strategy, as well as sig-nificant multi-agency regulatory over-sight. Should a solution fail to perform as designed then the question of where liability falls is questionable, i.e. the care organisation or the developer.

COST IMPLICATIONS

The implementation of mobile digital solutions is often seen as a double-edged sword when it comes to the issue of costs. Many of the solutions that are cur-rently in use, or which are being devel-oped, promise to significantly reduce the costs of delivering healthcare. This means that they are attractive to provid-ers and payers, as a means of containing expenditure.

Problems arise when there is a need to change workflows and clinical pathways in order to incorporate the technology.

When solutions are considered from this context, the short-term expenditure necessary for implementation e.g. equip-ment, staff training, policy changes, and changes to working practices are often viewed by commissioners as prohibitive, rather than as precursory enablers of long-term investment.

The only way to change this percep-tion of cost, is to introduce policy that encourages the use of innovation, whilst

accepting that initial invest-ment needs to be weighed

against longer term returns. A number

of western coun-tries have begun to adopt this outlook, but it requires vision from m u l t i p l e stakeholders

throughout the healthcare sys-

tem hierarchy, ini-tiated at government

level, to successfully ensure that the cost implica-

tions are acknowledged.

HEALTH ECONOMICS

In a similar manner, the way in which provider reimbursements are handled also need to be assessed, in order to accurately calculate the value of mobile digital health solutions. Many secondary care organisations around the world are reimbursed for their services, either by central funding or insurance payments, based upon the number of patients they treat, as well as a number of key, care quality, criteria. At present, many of these methods for calculating reimbursements are actually prohibitive of digital health solutions, despite their ability to improve patient outcomes, reduce hospital visits and reduce readmissions. By keeping patients in their homes for longer or by treating them away from traditional care environments, digital solutions actually reduce the number of patients that are physically coming through the doors of hospitals. Outdated reimbursement tar-iffs can sometimes then fail to acknowl-

edge that treatment has been provided.

This is a barrier that can be easily over-come, through central initiative, in order to invoke new ways of calculating the health economics of mobile digital health solutions and integrating them into a fair method of reimbursement. In turn this would facilitate the commis-sioning process and significantly acceler-ate the rate of adoption.

GOVERNMENT POLICY AND PAYMENT

Never in human history has the general health of most ordinary people been bet-ter than it is now. But paradoxically, there can scarcely ever have been a time when health care has been a more difficult political problem for the governments of advanced countries than it is now. It is precisely because of the advances in the treatment of disease that the role of government has become so contentious. With the scope for life-prolonging medi-cal intervention now virtually limitless – and thus spending on it being potentially limitless as well – there are moral and practical questions about its availability and distribution which every democratic society has to address.

The task for government is to balance the distribution of all healthcare solu-tions including digital to ensure that resources are well distributed, and access to services is equitable.

REFERENCES

1. Global health care outlook – Shared challenges, Shared Opportunities. Deloitte Report 20142. Patterson ES, Et al. 2002. Improving patient safety by identifying side effects from introducing bar coding in medication admin-istration. J Am Med Inform Assoc; 9: 5, pp. 540–5533. Kushniruk A, Et al. 2004. The relation-ship of usability to medical error: an evalua-tion of errors associated with usability prob-lems in the use of a handheld application for prescribing medications. Studies Health Technol Inform; 107 (Pt 2), pp. 1073–10764. Buijink AW, Et al. 2013. Medical Apps for Smartphones: Lack of Evidence Under-mines Quality and Safety. Evidence-Based Medicine; 18: 35. Visser BJ, Buijink AW. 2012. Need to Peer-Review Medical Applications for Smart phones. J Telemed Telecare; 18: 124. n

Potential patient safety, economic and

reputational damage may arise if organisations

lack appropriate security and privacy

controls.

8June 2014

INDUSTRY NEWS

News and Information for Digital Health Professionals

Samsung Electronics has launched a bold initiative aimed at directing the resources and innovation of the global technology industry toward empowering individuals to better manage their own health and wellness. The Samsung Digital Health Initia-tive is based on open hardware and software platforms that will accelerate the development of advanced sensors, algorithms, and data collection and analysis.

At an event in San Francisco this month, Samsung's Strategy and Innovation Centre team demonstrated its open platform in a wearable wristband form factor, showing devices built, based on this reference-design 'blueprint', could be used to track mea-surements such as heart rate, respiratory rate and blood pres-sure. The company also demonstrated its open software archi-tecture and how it could be used to collect data from a variety of sources, aggregate it and display it in a form that consumers can use to better understand what is taking place within their bodies.The open platforms, combined with agreements like the one recently announced by Samsung and the University of Califor-nia, San Francisco (UCSF) to validate new approaches to per-sonal health and wellness, are designed to help developers bring

innovative products to market more quickly.“Samsung's Digital Health Initiative provides an exciting

opportunity for the brightest minds in the technology world to come together to develop the products that will, for the first time, put individuals in the driver's seat in understanding their own health and wellness,” said Young Sohn, president and chief strategy officer of Device Solutions at Samsung. “At a time when healthcare spending is at record levels and when the number of people over the age of 60 worldwide is expected to exceed more than 1.2 billion by 2025, digital health is an incredibly important area for innovation. We believe this initiative will be an essential first step and we invite developers and partners across the globe to join us in creating the technologies of the future that will help make people's lives healthier.”

OPEN HARDWARE PLATFORM

Samsung's Simband is an open hardware reference design for wearable technology, capable of integrating the most advanced sensing technologies in the world. Simband is being designed in a modular way, allowing for innovation in areas like battery life, form factor and noninvasive sensor technology by differ-ent companies. Innovators are being invited to use the refer-ence platform to create and contribute their own advanced sen-sors, algorithms and other technologies. Simband is a reference design Samsung and third-parties will use to develop products. It will not be sold commercially. This approach is intended to lead to the creation of a hardware and algorithms ecosystem that will enable new technology and innovation to be easily built into finished products.

OPEN SOFTWARE ARCHITECTURE

The Samsung Architecture for Multimodal Interactions (SAMI) will be a cloud-based open software platform capable of bring-ing together fragmented data from a variety of sources for anal-ysis. It will allow devices and sensors to securely store data in the cloud regardless of the source's format or structure. SAMI's job is to make more information available, to break open infor-mation silos and give applications and services access to large amounts of data to provide better insights. Under Samsung's

Samsung Launches Major Digital Health Initiative

Industry News


approach, SAMI will allow data to be controlled by the indi-vidual generating it and not by third-parties, so that personal health data can be better protected.

The combination of Simband-designed sensor technologies and algorithms and SAMI-based software will take individual understanding of the body to a new level – for the first time giv-ing voice to a deeper understanding of personal health and well being. In addition, through the development of new sensing technologies and software, it is possible that entirely new and previously unimagined insights into health and wellness could be generated.

“Our bodies have always had something to say, but now with advanced sensors, algorithms and software, we will be able to tune into what the body is telling us,” says Dr. Michael Blum associate vice chancellor for informatics at UCSF. “Validation of these technologies will improve the quality of data collected and help advance the ability to bring new products to market quickly. UCSF is pleased to play an important role in this effort to focus increased technology resources on digital health.”

CLIP-ON CHARGER

To avoid a repeat of criticism levelled against its existing smart-watches, Samsung suggested that a magnetic battery charger could be attached to the device while the wearer slept, to avoid them having to take it off at night.

It also suggested one possible way of presenting the data would be to offer a "wellness score" as a simple percentage read-out that would indicate the extent to which the wristband's owner was taking care of themself.

Other details revealed at Samsung's event included a plan to include wi-fi and Bluetooth connectivity in the Simband device.

SAMSUNG DIGITAL HEALTH CHALLENGE

To support its Digital Health Initiative, Samsung also announced the Samsung Digital Health Challenge, a $50 million investment fund dedicated to innovative start-ups and technologies in the connected health area. The goal of the fund is to stimulate cre-ative new approaches to digital health and Samsung's open plat-forms.

Additional information about the announcements and the Sam-sung Digital Health Challenge may be found at www.samsung.com/ssic n

AbedGraham leads US IT Expansion towards the NHS

AbedGraham, the London based clinical and corporate strategy consultancy, has recently secured multiple engagements with leading US healthcare IT corpo-rates vying for market leadership in the complex NHS market. Following signifi-cant reforms and the allocation of nearly £1bn to fund hospital technology, the UK has become a top-tier commercial target for global providers of software solutions. AbedGraham's clinical exper-tise and domain knowledge of the com-

plexities of the system have been used to support the introduction of a range of solutions ranging from clinical docu-mentation and workflow to information management and data analytics.

Recent clients include the speech recog-nition giant Nuance Communications and Imprivata, the global market leading provider of single sign on and clinical workflow solutions. Dr Abed, Found-ing Partner at AbedGraham, comments,

"The UK presents complexities at so many levels for international providers. Whether it's understanding frontline clinical workflow or budget allocation and reimbursement we're seeing a great uptick in interest for our services in order to drive effective sales, marketing and clinical engagement strategies by US providers."

For more information please visitwww.abedgraham.com n

http://www.samsung.com/ssic

http://www.samsung.com/ssic

http://www.abedgraham.com

10

Industry News

June 2014

Gauss Surgical has announced that the Triton Fluid Management System™, the world’s first and only mobile plat-form for real-time estimation of surgi-cal blood loss on surgical sponges, has received U.S. Food and Drug Adminis-tration (FDA) approval.

Triton provides physicians a first of its kind device to accurately estimate intra-operative blood loss through the use of sophisticated cloud-based computer vision algorithms to estimate blood loss and hemoglobin mass on surgical sponges.

Current methods of estimating blood loss during surgery based on visual esti-mation are known to be inaccurate. Clin-ical studies indicate that the use of blood products beyond a level deemed medi-cally necessary can increase complication rates, ICU days, and overall length of hospitalisation[1,2]. Overuse can also sub-stantially increase the cost of care. The cost of a single unit of red blood cells averages as much as $1,100 when admin-istration and supply costs are included[3].

A recent study by Premier, a health-

care performance improvement alliance of approximately 2,900 U.S. community hospitals and 100,000 alternate sites, looked at 464 member hospitals and concluded that blood utilisation repre-sents the eighth highest savings oppor-tunity for hospitals – a savings of $1.06 million per hospital, per year.[4]

“Blood loss in surgery has always been estimated and in situations of large blood loss, erroneous,” said Aryeh Shander, M.D., FCCM, FCCP, Chief, Depart-ment of Anesthesiology, Critical Care Medicine, Hyperbaric Medicine and Pain Management, Englewood Hospital and Medical Center, Englewood, NJ. “Over or under estimation of blood loss may lead to wrong clinical decisions. This new technology avails us the ability to more accurately account for blood loss with the potential to not only improve patient outcomes but also conserve healthcare resources.”

“FDA approval marks a significant mile-stone for the company and brings a truly novel product into the surgical environ-ment,” said Milton B. McColl, M.D.,

Chief Executive Officer of Gauss Sur-gical. “The Triton Fluid Management System has the potential to improve the quality of patient care and drive signifi-cant savings to hospitals through bet-ter utilisation of blood products and reduced length of stay.”

At its core Triton uses standard off the shelf mobile computing technology in combination with cloud storage. Using the iPad camera, the system scans sur-gical sponges that are covered in blood, and sends the images to the cloud where

FDA Approval of First Mobile Platform for Real-Time Estimation

of Surgical Blood Loss

Created in collaboration with product designers, engineers, and people with vision loss, the Bradley Timepiece introduces a stylish innovative design to help the blind and visually-impaired. Marketed as a timepiece for all, and not just for those with a sight-impairment, The Bradley is named after Lt. Brad Snyder who lost his vision from a bomb attack in Afghanistan and then went on to win two Gold medals and one Silver at the London Para-lympics in 2012.

Powered by a Swiss quartz movement, the watch has a ball bearing riding the circumference of the watch that shows the hour and one on the face that points to the minute. The Bradley was designed by Hyungsoo Kim of Eone Timepieces and was originally funded using Kickstarter, where the project raised considerably more than its target goal. n

Innovative Timepiece for the Blind and Visually-Impaired

Continued on page 13

Industry News


Philips has completed its first field study for its Minicare handheld cardiac Troponin-I blood test, demonstrating the platform’s potential to produce lab-equivalent results with finger prick sam-ples within minutes. The Minicare cTn-I system is designed to help physicians, nurses and paramedics identify patients at high risk for acute cardiac events right at the bedside or in pre-hospital settings. The initial results are encouraging as Philips prepares for the Minicare cTn-I system’s clinical trial, scheduled for 2015.

The field study was executed at the Catharina Hospital, a leading cardiology centre in the Netherlands. The Philips prototype blood test, performed at the patient’s bedside using a finger prick blood sample, was run in parallel to the

standard laboratory cTn-I blood test. The field study demonstrated promis-ing correlation between the finger prick test and the results of the whole blood sample from a venous draw. Moreover, the study indicated that these results can be obtained near the patient in the hands of the care giver.

Only about 15 percent of patients pre-senting in emergency departments with chest pain suffer from acute myocar-dial infarction (AMI). At the same time, early diagnosis and treatment are critical to improving outcomes around acute cardiac events, and today’s standard lab tests, logistics and reporting can take up to 90 minutes to enable decision-making. With a quick finger prick cTn-I blood test, Philips Minicare is being designed to measure AMI indicators almost immediately, wherever the patient is located. This has the potential to enable doctors to identify high-risk patients ear-lier, reducing the time from diagnosis to treatment or quickly discharging patients not requiring emergency care.

Waiting on conclusive blood test results can cause anxiety for patients and delay a physicians' decision for treatment. Almost 70% of diagnostic decisions are currently based on information pro-vided by blood assays, but it often takes an hour or more to get the results from a central laboratory. In life threaten-ing conditions like AMI, every minute counts. The Minicare Platform, with a small and easy to use form factor and proprietary Magnotech technology, is being developed to provide blood test results, within minutes, at the point of care, such as critical care treatment cen-tres, ambulances and in the future in GP clinics as well as at home.

With heart disease still the leading cause of death and accounting for nearly $500 billion of healthcare spend worldwide, providers are under more pressure than ever to better serve that patient popula-tion. Near-patient diagnostics like Mini-care have the potential to revolutionise the way clinicians diagnose disease and determine intervention. n

New Diagnostic Device Aims to Deliver Lab-Quality Results at

Patient Bedside

The


Digital Health 250250 Companies Worldwide Leading the Way in Digital HealthTo suggest a company or to apply to be considered for the list please contact [email protected]


12

Industry News

June 2014

A new study released by mobile engagement provider Mobiquity, Inc has found that while 70 percent of people use mobile apps on a daily basis to track calorie intake and monitor physical activities, only 40 percent share data and insights with their doctors. Working with an independent research firm, Mobiquity’s “Get Mobile, Get Healthy: The Appifica-tion of Health & Fitness” study reveals the opportunity for healthcare professionals and organisations to leverage mobile solutions to drive positive behaviour change and health-ier patient outcomes. In fact, 34 percent of mobile health and fitness app users said they would increase their use of apps if their doc-tors actively recommended it.

Mobile drives healthier lifestyles

According to the research, 73 percent of people claim to be healthier by using a smart-phone and apps to track their health and fit-ness. Fifty three percent, in fact, discovered they were eating more calories than they realised. Sixty-three percent intend to con-tinue, and even increase, their mobile health tracking in the next five years. But it doesn’t stop there: 55 percent of today’s mobile health app users also plan to introduce wear-able devices like pedometers, wristbands and smartwatches to their health monitoring in coming years.

Smartphone health tracking beats social networking

For many, using a smartphone to track their health and fitness is more important to them than using their phone for social networking

(69 percent), mobile shopping (68 percent), listening to music (60 percent) and making/receiving phone calls (30 percent).

But there is room for improvement

What’s stopping people from using their health and fitness apps more? Doctor rec-ommendations would be a big motivator, said 34 percent. Privacy was also a concern for 61 percent. But the chief reason people quit using these apps is simply because they forget – something that could and should be addressed by app developers to ensure health apps are less disposable.

“Our study shows there’s a huge opportu-nity for medical professionals, pharmaceuti-cal companies and health organisations to use mobile to drive positive behavior change and, as a result, better patient outcomes,” said Scott Snyder, president and chief strategy officer at Mobiquity. “The gap will be closed by those who design mobile health solutions that are indispensable and laser-focused on users’ goals, and that carefully balance data collection with user control and privacy.”

Mobiquity commissioned independent research firm Research Now to survey 1,000 consumers who use, or plan to use, health and fitness mobile apps. The study was con-ducted between March 5-11, 2014.

Summary of results

A summary of the results from this survey can be seen in the accompanying infograph. n

New US Study Shows 70% of People Tracking Their Health and Fitness

Daily Using Apps

The


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Industry News


The mobile industry has scaled dramati-cally over the last decade. At the end of 2003, there were a little over one billion unique subscribers - one in six people had subscribed to a mobile service. By the end of 2013, according to the GSMA’s annual report, this figure had more than tripled and reached seven bil-lion mobile subscriptions in April 2014.

In the Mobile Economy, 2014, published last month, the GSMA reports that there will be a dramatic rise in the number of mobile connections (including hand-sets, tablets and machine-to-machine devices), with the number forecast to reach 11 billion by 2020.

The mobile operator’s association has also identified four key growth areas that present both significant opportuni-ties and benefits for con-sumers and provide clear opportunities for mobile operators:

These areas are Personal Data, Digital Commerce, Connected Living and a fur-ther category, Network 2020.

Network 2020 is shaped by the belief that mobile net-works will be at the heart of the all-IP mobile broadband era, connecting devices and acting as the key interface between the physical and digital world. In order to be able to provide connectivity on a cost-effective and sus-tainable basis, mobile net-

works will need to be smarter, responsive, modular, flexible, scalable, adaptable and open. The operator community will need to collaborate on the definition of com-mon processes, guidelines and standards in the network space to meet the chal-lenges and opportunities of the future.

According to the report: “Operators should look to avoid fragmentation, guarantee interoperability of services and enable new business opportunities at a regional or global scale. Only through this collaboration will the industry be able to meet increasing demands for capacity and provide the level of service customers will demand as mobile net-works play an increasingly important role in their everyday lives.”

The report maintains that “mobile ser-vices will increasingly migrate into the Cloud to deliver on the promise of ser-vice access anytime, anywhere through any device; such services will be depen-dent on the availability of consistent high speed, low latency connections.” This leads to natural opportunities in 4G/LTE and making networks more “self- aware” and dynamically configu-rable, to cope with the increased traffic demand and also to provide the quality of experience customers expect. n

Global Mobile Subscriptions Reach 7 Billion

image-processing algorithms estimate the amount of blood contained on that surface and sends it back to the OR in real-time. Triton features an intuitive iPad interface, requires minimal training, and seamlessly integrates into existing surgical workflow. The system is fully HIPAA compliant.

“We identified a critical unmet need for a fast and accurate way to estimate blood loss on sponges in the operating room,” said Siddarth Satish, Gauss Founder and Chief Technology Officer. “By leverag-ing the power of mobile devices in com-bination with our proprietary software we’re fulfilling that need with the poten-tial to reduce unnecessary transfusions

and the associated costs and complica-tions.”

The approval went through the de novo classification process, a regulatory path for some low- to moderate-risk medi-cal devices that are not substantially equivalent to an already marketed device. Under the de novo petition review pro-cess the FDA reviewed data from two clinical studies that demonstrated the accuracy of the device.

Gauss was an early participant in the StartX Stanford University incubator and has recently relocated its corporate offices to Los Altos. In October, Gauss closed a $6.2 M Series A round of fund-ing. The round was led by LifeForce

Ventures with Promus Ventures and Taube Investment Partners participating.

1. “56 Facts About Blood and Blood Donation” Brookhaven Science and Technology2. “Saving blood, saving money, sav-ing lives” University of Florida Health Science Center3. Shander, et al, 2010. Activity based costs of blood transfusions in surgi-cal patients at hospitals. Transfusion 2010;50(4): 753-654. Premier Healthcare Alliance Analy-sis, 2012. “Standardization of blood uti-lization practices could provide oppor-tunity for improved outcomes, reduced costs.” n


14

Industry News

June 2014

The ability to determine the molecular composition of materials has been avail-able to scientists for many years using expensive lab-based spectrometers, but now a new device offers consumers the same possibilities, at a fraction of the cost. Launched via a Kickstarter campaign, the SciO from Consumer Physics is a $150 handheld device that can determine the molecular fingerprints of a wide range of materials. When the device ships to crowd-funding backers at the end of this year or early 2015, it will come with apps that can report the physical composition of food and pharmaceuticals, says Dror Sharon, Consumer Physics CEO.

Sharon says Consumer Physics’ spectro-scopic sensor has the potential to divine the chemical composition of a wide range of materials, from gasoline and rubber to cosmetics and gemstones. And once you can determine what something is—on a precise molecular level—you can also extrapolate what it isn’t, inviting new possibilities for product authentica-tion, consumer safety and other applica-tions.

SCiO is based on the proven near-IR spectroscopy method. The physical basis for this material analysis method is that each type of molecule vibrates in its own unique way, and these vibrations interact with light to create a unique optical sig-nature.

SciO includes a light source that illumi-nates the sample and an optical sensor called a spectrometer that collects the light reflected from the sample. The spectrometer breaks down the light to its spectrum, which includes all the infor-mation required to detect the result of

this interaction between the illuminated light and the molecules in the sample.

Spectrometers used for near-IR spectros-copy are normally found in scientific lab-oratories and are very big and expensive. Designed for consumers, SCiO leverages a tiny spectrometer, designed from the ground up to be mass-produced at low cost. Consumer Physics achieved this advancement by reinventing the spec-trometer around low-cost optics and advanced signal processing algorithms. SCiO uses technologies developed for cell-phone cameras and optical commu-nications devices to dramatically reduce the cost and size of NIR spectroscopy systems.

To deliver relevant information in real time, SciO communicates the spec-trum of the sample to a smartphone via Bluetooth, which in turn forwards it to a cloud-based service for review. Advanced algorithms utilise an updat-able database to analyse the spectrum

within milliseconds and deliver informa-tion about the analysed sample back to the user’s smartphone in real time.

Sharon simplifies the process even fur-ther: “It senses the spectrum of the actual molecules, sends it to the cloud, and compares what it finds to a huge database.”

The company have targeted food com-positions for the initial roll out. The system enables a user to scan an item of food and to determine exactly its molec-ular composition.

Assuming that the database is pre-popu-lated with all the information it needs to identify various fats, carbs and proteins, the system can report back specific data on the food you scan.

The key, Sharon says, is for the Con-sumer Physics database to have molecu-lar profiles of everything we might tar-get. He says that when SCiO ships to

$150 Smartphone Spectrometer Can Determine the Number of

Calories in Your Food

Industry News


Kickstarter backers, he expects the data-base to recognise about 80 percent of all the various foods we eat. Proteins are the hardest to detect, followed by carbs, and then fats are the easiest to profile. But in the end, Sharon says, all these materials are within SCiO’s reach.

Consumer Physics is focusing on food for its initial roll-out, as the world is obsessed with nutritional data, and calo-rie tracking presents such an obvious consumer use case. But the sensor tech-nology itself is capable of analysing a wide range of substances.

Future use cases for the device include pharmaceutical authentication, allowing consumers to identify allergens in food, as well as many uses beyond the health and wellbeing market.

SCiO has launched with an open API, so third-party developers will be able to extend the list of materials covered by the Consumer Physics database, and also create apps suited to specific use cases.

For more information visit: www.consum-erphysics.com n

Low-cost Motion Controller Provides a Unique Approach to

Physical Therapy

Physical therapy isn't fun. It's a physical and emotional challenge that often con-sists of dull, repetitive tasks. It's boring, and offers patients almost no short-term rewards for their very real efforts, how-ever, a new breed of application that introduces key gamification concepts offers new ways to engage patient's in their rehabilitation process.

A new software platform called Visual Touch Therapy is trying to make physi-cal rehabilitation fun, gamifying repeti-

tive exercises by marrying a Leap Motion controller, a PC and a simple meme-inspired video game. The game itself is fairly simple: players perform simple motions over the Leap controller that cause a dog character to run (or fly a jet-pack) across the screen, and their perfor-mance and improvement can be tracked, quantified and even sent to their physical therapist for review.

Currently, the games are focused on helping stroke victims, but Visual Touch

Therapy hopes to build games in the future to help patients with arthritis, car-pel tunnel syndrome and even multiple sclerosis.

The use of motion controllers in physi-cal therapy is nothing new. Ever since the launch of platforms like the Nintendo Wii and Microsoft Kinect, rehabilita-tion units have been employing motion and gesture control programs and games to improve the way in which patients engage with their physical therapy excer-cises.

The Leap motion controller, is a unique proposition in this field as it introduces a low-cost easily programmable device that is capable of being incorporated across a diverse range of platforms.

The leap controller is being incorporated into a range of health related projects. MotionSavvy is an initiative to use the technology as a means of providing real-time sign language translation. Another innovative project called MACSAir aims to bring touchless capability to manipu-lating catheters in MRI machines during heart surgery – reducing the time that patients need to spend under the knife. n

http://www.consumerphysics.com

http://www.consumerphysics.com

16

Industry News

June 2014

The global market for mHealth is expected to reach $49 billion by 2020, according to a new study by Grand View Research, Inc. Monitoring services are expected to remain the dominant and fastest growing market segment, with market revenue of USD 1,227.5 mil-lion in 2012, and an estimated CAGR of 49.7% from 2014 to 2020.

In addition to the headline growth fig-ures, the report also outlines some of the key economic and social factors which are driving the market.

Per capita healthcare expenditures have been increasing, which makes medical services unaffordable for a large per-centage of the population. As a result, demand for mobile health is expected to increase considerably over the next six years. In addition to smartphone prolif-eration, uptake of 3G and 4G networks is expected to increase demand for tele-medicine services. Aging population and growing incidences of diseases linked to changing lifestyles have intensified the need for affordable and accessible healthcare.

The report also cites concerns among users, regarding the safety and privacy of information, along with the need for secure infrastructure, as some of the key

challenges for market participants, going forward.

Key mHealth services analysed and reported in the study include monitoring services, diagnosis services, healthcare systems strengthening and others. Other services primarily comprise wellness and prevention, and are focused on elderly care, drug abuse prevention, healthy liv-ing, smoking de-addiction and child care.

The European market is expected to be the largest regional segment by the end of the forecast period. Remote moni-toring solutions and patient treatment accounted for majority of the overall mobile health deployment in the Euro-pean region. On account of growing smartphone adoption, the region has also witnessed growth in health and well-ness based mobile apps. The UK domi-nated regional mobile health deploy-ments, with services delivered through channels ranging from SMS to complex apps.

Further key findings from the study suggest:

» The global market was valued at USD 1,950 million in 2012, and is expected to grow at a CAGR of 47.6% from 2014 to 2020.

» Chronic disease management was the largest contributor to the moni-toring services market, with higher demand from developed markets of North America and Europe. The market for post acute care services accounted for 19.5% of the over-all monitoring services revenue in 2012. Diagnosis services are more prevalent in developing markets, and

growing adoption of these services is expected to considerably augment access to healthcare in these regions.

» Mobile operators accounted for 48% of the overall market in 2012, with majority of their revenue originat-ing from monitoring services such as independent aging solutions. The market for healthcare provid-ers is expected to grow slower than the global average, at an estimated CAGR of 45.1% from 2014 to 2020. Quelling credible concerns among users, along with availability of regu-latory support is crucial for driving profitability of industry stakeholders.

» North America dominated the global market, accounting for 33.5% of total revenue in 2012. Highest demand originated from monitor-ing services, with growing incidences of chronic diseases necessitating the need for mobile health solu-tions among others. High per capita healthcare expenditure in developed markets is expected to be the key driver for regional growth. Driven by the need for accessible healthcare, the Asia Pacific market is expected to be the fastest growing regional mar-ket, at an estimated CAGR of 49.1% from 2014 to 2020.

» The market comprises of many stakeholders including mobile opera-tors, device vendors, healthcare providers as well as content players. Companies operating in the market differ on the basis of their offering, and play a key role in overall mHealth adoption. Strategic collaborations and partnerships with healthcare providers, and resolving standardi-sation and interoperability issues are essential for mass acceptance.

The full report “mHealth Market Analy-sis And Segment Forecasts To 2020,” can be found at: www.grandviewresearch.com/industry-analysis/mhealth-market n

Global mHealth Market Expected to Reach $49 Billion by 2020

http://www.grandviewresearch.com/industry-analysis/mhealth-market

http://www.grandviewresearch.com/industry-analysis/mhealth-market

Industry News


High blood pressure is known to be one of the greatest health risk, worldwide, behind smoking and alcohol consumption. In Germany, around 25 percent of the population suffers from arterial hypertension.

Microsystems engineers Dr. Dennis Plachta and Prof. Dr. Thomas Stieglitz from the Laboratory of Biomedical Micro-technology at the Department of Microsystems Engineering (IMTEK) of the University of Freiburg have teamed up with the neurosurgeons Dr. Mortimer Gierthmühlen and Prof. Dr. Josef Zentner from the Medical Center - University of Freiburg to develop a new implantable cuff equipped with electrodes that can lower blood pressure without causing side effects.

Doctors usually prescribe drugs against high blood pressure. In around 35 percent of patients, however, pills do not succeed in reducing blood pressure in the long term. Chronic high blood pressure leads to damage in other organs – the eyes, kidneys, the heart, and the central nervous system, in particular.

In order to help patients whose blood pressure cannot be reduced by means of drugs, the Freiburg researchers propose implanting a newly developed cuff with 24 electrodes in the so-called vagal nerve on the neck. The device starts by determining which electrode is closest to the nerve fibers that transmit the blood pressure signal. Then it uses electrostimulation to over-

write the information in these fibers with such precision that other bundles of fibers with other functions are not affected. The researchers have named this procedure for individual analy-sis, selection, and stimulation “BaroLoopTM.”

The scientists tested the device on rats and succeeded in lower-ing their mean blood pressure by 30 percent, without causing side effects such as a reduced heart rate or a drastic decrease in respiratory rate. The findings of the study have been published in the Journal of Neural Engineering.

The idea for the research project originated in 2004 within the context of the establishment of the Peter Osypka Endowed Chair in Neuroelectronic Systems at the Department of Neuro-surgery. Now that the scientists have determined that a cuff with electrodes is feasible in principle, they have begun to develop a completely implantable system. As such a device is classed as an active implant that must fulfill the highest level of safety stan-dards according to medical product laws, they do not expect to produce a licensed product for at least ten years.

Original Article: Plachta, et al. 2014. Blood pressure control with selective vagal nerve stimulation and minimal side effects. Journal of Neural Engineering 11 036011. n

New Method for Lowering Blood Pressure Without Side Effects

Clinicians are being given the opportu-nity to fit specialist learning into their busy lifestyles thanks to a tailor-made medical learning tool devised by Pap-worth Hospital experts.

The Papworth Hospital MCQ Learning App gives health specialists the opportu-nity to learn on the go.

Developed by Dr Alain Vuylsteke, Con-sultant Intensivist at Papworth Hospital, the App offers dynamic multiple-choice tests to users to provide a quick and effective way of learning about highly specialist medical techniques.

It is built so that two tests are never identical, includes comprehensive expla-

nations and will retrieve supplementary information from the internet.

On completing the test users are pre-sented with a virtual personal certifi-cate with their final score which can be archived, downloaded or emailed for their records.

It has already received worldwide interest from clinicians and other professionals.

Dr Vuylsteke, who worked with other Papworth Hospital Consultants to create this App, said: “It is great to have built a tool that facilitates the sharing of knowl-edge accumulated in an institution such as Papworth. We will hopefully gather enough support to realise this concept to

its full potential by including many more learning modules in the near future.”

The MCQ Learning App currently offers a range of multiple choice questions on transoesophageal echocardiography (TOE).

This procedure provides clear ultra-sound images of the heart and is used as an alternative to standard echocardiogra-phy.

It is hoped that the App will be expanded to include a variety of specialist heart and lung subjects, including electrocardi-ography and radiography.

For more information on this applica-tion visit: www.papworthhospital.nhs.uk n

App Offers Interesting New Way for Doctors to Learn

http://www.papworthhospital.nhs.uk

18

Industry News

June 2014

Touch Bionics, a manufacturer of high-end hand prostheses, has announced a number of new technologies that enhance their i-limb ultra revolution bionic hand.

Of particular interest are the companies new Grip Chips. These coin-sized Blue-tooth-enabled devices, can be stuck to any object to automatically activate a par-ticular grip of the hand when it comes near. For example, when sitting down in front of the computer, the hand can immediately fold all except one of the fingers to make typing on the keyboard easier.

Using the my i-limb app, patients can easily program grip chips with any grip or gesture and place in a desired loca-tion. Simply holding an i-limb ultra revolution device within close range to a grip chip will activate the programmed feature. The intuitive solution combined with the dexterity of the prosthetic hand

enables users to perform a variety of activities with ease and precision.

The limbs can be currently controlled using a smartphone interface that allows the user to select pre-defined grip posi-tions for their prosthesis. The novel Bluetooth-enabled devices mean that these pre-defined grips can be more quickly accessed in relation to the users environment, allowing the correct grip to be assumed at the necessary time of operation. Other examples of how this can be practically incorporated into a patient's everyday life would be for activ-ities like picking up a cup, or operating door handles. By automating the grip process the prosthesis becomes much more intuitive to the user's individual requirements.

The grip chips add to the range of con-trol options for users of the companies i-limb prosthetic limbs. In total there are 36 different grip options that can be pro-

grammed via the mobile app.

To make that process easier, the new i-limb skin active TS prosthetic hand sur-face works with touchscreen devices and all i-limb devices will be made compat-ible with the Android OS.

For more information visit Touch Bion-ics online at: www.touchbionics.com n

'Grip Chips' Let Hand Prostheses Think for Themselves

Proteus Digital Health has raised $120 million from new, undis-closed investors. The company will use the funding to continue its plans to commercialise its ingestible sensor system at scale, as well as to continue demonstrating the value of the technology on health outcomes and costs.

The Proteus digital medicine platform is a medication manage-ment and adherence system that includes unique measurement tools, like sensor-enabled pills, a peel-and-stick biometric sensor patch worn on the body, and companion smartphone apps. The patch records when a pill is ingested and also tracks other things like sleep patterns and physical activity levels. The ingestible sensor component secured FDA clearance in July 2012, while the company’s sensor-laden patch got FDA clearance in 2010.

“We are entering the commercial era of the Internet of Things (IoT) – your car, your clothes and increasingly your personal care products are going to be connected,” President and CEO Andrew Thompson said in a statement. “Our focus is on partnering with major health systems to deliver solutions that

enable consumers and their families to switch on their

own healthcare, creating critical information that can be used to ensure they and their doctors make positive decisions about use of medicines and personal health choices. A key part of our success will be to ensure that we have the support of investors as we build this market. The financing we closed is an important demonstration of investor confidence in the growth potential created by IoT companies.”

Proteus announced this past March that it would open its first international manufacturing plant for its digital medicine system in the UK, in partnership with parts of the UK’s National Health Service. The company expects to employ 200 at the facility.

“Proteus Digital Health has created a remarkable leadership position in the digital health care market by enabling medicines to communicate with the internet,” Symonds said in a statement. “This technology has the potential to enable Proteus Digital Health and its partners to re-engineer the existing commercial assets of the pharmaceutical industry in order to create high value proprietary products that leverage the drugs they already sell using the mobile phone in every consumer’s pocket.” n

Proteus Raises $120M to Scale Smart Pills

http://www.touchbionics.com

http://www.tactiosoft.com

20

The Value of Video in Modern Health and Social Care

June 2014

The use of video in healthcare is noth-ing new, in fact the concept for telecon-sultations has been around for decades. Despite this, it is only really in recent years that the use of video has become more widely accepted among healthcare professionals and providers as a viable operational tool.

As part of our consideration, in this issue, of the barriers and challenges that can affect adoption of digital and mobile health solutions, we have partnered with UK based healthcare video provider v-connect to consider the deployment, use, benefits, and barriers to adoption of video within modern health and social care clinical work flows. Using deploy-ment case-studies and user experiences, we analyse how this type of system can be best employed in order to integrate effectively within everyday use scenarios.

Video is an extremely compelling medium for healthcare, as it can provide the means to remotely administer care whilst maintaining the critical aspects of human interaction, that foster trust and rapport between patient and carer, something that can often be lost when using technology. In fact by increasing the ability to connect with care provid-ers in a wider range of circumstances, often facilitating the interaction, video can actually be used to underpin com-munication in care situations.

The Technology

The v-connect solution, developed by UK based Red Embedded Systems, is a dedicated secure and proven video com-munication service linking professionals together to improve the quality of care. Developed in partnership with the UK

National Health Service and local

authorities the system meets the high-est levels of security whilst delivering seamless communication. The service has been deployed throughout the UK to meet the needs of a number of dif-ferent health and social care priorities. By partnering with care organisations to enable the delivery of services that focus on outcomes, the system is creating new possibilities for accessing health and social care and associated services from the home, and other remote locations.

‘v-connect’ provides a service led solu-tion that incorporates a set-top box con-nected to a recipients television. The hardware and system requirements are easily installed resulting in an unobtru-sive, secure, encrypted, teleconferencing system. Recipients have access to a tai-lored carousel-style menu interface that incorporates all of the relevant services for their particular care requirements. This allows care providers to deliver multiple services at a single point of access. As well as live video features, it is also possible to upload learning or reha-bilitation content specific to an individ-ual recipient that can be easily accessed when required. Access can also be moni-tored to help maintain adherence with care plans, and the system easily inte-grates with other condition monitoring services to link live video with real-time bio-telemetry. With a small number of users the system works with a simple person-to-person approach. As the number of users increases and the need to integrate multiple services develops v-connect offer communications hubs. These are simple to use call-manage-ment panels enabling care providers to easily manage, triage, filter, and re-route all calls to ensure that they all receive the attention they require. The system has interfaces across all major IT platforms,

which means that video calls can easily be re-routed to the PC, smartphone or tablet of relevant consultants, doctors, or carers.

The use of a dedicated video solution delivers healthcare providers and the end user patient with significant benefits over other communication applications, such as domestic consumer services like Skype, and VoIP which is predominantly business orientated, and therefore inap-propriate for use in care situations. By developing the system with direct input from the NHS, the technical elements of the service have been designed to ensure that they integrate with existing IT pro-visions, meaning that care providers can access the system easily from behind corporate firewalls, ensuring that video can be effectively integrated into every-day work flow.

Health and social care deployment

Alasdair Morrison, Service Manager of STAY (Sandwell Telecare Assisting You) at Sandwell Metropolitan Borough Council in the UK has been working with v-connect for a number of years to provide video for a range of differ-ent health and social care deployments. He describes how Sandwell have been an early adopter of the technology, and how through their experience of using the system they have recognised the potential that video services can deliver, particularly when used across, multiple agencies, organisations and departments involved with health and social care delivery.

In one deployment, which highlights the significance of using video in social care situations, Sandwell Council was able to


Embedding video within health and social care provision has been shown to produce significant health economic and quality benefits. This report considers the implications of incorporating video in order

to underpin communication in modern clinical work flows.



save nearly half a million pounds in costs (in the first year of use). By analysing high-cost learning disability care pack-ages, provided by the Council, Morrison and his team were able to identify par-ticular cases where care and assistance could be better provided using telecare and virtual visits as a means of provid-ing targeted, assistive, at-home, care to people with learning disabilities, whilst also supporting those people to become more independent. The use of the sys-tem gave the Council the ability to create a dedicated video service that was pres-ent in each recipients home. The sys-tem was then networked across a range of services that combined to improve the assisted living solution. This meant recipients could network with each other across secure video and audio links, they also had access to a 24-hour alarm ser-vice, should emergency care or advice be required. The integrated nature of the solution additionally meant that contact with care stakeholders, family, and other support channels could be provided via the same solution.

The potential though is even greater. Sandwell have identified other preven-tative and social care services that can all be provided via the system at the single point of access, for example hous-ing management, tenancy support and community services. This means that a range of services can be accessed by the user, and multiple agencies can collabo-rate and use the system to administer services, which in turn reduces the unit cost of having the hardware located in a property.

The aim for Sandwell is to develop an inclusive system that deploys across access points located both in residential homes, and at various convenient com-munity locations like libraries, leisure centres, and council offices, etc. They also intend to integrate the system across all community health and social preven-tion teams, through the establishment of a Multi-Agency Prevention Platform. With video at the heart of the interaction this solution will combine existing ser-vices to provide a streamlined point of reference for interactive access to health and social care.

Delivering a package of services via a single system not only reduces costs, but also strengthens the effectiveness of each component offering, as well as fos-tering cross-discipline and multi-agency cooperation. This prevents duplication of resource commitment and better overall strategic management.

Other councils in the UK are equally recognising the benefits that can be derived from initiating this type of pre-ventative, in-community and in-home care, and are beginning to explore these across an interesting range of care cir-cumstances. Calderdale Council recently trialed the v-connect system as a means of providing relational care to out-of-area residents and found the system to be extremely useful in building relation-ships between their care providers and the care recipients. The Council is now exploring other cases that may benefit from this type of interaction.

For Alasdair Morrison of STAY the critical element of using video and other complimentary digital solutions is that it necessitates the re-engineering of ser-vices, thus adding not only the value of video interactions, but actually making the underlying services themselves more efficient.

This sentiment is echoed in primary and secondary healthcare. Dr Richard Pope of Airedale NHS Foundation Trust UK describes the motivation for video and digital solutions as not being led by a desire to negate or necessarily reduce admissions but instead it is about deliver-ing clinical efficiencies by ensuring that care is provided in timely, relevant situa-tions. Airedale have, over the past 9 years, successfully delivered a digital strategy built upon video services. Their initial work involving the provision of clinical video consultations to prison offenders, has significantly grown to encompass a range of remote care and consultation services, across a number of different medical disciplines.

All care situations involve multiple stake-holders. One of the critical elements to deploying a successful digital health solu-tion is being able to offer a system that is sufficiently flexible enough to meet the different demands of these stakeholders.

This is particularly critical where video is being used to manage patient care and provide remote consultations. It is important that the systems are available at the right time, in the right place, and via a method that fits with the needs of the user. One way to look at these inter-actions is to break down the relevant connections involved in the care con-tinuum into component relationships: Professional to professional communi-cation; professionals to a person at home or in a care home; and, where people are supported by family or carers. Each of these relationship will require slightly different operating work flows, and it is therefore imperative to establish proto-cols along with service level agreements to ensure successful operation.

As part of Airedale's Right Care strategy they are introducing a raft of services that enable patients to access the right care, in the right place, and at the right


Connecting people together in the community colleague

Connecting care professionals Connecting care and treatment in the home

v-connect.co.uk 01274 287 787 [email protected]

Connecting Care, Connecting Carers

Solutions that improve outcomes

We can work with you to implement a network of care that enables personalisation for the cared for and integration between care providers.

v-connect provides a complete solution to implementing video communication in the

remote delivery of care.

Connecting CareVideo connects people to each of their services giving them a single point of access to care in their home.

Connecting CarersUsing video to communicate between care providers allows better communication between carers.

http://www.v-connect.co.uk

v-connect.co.uk 01274 287 787 [email protected]

Connecting people together in the community

Connecting care and treatment in the home

Colleague, Care and Companion are three di�erent aspects of the v-connect service. By using the same infrastructure to deliver all three aspects, the service ensures maximum return on any investment. This simple one stop approach tackles some of the key issues facing health and social care:

- With the ever increasing �nancial impact of multiple morbidities and the ageing population, integration of services becomes essential to ensure the person is treated both e�ectively and economically.

Colleague is proven to deliver this.

- Connecting family members and other carers in a simple, visual way builds con�dence, reassurance and trust.

Companion is proven to deliver this.

Talk to us today to see how v-connect can connect your services to your people to improve your care and reduce your costs.

- A simple, single point of access to care in the home, provides immediate support and treatment, reducing acute attendance at the emergency department and number of bed days in hospital.

Care is proven to deliver this.

http://www.v-connect.co.uk

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June 2014

time. Video is seen as one of the key enablers to this policy, and the Trust has developed a range of services to deliver care via video and other digital channels. For Dr Richard Pope of Airedale NHS Trust this is all about individuals taking ownership of their conditions and allow-ing them patient-centred care that can be easily accessed. At present the various Airedale services operate as a central-ised digital triage, where highly-skilled nurses are available for video consults with managed patients. They then have access to manage the care pathway by which that patient either moves into the secondary care system, or remains under primary care in their own home. In terms of work-flows this delivers immediacy, in that a patient can be assessed via video immediately to determine whether they need hospital admission, additional primary care assistance or simply self-adminstered help.

“Often simply the reassurance of know-ing that the system is available is sufficient to reduce many hospital admissions, par-ticularly those related to anxiety” states Dr Pope.

The longer-term aim of the Airedale solution is to deliver connected care that will allow patients to easily conference with consultants or specialists, from all over the UK and ultimately around the world in order to gain the best possible care package for the patient, without the

need for extensive referral or relocation between care organisations.

Integration

For care providers often one of the big-gest challenges when adopting a video-led service network is the difficulties of deploying the system so that it integrates with their current service packages. This means that in order to be successful it is vital for video solution providers to cre-ate, design and deploy a full service, to ensure that there are agreements in place so that there is someone to call should problems arise, leaving the care provid-ers free to deliver care, and not manage IT systems. Allowing care providers to develop strategic plans for the imple-mentation of video across a range of services without worrying about cross-service network problems.

Alasdair Morrison, of STAY, describes how their experience of deploying video across health and social care services has been relatively easy in terms of the tech-nical elements of the provision.

“Because v-connect initially developed the system with the help and advice of the NHS, it meant that any deploy-ments in primary or secondary health-care, where IT systems used the same NHS standards, were relatively simple to deploy as they easily integrated within the current network architecture.”

Many solutions that are available to pro-

vide video services in healthcare work in such a way that they can compromise the integrity of the network security. By requiring open connections or disabling elements of a firewall, native systems can be left vulnerable to intrusion, or suffer from connection and reliability issues. Knowing that the NHS and other pub-lic organisations represent such a large part of the care provision network in the UK it is imperative to offer a service that can be effectively integrated without compromising the network integrity of the end user, whilst still delivering secure deployment and fully encrypted video and audio.

Airedale NHS Foundation Trust worked extensively with Redembedded to help deploy secure, stable and reliable ser-vices. Rebecca Malin, Deputy Director of Strategy and Business Development at the Trust believes that it is essential for developers and systems providers to use internationally accepted network and IT standards, in order to ensure that sys-tems can be easily adopted.These standards become even more vital when organisations begin to demand and implement a multi-system solution, and require those solutions to inter-connect.

Dr Shahid Ali, a GP and Professor of Digital Health, and Director at Dynamic Health Systems has collaborated with v-connect to integrate video into the Vitrucare patient management solution offered by the company. VitruCare is an internet delivered ‘self-care’ service that allows patients, with the continued sup-port of the GP, to make decisions, using data from their electronic health record to change their lifestyle to improve their overall health.

Dr Ali believes that the integration of different mobile and digital health solu-tions is a vital aspect of ensuring greater adoption throughout the sector. The collaboration between these two solu-tion providers demonstrates that inte-gration is possible, provided that indus-try partners are willing to cooperate on the development and interoperability of solutions.

“Technology itself is not the barrier!” states Dr Ali. “Providing the technology works in the manner it is designed, then the technology itself is not necessarily the problem. Integration is the barrier!




Solutions need to be able to talk to one another, system-to-system”.

Changing the culture of care provision

A long term proponent of digital and mobile health solutions, Dr Ali has spent nearly a decade advocating the need for institutional change in order to encour-age the greater adoption and wide-scale deployment of digital and mobile health systems. He believes that there are a variety of barriers influencing the wider adoption of these technologies in the UK, but also that we are finally approaching a tipping point whereby the wider medical industry is beginning to understand that change must happen and that digital connected solutions are a critical component in this equation for change. “In terms of where the push or pull for greater use of digital and mobile health solutions is coming from, it is not from one individual source, but instead we are beginning to see a multi-faceted push towards the wider adoption of these solutions. This is coming from: Demand from patients – for these types of ser-vices; from industry providers; from doctors and care providers; and from government policy” states Dr Ali.

Technology in the health sector can often be contentious, as it is perceived differ-ently by various stakeholders. Develop-ers and manufacturers of healthcare technology often view the solutions that they develop from a technical perspective that doesn't always translate into clinical benefit. One of the reasons for this is that technology is often grouped within the context of IT, something requiring extra training or knowledge aquisition in order to be used effectively. Because of this it is often viewed as a hindrance to care provision rather than as an enabler.

Providers must therefore demonstrate the clinical compatibility of their solu-tions in order for them to be more widely accepted. ‘v-connect’ recognised the need to clearly define their product within a clinical context, and have taken significant steps to undertake 'cultural shift' within the way that they, as tech-nologists, communicate the potential for their integrated video solution to health-care professionals.

Cultural change is a major obstacle and one which cannot be changed quickly or without full cooperation between all parts of the care-supply continuum. Resistance to change comes from the uncertainty that these solutions can have upon working practices, the impact on workloads, and the changes to the care provider - patient relationship are all concerns that need to be addressed in order to encourage clinicians and care commissioners to adopt digital health into primary methods of working.

Resistance from staff was initially an issue for Sandwell Council. This reti-cence, however, was very quickly over-come when staff realised the capabili-ties of the technology to support and empower care recipients in new ways, which freed up human resources for more serious or difficult cases. Airedale NHS Trust also witnessed similar early sceptism from staff, particularly among clinicians, in relation to data security and compliance.

Rebecca Malin from the Trust states that, “Once we had demonstrated to clinicians that we had implemented effective rules of governance, security and encryption,

then the concerns were quickly over-come. Clinicians quickly recognised that these type of solutions deliver positive outcomes to their patients, and there-fore represent an effective method of administering care. “Interestingly there was little or no reluctance from patients in terms of security, and in fact the adop-tion among patients has been extremely straight-forward.”

“We did have initial concerns that by offering 24/7 access to care providers, that we would be flooded with incom-ing requests, which is why we started the service small. However, this has not been the case at all, instead patients seem con-tent with the knowledge that the access is there should they need it”.

Upstream cultural change in organisa-tions is more problematic. The methods in place to commission services, and the tariff structures necessary to fiance them, are often poorly designed to cope with the commissioning of digital and technological solutions. In fact the way in which the current system operates in the UK, means that NHS managers are often


26


June 2014

ill-equipped to implement these services within the current structure. The need to re-engineer the way in which services are delivered and change the way in which payments for care are administered is often seen as too much of a risk to an organisation. The need for a body of evidence that demonstrates the cost-effi-ciencies and the improvements in care, particularly for patients with long-term or multimorbidity conditions, becomes the colloquial 'chicken and egg' situa-tion. For the industry at large the need for cultural change within the UK NHS has in many cases prevented technology providers from gaining significant trac-tion within the market.

According to Dr Ali, this is slowly begin-ning to change, as UK Clinical Commis-sioning Groups, which are still in their relatively infancy, are beginning to under-stand that changes in the way that care is delivered need to be made. So that it is necessary to embrace technology in order to empower the individual to take greater responsibility for their own medi-cal needs and as a means of controlling flows of information.

The need for a clinical perspective

Adam Hoare Managing Director at v-connect describes first-hand some of the barriers that have arisen in bringing a health care video solution to market, and the need to brand and convey the mes-sage of the solution effectively to health-care providers, in order for them to make informed decisions on the effectivness and likely return on investment from commissioning video services.

We have been deploying video to sup-port care delivery for five years. In that time we have come to understand how to lower some of the barriers to adoption. The original decision to provide a service was developed out of our early experi-ence. The service we have developed addresses barriers to adoption such as:

1. There is no one-size-fits-all approach. The video service we deploy underpins many different care services across primary, secondary and social care. Each engagement is unique and requires close collabora-

tion with the customer to design and develop the network of connections. This leads into the second point.

2. In different deployments the user interfaces need to support dif-ferent workflows. Implementing virtual waiting rooms, call transfers, mobile devices, touch sensitive triage panels and the set top box facilitate the use of video communication with different stakeholders. The abil-ity to develop these interfaces and work with customers leads to the next point.

3. In order to have video under-pin care delivery there needs to be a clear understanding of how the tech-nology interacts with practice. This means working with practitioners to appreciate their needs. This bottom up approach is slower as we are work-ing with very busy people. However, it is very necessary to understand how video can help without present-ing another barrier to getting things done.

These requirements cannot be met by a transactional, top-down approach where the technology and its implementation follow a template. Lowering the barri-ers takes time but all the evidence we are generating suggests that embedding the video in care produces health economic and quality benefits with many outcomes being emergent from the usage. These emergent behaviours often come when the network crosses traditional barri-ers or siloes. A further barrier to the adoption of video in care has been the idea that off-the-shelf or simple video approaches such as Skype can be used and that practice will assemble around them. We have worked on ensuring that our solution can cross secure networks such as N3 and that of Local Authorities so that the embedded video can enable these cross silo deployments. Many sim-ple solutions cannot do this as they pres-ent a security threat to these networks. In fact we have developed our service approach to have minimum impact on internal IT systems so that deployment does not become an IT headache for care organisations. This serves to lower another barrier to adoption.

The approach described is best navigated

by a small enterprise that can be flexible in terms of technology development and collaborate with partners to develop the video in a way that underpins care deliv-ery. Whilst developing this understand-ing we were very technology focussed in the way we initially discussed the service. We were lucky enough to deploy the ser-vice with Manorlands Hospice in Keigh-ley. Here we met Steve Davison who was managing the hospice. He was impressed by what the video could do for the resi-dents and has subsequently worked with us as a clinical consultant. With his back-ground in nursing he was able to help us reshape the message to be about out-comes. We are currently launching our new brand for the service v-connect. When discussing the v-connect service we focus on three groups of stakehold-ers:

» Care – looks out outcomes related to connecting practitioners to people at home or in residential care.

» Companion – looks at outcomes related to connecting family mem-bers to people being cared for.

» Colleague – looks at the benefits to practitioners of being able to use the video to communicate between themselves.

It is much easier to explain how care can become person-centred and better coor-dinated between care organisations using this new approach.

We still have a lot to learn. Where we deploy the video it is disrupting current pathways and opening up new ways of delivering care effectively and efficiently.

‘v-connect’ will be presenting a number of papers at this years King’s Fund Inter-national Digital Health and Care Con-gress held in London in September that will give a flavour of how v-connect is impacting on care delivery and bringing new combined opportunities through interoperability. The topics that will be considered will include: The integra-tion of cardiac monitoring with video to enable service transformation; promot-ing patient empowerment and sustain-ability in kidney care using telemedicine; and, technologies supporting integration and person-centred care. n


Social Networking 'Transforms' How Healthcare Teams Work


New technology which gives instant alerts about patients to healthcare staff and allows them to communicate on a secure social network has “transformed” how teams work and “signifi-cantly improves patient care”, according to a leading clinician.

Dr Michael Bedford, a renal research registrar, hailed the suc-cess of a trial which gives medical staff at East Kent Hospitals University NHS Trust mobile alerts in real time about acute kid-ney injury patients. Once alerted, the medical team, often spread across multiple sites, can discuss the next steps via a secure social media style system of messaging and responding.

The first four months of the pilot with DocCom’s Notify and Careflow software have shown faster decision making, enhanced patient care and improved overall efficiency within East Kent’s renal department. The team are hoping to see a further impact in terms of realising the subsequent cost savings over the com-ing months.

Dr Bedford said: “This technology really does have the ability to completely transform how we work and ultimately, improve patient care significantly.”

The team was frustrated that their existing system of emails, text messaging and paging, combined with face-to-face meet-ings was causing delays for patients and healthcare teams alike.

Dr Chris Farmer, Associate Medical Director for IT at EKHUFT, said: “In the past, we have seen cases where a patient has arrived at A&E and there has been an unavoidable delay before they are seen by a specialist in charge of their care. With the DocCom systems in place, the right people have been informed of their arrival immediately, and they have been with the patient within an hour.”

The EKHUFT team found the DocCom systems easy to set up and use, and said this significantly contributed to the trial’s success. Dr Farmer added: “It’s the easiest IT system I have

ever implemented. No training was required, it was completely intuitive. The benefits are immediate and obvious, and people like using it. The beauty lies in its simplicity. They haven’t tried to be clever and only kept in what is needed.”

Whilst the clinical teams have seen first-hand how the systems can transform their day-to-day practice, the Trust’s Medical Director, Dr Paul Stevens said there has been an improvement in overall efficiency.

“The system provides an easy way to get everyone together to make a quick decision. And importantly for me, this has fan-tastic potential for improving patient safety and ensuring the correct accountability,” he said.

Dr Stevens urged other Trusts to come and witness what can be achieved with this technology.

“For Trusts that are willing to adopt and embrace social technol-ogy, I believe the possibilities are endless. We could see major improvements in communication between primary and second-ary care for the explicit benefit of patients. With the DocCom systems developed, all Trusts need to do is invest in the infra-structure to make these improvements a reality.”

DocCom estimates that with results such as those in East Kent, significant cost savings can be made. For example, a 20% reduc-tion in an AKI patient’s length of stay would translate to savings for the hospital of up to £7.7m a year.

Dr Jon Shaw, DocCom’s Managing Director and Founding Part-ner, said: “We are delighted with how the renal team at East Kent – and most importantly their patients – have been able to benefit from the technology. Thanks to the success of the pilot, we are now working with EKHUFT to roll out the use of the technology to benefit other departments across the Trust.” n

Social Networking and Alerts Technology ‘Transforms’ How

Healthcare Teams Work

28June 2014

CONFERENCENEWS

In his speech to the annual ATA (Ameri-can Telemedicine Association) confer-ence in Baltimore, Edward Brown, Presi-dent of the Association, outlined plans to introduce an accreditation scheme for the telehealth industry.

The aim of the accreditation program, which is detailed in a draft consultation paper, aims to clarify the relationship between the industry and consumers. The American Telemedicine Association is working toward an autumn launch of the accreditation program for primary care and urgent care. Brown, who also heads up the Ontario Telemedicine Net-work, has said the program is needed to help consumers make good choices and to reassure patients that online medical

consultations are convenient and safe. It published a draft document earlier this month and is seeking public comment.

While the ATA has developed Core Guidelines for Telemedicine Opera-tions that provide overarching, broad guidance, the purpose of these draft guidelines is to provide specific recom-mendations on the use of real-time, two-way videoconferencing (VTC), and telephonic communications between providers and patients (i.e. direct-to-patient) in the delivery of primary and urgent care. The guidelines address clini-cal, technical, and administrative speci-fications, and establish baseline practice expectations for remote consultations, promote quality outcomes, and support

a more informed patient population.

The guidelines address the use and appli-cation of telehealth services suggesting that telemedicine in primary care settings should treat uncomplicated conditions or be used for simple or routine follow-up for patients with underlying chronic conditions, and for the management of patients with medical conditions such as allergies and asthma, influenza, low back pain, and upper respiratory infections.

The draft consultation document can be read online in full at: www.american-telemed.org/docs/default-source/standards/ata-primary-urgent-care-guidelines-draft-public-comment-final-(2).pdf n

ATA Plans to Launch Telehealth Accreditation Program

Today most medical devices are part of a larger system and they no longer work as stand-alone items. Information platforms are built into medical systems, wireless tools are rapidly evolving, and connectivity and interoperability have increasingly become an integral part of health systems.

Join industry professionals for this year's Medical Devices Sum-mit West in Fremont California! The only way to push the enve-lope of innovation is by sharing new ideas, promoting novel

technologies, and working together on strategies for foster-

ing development. Join us for discussions on the most cutting edge software and devices on the market, and most importantly- learn how they got there, and what they're doing to stay ahead!

Attendees will be given the opportunity to work closely with thought leaders to share ideas, experiences and strategies- while working towards a common goal of truly revolutionizing the medical devices industry.

For more information visit: www.opalevents.org/trk/mdswc1411.html n

Medical Devices Summit West 2014

http://www.americantelemed.org/docs/default-source/standards/ata-primary-urgent-care-guidelines-draft-public-comment-final-(2).pdf




http://www.opalevents.org/trk/mdswc1411.html


Conference News


Wearable technologies are all around us now. But what is in it for you? Is your current strategy the right one? Do you know the right people? Technologies worn close to the body, on or even in the body still leave a lot of open questions.

Meet new people, grow your ideas, and find the right partners at the world’s most profound gathering for Wearable Technolo-gies – the Wearable Technologies Conference 2014 I USA tak-ing place on July 8 and 9 in San Francisco.

For the 12th time Wearable Technologies will be gathering its entire ecosystem from chip vendors, integrators, test houses via network providers, product and service solution providers to distribution. Expect to meet representatives from companies of

all sizes but also creative thinkers, artists, designers and media.

You will see product launches of the hottest new wearables, hear discussions about tricky areas in this business, learn about the most innovative enabling technologies and meet invaluable new contacts. At the WT Innovation Show you will be able to test products and see demos live at the venue.

We are very proud that we can deliver the deepest insights to you as well as we are able to guide you with our expertise.

For more information please visit: www.wearable-technologies.com/events/wearable-technologies-conference-2014-usa/ n

Healthcare Revolutions: Big Data and Smart Analytics

Healthcare and insurance have always shared a symbiotic relationship. Changes in the delivery of healthcare through dig-ital intervention, big data collection, and intelligent analytics, all have a subsequent impact upon the way insurers perceive and value different aspects of health. As we recognised in the April issue of The Journal of mHealth, in our interview with Peter Ohnemus at Dacadoo the age of personalised insurance based upon our own individual health is already here. The question now is how will technology in the 'healthcare revolution' change the life and health underwriting landscape? If we are at the edge of a data-driven paradigm shift in healthcare, the effects on aggregate health and therefore on insurance models, will be considerable.

Healthcare Revolutions: Big Data and Smart Analytics, an event organ-ised by the Swiss Re Centre for Global Dialogue, brought together a formida-ble panel of presenters to consider some

of the topics relevant to this issue. In this article we bring you a number of perti-nent speaker abstracts.

From diagnosis to personalised prognosis: Will better information lead to better decisions?

(Karin Frick, Head of Think Tank, and Member of the Executive Board, GDI Gottlieb Duttweiler Institute)

Prediction was once the realm

of priests and magicians. In today's soci-ety it is increasingly a tool for planning.Where once we had post-illness diagnosis of a condition, the future promises pre-illness prognosis.

Our increasing faith in prediction is

based on technology. A body of data-driven tools is capable of discovering and analysing patterns so that past cor-relations can be used to forecast likely future outcomes. Predictive technolo-gies, which include data mining, neural networks, and system modelling and simulation, have been applied to the study of weather systems, traffic pat-terns, stock markets, epidemiology, con-sumer behaviour, terrorist activity, and many other areas of study where there can be a significant number of variables.

Technology and our ability to record data is expanding exponentially; and health-care is seen as one of the primary benefi-ciaries. Entrepreneurs are creating apps that can run on smart phones claiming to be capable of predicting conditions from depression to sport injury. These metrics not only benefit the individual, but also the wider healthcare industry. With the data gleaned from these devices, insur-

Wearable Technologies Conference 2014 – San Francisco


http://www.wearable-technologies.com/events/wearable-technologies-conference-2014-usa/



30

Conference News

June 2014

ance companies, employers and health-care providers can view a comprehensive picture of an individual and a popula-tion's health – one that is more accurate and trustworthy than a first-person nar-rative.

This increase in predictive ability should be a force for good, but human reactions may be unpredictable. Prognosis could provoke change, equally it could provoke over- or underestimation of the risk, or – if the prognosis is not positive – to ignore it altogether. We already know that humans have a tendency to drift towards hyperbolic discounting. The risk of a terrorist attack, which statistics tell us is highly unlikely, is seen by most respondents as being far higher than dia-betes – which statistics suggest is a much likelier fate. Moreover, most people have an inability to imagine how they will age and how their preferences and personali-ties will change.

The most effective way for humans to take on and realise information is through feedback loops. The first stage is evidence, the actual data; then comes the prognosis based on the data; the relevance of the prognosis has to be realised in its social and physical context; the consequences of the prognosis are understood; and the individual finally acts according to the previous four steps. The circle is started again.

These stages can be identified within the use of fitness armbands that record physical movement. Evidence (steps) leads to prognosis (expected gains in fit-ness); leads to relevance (frequently in a gaming context, which encourages par-ticipation); leads to consequences (feel better, weight loss); and finally action (take more steps in a day).

This does not mean there are not ques-tions about predictive technology. Human happiness is not a universally defined quantity. Some may feel uncom-fortable in the knowledge that our future is already defined. Moreover, it is diffi-cult to know what to do with progno-ses that may not be beneficial; such as a predisposition to criminal behaviour or a degenerative condition. Predictions can be self-fulfilling. As W.I. Thomas and D.S. Thomas suggested in 1928, “If

men define their situations as real, they are real in their consequence.”

Reducing the burden of chronic disease through remote monitoring and management

(Laurence Jacobs, Senior Research Scientist, University of Zurich Medical School)

The traditional approach to the management of

chronic diseases is not optimal from a medical perspective, and it is extremely expensive. Moreover, the worldwide growth in cases of chronic disease con-tinues to increase at a very fast pace. Reasonable cost estimates place the total financial burden caused by chronic disease in the several hundreds of bil-lions of dollars annually. This situation is untenable in the long run. Left unat-tended, this problem is such that in the not too distant future, no society will be able to afford the cost of caring for its ailing population. The traditional approach to this problem simply does not scale well.

Fortunately, there are alternatives to the traditional approach. These alternatives, at present mostly in the development or testing phases, are not only much cheaper, but they have the potential of being better for the patient from a medi-cal perspective.

The current opportunity was born not only of necessity, though that has played an important role, but also from the con-fluence of the general population's inter-est in health. Companies have developed small, accurate and inexpensive biosen-sors. These have led to a growing avail-ability of good quality data that can be used to derive accurate models that can generate alerts, or even trigger devices to react to critical changes in the one or more parameters being monitored.

Diabetes is a prominent example. As far as growth, it is estimated that there will be around 250 million sufferers world-wide by 2030, more than double the amount estimated in 2005. A key com-ponent of the process of managing dia-

betes is to measure the level of glucose in the blood several times a day. With the technology of a few years ago, this pro-cess is painful , expensive and cumber-some, requiring the extraction of blood and the use of portable meters. How-ever, current technology already allows for a reasonably practical way to mea-sure glucose continuously using a sensor that is implanted subcutaneously. Even better, several start-ups are announcing systems to measure glucose continu-ously without the need to extract any blood at all. These sensors, several using light, or estimating the levels of blood glucose by analysing tears or saliva, will soon become commercially viable. These systems will not only be simpler and cheaper, but they will also lead to better methods of treatment.

There are currently many clinical trials underway that aim to test integrated plat-forms, running smartphones, that mea-sure, analyse, and report on multiple con-tinuous measurements of a potentially large number of important biometrics that promise to optimise the treatment of several chronic diseases. Patients and their doctors can be informed in real time on effective treatment change, and alert on critical risk factors. This would have been impossible only a few years ago, and it will eventually revolutionise the management of chronic disease.

Using common data to make uncommon predictions

(Ben Reis, Director of the Predictive Medicine Group at Harvard Medical School and the Children's Hospital Informatics Program)

We are living in the age of many unknowns. In two major respects, we are entering new territory for human evolu-tion. One of those is age. Evolution has focused on keeping us healthy through reproduction and child-rearing years, but many people now live well beyond this stage. Those extra years bring co-mor-bidities and chronic conditions. Another novelty is urban living. There have been town dwellers for thousands of years; but never have we had more city dwellers than rural farmers. That implies differ-ent environments and different patterns of physical activity. The more we know about the effects of these new trends in human existence, the more we can seek to positively influence our health.


Conference News


Previous healthcare revolutions have not proved to be quite as revolution-ary as initially hoped. Although decod-ing the genome was a ground-breaking achievement, rather than providing a clear blueprint of our genetic selves, it revealed how much we did not know about the interaction of genes in deter-mining human traits and the existence of epigenetics, the interaction of genes with their environment. Similarly, whether the potential treasure trove of data that accompanies the smartphone revolu-tion will enhance our capacity to predict health status remains to be seen.

We already have, however, rich sources of data available to us. One source is claims submitted from the providers to insurers to cover medical costs. This data provides information on the frequency of individual visits to the doctor, the conditions the individual suffers from, the geographic placement of claimants, the prescriptions or treatments under-taken by the doctors, and the effective-ness of these treatments as registered by the need of the individual to return to the doctor subsequently. On the whole, insurance claims have produced some remarkable insights:

» Behavioural models: Health records provided a surprisingly accurate pre-diction as to those individuals who might be more susceptible to being victims of domestic violence.

» Epidemiological models: Insurance claims have proved a good proxy in the identification of disease clusters and outbreaks.

» Predictive drug affects: The safety of drugs is generally measured in com-parison to a reference drug. Using network models, adverse drug effects can be detected and even predicted years in advance.

There are other rich sources of exist-ing public data. One of these is search engine query data. One study suggests an inverse relationship between the avail-ability of abortion services in a partic-ular US state, and Google searches for abortion services. This may suggest that demand for abortion is relatively con-stant across different states, it is the sup-ply side that accounts for different abor-tion search rates.

The wireless future of medicine: How the digital revolution will create better healthcare

(Adrian Ionescu, Professor of Nanoelectronics, Ecole Polytechnique Federale de Lausanne (EPFL), and Chair, Guardian Angels Initiative)

Mobile health is not just an interface between individual and device. It will soon become part of a much more expansive and wider Internet-of-Things (IoT). This Internet-of-Things will not only capture health data; it will capture pollutant data; will monitor the way we drive and we live; will measure stress levels, with the final goal of proposing personalised safe and secure services for

a better quality of life. Eventually it will allow the creation of smart cities and of a smarter society. The foundation of the IoT will be trillions of tiny wire-less devices. Not only will it allow for smart care, it will allow for smart energy use and smart interaction. It will form part of our strategy to tackle problems caused by population ageing; the spread of chronic disease; and the associated healthcare costs.

Creating an Internet-of-Things repre-sents a major logistical challenge. Smart-phone handsets will eventually come to be seen as cumbersome relics. The IoT relies on multi-parameter sensing technology being tiny and power free. Guardian Angels are future zero-power smart autonomous systems with sens-ing, computation, communication, and energy harvesting features. Over three years the Guardian Angels research part-nership aims to reduce current energy device consumption by a factor of 100; over a ten year period, the partnership wants to reduce device energy consump-tion by a factor of a thousand.

This can be done through combinations of advances in biochemical technol-ogy; through the application of stacked nanowire sensors; through the use of emerging 1D and 2D nanomaterials; through nanoelectronics and nanome-chanics; enabling single molecule-sens-ing and novel functions in forgettable devices. These sensors will be able to function by use and storage of energy from adjacent energy sources, e.g. solar, thermal or vibration. All these technolo-gies must be able to broadcast signals to some form of receptor and ultimately processor. n

Health Datapalooza is a national conference focused on liber-ating health data, and bringing together the companies, start-ups, academics, government agencies, and individuals with the newest and most innovative and effective uses of health data to improve patient outcomes.

This year’s event, held in Washington DC, had over 2000 attend-ees, over three days of keynotes, sessions, and events.

Among the keynote addresses were speeches from: Kathleen Sebelius, Secretary, Department of Health and Human Ser-

vices; Francis Collins, MD, PhD, Director, National Institutes of Health; and, Adriana Lukas, Founder & Organiser, London Quantified Self. Conference attendees also heard about the launch of OpenFDA, a new initiative from the FDA’s Office of Informatics and Technology Innovation (OITI).

There were a wealth of digital solutions and health applications on show with live demonstrations from ActualMeds Corp, Pur-ple Binder, and Maxwell Health. Developers were also invited to participate in the Code-a-Palooza challenge, which was won by Lyfechannel. n

Health Datapalooza Review

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Conference News

June 2014

For those interested in the design and application of new tech-nologies that support improvements in health care, The King’s Fund is hosting its annual three-day digital health and care con-gress in September. Following on from last year’s success, this highly-acclaimed event brings together international researchers, policy makers, practitioners and innovators to share experiences and showcase new designs in digital health, mobile health, telehealth and telec-are.

The organisers have received an unprecedented response to their call for papers and are expecting to showcase an exciting range of projects during the event. Topics will include:

» sustaining independence as people age » preventing and managing chronic illness effectively » supporting people with mental health issues » digitally enabling service transformation » new innovations in health care technology

The congress also offers the chance to attend a pre-congress seminar on Wednesday 10 September, where attendees will

explore the latest research and evaluation methodologies

concerning health care technology. This is a standalone event for those involved in the research and evaluation of digital health and care programmes who may not wish to attend the full congress.

During Thursday 11 and Friday 12 September, there will be ple-nary sessions and breakouts focusing on the advancements and benefits of digital health and care. These will be aimed at UK and international health and social care professionals, technol-ogy providers and commercial and third sector health and social care.

In previous years the congress has sold out far in advance so the organisers recommend that you register soon to guarantee your place.

To find out more about the congress, the sponsorship opportu-nities and to register, visit www.kingsfund.org.uk/digital2014

The King's Fund is an independent charity working to improve health and health care in England. They help to shape policy and practice through research and analysis; develop individuals, teams and organisations; promote understand-ing of the health and social care system; and bring people together to learn, share knowledge and debate. They’re vision is that the best possible care is avail-able to all. n

International Digital Health and Care Congress: Improving Health Through the Use of Technology

mHealth + Telehealth World 2014 taking place July 22 – 24, 2014 in Boston, MA brings together hospitals, health systems, health plans, and innovators to share successes and failures of existing programs and discover new technologies and strategies for expansion of programs. Network with experts in mHealth and Telehealth as you learn valuable strategies to bring success

to your organization. We are happy to extend a $300 registration discount to you when you mention promo code MHJOU.

For more information or to register, please visit www.worldcon-gress.com/mhealth or call 800.767.9499 n

mHealth + Telehealth World 2014

http://www.kingsfund.org.uk/digital2014

http://www.worldcongress.com/mhealth



eHealth: Accelerating Towards a Healthy Future


Over recent years the European Com-mission has been working hard to shape a new vision that puts people in con-trol of their health and wellbeing. At the wheel are the patients, on the road towards efficient and effective health-care. The benefits are a triple win: put-ting the patient in control, saving on costs and efficiency, and creating huge opportunities for innovative services and start-ups. This is the ethos behind our European Innovation Partnership for Active and Healthy Ageing.

I attended the eHealth Forum in Ath-ens on 12-14 May (2014), which put this vision on the public stage at a time of substantial market opportunities. One of the key issues we discussed was the emergence of mobile health, or mHealth, defined as the use of mobile phones, tab-lets and other wireless devices in health-care. These are smart devices for disease self-management and remote monitor-ing, leading to prevention rather than cure, and more independent living; tools offering fitness and dietary tips as well as lifestyle and wellbeing apps. These new technologies can all help healthcare pro-fessionals treat patients more efficiently, get citizens more involved in managing their health and diseases and help Mem-ber States deal with tight budgetary and human resources, while facing an ageing population.

One example of an mHealth service is the EU-funded REACTION project

which developed a mobile system that helps doctors and nurses within the hos-pital to treat patients with diabetes. Via sensors, the system monitors vital signals such as blood glucose levels and admin-istered drugs and gives therapy advice; the data stored on a server is shared via tablet-computer used by the medical staff. This has significantly reduced the workload, increased the autonomy of nurses and improved the quality of care of diabetes patients.

BOOMING BUSINESSThe mHealth market is rapidly develop-ing: Around 100,000 health and well-being apps are already available across Apple’s AppStore, Google Play and on other global platforms. So far, more than 200 million individuals have downloaded sports, fitness and health apps. The rise of mHealth is unstoppable and we want to ensure mHealth reaches its full eco-nomic and social potential and contrib-utes to high-quality healthcare. This will create huge opportunities for innovative services, start-ups and the app economy.

Beyond mHealth, the market for digital health and wellbeing technologies is also growing rapidly. The global market for telemedicine alone is set to grow from €7.2 billion in 2010 to € 19.3 billion by 2016. At the same time, the conver-gence between wireless communication technologies and healthcare devices and between health and social care is creating innovative new businesses. And as our

population ages, the 'silver economy' is emerging as a highly promising market.

OVERCOMING BARRIERSOn the 9th April 2014, the European Commission published a consultation on mHealth to ask what should be done to increase user trust and patient safety in order to boost mHealth’s contribu-tion to high quality healthcare. We want to know whether this should be done regionally, nationally or at an EU level. We want feedback on issues related to ensuring that health apps meet citizens' demands for quality and transparency. mHealth services must adhere to strict data protection rules, and we should be intelligent about how we use the data: we could prevent an epidemic in the future.

For all eHealth systems to work seam-lessly across national borders, the many different systems used by hospitals and other healthcare providers need to be able to communicate with each other. While projects such as epSOS have taken great strides forward, this is not a widespread reality. On top of that, both patients and professionals need to learn to use these new systems. But perhaps the biggest challenge is the required change in mind-set: Getting used to managing our health and care in a dif-ferent way, from emailing your doctor to using devices to track your daily activities and levels of fitness.

CONNECTED CONTINENTIn order to benefit from the great advan-tages which eHealth offers us, we of course need fast, reliable broadband networks, as well as a quality guarantee for high-quality connections end-to-end, the connections that new healthcare innovations may depend on. Our proposed safeguards for the open internet mean providers cannot just decide to block or throttle any con-tent, application or services, including new health apps or services. And the success-ful vote of the Connected Continent regu-lation in the European Parliament recently is a huge step forward in achieving this guarantee. n

eHealth: Accelerating Towards a Healthy Future

Article written by Neelie Kroes Vice-President of the European Commission, responsible for the Digital Agenda

34

Can We Really Deploy mHealth at Scale?

June 2014

Can We Really Deploy mHealth at Scale?

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.

This is a question that gets asked a lot and asked of most companies either delivering in the mhealth space or look-ing to provide services for consumers, patients or healthcare professionals. I don’t believe it is the right question, I think there are far more pertinent ones for investors or those who procure these services for their patients to be asking. Such as talk to me about the quality of your products and the systems you have in place, show me how they work for my patients and users or what is it that you are developing that could help me change the way I work and deliver care to my patients.

I think the answer to the question is a very firm YES and YES in both cases.

It is delivering and there are good exam-ples of where and how that delivery is changing the way care is delivered. One of the best examples is the Whole Sys-tem Demonstrator in the UK, which delivered really significant results in hos-pital admissions and mortality rates for patients.

Can it be deployed and be effective at scale, there are good examples of where

this has happened and the US Depart-ment of Veterans Affairs is the best example currently of scaled deployment in the USA which has delivered excellent results.

Are there issues that we as an industry face – yes and some of these are harder to get past than others.

Technological issues – sometimes we struggle to get the technology to do what we want it to reliably and certainly we have to make sure that the users and the procurers of the service really under-stand what we are providing and equally what the technology can't do!

Regulatory issues – the differences between the US (FDA) and the Euro-pean Bodies (EMA and the EU) are cre-ating obvious strains for organisations that want to provide services in both markets. We need to get uniformity of agreement on what is a medical device, what software is a medical device and equally importantly which isn’t analys-ing and therefore doesn’t need to be classed as a medical device. Currently that interpretation is mainly made by organisations and developers themselves

and that will lead to procurers becoming confused and concerned about potential safety.

Acceptance and uptake – is very mixed in the market currently with a number of countries making steady progress forward with the adoption of technol-ogy and solutions but this is very varied across Europe and within the US as well. For me the positive acceptance seems to be in two key areas:

1. Strong uptake and understanding of managing patients at home, remotely and using technology to provide this solution.

2. Using technology that the patient already has – ie their own mobile phone or tablet rather then expensive pieces of equipment which need to be purchased by the payor.

Overall, the market is moving, people are seeing the benefits of mhealth and decision makers are starting to include the industry and the services it provides in changing healthcare delivery for the future. n

EXECUTIVE HEALTHCARE CONSULTINGNurcombe Consulting delivers interim senior management support, strategic business analysis, change management as well as develop-ment 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• ProvisionofstaffandcareforpatientsintheirhomeandalsoinNHSandprivatecaresettings• 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 [email protected]

www.nurcombeconsulting.com


Engaging Patients Using mHealth


When it comes to developing effec-tive mHealth solutions, it is essential to incorporate a range of proactive methods that engage with patients, and help to integrate the solution in to their accepted treatment process. Maintaining this level of engagement, is the only real way to ensure that a solution can help to deliver positive outcomes.

In a series of discussions Mark Brincat of Exco InTouch considers a variety of methods that can help solutions achieve successful and sustained patient engage-ment.

ADAPTABILITY

There are no hard and fast rules as to how mHealth adaptability is defined, but I would suggest there are a number of levels that help us understand the extent to which a product might respond to individual patient needs.

Perhaps the highest level to start with is personalisation. This is where a patient can put their own mark on a product and make it feel like something that is unique to them, perhaps including some elements of look and feel, or methods of interaction. Next, a patient could con-figure a product around their own spe-cific needs, the product might have been already configured with a patient’s clini-cal specifics by a health care professional, but patients could additionally configure to their own needs and priorities. Once the patient is up and running, the prod-uct would be designed to respond to a series of patient inputs and events, some adhoc and some scheduled. It is here that products are really going to differ-entiate themselves. These pathways are numerous and complex and a product must be flexible enough to respond to different patient profiles, requirements and progressions. Multi-level solutions might include assessment, medications management, lifestyle management and informational content, all of which need to work and adapt in sync with each other. For example, if assessment and medication tracking show a change in condition, then there is a likely need to reflect changes in lifestyle management

and informational support. Add on top of this a patient’s state of behaviour acceptance and you have a variable set of parameters that a product needs to interpret and respond to correctly.

Looking at the technology involved, this would require a rules engine to manage a dynamic set of interactions. At its sim-plest level, we can think of a rules engine as software which uses rules that can be applied to data to produce outcomes. It is important that rules are only defined where events and outcomes are suffi-ciently understood. In the future, expert systems will take findings from the sys-tem and dynamically build them back into the rules engine, so that a solution learns and improves interventions based on real world data. For now, we will learn from anonymised patient data findings and refine or build new rules and inter-ventions into the system. Companies will need to develop skills around the analysis of ‘big data’, identifying signals and pat-terns. This will be an exciting period in advancing our understanding of patient populations and disease anthropology.

When patients stop taking medication or stop proactively managing their con-dition generally, their change of mind did not happen that morning, it started weeks or months ago with a series of smaller issues slowly stacking up. mHealth solutions need to focus on the multitude of issues and support patients with a range of interactions that work in sync with each other and respond to an individual patient’s real world experience. As this level of mHealth product takes hold in the market, it will be remark-able how quickly we can advance disease management.

BUILDING BEHAVIOUR CHANGE INTO MHEALTH SOLUTIONS

We have seen the successful application of behavioural change theories in patient services such that there is now good rec-ognition of the ability of such methods to encourage patients to proactively manage their healthcare conditions. There are a number of behaviour change

models applied in the area of healthcare, examples include:

Health Belief/Health Action Model. This model suggests that a patient’s belief in a personal threat together with their belief in the effectiveness of behaviour will predict the likelihood of that behaviour. For example, a cardio-vascular patient may have certain beliefs about whether it is safe for them to exer-cise with such a condition.

The Health Action Process Approach. This is a framework of motivation and volition constructs that are assumed to explain and predict individual changes in health behaviours such as quitting smoking, improving physical activity lev-els or dietary behaviours. This approach suggests that the adoption, initiation, and maintenance of health behaviours should be conceived of as a structured process including a motivation phase and a volition phase.

I-Change Model. This model assumes at least three phases in the behavioural change process, these being; awareness, motivation and action. ‘Awareness’ is the result of accurate knowledge and risk perceptions of the patient about their behaviour. ‘Motivation’ to change behav-iour is dependent on a patient's attitude, social influence beliefs and self-efficacy expectations. While ‘Action’ focuses on self-efficacy, action planning and goal setting.

I do not profess to be an expert in the area of behavioural theory but I have and continue to work with teams to apply these behavioural models into patient solutions and services, and they really work. Linking back to the need to build adaptive patient solutions, incor-porating a behavioural layer into these solutions is another dimension of a solu-tion’s ability to understand and respond to individual patient needs. A solution needs to be able to incorporate elements of a behavioural model, be it methods of data capture, behavioural logic or patient messages. There are more than enough sources of expertise in the market from

Engaging Patients Using mHealthThought leadership article by Mark Brincat of Exco InTouch


36

Engaging Patients Using mHealth

June 2014

which a suitable approach for specific diseases or populations can be identified.

When developing an mHealth solution for a specific disease population, in addi-tion to understanding aspects of patient segmentation like age, disease stage and medication, we need to remember that that patients will also be at different behavioural stages. We therefore need to respond differently to a patient who is in denial of their condition, than to a patient who has accepted their condition and is trying to learn how to better man-age themselves. We also need to bear in mind that once we get patients to prog-ress from one behavioural stage to the next, they may revert back to a previous behavioural stage.

For some, trying to also incorporate behavioural change into mHealth solu-tions might feel like a bridge too far. Per-haps this is seen as a level of complexity too difficult to incorporate on top of everything else. However, when broken down to its constituent parts, behav-ioural change can be incorporated into an adaptive platform.

INCENTIVES

At Exco InTouch we have been work-ing to incorporate incentivisation into a patient’s goal and lifestyle management. Patients can either work towards pre-defined goal programmes, which might be specific to their condition or more generally around diet and exercise, or they can define their own personalised goals. Patients can then work towards these goals individually or collabora-tively.

In terms of patient collaboration, the universal growth of social media, soft-ware apps and gaming has made the concept and acceptance of collabora-tive engagement common place. This can either take the form of co-opera-tive engagement, which might include patients working together towards a common goal, or patients working indi-vidually or in teams in competition with others.

How then, do we plug incentivisation into goal and lifestyle management?

For those patients starting out,

they could view other existing patient’s socially shared activities, these patients would perhaps then display their own individual goals and achievements within the social environment. Patients look-ing to get started could then find others dealing with similar personal challenges and this acts as a powerful behavioural nudging mechanism to show what can be achieved. For those patients not wanting to engage within a patient community, they can still do their own thing and could still gain tre-mendous ben-efit from seeing other patient’s approaches and achieve-ments.

P a t i e n t s interested in joining the commu-nity, could join existing groups and activities or cre-ate their own. For example, individual patient step count activity targets could contribute to a group of patients working together to walk the equivalent of Paris to Rome (titled ‘The Paris to Rome Challenge’), a dis-tance of approximately 1,400 kilometres or 1,750,000 steps. Twenty-four patients working together and walking 2,500 steps per day could achieve this target in a month. This kind of social engagement could take any form, be it exercise or diet. These challenges can also be turned into competitive events, with teams perhaps competing against each other to achieve different targets, for example, first team to arrive, single longest activity in a day and more. We hear a lot about gamifi-cation and this is too often associated with on screen computer games. How-ever, this approach to social engagement offers the ability to build collaborative events amongst patients and provides a very effective form of gaming challenge, in fact this is a growing sector within the traditional gaming market.

You may have noticed that I have spo-ken about the activities and challenges, but not once mentioned reward. It is important to recognise that providing

patients the right kind of support and encouragement to work towards impor-tant healthy targets is fundamental to patient engagement. We can then build on this and explore new and appropri-ate ways to remunerative and financial incentive. This could take the form of a reward points or voucher based sys-tem that patients can spend in specified areas. With any incentive system with

monetary value, it will be important to build checks into the sys-

tem to prevent fraudu-lent activities. This

could simply be a case of link-

ing achieve-ment to clinical out-come, for example a reduction in BMI, p o s s i b l y r e q u i r -

ing health care profes-

sional verifica-tion. Although

the mechanics of a reward system can be

universal, a product might need to connect into different reward

programmes in different territories. I believe there is a real opportunity here for the pharmaceutical industry to con-sider a completely new approach to drug pricing. mHealth programmes like these can provide pharma companies anony-mous real world data on patient adher-ence to their medication and self-man-agement. This provides the opportunity to link reward to drug price by offering discounts to patients who achieve lon-ger term adherence and agreed clinical and health improvements. This discount could go directly to patients who pay for their drug products in some countries or feed through to health insurance premi-ums in other countries.

The challenges facing healthcare are enormous and as well as joining up concepts, we have to think about big-ger changes if we are to respond quickly enough to this crisis. This need is driving a real desire for change with all stake-holders and in my experience presenting innovative and revolutionary approaches is well received by regulators, healthcare providers and payers alike. n


...providing patients the

right kind of support and encouragement

to work towards important healthy

targets is fundamental to patient

engagement

AssessmentSet up any form of

information capture

Patient DataCapture data directly from medical & healthcare devices

AlertsIntelligent monitoring for patients, carers & HCPs

Treatment ManagementHelping manage treatments, clinical visits, tests & vaccinations

Goals ManagementSetting and managing pre-defined & personalized goals

RewardAcknowledging

patient progress & achievement

ContentThe right information &

educational content delivered in the right way & time

CareplanPatient’s summarized

view of their key data & progress

CaregiverHelping carers to

support & monitor relatives

ClinicianProviding required level of

support & integration to healthcare providers

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

mHealth Interventions Wheel

http://www.excointouch.com

38

Understanding Stress and Post-traumatic Growth

June 2014

BACKGROUND

Young people serving in the armed forces are given extensive periods of military training at entry to prepare them for service life. During training, they are provided with concepts and constructs of the military culture to ensure they are physically, mentally and emotion-ally fit for the tasks ahead. By contrast, preparation for return from the military to civilian life, jobs and family is given far less time and attention, even though this is an equally great change from their recent lives, experiences and the personal growth that occurred while they were in the military culture.

There remains stigma associated with reporting mental difficulties that may accompany the transition from military to civilian life and because of this, there is some distrust in seeking answers to these openly[1, 2]. Moreover, sleep dis-turbances[3], risky behaviours[4, 5], fam-ily problems[5] and homelessness[6], are common in returning veterans even in those without diagnoses of mental dif-ficulties.

With the goal of helping those in, or leaving the military to resolve some of these issues both conveniently and in pri-vate, the Young Adult and Family Center (YAFC) in the Department of Psychiatry at the University of California, San Fran-cisco has teamed up with Tiatros Inc. to leverage its scalable, cloud-based, social-network styled software platform that enables collaborative, individual-centric services. Using the HIPAA compliant Tiatros solution, we have designed an initial course that enhances understand-ing of their experiences by the Veterans.

The first course emplaced within Tiat-ros. 'Next Mission: Stress Resilience

and Personal Growth', is an exploration of the neurophysiology, biology and narra-tive process of the military experience to help service members tell their own stories and better understand their own journey into, through and out of the military. The course is intended also to develop the connections and sense of community that are so important to tran-sitioning veterans.

The course is given over sixteen 2-hour classes. Each class is comprised of 3 parts: The narrative portion is based on the 6 stages in Joseph Campbell's Hero with a Thousand Faces[7] and is illustrated with clips from movies and readings; A neuroscience portion deals with the com-mon changes that occur in the brain after stress and trauma; The third portion is comprised of mindfulness and writing exer-cises. There are two sets of writing assign-ments for each class: Journal writing for twenty minutes a day which is entirely private to the individual student, and writing in response to questions based on the narrative content and neurosci-ence portions of the course which can be viewed by course moderators and other students within the Tiatros solu-tion. Additionally, in the final sessions the students present to the others in the class group their course projects that are to be related to some aspect of the monomyth as it relates to their personal journey.

Course administrators post an individual invitation to each student to sign up for the course using Tiatros' secure mes-saging function. The platform supports secure communications (to one or to many) through various contemporary social networking methods including: Posts; audio and video blogging; Video chats; SMS; and, multi-party video con-ferencing, while allowing simultaneous

but separate communication threads among various subsets of students and instructors in the class. Tiatros uses a number of proprietary technical strate-gies to preset and enforce access rights that ensure the privacy of communica-tions. Easy-to-use and redundant meth-ods assure that instructors can exer-cise complete and instant control over which communications are available to everyone and which are available to only a subset of the class community. The course administrators have access through Tiatros to the site of each stu-dent who is taking the course to ensure the safety of all participants. Students individually control the degree of inter-student interaction.

Because Tiatros' proprietary content management and delivery engine han-dles content files of any size, and con-tent files that are created in virtually any underlying application, including all common document , image, audio and video formats, all of the course classes and content are contained entirely within Tiatros. Fidelity of the content files is fully preserved and the viewing experi-ence is identical to that experienced while watching a movie downloaded from a premium online service to a laptop. Content is streamed directly to mobile phones, and tablets as well as to laptop computers. Importantly, this capability in reverse permits flexibility in the for-mat of student to the required home-work; the student is allowed to choose from the most personally appropriate medium: video, uploaded photographs, written and/or and hand-drawn pictorial responses.

Assignments and course content are stored within the course Library on Tiat-ros. The course administrators can easily pre-set an automatic delivery schedule

Authors: K.P Norman, M. Dallman, K. Cerrone, S. Norman, D. Altobello, J. Homchowdhury


A course for returning veterans on Tiatros-Research, a flexible HIPAA-Compliant collaboration platform for clinical research



when specific content files are distrib-uted to students. There is a common blog site for students and instructors to discuss their responses to the course content, which is carefully monitored by course administrators. They are able to remove inappropriate comments at any-time (together with explanatory interac-tion with the poster) in order to main-tain the positive tone of the interactions and to encourage individual growth and understanding of experiences.

Evaluation of the student's progress is simple, in that each time an individual enters Tiatros, it is accompanied by a time-stamped record, and completed assignments are also noted. This allows the instructors to automatically prompt individual students to access and com-plete assignments and keep up with the course, as well as to spontaneously inter-act with the individual if they seem to be particularly troubled.

For troubled students who want more individual help, there is a list of sites to which they can go for that help, in addi-tion to private conversations with the psychiatrists involved in the course.

Efficacy of the course for students can be evaluated formally through pre- and post-course questionnaires, once institu-

tional approval for this is gained. Privacy is ensured through the transformation of student names into numbers. Tiat-ros supports technology-assisted, direct engagement of students that provides a unique and highly effective chan-nel to collect information in real-time through a variety of validated means, such as questionnaires about symptoms of PTSD, substance abuse, personality, growth relationships and other relevant information. Additionally, written course assignments by individuals can be auto-matically evaluated for changes in word usage and hopefulness in story telling that qualitatively estimates changes in outlook of the individual throughout the course. Tiatros support the capability of downloading the responses directly into a number of programs that can evaluate them for significance.

Figure 1: Schematic showing the Tiatros-Research product as it supports the Next Mission offering:

Two versions of Next Mission have been given in person in classes taught at City College San Francisco. The response of the Veteran students who took the course was positive with respect to aid from each of the narrative, neurosci-ence and writing portions. The course given through the Tiatros platform will

be beta-tested at several military sites in 2014.

Beyond the current course, future courses tailored toward the specific problems experienced by female veter-ans, and the families of returning veter-ans are now being developed.

REFERENCES1. Kim P. Y. Et al. 2010. Stigma, Barriers to Care, and Use of Mental Health Services Among Active Duty and National Guard Soldiers After Combat. Psychiatric Services 61:582, 2010.2. Hoge C.W. Et al. 2004. Combat Duty in Iraq and Afghanistan, Mental Health Prob-lems, and Barriers to Care. New England Journal of Medicine 351: 13. 2004.3. Seelig A. D. Et al. 2010. Sleep Patterns Before, During and After Deployment in Iraq and Afghanistan. Sleep 33: 1615. 2010.4. Hoglund M. D, Schwartz R. M. 2014. Mental Health in Deployed and Non-deployed Veteran Men and Women in Com-parison with their Civilian Counterparts. Mil Med 179(1):19. 2014.5. Blow A. J. Et al. 2013. Hazardous Drink-ing and Family Functioning in National Guard Veterans and Spouses. Journal of Family Psychology 27:303. 2013.6. Fargo J. Et al. 2012. Prevalence and Risk of Homelessness Amoung US Veterans. Prev Chronic Dis 2012:9:E45.7. Campbell, Joseph. 1949. The Hero with a Thousand Faces. 1St Ed Bollingen Foundation. n

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Ready for the most innovative ideas in healthcare ™"

40

A Clinician's Guide: How to Enhance Adoption and Diffusion...

June 2014

A Clinician’s Guide: How to Enhance Adoption and Diffusion of

Technology in HealthcareBy Dr Alexander Graham

Healthcare provision across the world faces unprecedented challenges in the modern day, with spiralling costs, aging populations and political pressures impacting on the quality and quantity of care given. As a result, front-line staff are consistently being asked to do more with less.

Having practiced as a doctor in the UK, I have seen the relationship first hand between healthcare professionals and technology. My anecdotal view, in the years I spent as a student and doctor, is that the vast majority of technology hinders rather than helps clinicians in their day-to-day work. But we have the technology to put a man on the moon so why can’t we reliably improve workflow, communication and outcomes in hospi-tals and clinics? Why is healthcare as a system so reticent to accept new technol-ogies that could improve workers’ condi-tions and improve patients’ lives?

The answer is unfortunately a complex one with many precipitating factors but if technology companies can understand some of the main barriers to adoption and diffusion then they can mitigate them with a bespoke approach. It is pos-sible to write whole books on this topic but I shall concentrate on what I feel are the three main barriers: culture, work-flow and staff heterogeneity.

CULTUREHealthcare professionals are frequently bombarded with sales pitches from a range of salespeople, from drug reps to device manufacturers to IT profession-als, often with a hard-selling, non-user-focused manner. The default setting amongst an increasing majority of clini-cians as a result of this is scepticism and disenchantment (sometimes referred to as ‘innovation fatigue’) such that when the next painkiller, hip replacement or

software innovation comes along, sellers will often start very much on

the back foot, even if the product or ser-vice is of high quality.

This means that the ‘pre-sales’ process for technology is critical. Sellers need to make a conscious and sustained effort to develop personal relationships with the people who will not only be their end users but should become their clinical champions in terms of driving forward procurement and then adoption and dif-fusion. Senior clinicians will often sit on the board of directors in hospitals and assist in procurement of new technolo-gies so this is a remarkably important step.

WORKFLOWThe representation of the day-to-day lives of doctors, nurses and other health-care professionals in the media and by the general public is unfortunately often far from the truth. It is impossible to explain the workflow patterns of clini-cians if you have not worked in a hospi-tal or at least spent an extended amount of time in clinical care before.

Technology will never be diffused within a healthcare system if it is not intuitive, easy to use and at least contributes to making the day-to-day lives of profes-sionals easier. To give you an idea of the scale of some of the pressures that workers can be put under, consider how a hospital operates over a weekend. It is regularly expected that 2-4 doctors will be looking after somewhere in the region of 400 patients, with the number of daily tasks (blood result checking, ordering scans, reviewing patients) in the hun-dreds. If you have a device or software platform that requires excessive time to use or creates superfluous data, it is unlikely to last much past the first trial.

By walking the walk of your target market, you will find numerous reflec-tion points and nuances in the system that you must use in either developing or refining your product or service. By overcoming these mini-hurdles, end-user engagement will be that much greater.

STAFF HETEROGENEITYAnalysing the workflow patterns of your target market will hopefully help assist in the realisation that you cannot group all doctors or all nurses in one homog-enous group. The work of an emergency consultant compared to an orthopaedic surgeon or the work of a ward nurse to a nurse consultant will be virtually incom-parable with different working patterns, environments and stakeholder interac-tions present.

As a result it is imperative to build in flex-ibility to your product or service such that individuals’ concerns, ideas and differ-ences can be allowed for. One of the most successful companies I have seen recently has a fully bespoke software application for patient data gathering so each depart-ment or professional can tailor the inter-face to their exact requirements rather than having a top-down implementation. Flexibility in your product will generate a much larger potential user base.

CONCLUSIONIf you do not have a bridge between the technology that is being produced and the end-users on the front line, then your products and services will never reach their potential. Fully understanding the environments in which your target mar-kets operate is crucial to any commercial success and imperative for companies to understand.

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 con-sultancy which assists global IT corporates to navi-gate the clinical, organisational and commercial com-plexities of the UK’s National Health Service (NHS). n



New portable, mobile, point-of-care handheld testing devices, that can undertake a wide range of advanced laboratory procedures, have the potential to radically change care processes, by providing rapid pre-hospital, bedside and at-home diagnostic testing.

Laboratory testing for accurate disease diagnosis is an essential and extremely effective everyday facet in the provision of medi-cal care, however, traditional laboratory facilities are not always suited to every care situation. Often the time taken between the extraction of a sample at the point-of-care and the return of conclusive results can delay diagnosis and in turn impede the required treatment. Whilst laboratory testing is taken for granted in parts of the world, as a normal part of diagnostic care, in many regions there simply isn't the technology or infra-structure in place to allow sophisticated and sometimes even basic laboratory testing. From a patient's perspective the ability to relocate the testing environment from the doctors surgery or hospital to their home is a promising development that can sig-nificantly change the way in which a medical condition is moni-tored and treated.

Basic bedside laboratory tests are nothing new, however, a new breed of portable devices are starting to deliver the opportunity for advanced testing procedures to be undertaken directly at the point-of-care with results being placed instantly in the hands of the attending physician.

The possibilities of this type of technology spell cogent changes to the manner and particularly the rate at which diagnostic tests can be undertaken, and subsequent treatment prescribed. It also provides opportunities to conduct tests, that would previously have only been undertaken in a hospital or traditional care envi-ronment, remotely, wherever, and whenever they are required.

All of these devices deliver rapid results using mobile tech-nology to capture, store and relay disease specific information. By coupling the testing device with smartphone applications, it also means that manufacturers are able to reduce costs to deliver complex, yet affordable, solutions.

Providing a patient with quantitative information, through self-testing and enabling this information to be shared with both care stakeholders, and software applications that can analyse the results, means that the user is given an increased role in the management of their own condition. The mobile aspect then provides connectivity to allow the transfer and sharing of this information with care providers, doctors, specialists, as well as enabling data capture in electronic medical records and other condition management solutions.

Many lab-on-a -chip (LOAC) and nano-technologies are in the feasibility stages of development, and these devices use a vari-ety of analytical methods for measurement of a specific ana-lyte such as a routine chemistry, biomarker (protein or peptide), DNA/RNA, or a pathogen. Point-of-care-testing is accom-

plished through the use of transportable, portable, and hand-held instruments (e.g., blood glucose meter, nerve conduction study device).

The goal of these devices is to collect the specimen, test, and obtain test results rapidly at or near the location of the patient so that the treatment plan can be adjusted as necessary. Smaller, easier to use, faster, smarter, and connected devices are increas-ing the use of point-of-care-testing because it is now cost-effec-tive for diagnosis and management of many diseases, such as diabetes, carpal tunnel syndrome, and acute coronary syndrome, while with the patient.[1]

In diabetes care, continuous glucose monitoring systems are in routine use. These subcutaneous devices monitor glucose in real time and communicate with an insulin pump wirelessly. Insulin dose is then adjusted based on pre-programmed patient specific algorithms.

These devices also enable seamless, real-time capture of patient data not only for immediate patient assessment and treatment but also for data collation, analysis, and evaluation to determine new approaches to improving patient safety (reduction in medi-cal errors) and improved patient outcomes.

A number of examples of this type of device are currently in advanced stages of development, and as a result we are begin-ning to see a growing number of different technologies available across a wide range of disease and condition types.

UK manufacturer QuantuMDx is one company at the forefront of handheld laboratory testing devices. They have developed a molecular diagnostic platform called Q-POC™, which is capa-ble of extracting DNA from a variety of biological samples, and analysing them for specific disease characteristics. The uni-versal device is a small handheld unit that can fit into a lab coat pocket. It incorporates an intuitive graphical user interface oper-ated by a touchscreen and accepts cartridges that contain all the reagents and sensors required to process a whole sample such as blood, tissue (fresh and FFPE), thinned sputum, swabs, etc and to provide a molecular diagnosis in 10-15 minutes.



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The system operates using cartridges pre-loaded with reagents and probes specific to a disease, such that the operator can insert different cartridges for different conditions into Q-POC™ allowing the device to be used to test for many different dis-eases. The operation is equally as simple: input the sample into the cartridge, insert the cartridge into the device and press go. In 10-15 minutes a result will be presented on-screen.

The company uses their proprietary Q-FILTER™ technology to capture cellular debris in a lysed sample, allowing the DNA to continue flowing through the fluidic channel in solution. This simple methodology rapidly purifies DNA for amplification. Lyophilised reagents, stored on-chip, are rehydrated by the sam-ple as it passes through the fluidic channel. These heat and time stable reagents provide the disposable test cartridge with a shelf life of 18 months. On-board reagents also allow fully automated sample to result testing, with no further hands on involvement. The Device then employs a nanowire biosensor microarray to detect 10's to 1000's of features. Thousands of uniform, repro-ducible nanowires are arrayed on a mass producible, low cost computer chip. The nanowires are printed with DNA probes associated with disease or drug resistance. When the amplified DNA flows over the biosensor, target sequences hybridize to the probes. As DNA is naturally negatively charged, this causes a change in charge density at the surface of the nanowire, which in turn causes a change in resistance in the nanowires.

The nanowires are individually calibrated and monitored in real-time with the signal processed by an on-board application spe-cific integrated circuit (ASIC) and analysed by algorithms to give a diagnostic result.

QuantuMDx are currently working on a number of proj-ects to deploy their technology as a means of tackling disease around the world. The company is in the process of developing Q-TB™, a rapid and cheap test that will analyse sputum sam-ples at the patient's side and diagnose multi-drug resistant TB (MDR-TB) within 15 minutes enabling immediate personalised prescription of the most effective TB drug treatment.

The three year £2m project will integrate QuantuMDx's state of the art DNA analysis device with a novel sputum disrup-tion technology and a comprehensive TB biomarker panel developed by St George's, University of London. The project is particularly strong as it also embraces the expertise of various global academic TB Groups and several TB focused charities and NGOs who are currently working in the field to help eradi-cate the disease and who understand, first hand, what is needed for a rapid TB diagnostic.

The state of the art device will enable doctors, nurses and health professionals alike to perform complex testing that will guide prescription of targeted drug treatments.

In a similar deployment the company is also working on a malaria diagnostic to allow health workers to tackle drug resis-tance. With no need for clean water or stable electricity, Quan-tuMDx's handheld lab will offer a technology leap to developing nations, giving even the most rural communities access to life

saving diagnostics.

Advanced portable point-of-care laboratory devices are also being developed for bedside testing in hospital environments. Philips Healthcare recently announced the completion of its first field study for its Minicare handheld cardiac Troponin-I blood test, demonstrating the platform’s potential to produce lab-equivalent results with finger prick samples within minutes.

The Minicare cTn-I system is designed to help physicians, nurses and paramedics identify patients at high risk for acute cardiac events right at the bedside or in pre-hospital settings. Only about 15 percent of patients presenting in emergency departments with chest pain suffer from acute myocardial infarction (AMI). At the same time, early diagnosis and treat-ment are critical to improving outcomes around acute cardiac events, and today’s standard lab tests, logistics and reporting can take up to 90 minutes to enable decision-making. With a quick finger prick cTn-I blood test, Philips Minicare is being designed to measure AMI indicators almost immediately, wherever the patient is located. This has the potential to enable doctors to identify high-risk patients earlier, reducing the time from diag-nosis to treatment or quickly discharging patients not requiring emergency care.

Waiting on conclusive blood test results can cause anxiety for patients and delay a physicians' decision for treatment. Almost 70% of diagnostic decisions are currently based on information provided by blood assays, but it often takes an hour or more to get the results from a central laboratory. In life threatening con-ditions like AMI, every minute counts. The Minicare Platform is being developed to provide blood test results, within minutes, at the point of care, such as critical care treatment centres, ambu-lances and in the future in GP clinics as well as at home.

Disease specific testing devices are starting to emerge across a whole range of treatment pathways, allowing patients to con-duct testing in their own homes without the need to travel to doctors surgeries or hospital. These devices are generally con-nected, allowing data to be easily shared across the whole spec-trum of care stakeholders. Proving patients with accurate bed-side testing also allows them to more easily manage their own condition.

One particular innovation that has been designed with a con-sumer focus on point-of-care-testing comes from US company CUE. Their POC mobile connected testing platform has been specifically targeted at the consumer health-tracking audience, allowing health conscious consumers to go beyond simply activity and vital sign monitoring, to tracking health at the molecular level.




The CUE system works in a similar manner to Q-POC™ using different cartridges to test biological samples for different bodily responses. The company sees its product as an adjunct to the currently available health trackers by providing consumers with intelligent, actionable, data on five key aspects of their health. At present the modular system has been designed as an at-home lab test, which, using a sample of blood, saliva, or mucus can conduct at home versions of five laboratory tests: Influenza,; Testosterone, Vitamin D, Inflammation, and Fertility. Informa-tion from each test is sent via Bluetooth to the user’s iOS or Android smartphone, providing a platform for analysis.

According to founder and CEO Ayub Khattak, Cue picked five tests which people already pay for in large numbers, despite the relative inconvenience and expense of getting a laboratory test done. Testosterone levels are something athletes often want to know about, as well as older men. People are interested in Vita-min D because of its effect on mood — according Khattak over 70 million Vitamin D tests are ordered each year. Inflammation is both a predictor of heart disease and a counter-indicator for intense workouts — if people detect that they’re inflamed, it might be a hint to back off from exercise for a little while. Those three tests, as well as the fertility test, are designed to be done regularly, more like a tracking device than a one-time test.

The influenza test on the other hand, which was the original concept behind the company, is designed to be used by parents or other individuals to check for flu at home, in order to reduce unnecessary doctor visits, especially during an epidemic or a heavy flu season.

“We’re not intending to replace the doctor, that’s not what we want to do,” said Khattak. “We want people to have more informed conversations with physicians. A mother, for example, who’s worried her child has flu. She’s able to get the piece of mind she wants by taking that test as soon as the child is sick. And then she can call the physician and have a more informed conversation. And then that doctor can make better decisions based on that information.”

Cue hopes to expand to other lab tests as time goes on. Khat-tak said he wasn’t allowed to make specific claims about accu-racy prior to FDA clearance, but he thinks that the tests have the potential to actually be more accurate than their laboratory counterparts, simply because so much more of the process is automated.

Cue’s technology is not yet FDA cleared. Like several recent technologies, the company plans to use an investigational device exception to sell some advance copies of the device prior to securing clearance, and then use information from those units for the usability testing required by FDA. The company hopes to ship the pre-sold units by spring 2015.

Cue is just one of many start-up and research projects that are in the process of developing this type of consumer-facing, at-home, testing solution.

Matrilyzer is a company developing a mobile application and device that attaches to existing iPhones, iPods or iPads. It is designed for patients to monitor an enzyme called collagenase, which is released by existing tumour cells allowing them to spread to new parts of the body by breaking down the matrix that holds healthy cells together. Matrilyzer will enable patients to monitor their collagenase with one drop of blood.

When the amount of collagenase increases in the body, it sug-gests to doctors that new cancer cells might be growing in other parts in the body. Collagenase has been studied for a long time in cancer patients, and suggests that cancer cells are leaving the primary site, invading distant healthy tissue, and forming new tumours.

The solution which is still in the early stages of development is intended to help patients easily measure collagenase from their home. That data can then be used as more information for doc-tors to potentially run scans, consultations or prescribe treat-ments.

Barriers to Acceptance

The key issue of alignment and concordance of point-of-care with central laboratory methods cannot be overlooked by labo-ratories, regulators, and the industry. Lack of alignment with definitive methods remains a potential barrier to further accep-tance and the subsequent growth of point-of-care devices. Manufacturers must demonstrate accurate correspondence of their devices to definitive laboratory tests, or properly aligned reference methods.

Microfluidics

A major innovation that is paving the way for the increasing number of lab-on-a-chip devices is microfluidics. When a test is relatively simple, then lateral flow tests can work perfectly well without fluid management technology, however, as the complex-ity of the test increases then it becomes necessary to incorporate microfluidic management systems. Microfluidics is therefore seen as an enabling technology allowing for the miniaturisation and integration of laboratory protocols into portable devices.

Such is the promise of microfluidics in the healthcare sector that a recent report from Yole Developpment suggests that point of care testing based on the technology is expected to grow sharply, from $1.6B in 2013 to $5.6B in 2019.[2] The report also estimates that the wider point of care market’s contribution


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to in vitro diagnostic is poised to increase from 13% to 17% over the next five years, leading to a market of around $30B in 2019. The application of these types of portable mobile testing devices covers a range of scenarios, including: Emergency test-ing; Home tests; Doctor’s office screening; Decentralised hos-pital tests; Environmental testing; Forensic and military; Third-world infections; and, Agro-food.

Medical Device applications in microfluidics are being enhanced by electric field manipulation, novel ligand sequestration, photo-metrics, spectroscopy, florescence, and a whole host of adjunct technologies. The potential applications in the medical space are nearly limitless and with advancements in micro fabrication, have become very cost effective.

There are several advantages to the lab-on-a-chip approach, beyond the convenience of being able to test in the field. The test sample required is much smaller because of the sensitivity of the chip, which is useful if you need to measure the very earliest stages of a disease when the chemical markers in the blood are low in number and would probably be missed by standard tests.

New Financing Options Driving Development

Another interesting factor driving forward the adoption of some

of these types of testing device, (particularly consumer targeted products) are the use of crowd-funded financing options to help develop devices specific to certain disease types.

Crowd-funding investment platforms, allow developers and innovative start-ups to go directly to their end consumer (patients) prior to fully developing a device. By gaining sup-port and financial backing, often through pre-orders, companies reduce their risk of going to market, by ensuring that at the very least prototyping funds can be secured. The initial sales of the product can help deliver information on efficacy and the capabilities of a solution, which can in turn assist in gaining additional market approval.

By undertaking this type of route to market companies are also creating communities of potential users, that have a vested inter-est in the successful development of the product. This signifi-cantly helps to gain traction in the marketplace, test products, secure early sales, and demonstrate a demand that can then be used as evidence to secure further future development funding from more traditional financing sources, and help ensure the long-term viability of the solution.

1. Dubois, J A., 2013. "The Role of Point-of-Care-Testing and Rapid Testing." Medical Laboratory Observer

2. Yole Developpment Report 2014. “Point of Care Testing 2014: Applications for Microfluidic Technologies.” n

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The Changing Face of Healthcare: Quality in Medical Applications


For generations, innovations that cre-ated direct impact and value were per-sonified by lone geniuses, the likes of Thomas Edison and Steve Jobs toiling away in their laboratories. Today's real-ity, however, paints a different picture; the confluence of Political, Economic, Social, and Technological forces forge a diverse, and often complex ecosystem that shapes, fosters and demands innova-tion. The medical technology field, espe-cially in the developed economies, long profited from the convergence of forces that spurred innovations, such as pros-thetic limbs, hearing aids, imaging tech-nologies and less-invasive cardiovascular procedures, which have reduced recov-ery times and greatly improved health-care outcomes.

However, according to PwC’s report titled, “Operating performance in the Medtech industry: Trends and impera-tives”, Research and Development (R&D) activities are not generating as much value and growth as they histori-cally did. PwC's study of 56 global medi-cal technology companies revealed that the impact of R&D on revenue growth declined at an average annual rate of 10% between 2005 and 2011. These companies compensated for this decline through cost cutting measures and by increasing operational efficiencies.

The most significant challenge faced by the medical device industry is that the fundamental nature of innovation has changed dramatically. It was a world built on incremental innovations with hard-ware focus. The notion that the players could demand price premiums for these innovations is slowly disintegrating. This phenomenon is accelerated by the emer-gence of modular systems that comple-ment hardware ubiquitously available among healthcare stakeholders and by shift to software-centricity.

The adoption of mobile technology at breakneck speed has also transformed the Healthcare industry, creating an area of innovation - Mobile Healthcare

(mHealth), fueled by numerous mobile applications developed and released by companies and developers alike for gen-eral use by lifestyle consumers, patients and healthcare professionals’. In 2012, the number of medical application users reached 247 million and the global rev-enue from mHealth apps grew to USD 1.3 billion, and continues to grow on an upward trending curve.

With mobile applications, regular smart-phones could be easily converted into an effective healthcare platform that patients come to rely on.

Disease symptoms and medication side effects can be easily and progressively tracked, logged and electronically shared with healthcare practitioners. Gathering diagnostic data, such as blood pressure, heartbeat rate, and even much more complex and kinds of diagnostics such as e.g. for antibiotic resistance and eye diseases can be automated. Appoint-ments with healthcare specialists can be scheduled with a single click and these meetings improve in quality as patients could systematically record and share their concerns with these experts before a physical visit. In case of physical dis-comfort, sickness or diseases, patients could browse through a comprehensive FAQ database through a mobile device to see available medications and options before physically consulting a practitio-ner. In extreme scenarios, as in cancer, patients could gain access to a commu-nity of patients, where they could dis-cuss their problems, ask questions, derive inspiration from success stories, par-ticipate in information exchanges, gain moral support and stay positive, know-ing that they are not alone in their battle for cure. Healthcare organisations could curate knowledge from diverse infor-mation sources and provide structured access to healthcare consumers where and when they need it. Pharmaceutical companies could use mobile channels to disseminate information, organise webi-nars, work directly with patients, and so on. The possibilities are boundless.

Surveys reveal that mobile applica-tions have become increasingly impor-tant to both, patients and doctors alike. Research conducted by Dutch physicians showed that over 60% of doctors use medical apps on their mobile devices. 83% of them use mobile apps to find information; 47% utilise them for refer-ence purposes, and about 40% use them for support during consultations.

However, another study published by the Department of Neurology in the Academic Medical Centre, University of Amsterdam also discusses the dangers, lack of regulation, and proposes quality assurance guidelines for mobile health-care apps. The authors of the study agree that medical apps have tremendous potential, but also underline the alarm-ing lack of knowledge about risks these apps pose. Regulation and guidance are urgently required.

Furthermore, medical apps should be peer-reviewed by healthcare experts and quality control measures should be streamlined to safeguard the quality of care. Because doctors and patients rely on the information and tools around cure, ensuring quality and safety are of paramount importance in gaining their trust in medical apps. Awareness among medical professionals is absolutely required, so that they can make informed choices about the apps they use in clini-cal care knowing that some apps may contain unreliable, non-peer-reviewed content.

Hence, it's easy to recognise that mHealth is a very complex and diverse ecosystem; mHealth applications require the highest degree of accuracy from both, device and software. The medical app frontier is an entirely new development for estab-lished regulatory bodies like the US Food and Drug Administration (FDA). In July 2011 in its “Draft Guidance for Indus-try and Food and Drug Administration Staff: Mobile Medical Applications”,

The Changing Face Of Healthcare: Quality in Medical Applications

A thought leadership article by Dieter Speidel


46

The Changing Face of Healthcare: Quality in Medical Applications

June 2014

the FDA proposed that certain types of mobile apps targeted for medical use be considered medical devices and placed under its scrutiny before they can be released for public use.

However, the FDA clearance processes for medical apps do not require compre-hensive clinical testing to ensure safety and quality as the processes for drugs and medications. With the increasing com-plexity of software systems, the possibil-ity of failure through software defects increases exponentially, reinforcing the need for stringent quality assurance mea-sures. Even though FDA's guidelines on medical apps has been finalised, it only addresses a subset of the entire medical app space.

According to a study, “Medical apps for smartphones: lack of evidence under-mines quality and safety”, although no harm caused by medical apps has been reported, without app quality assurance and safety standards, it's only a matter of time before some medical errors happen and unintended harm to patient occurs. To ensure quality of medical apps, authors of the study suggest:

1. Official certification marks that guarantee quality

2. Peer review system implemented by physicians’ associations or patient organisations

3. Making high quality apps more find-able by adding them to hospital or library collections

Presently, the feedback and ranking mechanism in place at app stores, while good for games and less critical apps, is highly inadequate for medical apps. The medical community, app store opera-tors, regulatory bodies, auditors, patients, and other stakeholders need to get more involved in evaluating medical apps, at least on the following aspects:

1. Validation and certification of soft-ware quality that endorses apps' fit-ness for purpose and use

2. Peer reviews by diverse stakeholders – physicians, medical associations, patients, regulatory agencies, subject matter experts, etc.

3. Continuous monitoring of user feedbacks, complaints through establishment of vigilance systemsThe responsibility of addressing

the aforementioned requirements falls on the medical app development compa-nies; they are required to validate the apps they develop – a responsibility requiring a spectrum of expertise and experience. Many medical app development com-panies have neither the bandwidth nor the resources to handle comprehensive quality assurance and validation. Though several journals now include app reviews by doctors and healthcare practitioners, evaluating the apps from a 360-degree perspective requires cross-functional skills and knowledge.

For example, medical app design is an area of paramount importance when developing mobile medical apps. Medi-cal apps are intricate tools placed in the hands of doctors and patients, which can significantly influence healthcare outcomes. Hence, these apps must be designed and developed with usability in mind and addresses human factors, including user errors that result from unintuitive design. In an article titled, “Developing a Mobile Medical App? Don’t Forget Human Factors!”, medical app developers should consider at least the following human factors:

1. Preliminary analyses (such as haz-ard analyses, contextual inquiries, task analyses, heuristic analyses, and human factors expert reviews)

2. Exploratory human factors research3. Formative human factors usability

testing4. Human factors validation testing

The FDA guidance also recommends app manufacturers to follow the human factors guidelines, even when their apps are not subject to regulation. This strat-egy is perceived to be the best way to both, mitigate risks and encourage adop-tion, while simultaneously avoiding high costs associated with unnecessary rede-signs and product recalls.

From a software engineering perspective, even small changes in software could dramatically change the way a mobile medical app works. These changes may stem from requirement changes, design modifications, or amendments required by regulatory agencies. Ensuring the continued quality, accuracy and safety of mobile medical apps requires that any software modifications undergo a life cycle of software quality assurance and validation process. Regression test-

ing should be as comprehensive as pos-sible to demonstrate that the changes were implemented correctly and, did not adversely impact other parts of the product.

FDA's final guidance addresses these perspectives required of mHealth apps and states that regulating mobile medi-cal apps will be a high priority from 2013. The ramifications of this decision implies that medical app development companies are forced to implement rig-orous testing procedures to ensure com-pliance – a development that's perceived to be associated with high costs, com-plexity, and scope. Raising the bars might improve the overall healthcare outcomes, but may simultaneously deter aspir-ing developers and entrepreneurs from developing Healthcare IT solutions.

Complex challenges such as these often spur innovative, creative and simple solutions, but in the case of mHealth apps these challenges can be thoroughly addressed using the help of professional communities and users, in other words through crowdsourcing testing and eval-uation.

Crowdtesting, a variant of outsourced software testing, undertaken with a com-munity comprising of subject matter experts, professional testers, legal con-sultants, software engineers, healthcare professionals, patients, usability experts, etc. easily scales the scope and support required by a medical app development company to ensure that their solutions have been evaluated at all angles and comprehensively tested. The concept of crowdtesting, traditionally used to ensure quality of general purpose web- and mobile apps, subjects the medical app to an exhaustive battery of tests performed under real-world conditions on a variety of devices with a group of profession-als plus an identified target users group, before the medical app is released to the marketplace. Crowdtesting encompasses the rigor of traditional, formal software testing methods and complements these formal methodologies by emulating real-world conditions - a development that many medical app companies haven't had access to before.

The fundamental concept of crowdtest-ing is the idea of distributing a specific quality assurance problem among a com-munity of experts, specifically curated to


US and UK Working to Strengthen Use of Health IT for Better Patient Care


solve the task. These experts are inher-ently motivated to solve the challenges for, either monetary or non-monetary rewards. Medical app development com-panies could avail crowdtesting services ranging from fully managed testing ser-vices offering to a self-service concept, where the company only seeks access to the testing platform and the expert com-munity when needed.

In addition, the company could save on associated overheads, such as hardware and software costs because the commu-nity already owns various combinations of different device types, operating sys-tem and language versions – a situation that's almost impossible to simulate in an

internal lab. Crowdtesting opens a large pool of software testers and domain experts to medical app companies, so selection of target groups could be achieved at different levels of granularity.

As the crowdtesting process is fast and flexible by design, it could easily be integrated into existing software release cycles and delivery models, so that the shortcomings could be identified and corrected immediately before the soft-ware is released. Crowdtesting also per-mits testing at different stages of soft-ware development - from the prototype evaluation to a final check at the end of the beta stage. The ability to lever-age real medical app users and devices

helps achieve a substantial cost reduction during development and maintenance phases of the medical app lifecycle. Fur-thermore, human factors enumerated by FDA could be progressively validated through the various stages of software development through post-deployment and maintenance. As a result, the soft-ware quality increases exponentially while simultaneously relieving the app development company of important domain considerations beyond their area of expertise and freeing up their internal resources to focus on core operations.

Dieter Speidel is the Founder & CEO of PASS Group, a leading Swiss provider of software and system testing services. n

As the use of health information technology grows in both the United States and the United Kingdom, HHS Secretary Kath-leen Sebelius and U.K. Secretary of State for Health Jeremy Hunt have recently signed a bi-lateral agreement for the use and sharing of health IT information and tools. The agreement strengthens efforts to cultivate and increase the use of health IT tools and information designed to help improve the quality and efficiency of the delivery of health care in both countries. The two Secretaries signed the agreement at the Annual Meeting of the HHS Office of the National Coordinator for Health Infor-mation Technology.

“While we have very different health care delivery systems and payment models, we both face similar challenges posed by aging populations, increased levels of co-morbid chronic disease, and escalating complexity of care delivery and costs,” Secretary Sebelius said. “By working together, we can more effectively take on these challenges, improve the health IT economy, and the health of the American and British populations.”The agreement signals a formal commitment by both countries to collaborate to advance the applications of data and technol-ogy to improve health.

“This is a ground-breaking agreement that will help both of our countries use information and technology more effectively to improve care, safety and give people more control over their health, which is now even more important as we transcend care boundaries,” said Secretary Hunt. “By bringing knowledge together this will not only offer insight into tackling common problems across health IT, but through innovation, it will help small to medium enterprises play an effective role in our health-

care market. I would like to thank all involved in making this agreement happen and look forward to collaborating across our health IT economies.”

Originally identified at the June 5, 2013, bilateral summit meet-ing between the United States and United Kingdom, the collab-oration focuses on four key areas for health IT and innovation.

Sharing Quality Indicators – The collaboration reviewed exist-ing quality indicators and selected Depression symptom screen-ing and knee/hip quality indicators, and is now identifying alignments across existing British and American repositories to identify best practices in the design and use of quality indicators. Future work will include mutually leveraging technical experts and data, and working on a standardised approach to quality indicator development.

Liberating Data and Putting It to Work – HHS and the National

US and UK Working to Strengthen Use of Health IT for

Better Patient Care


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China: A Market for mHealth?

June 2014

Mobile health (mHealth), referring to the use of mobile devices (or more generally wireless technology) in health-care delivery, is still in its early stages of development but is attracting increasing attention from healthcare providers and payers in both developed and emerging markets worldwide. By improving com-munications between healthcare provid-ers, payers and patients, enabling the remote monitoring of symptoms and allowing patients to take greater con-trol of their own treatment, mHealth is already demonstrating that it can be highly effective for delivering better and more cost-effective patient outcomes.

mHealth has a particularly strong poten-tial in China to address the country’s rapidly ageing population. With few children to support their parents and an exploding middle class that views health-care as a luxury good they can consume, there is also a shortage of hospitals, clin-ics, physicians and nurses to meet these demographic and economic demands. With its unique market characteristics and rapidly developing healthcare sys-tem, the country is facing particular chal-lenges to provide basic primary health-care equitably and universally, whilst also providing quality, medically advanced and patient-centric clinical care for those who are able and willing to pay for pre-mium services. China has the largest and fastest growing ageing population in the world (with one fifth of the world’s elderly population), and the one-child policy means that two ageing parents have only one child to care for them in their later years[1]. The Chinese middle class is larger than the population of the United States and already makes up more than half of the urban population. With

their growing disposable incomes

and generally more advanced education levels, the Chinese urban middle class increasingly prefers international-style medical services. While the Chinese gov-ernment has aggressive plans to reform the healthcare system in China, as illus-trated by the healthcare reform goals in the 12th Five-Year Plan (2011-2015), it will require the adoption of transforma-tive technologies and medical practices to meet these demands. Innovative yet practical mobile health solutions could potentially fill many healthcare gaps in China, where consumers are willing to pay out of pocket for services from both public and private medical service pro-viders. It would also enable providers to overcome difficulties in generating these offerings within existing budget con-straints.

Pilots of mHealth services are under-way or already completed in a number of provinces, and are delivering both real benefits to consumers and poten-tially attractive returns to investors. For example, the “12580” hospital booking and reminder system in Guangdong,

Nei Menggu, Tianjin and Zhejiang sup-ported by China Mobile has helped to reduce the cost of healthcare delivery and at the same time improve patients’ access to doctors and medical facilities. Shanghai Jiaotong University has set up a remote service centre to serve patients equipped with mobile-enabled medical devices provided by hospitals to monitor and diagnose their conditions. Experi-ence from these pilots will help to shed light on how to address the problems of uneven distribution of medical person-nel and facilities across rural and urban areas.

The pervasiveness of technology is enabling the emergence of a new, more patient-centric healthcare value chain. For technology vendors, service pro-viders and investors(1), mHealth offers many opportunities. The mHealth sur-vey projects that by 2017, China will be the second largest mobile health market after the United States, with an estimated US$2.5 billion in revenues[2]. Devel-opment of this market will be further facilitated by the establishment of elec-

China: A Market for mHealth?The China-British Business Council recently published this article, looking into the opportunities for mHealth in China. The Chinese healthcare market represents huge potential opportunities for digital health and mhealth service providers, but there are still significant barriers to widespread adoption. Following the theme of this issue the article illustrates the global appeal that mHealth and Digital Health services have, and the options that they can potentially provide centralised governments to meet the

needs of rising populations by providing effective care solutions.

China: A Market for mHealth?


tronic health records, with the Chinese government aiming to cover 75 per cent of the population by 2015[3]. There will be a range of commercial opportuni-ties relating to the sale and integration of the devices, as well as the processes and associated IT platforms required to deliver mHealth solutions. There will also be opportunities for investments and joint ventures with companies spe-cialising in this area. Overall, stakehold-ers should revisit their business models so that mHealth is conceived, positioned and developed as a critical component of an integrated, efficient care system and not as a standalone solution. Inspi-ration may be found in other industries, such as media, retail and travel/tourism, that provide value-added online services – free of charge – in order to generate a

competitive advantage.

Overall, mHealth presents excellent opportunities for both Chinese and for-eign companies to work with healthcare providers and payers to bring better, faster and more cost-effective treatment to patients globally. Mobile technology holds the potential to address some of the long-standing issues in healthcare provision, as current trends dictate. By acting promptly, stakeholders can ensure they are active players in this exciting and inevitable new futurefor medical care.

1. Kaneda, T. ‘China’s Concern Over Population Ageing and Health.’ Popula-tion Reference Bureau, June 2006. An ageing population is defined as those

who are aged 65 and above. It is esti-mated that there are approximately 102 million elderly people in China.2. Emerging mHealth: Paths for Growth, Economist Intelligence Unit, 2012 (www.pwc.com/mhealth).3. China healthcare reform goals in the 12th Five-Year Plan for National Eco-nomic and Social Development of the People’s Republic of China (2011-2015)

This article was taken from China-Britain Business FOCUS, a monthly magazine published by the China-Britain Business Council for its members.

The China-Britain Business Council helps companies of all sizes from all sec-tors to do business with China. Find out more at www.cbbc.org n

Health Service will discuss and find areas of collaboration around:

» Open data and safe and secure data transparency of sec-ondary stored data, with the consent of patients to allow for the two countries to further assess the quality of pre-ventive interventions and health care delivery

» Interoperability standards for improvement of data sharing and clinical care respectively, with a focus on consumer/patients accessing and sharing their data

Adopting Digital Health Record Systems – Both organisations will work to maximise successful adoption of digital records

across the health care spectrum and support the development of a robust health IT workforce; and

Priming the Health IT Market – Both organisations will work to support the Health IT Marketplace by identifying barriers to innovation, sharing individual certification approaches for patients and clinician-facing applications, and strategies to sup-port small and medium enterprises/start-ups.

The full text of the memorandum of understanding can be found at www.healthit.gov/policy-researchers-implementers/health-infor-mation-technology-use-united-states-and-united-kingdom n

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The Journal of mHealth Vol 1 Issue 3 (June 2014)

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