The Journal of mhHealth Vol 2 Issue 2 (Apr 2015) by The Journal of mHealth

WHATâ&#x20AC;&#x2122;S INSIDE

NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

The

Journal of mHealth The Global Voice of mHealth

April 2015 | Volume 2 Issue 2

Digital Health Solutions for Condition Management and Treatment

TECHNOLOGY

ARTICLES

INTERVIEW

Mobile Device Aids Cervical Cancer Detection

Technology to Manage Care Transitions

With Jon Linkous: Connections in Digital Health

mHealth Interventions Wheel

Assessment Set up any form of information capture

Clinician

Patient Data

Providing required level of support & integration to healthcare providers

Capture data directly from medical & healthcare devices

Caregiver

Alerts

Helping carers to support & monitor relatives

Intelligent monitoring for patients, carers & HCPs

Treatment Management

Careplan Patientâ&#x20AC;&#x2122;s summarized view of their key data & progress

Helping manage treatments, clinical visits, tests & vaccinations

Content

Goals Management

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

Setting and managing pre-defined & personalized goals

Reward Acknowledging patient progress & achievement

Exco InTouchâ&#x20AC;&#x2122;s health solutions are patient centric self-care models that allow patients, carers and healthcare professionals to interact, support and be involved in patient care remotely. The system is built on a modular platform of functionality that can be combined with individual workflows, rules and content to create a highly specialized therapeutic product. These functions, part of a larger library, are built as generic modules that can be configured and adapted to deliver specific programs, as well as being presented with a look and feel that reflects patient and customer needs. These programs and platforms are built on the background of systems that have supported hundreds of thousands of patients in clinical trials.

Editor's Comments

Welcome A major difficulty facing healthcare professionals throughout the world is the need to constantly do more with less. Less time and fewer resources! For patients this means that they can often be unintentionally left feeling unsupported and at times isolated from their own care provision. Digital health solutions are proving an important means of filling this care gap. By tailoring solutions to the specific requirements of an individual patient digital healthcare has real potential to offer significant value, by helping with the management, and in some cases treatment options, of specific medical conditions. In this issue we include a number of articles that consider the role that digital and mobile technologies can play in the management and treatment of conditions. As well as discussing examples of solutions that are providing vital enhancements to the communication between HCPs and patients and improving care pathways.

Published by Simedics Limited

With the American Telemedicine Association’s annual meeting (one of the largest telemedicine and digital health events of the year) coming up at the start of May we were fortunate to be able to talk to Jon Linkous, CEO of the American Telemedicine Association, ahead of this year’s event in Los Angeles. The ATA is a leading international resource and advocate for promoting the use of advanced remote medical technologies. In this interview Jon discusses the current state of the market and highlights what we can expect from the event.

For editorial, research and paper submissions, and advertising opportunities please contact: Matthew Driver

Also, in the first of a new series of articles discussing the changing regulatory landscape of the digital health market, Bradley Merrill Thompson of US law firm Epstein, Becker & Green provides an expert evaluation of the guidance document on “General Wellness: Policy for Low Risk Devices” which was proposed by the FDA earlier this year. We would like to take this opportunity to thank Bradley and the team at Epstein, Becker & Green for partnering with us to produce this content. We know that the changing regulatory landscape surrounding digital health is a particular topic of interest to many of our readers, and we hope that through insight pieces like this we are able to offer some clarification on the evolving situation.

www.thejournalofmhealth.com

www.simedics.org

Editor: Matthew Driver Design: Jennifer Edwards

matthew@simedics.org

+44 (0) 1756 709605 Subscribe at The editor welcomes contributions for The Journal of mHealth. Submissions can be sent to the editor by email, images and graphics should be submitted in high resolution format.

Finally, following the overwhelming success that we had with last year’s Global Digital Health 100 Award I am pleased to be able to announce that we are running the award list again for 2015. Aimed at highlighting the best innovations and technologies, with the greatest potential to change the way that modern healthcare is delivered. The awards are open to any company or organisation - from around the world - involved in the development or delivery of digital health products and services. Last year’s recipients received significant market exposure from their inclusion on the list, and we fully expect the same, and more, for this year’s final line-up!

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

Don’t miss out and nominate now at www.thejournalofmhealth.com.

Matthew Driver Editor

The Journal of mHealth

Table of Contents

In This Issue 4

Connections in Digital Health: An Interview with ATA CEO Jon Linkous Ahead of this year’s ATA2015 event in Los Angeles we talk to Jon Linkous CEO of the American Telemedicine Association (ATA). Based in Washington, DC the ATA is a leading international resource and advocate for promoting the use of advanced remote medical technologies.

FDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease In the first of a new series of articles discussing the changing regulatory landscape of the digital health market , Bradley Merrill Thompson of US law firm Epstein, Becker & Green provides an expert evaluation of the guidance document on “General Wellness: Policy for Low Risk Devices” which was proposed by the FDA earlier this year.

Using Technology to Manage Care Transitions and Reduce Readmissions The healthcare industry is increasingly conscious of effective care transition management to reduce hospital readmission rates. In this article by Douglas Naegele and Janica Lee from Infield Health the role of technology in managing care transitions, to help reduce hospital readmissions, is discussed.

April 2015

Table of Contents

Industry News

Enabling Patient-Centred Care through Information and Technology

Intelligent Stethoscope Attachment Set for Clinical Trial

Mobile Ultrasound Project Wins ‘Best Mobile Innovation for Health’

NHS Innovation Challenge Prize Winners Announced

Engaging Patients to Deliver Improved Surgical Outcomes

Electric 'Noise' Treats Parkinson's Symptoms

How Digital Health Can Change Condition Management

FDA Launches Drug Shortages Mobile App

Healthcare at the Touch of a Finger

Europe’s First Fully Remote Diabetes Trial Approved

12 US Start-ups Influencing the Future of Digital Health

Nursing Study Finds Mobile App with Evidence-based Decision Support Helps Diagnose Obesity, Smoking, and Depression

Wearable Sensor to Allow Safer Monitoring of Ebola Patients

Using Digital Solutions for Condition Management

Open-Source Robotics Turns Hospitalised Children into Virtual Explorers

Nurses Say Medical Errors Could Be Reduced If Devices Were Connected, Survey Shows

ResearchKit to Give Scientists Easy Access to Study Subjects and Data

In Depth with the Global Digital Health 100

Breakthrough in Blood Pressure Testing Technology

Bringing Hands-free Gesture Control to the Operating Room

Philips and Janssen to Develop New Handheld Blood Test

Upcoming Events

Advertisers Index

12 13

13 14 15

Revolutionary ‘Pregnancy Tester’ to Help UK's 1m Undiagnosed Kidney Disease Cases Oxehealth Advances Baby Safety with Camera-based Vital Signs Monitoring

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Mobile Device Aids Cervical Cancer Detection in Low-Resource Settings

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mHealth will Benefit from New Mobile Initiatives Announced at MWC

The Global Voice of mHealth

The Journal of mHealth

Connections in Digital Health

Connections in Digital Health: An Interview with ATA CEO Jon Linkous

An Interview with ATA CEO Jon Linkous Ahead of this year’s ATA2015 event in Los Angeles we talk to Jon Linkous CEO of the American Telemedicine Association (ATA). Based in Washington, DC the ATA is a leading international resource and advocate for promoting the use of advanced remote medical technologies. As the chief staff executive of ATA since its inception in 1993, Mr. Linkous has lectured and written extensively on healthcare modernisation, technology issues, emerging applications and market trends in the U.S. and around the world. What do you consider to be the most important market trends affecting the industry at this time? “There are several things that are happening, all at once, within the industry. We have a huge number of new investments coming into the industry that are leading to different types of approaches, and with this leading to the development of different types of business models and services.” “Most recently, we have begun to see services based around direct-to-consumer online consultations. These platforms, which work over an internet connection using your laptop or desktop, or even a mobile application, are being offered by a number of companies and we are also starting to see a number of traditional service providers starting to offer these services as well.”

“It represents a natural outgrowth. Physicians are offering their patient’s portals, through which they can access their electronic information, collect lab results and correspond and communicate easily with physicians [and other healthcare professionals] via email. In addition to this in many cases patients are also now

April 2015

given access to video consultations as well.”

“It is an exploding field.”

“We estimate that somewhere in the region of 800,000 consultations will be conducted online this year, just in that one space alone [the telemedicine area].”

Do you believe telemedicine services and remote monitoring solutions are now an accepted part of mainstream care pathways?

“Another particular area of growth is the use of remote monitoring for intensive care unit patients. There are somewhere in the region of 550,000 patients that will be monitored remotely, this year, within intensive care units, which is a growth of about 20-30%. This is such an important part of the delivery of healthcare. It offers not only efficiencies of care, but also greater quality of care by allowing highly trained intensivists to look after people in intensive care units, in multiple hospitals.”

“Absolutely.”

“There is also growing interest from governments and central organisations which is having a profound influence upon the industry landscape. In the USA, since the beginning of this year’s calendar session, we have already had over 100 pieces of legislation introduced across the various states. This proposed legislation is all designed to expand either reimbursement or coverage of some sort of support for telemedicine. So there is a huge growth in that sense.”

“Many of the medical societies, the American Medical Association, in this country, and medical associations in other countries, are starting to address this. You now have many, if not most, of the major providers in the US heavily investing in some form of telemedicine, for a variety of reasons.” “The other thing that we are just starting to see, and we are just at the very tip of this, is consumer demand. Consumers in the past didn’t know what telemedicine was. It was always done behind the scene, and in most cases the patient would be unaware that a remote consultation had even occurred. One good example of where this has been happening for a considerable time is in radiology. But, now with direct online consultations, and other innovations, consumers are getting to see what the difference is by having these types of technology available.”

Connections in Digital Health: An Interview with ATA CEO Jon Linkous “I draw a parallel, to this, with the changes that we have seen in the banking industry over many years. With introduction of ATMs and card payments, you no longer had to go to the teller to get your cheque cashed, and when this was first introduced there was considerable scepticism from the public. But, now the technology is so entrenched that you wouldn’t go to a bank anymore that didn’t offer access to an ATM, and I think that the same thing is happening in healthcare. I think that consumers, within the next 5 years, will step up and they are going to demand that their own providers, hospitals and primary care physicians, all have some form of electronic access. That is just a convenient way of providing care.” What are the major considerations for the industry over the near future?

with a video consultation, and there are some doing it using a phone conversation. Finally, there are also some providers who are getting to the point where you can do it using a data transcription, where you have information entered by the patient, that is then analysed using a computer algorithm which then comes up with the diagnosis. The question that is being raised, is, at what point is this safe and effective? I think that regulators are grappling with this.” “This is one of the issues, and something that we will address at our annual meeting, coming up in May, where we will have a session designed to specifically discuss this whole issue of what is effective and what is the appropriate way of providing accurate care and guaranteeing patient safety when you are using electronic means to diagnose and treat patients?”

“Many primary care physicians and health systems, including the NHS in the UK, are moving towards developing patient portals, where patients will be able to access their own medical records, lab results, and find out other information about things like when a diagnosis has been made, ask questions either via email or some other electronic form, or upload their own data like vital signs. How does all that get integrated into the healthcare system? How, with mobile devices, can you make these types of application available? These are all questions the industry needs to answer.”

Does this tie in with the ability to demonstrate positive outcomes?

“All of these things are quickly transforming themselves and once we have the patient portals available, and once patients, as consumers, start to look and demand this type of information then the questions become - How do you best meet this demand? How are competitors meeting this demand? And, if you don’t meet this demand then you are going to lose market share, or in this case patients.”

“But we are still in the process of this. It is a field that has been around now for many years, but I think that we are now at a scale where there are some major innovations that will have very serious impact on the delivery of healthcare within the next couple of years.”

“There are a host of issues that always accompany change, particularly changes in healthcare. There are always a number of ethical, legal and financial issues.” “One of those particular issues, for example that we are seeing with the growth of online consultations is the question - On what basis can you provide an accurate diagnosis and then provide a prescription? You can do that face-to-face in an office, you can do that

“Absolutely, telemedicine has always had people saying we need more research. There have been a number of studies that have been very informative and helpful, but often they have been small. I think the studies that have been coming out over the past couple of years have really changed that. We now have fairly widespread use and a lot of the pilots and the research that has been done have large patient populations, which is certainly helping to resolve that issue.”

Do you see the need for accreditation becoming more necessary as the number of available solutions and services grow, in order to ensure standards? “From a consumer perspective it can get a bit confusing, where you may have a patient who wants to go online and talk to a doctor or another type of healthcare provider, because they do not always know who they are talking to.” “How do you know that the organisation that is providing this is protecting patient

privacy? Are they making sure that it is a qualified doctor or health provider that you are talking to? And, what is the appropriate ways of disclosing information?” “That is why we decide to develop our accreditation program. We have had somewhere in the region of 200 organisations indicate an interest in becoming accredited, and we are still finalising our first round of accreditation, which will be announced shortly. But, I think it is an important point for providers, payers, consumers, and for regulators to look at and to be able to separate out providers, and also to help establish some best practices.” What are the main changes that ‘mobile technologies’ are bringing to the traditional models of telehealth, telecare etc? “I think that mobile is an accelerant to everything that is happening, because again you are providing greater consumer access, and placing greater power in the hands of those consumers. It has been a slow uptake, but healthcare in general is a late adopter of technology.” As some of these systems grow in terms of the level of ‘intelligence’ available to help automate various aspects of the delivery of care, do you foresee this producing a new set of challenges for the industry? “The use of data analytics has been growing in healthcare for quite some time, and what you have with that is the growth of automated diagnostics. These systems which incorporate diagnostic algorithms are being used - and actual have been used for quite some time - in a very simple way. For example, when considering drug interactions there are some very simple programs that physicians use, on handheld devices, that will help them make sure that when they prescribe a drug to a patient it won’t interact with any other drugs that they may already be taking. Then in a more advanced way a physician looking after an intensive care unit often uses a range of sophisticated computer-assisted diagnostic tools that will help them look at the various vital signs being collected from patients within the intensive care unit. Quite often this will involve a ‘complicated patient’ who will have many difContinued on page 6

The Journal of mHealth

Connections in Digital Health: An Interview with ATA CEO Jon Linkous Continued from page 5

ferent things going on at the same time, so it can help if you have intelligent software to help you, and guide you through the necessary decisions.” “Radiologists also use assistive technologies for diagnosing images on a more automated basis, so we are seeing this already. It is creeping into things, and obviously it does present a challenge for the industry from an ethical and legal point of view. When you look at more of these analytics that are being introduced then you need to make sure that it is done in the right way and that you have outcomes that are not only as safe, but actually, have outcomes that are safer than what you would have otherwise.” “But, I don’t think that we are going to have a doctor replaced by a computer any time soon!” What are the primary policy issues for the ATA at this time? “I think that one of them is standard of care, in terms of agreeing the appropriate ways of delivering care using electronic means. There are still some questions that people have about the efficacy of delivering a diagnosis and treatment plan and issuing a prescription online.” “The whole standard of care issue, in terms of what is an appropriate way of delivering healthcare, not only in this country but globally, is an issue. As we go towards electronic means, and we have shortages of physicians, we also have to ask the question of not just standard of care, but also consider practice of care by various new types of providers. In some states in the US pharmacists, for example, are being empowered to provide certain types of prescriptions. This will happen whether or not you have telemedicine but certainly the advent of electronic means and digital healthcare is certainly accelerating that debate.”

“We also have the issue of payment. In a fee-for-service environment like there is in the US and other countries, it is somewhat vexing because you have to consider how to pay for electronic monitoring when it is not the same type of thing as going to see your doctor and having a consultation? But, that is being resolved as we change our healthcare system from a fee-for-service model, slowly, into

April 2015

more of a managed care, capitated care system where you have a single payer.”

meetups, so we will have over a hundred different meetups for different groups.”

“We are moving towards various approaches and with that are coming a variety of different ways of paying for healthcare. That tends to really accelerate the use of telemedicine and various types of telecommunications in the delivery of care.”

“It is always good to have the collection of people from around the world who come to network, and I think that is the biggest attraction of this meeting. You have the educational sessions and the big exhibits, but to have people from so many different countries that are doing so much, and so much of it is brand new, that you have never seen before. There are so many application that are available that consumers can use on their own now, it is just amazing what some of these innovations can do, so that is certainly one of the areas we will feature at the event.”

What will be the key issues covered by this year’s ATA2015 event? “Some of the issues that we will be looking at are the emerging new business models. Some of these solutions are working within traditional and established healthcare systems, whereas in other cases there are new companies that are formed just to provide remote distance care, and sometimes it is done in partnership with a traditional healthcare provider and at other times it is done in competition.”

“It is also about getting some of the traditional mainline healthcare providers, the captains of the healthcare industry, together to sit down and talk, and to say ‘how do we take some of these innovations and really integrate them into what we are doing in our health system on a day-today basis? Because that is where the rubber hits the road! When you have a large hospital that is starting to use all of these innovations in their delivery of care on a day-to-day basis. That is the jackpot in my opinion. All of these new innovations are fun to talk about but to really make sense of it you have got to get it incorporated into the daily world of healthcare delivery, and to me that is the most exciting thing!”

“I think that mobile is an accelerant to everything that is happening...”

“We have some interesting new research that has been coming out on established patterns of care practice. In addition to this many of the issues that I have mentioned earlier will be discussed on our main stage and we will be talking about them with our incoming president Reed Tuckson.” What do you expect to be the highlights of this year’s event?

“We have a fantastic line-up including Dr Sanjay Gupta, who is a well-known commentator in the healthcare world and chief medical correspondent for CNN, we also have Dr Patrick SoonShiong who is a very well-known figure, and entrepreneur in the healthcare space who is also helping to transform it. And, that is really what this organisation is trying to do, we are on a mission, and the mission is to improve the delivery of healthcare throughout the US and throughout the world.” “Another thing we are doing this year, is given the diverse number of issues that will be discussed, we are arranging a lot of

About ATA2015 With a focus on networking and interactive learning, the ATA 2015 program offers an opportunity to learn and engage with leaders in healthcare technology. With over 6,000 attendees, 13 educational tracks and the largest telemedicine trade show in the world, the ATA meeting connects like-minded telemedicine, telehealth, mHealth professionals from around the globe. For more information visit www.ATA2015.org n

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

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

INDUSTRY NEWS News and Information for Digital Health Professionals

Intelligent Stethoscope Attachment Set for Clinical Trial Eko, a smart stethoscope developer has announced the start of a clinical study with UCSF Cardiology and the closing of a $2 million funding round. According to the company ‘Core’ by Eko is the first stethoscope to be wirelessly connected to a smart device – ushering in a new era of advanced heart sound analytics and monitoring by any stethoscope owner.

The Eko Core isn’t a fully digital stethoscope but an attachment to the familiar analogue version. “We realised the form factor actually matters a lot,” says Eko Devices’ CEO and co-founder, Connor Landgraf.

The device, which slips onto an analogue stethoscope and connects via Bluetooth to software on the operator’s iPhone or iPad, can not only amplify heartbeat sounds but track and log them as well. Heartbeats can be stored in the company’s HIPAA-compliant database and attached to electronic health records.

The device has been developed to easily integrate into clinical workflows. By attaching to a clinicians stethoscope in under a minute it can also be used to reduce unnecessary screenings – a heart sound can be securely sent from any doctor or nurse to a cardiologist for review before the patient is given an expensive and potentially unnecessary echocardiogram. Eko has also formed partnerships with EHR companies, like Dr. Chrono, to seamlessly connect heart sound data with patient records.

Using the Core electronic stethoscope attachment and connected software, clinicians can amplify, record, save, share, and analyse patient heart sounds from the stethoscope they already own. The ability to evaluate cardiac health with unprecedented clarity and use recorded heart sounds for short and long-term patient monitoring will reduce unnecessary cardiac screenings and improve continuity of care. “Though the stethoscope is an icon of medicine and one of clinicians’ most trusted tools, it is a 200-year old technology greatly in need of an update. This investment round and upcoming UCSF study is a momentous step towards a new age in stethoscope intelligence and cardiac monitoring” said Eko’s CEO and Co-Founder, Connor Landgraf.

April 2015

“The stethoscope has remained an icon of medicine for 200 years we’re not going to change that.”

Landgraf claims the idea came about during a project while he was at Berkeley in graduate school for biomedical engineering. He and his two cofounders, then-undergraduates Jason Bellet and Tyler Crouch, were introduced to a panel of six physicians brought in by a professor to talk about issues in their practice. One challenge that stood out: stethoscopes. It takes lots of practice to interpret a heartbeat, and according to Landgraf, some of the physicians from that first panel simply didn’t feel confident with them. “What’s really exciting is it has the potential to make internists and nurse practitioners and other

Industry News types of providers into cardiologists,” says Dr. John Chorba, who is heading up the clinical study. One common issue analogue stethoscopes pose, he says, is difficulty in distinguishing benign heart murmurs from something that may be indicative of pathology. In the study, data from the Eko Core will be compared with echocardiogram results–the “gold standard,” according to Chorba–to see if the two measurements’ assessments of a patient are similar. If they are, then the Eko Core could be used in clinical practice to better determine whether a patient even needs an EKG. The Eko Core also has potential as a research tool for gathering and analysing data. Chorba is optimistic about using the tool’s algorithm to find new patterns in heart function, potentially leading to new discoveries. But he’s cautious – that is, “if it can

do what we think it can do, or what we think it might be able to do.” And that point is still a ways off. The UCSF clinical study will be used to validate the current product’s clinical efficacy in advance of an official launch scheduled for summer 2015, pending clearance by the FDA. The Eko Core is set to retail for $199 with the accompanying mobile and web-based software platform available for free for individual clinicians with a paid enterprise version available for clinics, hospitals, and health systems. The investment, led by Founder.Org Capital and Splunk founder, Michael Baum, includes co-founders of sound recognition platform, Shazam, Stanford University’s StartX Fund, and former Senior Advisor to the U.S. Secretary of Health and Human Services, John Noonan. n

NHS Innovation Challenge Prize Winners Announced Janssen, in partnership with the UK NHS, has announced the winners of the NHS innovation Challenge Prize, recognising solutions that have demonstrated cost savings to the healthcare system and improved outcomes for patients with diabetes. The three NHS Innovation Challenge 1 and Challenge 2 winners will benefit from a share of a £200,000 funding pot, as well as access to mentoring from Janssen, a company leading the way in diabetes treatment and care, which sponsored the awards. The winners are: King’s College Hospital—awarded £50,000 to support its project aimed at Type 1 diabetes patients. Entitled 3 Dimensions of Care for Diabetes, the programme aims to bridge the gap between mental, social and clinical care that prevents people from using available services Hillingdon Hospital—awarded £50,000 for its diabetes services to the schools of children and young people most affected by Type 1 diabetes George Eliot Hospital NHS Trust Apnee Seehat—awarded £100,000 for their South Asian Specialist Intervention pilot mentoring those at a high risk of Type 2 diabetes

Mark Hicken, managing director of Janssen, UK & Ireland, said: "We’re proud to partner once again with NHS England on the NHS Innovation Challenge Prizes. This year’s winners demonstrate the enthusiasm and motivation within the NHS to modernise healthcare delivery and provide better, more effective care at a lower cost to society. The winning programmes prove that integrated, personalised care can really make a difference.” NHS Innovation Challenge 1 looked for ventures that could demonstrate improved outcomes and enhanced quality of life for people with Type 1 or Type 2 diabetes through the implementation of integrated care services.

per patient per year was made. The prize money will be used to roll out further pilot projects as well as introduce an electronic register trial to test the diabetes care pathway in action and establish a new e-learning model to help manage early symptoms of depression. The money awarded to Hillingdon Hospital will enhance its Type 1 diabetes service within schools. A first for the UK, the outreach team is working with six local schools to run the clinics and has recorded a 98% attendance rate and reduced its ‘Did not attend’ rating from 30% to almost zero.

Challenge 2 sought innovative solutions to help improve diabetes outcomes among black and minority ethnic (BME) communities, for whom the prevalence of Type 2 diabetes is up to six times greater compared to the UK’s white population.

Over the next few months the team is looking for ways to extend the scheme to community centres, youth clubs and GP practices in addition to expanding the scope beyond diabetes to include asthma and obesity.

At King's College Hospital, the skill set of the existing multi-disciplinary team has been bolstered with a psychiatrist, community support workers and trained volunteers resulting in greater patient engagement and a 45% fall in the number of sufferers resorting to unscheduled emergency care. The analysis indicated that not only did this improve patient outcomes, but a saving of £850

The George Eliot Hospital NHS Trust and Apnee Seehat will use its Challenge 2 funding to work with GP surgeries in the West Midlands using culturally-trained diabetes specialists to connect with patients who are at high risk of Type 2 diabetes or who have poorly-managed symptoms, through telephone consultations and outpatient clinics. n

The Journal of mHealth

Industry News

Electric 'Noise' Treats Parkinson's Symptoms A wearable device that stimulates the sense of balance with electric "noise" could help Parkinson's disease patients, according to Swedish scientists. Scientists from the University of Gothenburg's Sahlgrenska Academy have developed a portable pocket-sized vestibular, or balance, stimulation device in a bid to improve the lives of Parkinson's sufferers. The research was led by Associate Professor Filip Bergquist, who said the simple device was similar to the TENS (Transcutaneous Electrical Nerve Stimulation) therapy which is used for pain relief, for example in child birth. "So this is really not a very complicated device. It is a current device which is very similar to the ones that people use for pain relief with electrical stimulation of muscles and nerves, what's called TENS. The difference is that we use a particular current profile where you can stimulate the balance organs without creating a balance disturbance. So you do not get the impression that the world is moving or that you are moving, you actually do not feel anything," Bergquist explained. The device operates by providing stimulation via patches attached to the patient's head behind the ears, where the vestibular system is located. Parkinson's disease is characterised by reduced levels in the brain of the hormone dopamine, a neurotransmitter that allows different regions of the brain to communicate with one another. Symptoms of advanced Parkinson's disease include an impaired sense of balance, as well as tremors, poor mobility, slowness and stiffness. Nearly all patients diagnosed with the disease are treated with levodopa, a drug that stimulates the production of dopamine in the brain. The effectiveness of oral levodopa reduces as Parkinson's disease progresses in the patient and can lead to involuntary movements, or dyskinesia.

In earlier experiments on rats,

April 2015

researchers at Sahlgrenska showed that noisy electric stimulation of the balance organs could be used to change the activity of the brain, thereby balancing the effects of dopamine shortage and improving the animals' motor skills and balance. The researchers have also tested the method on ten Swedish Parkinson's patients, in both medicated and unmedicated states. According to Sahlgrenska, on one day the patients received an active noise stimulation and on another day inactive treatment, not knowing which day the current was active. According to the research institute, the experiments showed that the active noise stimulation improved both the patients' balance and the combined symptoms. Parkinson's sufferer Staffan Lindblom said he did not expect any great advances, but would be thankful for anything that

would make living with the disease easier. "I have become hardened in the sense that I do not have too great expectations. But I still believe that something will be found at some point which could be useful. There is extensive research in this field and I hope that it eventually will come up with a result. Not a significant result but a few steps forward would really be appreciated," he said. Unfortunately this particular treatment did not work on Lindblom, with Bergquist suspecting there could also be other causes to Lindblom's balance problems. Bergquist said he hoped the device could treat patients for whom the Levodopa drug, which turns into dopamine in the body and increases levels of the chemical, was not enough. He also said they were working on the

Industry News hypothesis that other diseases which affect the dopamine system, such as ADHD (Attention Deficit Hyperactivity Disorder), could also benefit from this kind of treatment. "What we are hoping for with this device is to find a treatment for movement disorders like Parkinson's disease where

Levodopa is not enough. And in particular in patients with Parkinson's disease where there is problem with gait and balance. But this may not be restricted to Parkinson's disease, so there may be other conditions with poor balance where you could use electrical stimulation of the vestibular organs, the balance organs to improve balance and gait," he said.

The plan is now for the device to be tested in a longer-term study, where patients will be using it at home. If those trials prove successful, the developers hope the device could be available to the public within five years. Source: Reuters Health n

FDA Launches Drug Shortages Mobile App The U.S. Food and Drug Administration has launched the agency’s first mobile application specifically designed to allow rapid public access to valuable information about drug shortages.

Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”

The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

App users can search or browse by a drug’s generic name or active ingredient, and browse by therapeutic category. The app can also be used to report a suspected drug shortage or supply issue to the FDA.

Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage. “The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug

The agency developed the drug shortages app to improve access to information about drug shortages, as part of the FDA’s efforts outlined in the Strategic Plan for Preventing and Mitigating Drug Shortages. The app is available for free download via iTunes (for Apple devices) and the Google Play store (for Android devices) by searching “FDA Drug Shortages.” n

Europe’s First Fully Remote Diabetes Trial Approved eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, has announced the Ethical Committee approval of VERKKO in Finland – Europe’s first remote clinical study to include full electronic informed consent. The primary objective of VERKKO (developed in collaboration with Langland, Mendor and Sanofi) is to study Mendor’s 3G-enabled wireless blood glucose meter with a glucose profiling technology (Mendor Smart) in patients with diabetes. The secondary objective is to evaluate the feasibility and efficacy of patient engagement and patient-investigator interaction

through Clinpal – eClinicalHealth’s fully integrated web-based platform. Clinpal engages patients by:

site. Then, once enrolled, Mendor’s innovative blood glucose meter wirelessly transmits patient data to the platform.

»» Supporting patient recruitment »» Performing electronic informed consent »» Facilitating online patient-site communication »» Capturing patient-reported outcomes and measurements

“As well as being Europe’s first remote clinical study to include full electronic informed consent, VERKKO is the world’s first trial to use our pioneering glucose monitoring & data analysis technology,” says Kristian Ranta, Mendor’s CEO. “The blood glucose meter coaches the patient through the process, helping to generate reliable data.”

The pioneering platform also allows study stakeholders to work together seamlessly. For example, Langland, a healthcare communications agency, has developed a vibrant social media and web banner campaign that will drive potential participants to a Clinpal-supported web-

Sanofi R&D is contributing to the VERKKO study as part of its innovation program to develop patient centric clinical trials, to assess the efficiency and perceived value form study participants. n

The Journal of mHealth

Industry News

12 US Start-ups Influencing the Future of Digital Health From patient data management and 3D prosthetics to diagnostic mobile apps and personalised cancer treatment, the landscape of the healthcare industry is undergoing incredible change. This infographic visualisation created by Northeastern University illustrates 12 companies that are helping to shape the future of digital health.

Wearable Sensor to Allow Safer Monitoring of Ebola Patients The U.S. Agency for International Development (USAID) have unveiled a new biomedical suit and the Multi-Sense Memory wearable sensor: Two innovations that point to a new way of tackling the world’s poverty, health and disaster response issues facing the agency. The innovations came about as the result of a competition call that represents a new process of sourcing technology for the agency. “Usually we issue an RFA or RFP and we get the usual suspects for proposal. This is a new approach to open it to more people through something called a ‘Grand Challenge,’” said Ann Mei Chang, the executive director of the U.S. Global Development Lab. USAID, which is tasked with ending extreme poverty and often acts as an early responder at disasters like the 2010 earthquake in Haiti, Japan’s 2011 tsunami and the recent Ebola outbreak, received over 1,500 suit submissions as a result of the competition call. The winner is a suit developed by Johns Hopkins lab, which is a one piece garment, takes two minutes to put on, has antifogging and, will eventually incorporate, a built-in cooling system. By contrast, the original suits were complicated, multi-piece numbers that took 30 minutes to put on. They were hot (their boots would literally fill with sweat), uncomfortable and doctors could only

April 2015

wear them for 45 minutes at a time. It could be a while before the suits are deployed in Africa, but in a “couple of months we’ll get some of the elements of that suit into the field,” said Wendy Taylor, of the USAID Center for Accelerating Innovation. Even with a new biomedical suit in the wings, doctors in the field still face significant challenges. “Tools are hard to use in an Ebola setting—you can’t use a stethoscope,” says Taylor. With the Multi-Sense Memory patch or "smart “Band-Aid,” as Taylor likes to call it, they won’t need a stethoscope. It’s a flexible, sensor-rich-patch that attaches to the sternum of a patient with adhesive. It will monitor and record a baseline vital rating—heart rate, temp and oxygen saturation—and then measure all changes from the baseline. More importantly, doctors will be able to place the sensors on patients and then track their vitals from outside the hot zone. The prototype uses a USB cable to transmit data, but the final version will use Bluetooth and doctors will monitor, for instance, all the patients in a tent from one screen. The device, which costs $100 per patch, will have 7 to 10 days of battery life. USAID executives have said that, once in treatment, the average Ebola case runs its course in five days. n

Industry News

Open-Source Robotics Turns Hospitalised Children into Virtual Explorers A new system is hoping to enhance the lives of sick or terminally ill and bedbound children, by allowing them to selfdirect a first-hand, virtual experience of a day trip to London Zoo. The Robots-for-Good open-source data project, which features on web platform Wevolver, utilises an InMoov humanoid robot and an Open Wheels Segway, combined with Oculus Rift, a virtual reality head-mounted display. The system basically allows a person to navigate through the eyes of a robot, even to the extent of being able to move the robot's head and adjust your outlook. The project almost floundered though the lack of a viable means for the InMoov robot to manoeuvre; the prospect of legs is still some way off. However Robots-for-Good founder Richard Hulskes, hit on a creative solution: the use of another open-source project called Open Wheels, which enabled the robot to drive on the wheels of a Segway. “There is a huge community around

the robots already, with more than 300 people around the world building the robots," says Hulskes, “… but they’re doing it without legs. However, there’s also a huge community building this open source Segway. The only thing we’re doing is bringing them all together and mixing them up and making sure that they work together.” Since launching the website, Robots-forGood has attracted interest from engineers and designers from all around the world who want to help. They now have a team in London working on the design and one in the US working on the software. Hulskes is also working with Great Ormond Street hospital and London Zoo to begin trialling the technology. The project is also aiming to give young people an intro to working with robots by partnering with Ultimaker, a 3D printing company with a heavy emphasis on education. It will oversee children as they assemble the final product in maker-spaces throughout London. They’ll learn skills including 3D printing and simple coding.

But perhaps the most remarkable part of the Robots-for-Good project is its surprisingly low cost. Where consumerfacing robots can often cost in the range of £65,605, the Robots for Good prototype can theoretically be produced for as little as £1,640. “Because our robot is 3D printable, it’s easily replicable, says Hulskes. “Plus there is no need to make a profit so we can directly link people to the supply chain and tell them where to buy the cheapest parts and what machines to use. It’s an example of how people can now start building products themselves and don’t have to wait for big companies to do it for them.” The potential to give hospital bound patients the ability to explore new environments, beyond the confines of the hospital setting, are significant. The project hopes to help aid rehabilitation and reduce some of the difficulties associated with long-term hospital stays. Source: connect.innovateuk.org n

ResearchKit to Give Scientists Easy Access to Study Subjects and Data Apple has announced the release of ResearchKit, an opensource software tool designed to give scientists a new way to gather information on patients by using their iPhones. The format will allow users to decide if they want to participate in a study and decide how their data is to be shared as part of the study. It will also give researchers access to accelerometer, microphone, gyroscope and GPS sensors in the iPhone to gain insight into a patient's gait, motor impairment, fitness, speech and memory. The software is designed to help researchers build more diverse study populations, which traditionally have been limited by physical proximity to large academic medical centres. Continued on page 17

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Industry News

Breakthrough in Blood Pressure Testing Technology A major breakthrough has been made in blood pressure monitoring, with news of the launch of a new sensor that could revolutionise the way readings are taken in both clinical settings and in patients’ homes. Tarilian Laser Technologies (TLT) has unveiled two systems; the first a cuffbased device that does not need calibration to ensure the accuracy of readings. On the back of this the firm is also launching their next-generation Sapphire sensor system, offering a completely new method of taking readings that could effectively see an end to the less accurate and traditionally bulky cuff-based devices. Heralded as one of the most-important innovation in the sector for decades, the sensor does not just measure continuous beat-to-beat blood pressure, but can also give a complete vascular assessment, providing clinicians with an improved toolset for monitoring, diagnosing and treating patients suffering from a wide range of diseases. These capabilities include taking a blood pressure measurement of the eye without putting pressure on the eye itself, taking foetal heart readings, and checking the health and blood pressure in the arteries in the leg and neck. What makes the sensor even more ground-breaking is its ability to take measurements from virtually any part of the body without exerting pressure and with no energy entering the body. This means it could be incorporated into items of clothing, wearable devices and even mobile phones, laptop computers or jewellery, enabling patients to monitor their own health in almost any environment and by at home. Dr Sandeep Shah, chief executive of TLT, said: “We have struggled for many, many centuries to accurately measure blood pressure. The first successful technique was mercury sphygmomanometry, but this was environmentally toxic. The alternative is the oscillometric method, which is the current system based

April 2015

on vibrations of a cuff, but this is not very accurate and requires inflation and deflation of the cuff, which does not give the answer very quickly.” This system, he added, is also prone to false readings, particularly where patients are anxious when attending a GP surgery, providing a high reading, which may not actually point to a medical problem. Dr Shah said: “Sometimes patients are scared, so the reading in a surgery is higher than it would be when they are relaxed. At home in their own environment, they get a very different measurement. There are a lot of papers that say home monitoring is the best way to check patients’ health and the advantages of this sensor is that it is so small it can be hidden easily in clothing or, for example, a watch or bracelet.” The new technology would mean patients could take continuous readings while they go about their everyday lives. Dr Shah said: “The advantage is that rather than waiting for systolic and diastolic readings, which normally takes several minutes, we can achieve a reading in nanoseconds and on a continuous basis. Before a patient even enters a hospital the doctor could have an entire cardiac profile on his screen. “Providing more than just blood pressure, it is almost akin to having an ECG, a heart scan and a blood pressure reading.” The device also does away with tubes and lines, meaning it can be used during transportation and in critical care environments. “Current systems are bulky and have poor patient compliance,” Dr Shah explained.

“For the first time, we are offering a beat-by-beat sensor without the need for any intra-arterial line. This means it has a secondary effect of enabling a patient to remain mobile, which is very important for recovery and wellbeing and vital for maintaining optimal circulation.” The company will shortly publish the results of an independent study into the technology and has already passed regulatory tests. Dr Shah said: “There is no other single system that can deliver what Sapphire can in terms of performance or ease of use.” Dr Art Tucker, principal clinical scientist and vascular researcher at St Bartholomew's Hospital in London, has welcomed the breakthrough. He said: “The sensor is highly novel, promising new technology that will have a large and positive impact in this field. It is an exciting and powerful new development in vascular science and has created a new state-of-the-art solution for blood pressure measurement. It will no doubt be of great value both in hospitals and primary care settings, as well as at home for the consumer and offers a new paradigm in vascular biometrics.” Dr David Jefferys, former chief executive and director of the UK Medical Devices Agency and current president of The Organisation for Professionals in Regulatory Affairs (TOPRA), added: “Blood pressure is a critical biometric measurement in medicine and has ubiquitous utility in all areas of medicine and also in research, including pharmaceutical trials. “There has been significant controversy and debate about the current technologies and a lot of this debate has centred

Industry News on the inaccuracies and the poor reliability of these systems, which has led to a series of regulatory concerns and investigations. These concerns do not just relate to causative morbidity, but also mortality. Indeed, of particular note are the concerns of poor performance of these systems in sub-populations, such as the elderly, children and also in pregnancy.

“A series of recent papers has highlighted technical performance issues with these older systems and also the limitations of their accuracy and reliability. Hence, there is a clear need for a better and more accurate, more robust, versatile technology to be made available within this critical field of medicine - not just from the view of experts, but also

from a general patient and consumer perspective. "The TLT Sapphire sensor development has created a pioneering platform from which further technological advances in haemodynamic profiling may be realised and thus improve the management of an array of medical conditions." n

Revolutionary ‘Pregnancy Tester’ to Help UK's 1m Undiagnosed Kidney Disease Cases New report highlights how a nanoparticle device could save NHS millions of pounds a year and revolutionise kidney disease treatment. A new medical device which combines nanotechnology with a pregnancy tester could help diagnose and treat the 1 million people in the UK who don’t know they have kidney disease, a new report by the Institution of Mechanical Engineers reveals today. Developed by engineers in London, the £10 device can be used at home and could revolutionise kidney disease care in the UK, which currently costs the NHS over £1.4 billion - more than breast, lung, colon and skin cancer combined. Created by Bio Nano Consulting, the device – called quantitative electrochemical lateral flow assay (QELFA) – uses nanoparticles to test the patient’s urine giving results in seconds. It is also linked to their surgery, via mobile technology, so that doctors can track how the disease is developing. The device is highlighted in a new report by the Institution of Mechanical Engineers. The report, titled – Nanotechnology: The Societal Impact of the Invisible – highlights the enormous potential for nanotechnology in our society but also calls on the British Government to increase funding for nanotech development to ensure the UK does not fall behind other nations. Report author Dr Helen Meese, Head of Materials at the Institution of Mechanical Engineers, said: “Nanotechnology could revolutionise the way we live our lives – it can be used in everything from food and healthcare to electronics, clothing and cosmetics. But despite its 40 years in the public domain, the nanotechnology industry is still failing to engage with society in an open and clear way, and governments continue to lack impetus in committing to international regulation. The UK Government must provide more funding to ensure that the UK benefits fully from nanotechnology’s potential. “The QELFA device is a brilliant example of what’s possible. Using an old technology like a pregnancy tester and combining it with nanotechnology, you have a device which could not only

diagnose the million people in the UK who are unaware they have kidney disease, but also help doctors effectively monitor those undergoing treatment. It could also save the NHS millions of pounds a year. “But although the UK has been at the forefront of nanotechnology development, we still lag behind in its commercialisation and many people are still unsure of its potential. We must change this.” Every day 19 people in the UK are diagnosed with kidney failure yet there is currently no device that can be used by doctors for day-to-day monitoring of kidney disease. Four of these people will not have been known to specialist services for sufficient time to prepare for their treatment. After 90 days one of them will have died, two will have had a transplant, and the remaining 16 will be receiving dialysis treatment at a cost of over £25,000 per year. Many more will have a lesser degree of kidney dysfunction that will place them at increased risk of cardiovascular disease and acute kidney injury. n

The Journal of mHealth

Industry News

Oxehealth Advances Baby Safety with Camera-based Vital Signs Monitoring

New technology, successfully trialled at Oxford’s John Radcliffe Hospital, will drive a significant change in baby monitoring.

abilities to monitor key vital signs continuously in the neonatal intensive care unit (NICU).

Oxehealth, a camera-based health monitoring company, has developed software that will enable a new generation of smart video baby monitors to measure a baby’s vital signs without the need for physical contact or wearable devices.

The accuracy of the product met the clinical standards expected of a medical product, opening the door to a whole new world of neonatal camera-based health monitoring possibilities.

Oxehealth’s technology promises to revolutionise the world of baby monitoring – turning a passive video monitor into one that provides genuinely useful health information Using its technology, video baby monitors will be able to measure the heart and respiratory rate of a baby remotely. The technology will send accurate alerts to parents or caregivers when it detects sudden changes in vital signs, allowing them to react to potential health risks that otherwise would not be visible. The software, which has been successfully trialled at the John Radcliffe Hospital, part of the Oxford University Hospitals NHS Trust, demonstrated its

April 2015

“Virtually every new parent in the UK buys a baby monitor when they first have a child, and some will buy multiple monitors as they seek to find the best on the market,” said Jonathan Chevallier, chief executive at Oxehealth. “Many current monitors with their passive audio/visual feedback do not provide warnings of problems – other than baby distress. Building vital signs monitoring into these devices would enable constant feedback to parents on the baby’s heartbeat and breathing rate, providing considerable reassurance to parents and early warnings of any problems. This is a huge step forward in infant monitoring.” The ability to monitor babies’ vital signs

without the need for contact is also a significant advantage in baby safe vital signs monitoring. Contact-based devices can be uncomfortable and irritate delicate skin, especially among pre-term infants. Using camera technology can

Industry News into one that provides genuinely-useful health information,” said Chevallier. “In a world in which people are choosing to install and use cameras in ever more settings, this is just one example of how technology will invisibly monitor personal health, enabling us all to live safer, healthier and longer.”

eliminate the need for potentially-dangerous cables from mat-based devices and potentially harmful close-proximity to wireless transmitters. The Oxecam can provide ongoing monitoring throughout the night and day – it

Oxehealth is a spin out from the University of Oxford’s Institute of Biomedical Engineering and Oxford University Hospitals NHS Trust. Its monitoring technology, which is based on algorithms which monitor patient movement and breathing for signs of distress, as well as heart rate and other parameters that can be measured to assess a patient’s wellbeing, is also being funded to monitor patient wellbeing in other situations such as secure hospitals, and post-operative cancer and renal wards. n

can also alert to a number of risk factors such as the baby turning onto its stomach or covering itself in bed clothes. “Oxehealth’s technology promises to revolutionise the world of baby monitoring – turning a passive video monitor

Continued from page 13

Several top research institutions have already developed applications to work on the ResearchKit platform, including Stanford University School of Medicine and Weill Cornell Medical College. "With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research," said Jeff Williams, Apple’s senior vice president of Operations, said in a statement. The ResearchKit platform is designed to work alongside with Apple's HealthKit software, which allows iPhones to work with health and fitness apps that gather information on weight, blood pressure, glucose levels and asthma inhaler use. One app, already designed by Massachusetts General Hospital, is GlucoSuccess which allows diabetics to participate in a research study that will provide feedback on how their diet and exercise patterns impact daily glucose readings. The app also collects relevant information on participant’s routine by asking volunteers questions like whether they have taken all of their medications or inspected their feet. Other apps released at the ResearchKit launch involve studies on asthma, breast cancer and Parkinson’s disease. For volunteers, the apps are designed to help people with chronic disease follow through with important health behaviours. "It's very hard in practice for people to carry out all the recommendations and stick with them over time," said Dr. Stanley Shaw, co-director of the Center for Assessment Technology and Continuous Health at Massachusetts General. For researchers, the data improves upon the many pages of survey questions study volunteers would normally have to complete dur-

ing the course of a research study, often based on their recollection of what they ate or how much they exercised, in the prior week. Shaw said the fact that Apple have made ResearchKit open source will allow "a whole host of medical researchers" to develop apps for their own research projects. "We view this as the opening salvo," he said. Another app called MyHeart Counts will collect data about physical activity and cardiac risk factors for Stanford scientists studying heart disease. It allows users to complete tasks, such as performing a six-minute walk if they are able, and answer surveys from their iPhone, and provide them with an assessment of their heart health and information on how to improve it. “The app can tap into data gathered by other wearable gadgets such as Jawbone or Fitbit, but it can also be used with the iPhone, as long as people remember to keep their phones turned on,” said Dr. Euan Ashley, chair of Stanford's biomedical data science initiative. Researchers say ResearchKit simplifies their recruiting work. Volunteers can decide how much data to share directly with the research institutions. "The data does not go to Apple," Ashley said. Dr. Eric Schadt, a genomics professor at the Icahn School of Medicine at New York's Mount Sinai, used the platform to develop an asthma app along with Weill Cornell Medical College and LifeMap Solutions, a subsidiary of BioTime. “The fact that researchers can recruit, consent and enroll participants remotely should produce study sample sizes that are "orders of magnitude" greater than in the past at a fraction of the cost,” Schadt said. Source: Reuters Health n

The Journal of mHealth

FDA Releases from Regulation Certain Digital Health Solutions

FDA Releases from Regulation Certain Digital Health Solutions Aimed at Chronic Disease By Bradley Merrill Thompson FDA recently has been looking for ways to lighten the regulatory burden on digital health, and this is especially true for those developing solutions for chronic condition management and treatment. On January 20, 2015, FDA proposed a new guidance document on “General Wellness: Policy for Low Risk Devices.” While the document addresses digital health solutions for keeping healthy people healthy, the more interesting part of the document focuses on helping those suffering from chronic conditions. It’s that latter category that I’d like to examine in this article. Under this proposed guidance, FDA does not plan to regulate digital health solutions and other products that make “an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition).” More specifically, FDA intends not to regulate products intended “to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help:” 1. “reduce the risk of certain chronic diseases or conditions;” or 2. “living well with certain chronic diseases or conditions.” Elsewhere in the guidance document FDA explains that only low risk apps fall within this unregulated category. That’s the framework. FDA packs a lot of nuances into those two sentences. Let’s start unpacking it. Overarching Scope: Healthy Lifestyle This whole category revolves around the concept of helping people adopt healthy lifestyles. Indeed, this is the beginning and the end of this category. The

April 2015

digital health solution, to qualify, must help people overcome the obstacles to living a healthy life, including things like understanding and motivation. Understanding. Many of us need to learn more deeply the benefits of eating fruits and vegetables, exercise, sleep, and stress management. While many of us may understand those benefits at a high level, we may not understand and fully appreciate how those lifestyle factors can impact the risk of contracting specific chronic diseases, or even just living with those diseases. Here both statistics and anecdotal stories may help. Motivation. Many of us know that we need to lose weight, but getting from here to there is difficult. So FDA wants to encourage digital health solutions that help us find that motivation by giving us reasonable goals and helping us manage the information necessary to see our progress toward those goals produce. Indeed, we may also need to see the benefits spelled out more clearly as we reach intermediate goals. Thus, step one in determining whether or not this new category applies is making sure that the digital health solution is about helping us understand the need for a healthy lifestyle, and helping us find the will to pursue it. Association with Chronic Disease This may be the trickiest part of fitting within this exempt category. To qualify, the developer of the digital health solution may not make claims that the product can be used to treat or manage the disease itself. Instead, the exact wording of promotional claims really matters, and the developer must focus on achieving a healthy lifestyle as the goal of using the solution, and can only incidentally mentioned the connection between the healthy lifestyle and the disease. Here, as already mentioned, FDA gives

us two different associations that are permitted. We may communicate to our customers that pursuing a healthy lifestyle will: 1. “reduce the risk of certain chronic diseases or conditions;” and 2. help us live “well with certain chronic diseases or conditions.” Thus, the developer can promote the use of the digital health solution to those who are healthy and simply note that the healthy lifestyle encouraged by the digital health solution is of a kind that reduces the risk of developing the chronic disease. Or, the developer can target those with the chronic disease and explain that it is a good idea to adopt a healthy lifestyle in order to avoid aggravating the disease or condition. Some examples may help explain the difference. • Permitted: 99 Product X promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure. • Not permitted: 99 Product X may help reduce the risk of high blood pressure. • Permitted: 99 Product Y tracks your caloric intake and helps you manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type 2 diabetes. • Not permitted: 99 Product Y helps you reduce the effects of high blood pressure and type 2 diabetes. • Permitted: 99 Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes. • Not permitted: 99 Product Z helps you reduce the risk of developing type 2 diabetes

Mobile Device Aids Cervical Cancer Detection in Low-Resource Settings Well-Understood and Accepted Association I think FDA spends too little time in the guidance explaining this concept. FDA has a long history with the concept of “general recognition.” While that concept is found in the FDA’s food and drug regulations, it is not well known to people in the medical device arena. A food additive that is “generally recognized” as safe does not need to be submitted to FDA for approval. A drug that is “generally recognized” as safe and effective does not need to be submitted to FDA for approval. In those contexts, FDA has written quite a bit about what it means for a principle to receive “general recognition.” In the wellness guidance, FDA explains that general acceptance means “such associations [between adopting the healthy lifestyle and either the risk reduction or the better coping with a chronic disease] are typically described in peerreviewed scientific publications.” What this means is that there must be objective evidence that the scientific community would say that, for example, a healthy diet helps reduce the risk of developing type 2 diabetes. Does it mean that every single scientist must agree? Of course not. But the association ought to be generally (but not necessarily universally) accepted by the relevant scientific community, as evidenced for example by the literature.

Permitted Functionality I’m not sure whether FDA intends these to be words of limitation, but the agency suggests that classic functionality in this category will include digital health solutions that “promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle.” I think those will certainly turn out to be the typical functions, but I would not discourage creative people from thinking of other ways to achieve the overall objective of educating and helping people find motivation to live healthier lives. Low Risk An overarching requirement of this unregulated category is the product be low risk. Honestly, most standalone software should qualify. The FDA seems to be concerned about technology that comes in contact with the body as potentially too risky to qualify for this exemption. At the same time, to pick an extreme example, a mobile app that analyzes a photograph of a mole to determine whether it is melanoma would probably not qualify as low risk. Developers will need to use some judgment here. Conclusion On the whole, U.S. policymakers are strongly encouraging digital health developers to pursue products that can help

people learn how to live healthier lives, and then actually live those lifestyles. We are confronting epidemics of obesity, diabetes, heart disease and high blood pressure, and a healthcare system that simply tries to manage those conditions is not enough. Society desperately needs to learn how to reduce the risk of these diseases, and cope with them better if they manifest themselves. FDA’s proposed guidance is designed to reduce the cost of developing technologies that can help prevent disease or its complications, so that the technology might flourish. Author Bradley Merrill Thompson is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. He has served as regulatory counsel for Continua Health Alliance; as counsel to AdvaMed for payment issues; as General Counsel to the Combination Products Coalition, the mHealth Regulatory Coalition, and the CDS Coalition(focusing on clinical decision support software). He has been recognised by his peers for inclusion in The Best Lawyers in America© (2015) in the field of FDA Law and was recommended in the Life Sciences category by The Legal 500 United States (2014). n

Mobile Device Aids Cervical Cancer Detection in Low-Resource Settings MobileODT is a Tel Aviv based company working to bring cervical-cancer assessments to two billion women worldwide who have no access to qualified physicians. The company’s mobile colposcope provides low-cost, easy-access screening for cervical cancer, and the means to improve care in medically underserved areas, where the disease’s fatality rate is high.

ration. Successes in field pilots around the world have demonstrated enormous promise to make colposcopy affordable to physicians working in challenging locales, and to help aid the training of medical professionals in conducting colposcopic examinations.

In 95 per cent of cases, cervical cancer is an entirely treatable disease and can be treated for $28 in less than 40 minutes. Yet, due to lack of access to physicians and reliable medical equipment, hundreds of thousands of women in low-resource settings die unnecessarily every year simply because they are not getting diagnosed in time.

The mobile colposcope integrates a mobile phone for highresolution image capture of the cervical epithelial tissue and subsequent transmission and consultation for diagnostic and treatment decision support. The first-generation product, which is currently in use, enables health providers with limited training to inspect the cervix, capture high-resolution images, and seek guidance from healthcare professionals through automated mobile image transmission.

The mobile colposcope has been designed to connect medical professionals and increase accuracy through support and collabo-

Continued on page 20

The technology combines the power of collaboration and tele-

The Journal of mHealth

Mobile Device Aids Cervical Cancer Detection in Low-Resource Settings Continued from page 19

health features with cutting-edge biomedical optics to enable healthcare providers to improve case management and optimise the use of healthcare resources, in order to aid accurate diagnosis of cancer at its earliest stages. Typical optical coherence tomography (OCT) machines in large medical practices or clinics cost upward of $50,000USD; MobileODT's costs just $400USD. The device connects to a smartphone, and projects white or green light onto the cervix, it then takes an image clearly at high magnification, and uploads it securely so a physician can quickly—and correctly—detect whether cancer treatment is necessary. Ariel Beery, MobileODT’s CEO, says “five out of every six women screened for cervical cancer are unnecessarily sent for treatment. MobileODT’s device eliminates this waste by getting the diagnosis right, thereby enabling budget-limited municipalities and countries to screen 3.6 times more women for every dollar spent on standard examinations.” Cervical cancer prevention remains a top medical priority for much of the developing world. In order to minimise the gap in screening availability between the developed and the developing worlds, visual inspection with acetic acid (or VIA) was developed as a cheap, relatively efficient and easy to implement screening method for low-income settings. As a result, in many developing countries, VIA is the primary step, and the accepted standard, for cervical cancer screening; however, it is rarely corroborated by colposcopy and biopsy. Despite its success, VIA presents a major challenge: with a positive predictive value (PPV) of 17%, five out of six patients receive cryotherapy unnecessarily, as a result of a false positives. In order to reduce the number of false positives, the mobile colposcope serves as an adjunct to VIA, while also providing a technological platform that enables high-end multi-modal imaging. MobileODT is currently conducting additional trials with the St. Francis Hospital, Scripps Medical Centre at the University of Pennsylvania, and Rambam Hospital in Israel, to test their proprietary approach to polarization difference imaging and multispectral imaging. The company also has partnerships in place with a range of global health organisations including Partners in Health, the Centre for Global Health at Massachusetts General Hospital, PROSALUD, the Botswana-UPenn Partnership, and the Scripps Medical Centre, to pilot an advanced prototype in Kenya, Haiti, Mexico, Botswana and the United States. Speaking to the Washington Post at last month’s SXSW event the company’s Director of Strategy and Communications Amit Safir said, “Our product uses a smartphone to help detect cervical cancer, which kills more than a quarter of a million women every year, many of them living in areas without access to screenings. Our product brings cervical cancer screenings to anywhere with access to a smartphone. What we’re building is a low-cost, mobile colposcope device that’s equivalent to a regular colposcope by leveraging the optics, connectivity and the processing power of today’s mobile phones. Our device basically consists of a powerful light source on one side of the phone, and on the other side, we have built a lens that aligns with

April 2015

the camera on the phone. This allows health care providers to image the cervix in a much easier way using some of the technology many of them already have in their hand.” Describing the foundation for the company’s technology Safir says “the core of our company is around bio photonics and the use of light and the analysis of the absorption of lights. One of our founders, Dr. Levitz, has a PhD in bio photonics and medical optics, and he started to realise that a lot of the technology currently used in labs and hospitals relies on camera sensors that are no more advanced than the camera sensors in today’s mobile phones. So he started looking for ways to leverage the power in those smartphones to make these devices cheaper and more portable.” The company has received several awards, including first place in Vodafone’s 2014 Wireless Innovation Project (presented at the United Nations’ Social Innovation Summit), first place at mHealthIsrael 2013, and the grand prize at the International Start up Festival’s Elevator World Tour in 2013. For more information visit www.mobileODT.com n

Delivering Coordinated Care Through mHealth Programs

Delivering Coordinated Care Through mHealth Programs By Tim Davis, CEO and Founder, Exco InTouch I recently saw an interesting quote from Bruce Hellman, CEO of uMotif, regarding healthcare in the UK: “Most chronic health patients only spend around 3 hours being cared for by clinicians for every 8,700 hours they spend caring for themselves” - i.e. only around 0.03% of their time in front of a health care professional. The statistic itself isn’t surprising, but when laid out in such straight-forward terms we can see this quote has two very clear implications. Firstly, it is now clear that healthcare doesn’t happen at the doctor’s office; what we do every day impacts our lives and health far more powerfully than we think. Secondly, we can now see that digital health solutions have the opportunity to make a huge impact on supporting condition management. It is widely recognised that non-adherence to treatment regimes, especially by those suffering from chronic conditions, has a major impact on overall population health. Patients incur the risk of less-effective therapies and greater likelihood of hospital stays, whilst health services suffer the effects of poor outcomes, wasted healthcare expenditure and the draining downstream impact of poor control. The pharmaceutical industry itself faces challenges associated with lower prescription sales and less evidence demonstrating a drug’s efficacy profile.1 Patient engagement and patient empowerment go hand-in-hand in with health management programmes and are vital in improving adherence and compliance to treatment regimes. The engagement of patients in their own care plans empowers them to make better choices and take an active role in managing their condition, essentially becoming a fully responsible member of the healthcare team. Today patients are increasingly learning everything they can about healthcare options, the obstacles to good care and the steps they can take to get the best treatments possible. The internet is driving this paradigm shift, with 72%

of users saying they looked online for health information in 2012.2 In response to patients’ increased desire to manage their own conditions, many pharmaceutical companies are looking to go ‘beyond the pill’ with a strategic move towards more intelligent pharmaceuticals that focus on patient outcomes once medicines have been commercialised. As a result, there is a growing need for solutions that embrace this market trend and stimulate enhanced engagement between patients and healthcare providers. Mobile technology is increasingly being used as a means of communicating directly with patients across broad demographics and multiple locations in healthcare programmes. The familiarity and universal nature of mobile devices and the ability to select the right tool according to the patient population makes the technology perfectly positioned to integrate into global markets. The use of mobile technology in healthcare programmes is no longer seen as a far-off distant dream, a curio or a fad; vendors are actively searching for opportunities to incorporate mobile solutions into their health programs. A mobile technology-based digital health program can bring together multiple elements onto one, easily recognizable platform. These can include tools which enable the support and monitoring of patients outside of doctors’ surgeries; tools which help and empower patients (and their caregivers) to take better care of their condition; and platforms that help patients feel involved, wanted and adherent to their therapy regimes by providing information to patients, including educational and motivational content at the right time and in the right way, such as personalized coaching and real-time information about their disease and treatment via their mobile phones or other web-enabled devices. Finally, a mobile-based platform can also include tools to capture patients’ data when paired with medical devices via Bluetooth (e.g. glucometers, blood pressure monitors, etc.) using digital tech-

nology to securely collect, transmit and review patients’ clinical data. This holistic approach reaps huge benefits for the pharmaceutical industry. Improved health outcomes not only mean a better a quality of life for patients, they also relieve burden of cost care for the payers. Additionally, such a holistic approach also allows healthcare providers to be able to make more informed decisions and personalize each patient’s disease management through tailored care pathways. If caring for patients outside of the doctors’ surgeries is to become more effective, then healthcare professionals should consider providing co-ordinated, digital care plans to patients via familiar mobile technology. Today, patients are more aware of their conditions, the reasons behind them, and what outcomes successful treatment can bring about. By adopting a holistic approach to healthcare, not only will patients be motivated to adhere to healthcare regimes, their health will also improve, thus reducing the burden on healthcare providers. You could say that everyone’s a winner… References 1. Patient Adherence, Communication and Enagagement (PACE) – Increased Investment and Adoption of New Digital Tools Enable Key Stakeholder Collaborations and Encourage Compliance (2012) – www.gbiresearch.com 2. http://pewinternet.org/Commentary/2011/ November/Pew-Internet-Health.aspx Author Tim Davis is CEO and Founder of Exco InTouch, the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers. As a widely respected clinical technology subject matter expert, Tim has been recognized through many accolades, including the PharmaVOICE 100 annual list of the most influential people in life sciences for his vision to utilise mobile technology to engage patients during clinical studies and real world healthcare programs. n

The Journal of mHealth

Conference News mHealth will Benefit from New Mobile Initiatives Announced at MWC Common Remote Provisioning Specification to Put Consumers in Control of Connecting Mobile Devices and Help to Grow Market The GSMA announced during last month’s Mobile World Congress event in Barcelona that it is working with mobile network operators, mobile device manufacturers and SIM vendors to create a common and global specification for the remote over-the-air provisioning and management of connectivity to consumer devices. The industry-wide initiative will allow consumers to activate the SIM embedded in a device such as a smartphone, tablet or wearable with the mobile network operator of their choice. A common approach and consistent user experience will also help to grow the market by allowing consumer device manufacturers to build products that support global deployment. The initiative will have significant benefit for health consumers using mobile health apps or connected health and medical devices to more easily travel throughout the world without fear that their device or monitoring solution will not be compatible with local network providers. It also opens the door for finally enabling the true benefits of technology mobility to be realised. “Currently there is no agreed industry solution for how consumers can remotely connect devices to a mobile network,” said Alex Sin-

April 2015

clair, Chief Technology Officer, GSMA. “This announcement demonstrates that the industry is unified in working to create a common and interoperable specification that will reduce market fragmentation and maintain the experience of connecting devices in the future.” The GSMA Consumer Remote SIM Provisioning initiative is leading and coordinating industry activities with a number of complementary “proofs of concept”, which together are contributing to the development of an end-to-end remote SIM solution. These have been designed to help shape the best technical specification for the mobile industry as well as for consumers. Results are expected in Q3 2015 with the delivery of a common specification for the remote provisioning of consumer devices anticipated by 2016. The initiative has received strong industry support from mobile operators including AT&T, Deutsche Telekom, Hutchison Whampoa, KDDI, Orange, Ooredoo and Vodafone. “AT&T has been innovating in this area for years with our current global solution called AT&T global SIM, making wireless connectivity for consumers and businesses simple, seamless and highly secure," said Chris Penrose, Senior Vice President, Internet of Things Solutions, AT&T. "We look forward to continuing to work with

the GSMA Consumer Remote SIM Provisioning initiative and carriers around the world to make it even easier for our customers to mobilise their world.” “What we want to achieve with eSIM is simplicity and convenience for our end customers,” said Thorsten Müller, SVP Core Telco Products at Deutsche Telekom. “Adding a device to my personal data plan will become as simple as scanning a barcode.” “Embedded SIM is a promising solution that brings delightful consumer experiences to our customers as well as ever-increasing roamers,” said Yasuhide Yamamoto, Vice President, Product Sector at KDDI. “KDDI is working to establish a globally unique, interoperable ecosystem with the GSMA and partner operators to enable greater convenience for our customers.” “Ooredoo is striving to offer an enhanced, consistent customer experience across its footprint, and we are fully committed to this industry-wide effort to support an agreed approach to remote provisioning by wireless devices. This shared effort will enable customers to benefit from the full potential of mobile technology including mobile identity, M2M and mCommerce,” said Dr. Nasser Marafih, Group CEO, Ooredoo. “Orange is committed to develop with the GSMA an open embedded SIM solution accessible to all the industry that

Conference News would offer a convenient and simple user experience for customers in any circumstances as the existing SIM,” commented Mari-Noelle Jego-Laveissière, EVP Innovation at Orange. “This solution should also ensure a high secure environment to protect customers’ privacy.” “Having pioneered embedded SIMs with Sony’s PSP Vita and the Amazon Kindle, Vodafone is fully engaged in developing a single joint standard. Embedded SIMs can give consumers new ways to connect to Vodafone’s fast and reliable networks. It is important that the telecoms industry works together to offer a consistent customer experience across the globe,” said Patrick Chomet, Group Terminals Director, Vodafone Group. Single Digital Market for Europe to Improve mHealth Integration Following a meeting of European Union Member State ambassadors, it announced its support of regulatory reforms to create a digital single market for Europe.

The European Commission has described its proposal for a single digital European market. “Europe is still a patchwork of national online markets, and Europeans are prevented by solvable problems from enjoying the benefits of a digital single market. Commercial and cultural content and services need to flow across borders; this should be achieved by eliminating regulatory barriers and facilitating electronic payments and invoicing, dispute resolution and customer trust. More can and must be done under the current regulatory framework to weave a single market in the telecoms sector.” Anne Bouverot, Director General, GSMA, commented; “The GSMA fully supports the efforts to establish a European Digital Single Market and is committed to help realising this goal in the near future. While we believe that the reduction in scope of the Connected Continent proposals to net neutrality and roaming represents a missed opportunity, the immediate priority is for these proposals to reach a positive conclusion

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so that we can start the process of creating a truly Digital Single Market that will benefit Europe’s citizens and businesses. “A single market for Europe will accelerate innovation in mobile services, boost investment in mobile networks and deliver significant economic and social benefits. To kick-start this transformation and maintain its momentum, progressive, ongoing changes to Europe’s policy and regulatory environment are required.” Within such a framework, the priorities for reform should be to: »» Maximise incentives for investment in new network capacity and technologies; »» Ensure that service platforms are open and interoperable; »» Reduce excessive regulation, focusing instead on ensuring effective competition; and »» Reform spectrum policies to ensure greater regulatory certainty and supporting harmonisation for mobile broadband deployment. n

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The Journal of mHealth

Conference News

Enabling Patient-Centred Care through Information and Technology Digital Health and Care Congress 2015 16 – 17 June 2015 | The King’s Fund, London This congress explores how the innovative use of information and technology is supporting improvements in health and social care services. The event is a showcase for exciting new digital health technology, research, and service delivery methods that are having a positive impact on care providers and patients. All of the projects that will be featured at the congress have been through an extensive, peer-reviewed submission process. Let these innovative approaches to care delivery and patient engagement inspire and motivate you. Check out some of the new digital health applications and wearable devices you may have heard about in the exhibition hall and innovation hub, and mix and mingle with more than 500 attendees from: the NHS; local government; academic institutions; third sector; commercial providers; digital health start-

ups; entrepreneurs, and innovators. Hear from leading speakers from the NHS: »» Simon Stevens, Chief Executive, NHS England »» Tim Kelsey, National Director for Patients and Information, NHS England »» Beverley Bryant, Director of Strategic Systems and Technology, NHS England »» Paul Rice, Head of Technology Strategy, NHS England *Also featuring keynote speaker, e-patient Dave!* Dave deBronkart, known on the internet as e-Patient Dave, is the author of the highly rated Let Patients Help: A Patient Engagement Handbook and one of the world’s leading advocates for patient engagement. Find out more www.kingsfund.org.uk/events/digital-health-and-care-congress-2015 n

Mobile Ultrasound Project Wins ‘Best Mobile Innovation for Health’ Trice Imaging in partnership with Qualcomm Wireless Reach and SonoSite Fuji Film, has won the prestigious Global Mobile Award in the category “Best Mobile Innovation for Health” at the 20th Global Mobile Awards by the GSMA.

among women living in rural areas, and in poorer communities. Many high-risk conditions such as multiple pregnancies, placenta previa, abnormal fetal presentation and ectopic pregnancies can only be detected via an ultrasound.

In a statement Trice Imaging commented; “This is such a thrill and a great reward for our team that has been working so hard to not only invent this novel technology but to prove its magnificence.”

In a trial performed in Morocco, the Mobile Ultrasound Patrol Project equipped health care professionals working in resource-poor communities with a small, mobile ultrasound machine and Internet-connected mobile devices, allowing them to perform ultrasound exams on pregnant women and, within seconds, wirelessly transmit the images to a prenatal specialist anywhere in the world for a second opinion. This approach to early detection and treatment of placenta complications greatly increases the mother’s chances of a healthy, safe pregnancy.

“This recognition is important to the paradigm shift in imaging. We see two industries merge, medical devices and telecommunications. Getting the most prestigious reward in the world of telecommunications brings attention to the grand potential of Mobile Imaging.” Every day, around the world, approximately 800 women die from preventable causes related to pregnancy and childbirth. 99% of all maternal deaths occur in developing countries and the rate is higher

April 2015

The project resulted in reduced diagnostic review times from two weeks to less than 24 hours, and the cost fell from $80 to $2 per patient. It also increased the medical

practitioner’s skills to deliver ultrasounds from 20% sufficient for diagnostic purposes to 92% sufficient for diagnostics. The time and cost efficiencies gained, without any compromise in quality, improves the likelihood for early detection and treatment of the major causes of maternal morbidity and mortality which could, ultimately, reduce the number of maternal and child deaths. “We are very proud of The Mobile Ultrasound Patrol Project. Using innovative but simple technologies to provide access to health care where it’s most needed and less available is paramount to Trice. We are committed to connect all imaging systems out there, linking patients with physicians and physicians with physicians closer together. Our partners in the project; Qualcomm, SonoSite and Sony have made invaluable contributions to the success. Having the project and our technology acknowledged by GSMA is an honor,” says Asa Nordgren, CEO and Co-founder of Trice. n

Using Technology to Manage Care Transitions & Reduce Readmissions

Using Technology to Manage Care Transitions and Reduce Readmissions Article by Douglas Naegele and Janica Lee The healthcare industry is increasingly conscious of effective care transition management to reduce hospital readmission rates. Because hospitals can be penalized for excess hospital readmissions, a greater focus is placed on improving discharge and follow-up care. US hospitals, for example, have reduced cardiac readmission rates by up to 50% by simply granting greater attention to this issue. Consequently, new programs have sprung up across hospitals – ranging from lowtech to high-tech solutions. While many believe that drug adherence is the largest determinant of readmission, scheduling timely follow-up appointments and enrolling in proper follow-up care also play a role in reducing readmission. Changing Workflows Research shows that patients only retain between 10% and 50%1 of the instructions communicated to them. Recently, hospitals have rolled out new initiatives to bridge that gap. A group of hospitals in Pennsylvania – St. Vincent and Jameson Health System – found promise in a non-tech solution. Patient navigators within hospitals filled the specific role of improving patient care transitions. They are responsible for conducting patient follow-ups, connecting patients to local care services, and scheduling physician appointments. A 60%2 reduction in readmission rates was noted following implementation, demonstrating that a modification in workflow alone can have an impact on reducing readmissions. Telephone and IVR Not everybody has the time and resources, however, to create and staff new roles. Over the past ten years, telephone follow-up has emerged as one of the tools hospitals implement to ease transitions and follow-up with patients. In a 30,000+ patient study, those that received at least one follow-up call within 14 days were 23%3 less likely to be readmitted within 30 days.

Recently, IVR technology has automated and standardized some of the outbound calling and inbound patient data collection. Geisinger, an eight-hospital system in Pennsylvania, implemented the Geisinger Monitoring Program; an IVR to monitor recently discharged Medicare patients. Patients who enrolled in GMP, along with the hospital’s case management had a 44%3 reduction in 30-day readmissions vs. a risk-adjusted control group. Enter the Apps A number of app-centric interventions have emerged to guide patients through the pre- and post-hospital phase. This area of ‘patient time’ is critical because if certain things go undone (medication fills, follow-up scheduling etc.) – readmission rates are shown to rise predictably. Patients using Mayo Clinic’s app had a 20% readmission rate compared to the 60% of those who did not.4 The app, showcased at the 2014 Annual American College of Cardiology Scientific Session, helps reduce cardiovascular risk factors in addition to readmission rates. Patients are

able to record BP, glucose level, physical activity and dietary habits. They also have access to educational activities that encourage healthy lifestyle behaviors for cardiac patients. When the app is used in conjunction with cardiac rehab, patients saw greater improvements in health compared to the group who only received the latter. Created by Boston Children’s Hospital, ReadySetGo aims to better prepare parents for their child’s discharge from hospital care, an often rushed and chaotic process. If parents are inadequately prepared, their child is much more likely to be readmitted. ReadySetGo ensures that all components of the discharge process are covered to reduce preventable hospital readmission in children. Infield Health’s app–HealthySteps–helps providers manage pre- and post-op surgical patients. Often, same-day surgery patients arrive unprepared, contributing to a 9% cancellation rate that is expensive for providers and patients. In addition, misunderstandings around post-op requireContinued on page 26

The Journal of mHealth

Engaging Patients to Deliver Improved Surgical Outcomes Continued from page 25

ments often contribute to increased readmissions. Lastly, patients often do not stay in-network for physical therapy, resulting in a lost revenue opportunity for providers that own PT or cardiac rehab practices. HealthySteps addresses all of these patient pain points and contributes to better patient management for providers. Conclusion More than ever, providers have a suite of

new processes and technologies to enlist the help of patients to curb preventable readmissions. Working together, with smart technologies and processes in the middle, providers and patients should be able to enhance outcomes and reduce total cost-of-care. References 1. Mayo Clinic Proceedings (2005), “Patients’ Understanding of Their Treatment Plans and Diagnosis at Discharge”

2. Fierce Healthcare. http://www.fiercehealthcare.com/story/patient-navigatorsreduced-readmissions-overuse-er-pilot-program/2015-01-27 3. Population Health Management (2011), The Impact of Postdischarge Telephonic Follow-Up on Hospital Readmissions 4. Mayo Clinic. http://newsnetwork.mayoclinic.org/discussion/cardiac-rehab-patientswho-use-smartphone-app-recover-bettermayo-clinic-research-shows/ n

Engaging Patients to Deliver Improved Surgical Outcomes A recent trial conducted at Toronto East General Hospital (TEGH) has demonstrated the benefits of using a web & mobile-enabled, patient engagement program to help improve the outcomes and experiences of patients undergoing thoracic surgery. The results have shown significant improvements in surgical outcomes and reductions in cancellations of procedures. The trial which was undertaken as a joint project by TEGH in partnership with SeamlessMD was introduced with the aim of improving the patient experience, as they underwent thoracic surgical procedures, by providing a technology-enabled support platform, designed to help guide and inform them during the pre-operative and post-operative stages of surgery. Results from the trial have been extremely positive with significant reductions in cancellation rates, better patient adherence to clinical guidance, and increased patient satisfaction. TEGH is well known for having an established Level 1 Centre of Excellence for thoracic surgery. The multi-disciplinary surgical team which includes 3 full-time thoracic surgeons is led by Dr. Carmine Simone, Chief of Surgery, who was also responsible for overseeing the trial.

The trial was therefore established with the aim of introducing a patient engagement program for thoracic surgery delivered using smartphones, tablets and computers. The program was designed to guide patients through pre-op preparation and postop recovery phases, using: Electronic reminders for patients & caregivers, Interactive education (illustrations, videos, etc.), Symptom tracking, Automated feedback during recovery, and Electronic data collection to record patient satisfaction.

The hospital originally approached SeamlessMD with the aim of introducing an integrated patient engagement solution to help try and solve a number of issues. Despite providing more coordinated care as a Level 1 Centre, Dr. Simone found his patients faced difficulties adhering to their instructions and staying engaged in the process between visits. He also found that patients were often overwhelmed by all the instructions they had to remember for preparing for major cancer surgery and during the recovery period afterwards. He realised verbal and written instructions are often complicated and difficult for patients to understand, and in many cases these become lost or forgotten.

In addition, TEGH staff had access to a real-time analytics dashboard to track patient progress and analyse data, such as patient satisfaction, in real-time. SeamlessMD also worked closely with TEGH staff to ensure integration of the program into the clinical workflow.

In a review of hospital data, it had also been found that during the 3 months prior to the trial the thoracic surgery program had 6 procedures cancelled due to patients failing to stop medication. In addition the existing program often experienced a significant number of unnecessary post-op phone calls.

77 patients and 35 caregivers were involved with the trial which revealed numerous benefits for the surgical centre, including: a dramatic reduction in same-day surgery cancellations, high patient satisfaction and better collection of patient satisfaction data.

April 2015

Simone comments, “It [the SeamlessMD platform] acts like front-line customer relations to answer questions that the patient has. This has reduced a lot of avoidable calls. They [the patients] feel more connected to their instructions, and they self-manage much better than before.”

Engaging Patients to Deliver Improved Surgical Outcomes Patients also reported feeling more engaged in their self-management, less anxious about the prospect of undergoing the surgical procedure, and that they felt they had a significantly improved connection to their healthcare team. Paul, a patient involved in the trial, says â&#x20AC;&#x153;The app has many benefits. The reminders during pre-op were very helpful. The postop experience I think is even better. The daily check-in gave me some confidence that everything was going well, and it made me more cognizant and aware of what I needed to do.â&#x20AC;? The team at SeamlessMD have approached the task of engaging patients along their surgical journey, by identifying key episodes of care within the surgical treatment pathway. The care pathway involved with any surgical procedure is complex (see image), with many stages, which require careful patient and caregiver management to ensure a patient transitions along the pathway in the expected manner. The SeamlessMD platform enables clinical staff to ensure that patients are well-informed and adequately prepared prior to surgery and then subsequently monitor key aspects of the recovery process, thus ensuring that patients are progressing as expected. Using mobile technologies allows the majority of these processes to be conducted in real-time and the necessary valuable clinical insights to also be gained concurrently. The platform also forms a valuable education channel by which physicians and clinicians can ensure that patients have access to approved, relevant resources that can help guide them through their treatment.

CEO and founder Joshua, MD, was midway through medical school at the University of Toronto when he began doing research on readmissions. Through his research it became apparent that rates could be noticeably lowered, if patients adhered more closely to their care plan and if providers were better able to monitor their patientsâ&#x20AC;&#x2122; progress. Re-admissions of a surgical patient can cost upwards of $10,000. Re-admissions in Canada cost in the neighbourhood of $1.8 billion annually, while Medicare in the U.S. spends $25 billion on readmissions each year. Research published by Tulane University Medical Center, in 2012, revealed that from a surgical outpatient cancellation rate of 6.7%, 30% of those cancellations were due to patients not showing up, which in turn led to an average revenue loss of $2,900 per cancellation.1 As healthcare organisations and care providers seek to reduce costs and improve coordinated delivery of care, patient engagement programs are seen as an important tool to help streamline clinical care pathways, and effectively manage unnecessary costs. Today, the SeamlessMD platform is being used for a variety of surgical procdeures at medical centres in Canada and the United States. References 1. Bent, S. Mora, S. Russo, N. Et al. (2012). The Financial Burden of Cancelled Surgeries: Implications for Performance Improvement. Practice Management, Research in Perioperative Management. PM23. n

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The Journal of mHealth

How Digital Health Can Change Condition Management

By Dr Alexander Graham

Dr Alex Graham is a medical doctor by background, having trained in London before entering the business world. He is currently a founding partner at AbedGraham, a research and strategy consultancy which assists global IT corporates to navigate the clinical, organisational and commercial complexities of the UK’s National Health Service (NHS). He is also medical director of EMEA for Imprivata. So much of the talk around the digitisation of healthcare and indeed a huge part of my work in healthcare IT revolves around the ‘bricks and mortar’ solutions. In the UK, we are almost singularly focused on initiatives such as the ‘paperless NHS’ or EHR maturity that it’s sometimes easy to forget the impact of technology on conditions and individuals, which is after all the reason that healthcare systems exist. Similarly, it’s also worth revisiting the colossal cost that widespread, chronic conditions incur and where technology fits in to this process. Diabetes is the condition with the single biggest spend attached to it. Accounting for at least 10% of the UK healthcare budget, and costs spiralling year on year, diabetes is the ticking time-bomb that will financially bring down every single healthcare system if not dealt with. As a result, the market has been flooded with sensors, trackers, data gatherers and more, with the end result being quite a murky pool of disparate technologies. Standing out from this are a number of companies and products that have grown to achieve a significant presence, predominantly in the US. iBGStar and Telcare are two of the larger ones that allow for digital testing, data sharing and lifestyle modification and are seen as poster boys almost for the new wave of diabetes technologies. As with the majority of my thoughts on health IT, I think we are on the right path, but several potholes need to be negotiated. I have no doubt that the future of chronic disease tracking is digital. Many times I have seen educated, informed patients with myriad pieces of paper detailing all their tests, readings and diagnoses, the end result being either I physically type them all into my GP or hospital sys-

April 2015

tem or they are lost to the system. The richness of this individual data can guide everything from personal treatment to nationwide public health programmes, so the first step of collecting data in a digital form that can (in theory) be shared across the healthcare spectrum is particularly welcome. The ideal scenario of patient data being available quickly and efficiently to all healthcare professionals in all locations is one we have to aim for. The next major benefit is the beginning of an attempt to understand chronic disease and its management from a behavioural point of view. In the case of diabetes we are still in the process of truly understanding its causes, and until we are certain, early diagnosis and chronic management are the mainstays of preventing morbidity and mortality and reducing costs. Within this, there is still a huge cohort of patients that, for a number of complex reasons, don’t engage fully in the management of their condition. We are only just now starting to understand what are known as the ‘behavioural determinants’ of chronic disease management, and I believe that this will be an integral part of future condition control. Fortunately, technologies companies are starting to build some of these ideas into their products. Telcare for example, has personalised engagement strategies built into the software, to try and motivate and change the behaviours of the user rather than simply transfer documentation from paper to digital. The impact and the benefits of digital solutions have not yet been fully quantified and it will take a lot of work to highlight the clinical, financial and operational benefits so as to convince the naysayers in the healthcare community. I also think the solutions that exist currently are not yet the ‘silver bullets’ to transform a condition like diabetes. Building from what has been done

already, some areas will need ongoing work: Interoperability I often sound like a broken record when it comes to interoperability, but it is perhaps the most important part of a digital strategy. The ability to have a digital record of a patient’s diabetic control that is fully interoperable across all geographies, specialties and professionals is the end game and the true scenario in which the benefits of digital will be realised. This requires vendors, clinical staff and central and local government institutions to work together constantly. Finding the laggards When it comes to technology adoption in any vertical, there will be people who are early adopters and some who will cling on to their decade-old technology for dear life. Rather than leaving these people (both patients and professionals) behind, we must endeavour to build as waterproof arguments as possible for its uptake. For the patients, this may include more behavioural studies around condition management and for the professionals this will likely be evidence based (business cases and ROI studies) and around personal benefits (what is it going to do for me). There is little point in having revolutionary technology if a significant number of people are not using it. I am sold on the idea of digital technology in the diagnosis and management of chronic conditions, but we need to build on the work already done to truly realise the power of digital. The more we engage stakeholders and continue to delve into the ideas behind chronic disease, the more we will transform conditions rather than just digitising their existing problems. Disclosure: I have no commercial ties with any of the companies mentioned in this article. n

Healthcare at the Touch of a Finger

Healthcare at the Touch of a Finger New fingerprint ID device gives healthcare workers access to accurate patient records A pocket-sized fingerprint scanner that links individuals' fingerprints to their health records, developed by a team of students, could have the potential for widespread health benefits, according to a new study. In an article in the journal Global Health: Science and Practice, four students - three of them Gates Cambridge Scholars - outline how the device, known as SimPrints, addresses a major problem in developing countries, in terms of having the means to identify patients. Accurately linking people to their digital records is a critical bottleneck in the delivery of mobile services in healthcare, microfinance, and aid distribution. To help improve this situation the scanner has been designed to wirelessly sync with a health worker's smartphone, thus providing an efficient method for identifying individuals and empowering the mobile tools used by researchers, NGOs and governments around the world. The students - Daniel Storisteanu, Alexandra Grigore and Toby Norman from the University of Cambridge and Tristram Norman from the Royal Holloway, University of London - say the benefits of the SimPrints system include high accuracy and secure identification, which lead to rapid access and modification of records. This allows health workers in the field to make better decisions by providing immediate and reliable access to critical medical information, and increased programme accountability by facilitating the measurement of indicators such as vaccination coverage and supporting civil registration and vital statistics systems by enabling tracking of vital events (such as births). In areas where connectivity in the field is poor, the students say the SimPrints system can access and modify offline health records that have been previously downloaded and are stored in a local database on the phone. Any updates to the health records will then be synced with the central database once Internet connectivity is restored. In order to increase access to charging points and make it easier to replace parts, the SimPrints scanner uses the same BL-5C Nokia batteries commonly used in mobile phones globally. According to the study challenges still remain in terms of fingerprint identification of

infants, the elderly, and individuals with worn fingerprints due to manual labour but these problems can be largely overcome using current strategies including connecting an infant's record to the fingerprints of their legal guardians and enrolling multiple fingerprints for manual labourers and the elderly to increase matching accuracy, as well as using secondary identification tags, such as their name or location, as a back-up. Supported by funding from the Saving Lives at Birth innovation grant and ARM Ltd, the SimPrints team are conducting a pilot study in partnership with BRAC and the Johns Hopkins Global mHealth Initiative to test the system with health workers in Gaibandha, Bangladesh. The study is focusing on threshold testing to assess false positive, false negative, and failure-to-enroll rates, and research on performance analysis, usability, acceptability, usage patterns, and key health indicators such as the number of successful antenatal health visits. The technology is also being piloted in Mozambique. Professor Alain Labrique, Director of the JHU Global mHealth Initiative, expressed his enthusiasm for the project saying, â&#x20AC;&#x153;This is a very exciting initial investment into a promising technology that addresses a key bottleneck in global health programs. As we struggle to identify ways to strengthen vital registration systems that improve our ability to deliver care to every person who needs it â&#x20AC;&#x201C; knowing who someone is and being able to pull up their prior health record is a real game changer for the footsoldiers of global health.â&#x20AC;? The idea for SimPrints came through a global health comContinued on page 30

The Journal of mHealth

Nursing Study Finds Mobile App with Evidence-based Decision Support Continued from page 29

petition where teams of students had to address different health challenges. SimPrints won the competition and Toby Norman formed a development team which sought funding through various grant initiatives. Last year the team won funding of $250,000 from the Bill and Melinda Gates Foundationâ&#x20AC;&#x2122;s Saving Lives at Birth competition and $180,000 from Cambridge-based ARM Ltd, whose technology is incorporated in over 95% of all the world's mobile phones. Toby Norman, who is doing a PhD in Management Studies, said: "Despite the incredible potential of mobile health to improve lives, accurately linking a patient to their health records has proved a critical stumbling block in too many projects. This technology can ensure that even the poorest have the right to an identity within health systems." Biometric identification has significant implications in other health related areas. An overwhelming body of evidence shows that immunizations are one of the most successful and cost-effective health interventions ever known. Yet still in the developing world 1.5 million children die of vaccine preventable diseases every year, accounting for 17% of deaths in children under 5 years old (UNICEF 2014).

With the support of the Gates Foundation, pioneers like VaxTrac are developing biometric vaccine registries to ensure the right child receives the right vaccination on time. Yet commercially available scanners are poorly designed for these contexts in terms of accuracy, robustness, and proprietary software. SimPrint hope that by developing better hardware and open software then this will have the potential to save lives. Similarly, biometric identification scanners can be used to help reduce problems in pregnancy and improve maternity services in countries with limited access to health records. The perinatal period is fraught with risks for both mother and child, accounting for over 70% of preventable maternal and neonatal deaths annually in developing countries (Ahman & Zupan 2007). Many of these deaths can be prevented by timely visits from community health workers. The World Health Organization recommends a minimum of four check-ups before birth, however only 39% of all mothers are receiving these visits due to challenges in identification and accountability (Dieleman & Harnmeijer 2006). Biometrics provide a powerful tool to identify patients in these settings, instantly finding the right patient record in mHealth systems with the touch of a finger. They also empower managers with new tools to monitor and support health worker visits. For more information visit www.simprints.com n

Nursing Study Finds Mobile App with Evidence-based Decision Support Helps Diagnose Obesity, Smoking, and Depression Nurses who use a mobile application with evidence-based decision support tools are significantly more likely to diagnose depression, weight issues and tobacco use than nurses not using such tools, according to a recent study published in the Journal for Nurse Practitioners, Clinical Innovation & Technology reports. Smartphones and tablets may hold the key to getting more nurses to diagnose patients with chronic health issues like obesity, smoking, and depression - three of the leading causes of preventable death and disability. Mobile devices loaded with a custom app that prompts clinicians to follow evidence-based guidelines to make treatment decisions and document care plans makes nurses significantly more likely to identify these health issues during routine exams, according to the study conducting by the Columbia University School of Nursing. "What clinicians need is decision support tools that fit into their workflow and remind them of evidence-based practices," says lead study author Suzanne Bakken, PhD, RN, FAAN, FACMI, Alumni Professor of Nursing and Professor of Biomedical

April 2015

Informatics at Columbia Nursing. "Our app focused specifically on the work that nurse practitioners do to identify health problems, counsel patients, and coordinate care plans, resulting in higher diagnosis rates and more opportunities for intervention." For the study, Columbia University School of Nursing researchers analysed diagnosis rates of adult and paediatric depression, obesity and tobacco use during 34,349 patient exams carried out by 363 registered nurses enrolled in the school's nurse practitioner programs. The nursing students were randomly assigned to mobile devices preloaded with either an app with evidencebased decision support tools or an app that provided nurses with simple tools to record patient exam results. According to the researchers, the decision support tool app prompted nurses to have detailed conversations with patients. In addition, the app calculated a patient's body mass index to quickly determine individuals who could benefit from intervenContinued on page 32

Using Digital Solutions for Condition Management

Using Digital Solutions for Condition Management 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. So now we get to a place where digital health solutions are really starting to change the way that patients manage their health and the way that healthcare is delivered to patients in lots of different countries. It has taken a while – in fact far too long to get the traction it has, but things are starting to really roll forward. I think the testament of this is to look at a couple of conditions to see how digital management has really changed the way patients manage their health in this new digital world. COPD Traditionally these patients can become very unstable as their condition worsens requiring regular unplanned admissions to hospital which is very expensive and not ideal for the patient. On average this occurs three times a year, at a cost to the provider of over £10,000, which is on top of the other associated care costs for the patient. So how does a digital healthcare world change this scenario – here’s how! The patient downloads an application for their smartphone or their tablet, which gives them a bespoke self-management tool designed to help them manage their day-to-day life with COPD. The solution asks questions, captures readings from peripheral devices and records patient entered information in order to deliver a tailored self-care management system for

the patient. It also helps them with their medication reminders, records inhaler usage, how well the inhalers are used and manages exercise and other lifestyle measurements. All of this information is then combined to help the patient better manage their condition and allows healthcare professionals with access to the information to make educated and appropriate decisions. Over time, the system starts to understand patterns within the patient journey and how their condition changes. This allows the healthcare professional to identify issues before they arise and potentially prevent the patient from being admitted to hospital. The savings for the patient and the healthcare providers, derived from these reductions in admissions can be huge – potentially saving 50% of the cost of COPD hospital admissions, in a year, in return for a very small outlay in technology and digital healthcare solutions. Warfarin Management Traditionally, a large number of patients are prescribed warfarin for various heart conditions. As a result of this, patients are required to attend their local hospital or GP surgery, on a monthly basis (or more frequently), to have their blood taken to test their INR level (a measure of the rate at which blood clots), wait a week for the results and then go back to see a GP

and have their medication intake levels adjusted accordingly. This process takes a long time and is not ideal for either the patient or the healthcare professional. So how does a digital healthcare world change this – here’s how! The patient takes a finger-prick blood test at home which returns a rapid result, with a colour-coded level representative of their INR level. They then upload that result to an application on their mobile phone or tablet which can then immediately be shared with their healthcare professional. The healthcare professional can then contact the patient to inform them whether they should maintain the same dosage or whether there needs to be an adjustment made to their medication. The result is a seamless medical management experience for the patient and a reduction of costs for the healthcare provider of around 75%. This model is being rolled out across a number of hospitals in the NHS, in the UK, very successfully. These are just a couple of small examples of the many new digital healthcare solutions that are being delivered and offered throughout health and social care systems. The world is changing and healthcare professionals and patients better watch out and get on the train for a potentially really exciting journey. n

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

The Journal of mHealth

Nurses Say Medical Errors Could Be Reduced If Devices Were Connected dence-based clinical guidelines to screen, diagnose, and manage specific conditions and encouraged detailed conversations with patients about their health, Bakken says.

Continued from page 30

tions such as weight-loss counselling. For each of the health issues studied, mobile apps with decision support features resulted in significantly higher diagnosis rates than apps with only bare-bones tools for recording results from a patient exam. Increased diagnosis rates with decision support were: »» Seven times more for obesity and overweight health issues (33.9% vs. 4.8%) »» Five times more for tobacco use (11.9% versus 2.3%) »» 44 times more in adult depression (8.8% versus 0.2%) »» Four times more in paediatric depression (4.6% versus 1.1%) The app may have worked because, unlike software aimed at physicians that focuses more on diagnostic codes needed for medical billing, it prompted nurse practitioners to follow evi-

For tobacco screening, for example, the app prompted nurses to ask not just about cigarettes but also about other products such as chewing tobacco. To diagnose patients who are overweight or obese, the app calculated a body-mass-index to quickly pinpoint people who might benefit from weight-loss counselling and other interventions. With depression, the app prompted nurses to ask a series of questions to make it easier to identify patients with depressive symptoms. The paper is titled: "The Effect of a Mobile Health Decision Support System on Diagnosis and Management of Obesity, Tobacco Use, and Depression in Adults and Children" and it appeared in the November/ December 2014 issue of the journal. Co-authors from Columbia Nursing are associate professors Haomiao Jia, PhD and Rita John, DNP, EdD. n

Nurses Say Medical Errors Could Be Reduced If Devices Were Connected, Survey Shows Half of Nurses Surveyed Have Witnessed a Medical Error Because Medical Devices Were Not Coordinated, According to Survey. Nurses believe medical errors could be reduced if the devices hospitals rely on for testing, monitoring and treating patients could seamlessly share information, according to the results of a national survey of more than 500 nurses in the US, conducted online by Harris Poll on behalf of the Gary and Mary West Health Institute. Each year, it is estimated that more than 400,000 Americans die from preventable medical errors. This not only takes an enormous emotional toll on families and friends, but also places a heavy economic burden on the nation — an estimated trillion dollars or higher. As hospitals wage a war on error, there is growing appreciation that medical devices, while individually safe and effective at improving care and saving lives, can create risks for patients and challenges for clinicians when not seamlessly connected. According to the survey, half of these nurses reported witnessing a medical error resulting from a lack of coor-

April 2015

dination among medical devices in a hospital setting. Devices include everything from infusion pumps, ventilators, pulse oximeters, blood pressure cuffs to electronic health records. Among these nurses, three in five (60 per cent) said medical errors could be significantly reduced if medical devices were connected and shared data with each other automatically. This problem could be addressed by the widespread adoption of open communications standards that allow for the safe and secure exchange of data. “Nurses are the front line of patient care and have an unrivalled ability to identify and address problems at the intersection of patients and technology,” said Dr. Joseph Smith, West Health Institute’s chief medical and science officer. “This survey helps show how much of a nurse’s time could be better spent in direct care of patients and families, and how errors could be potentially avoided if medical devices, which have been so successful at improving patient care, were able to take the next step and seamlessly share critical information around the patient’s bedside.” Medical device interoperability, the abil-

ity to safely share health information across various technologies and systems, could provide important benefits such as enhanced patient safety and better clinical outcomes at a lower cost. The West Health Institute has estimated that a system of connected devices could potentially save more than $30 billion each year by reducing redundant testing, manual data entry and transcription errors. According to the survey, “Missed Connections: A Nurses Survey on Interoperability and Improved Patient Care,” nearly half of these nurses (46 per cent) said an error is extremely or very likely to occur when information must be manually transcribed from one device to another. “I have seen many instances where numbers were incorrectly transcribed or put in reverse or put in the wrong column when typed manually, which can cause errors,” said one nurse who participated in the anonymous poll. But perhaps even more important, transcribing data “takes too much time for the nurses to adequately care for the patient,” one nurse responded. Many of these nurses agreed, with more than two

Nurses Say Medical Errors Could Be Reduced If Devices Were Connected out of three (69 per cent) saying manually transcribing data is very likely to take time away from patients who need attention. “Nurses enter the profession because they want to care for patients, not because they are interested in programming machines,” said Patricia H. Folcarelli, RN, senior director of Patient Safety at the Silverman Institute for Health Care Quality and Safety at Beth Israel Deaconess Medical Center. “As many as 10 devices may monitor or treat a single patient in an intensive care unit. The nurse not only has to program and monitor the machines, he or she often spends a significant amount of time transcribing data by hand because the devices are not designed to share information.” Other key survey findings: »» 74 per cent of these nurses (strongly/ somewhat) agreed that it is burdensome to coordinate the data collected by medical devices »» 93 per cent (strongly/somewhat) agreed that medical devices (e.g. monitors, diagnostic devices) should be able to seamlessly share data with one another automatically »» Half (50 per cent) said they have witnessed a medical error because of lack of device coordination “It’s time that we free our healthcare workers to do what they do best and what they are most needed for, which is caring for patients,” Dr. Smith said. “Let’s not ask busy clinicians to do those things that technology can automate easily and effectively. Medical device interoperability can save lives, time and money, and at the same time allow nurses to focus on caring for patients.”

The weighted survey was conducted online by Harris Poll from January 7–16, 2015 and included 526 nurses (credentialed at RN or higher and with an education of BSN or higher) who work full–

time in a non–school setting. For more information visit www.westhealth.org/igniteinterop n

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In Depth with the Global Digital Health 100

In Depth Global Digital Health with the

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

100

Here we continue our coverage of the Awards list by featuring some of the 2014 winners. Due to the success of the Awards we will be running the Global Digital Health 100 Awards again in 2015. If you would like to nominate a company for consideration, or for your chance to partner with us as a sponsor of this high-profile global event then please do get in touch at enquiries@simedics.org.

Bringing Hands-free Gesture Control to the Operating Room

Developing technology that allows healthcare professionals to access digital information using touch less, intuitive methods can help reduce contact infections and protect sterilisation across the hospital landscape, but can especially be useful in the operating room. Spanish company TedCas was recognised in the Global Digital Health 100 list of 2014 for their work to revolutio-

April 2015

nise access and handling of medical information in healthcare environments using touch-free, natural user interfaces. Deployed in hospital areas and associated medical devices that require special aseptic conditions, TedCasâ&#x20AC;&#x2122; technology has demonstrated that this kind of interface has a relevant positive appli-

In Depth with the Global Digital Health 100 cation in a great range of healthcare areas. Offering touch free integration for a variety of medical software applications and devices the TedCas interface avoids all contact with computers, reducing the probability of infections whilst improving surgical efficiency. Dr. Nicola Bizzotto an orthopedic and trauma surgeon of the University of Verona, is an eager early adopter of any technology with the potential to make his OR cleaner and more efficient. “In the OR, new technologies really help the surgeon operate faster and reduce risks for patients.” According to Bizzotto, X-ray and CT scans are typically displayed on a screen situated over the patient (though in older facilities, the screen will be on a wall, stationed out of arm’s reach). Using a mouse and keyboard in a sterile setting comes with its own unique set of problems. If a surgeon manipulates the images, that means several minutes of scrubbing to prevent cross-contamination. Otherwise, they verbally instruct support staff through the images. This can be an awkward, time-consuming process, especially when a patient is in critical care. Using the TedCas module, Dr. Bizzotto is able to navigate images quickly and intuitively without being forced to slow down. Additionally, because OR image manipulation can require many hands on deck, the touchless

interface gives medical practitioners an aerial safeguard against cross-contamination – a level of protection that even a sterilized mouse cannot provide. The TedCas Surgical Information System has been designed to manipulate using only gestures through intuitive touch free technology. TedCas are working with a number of technology partners to incorporate motion control into surgical workflows. Using devices like the Leap Motion Controller and the Myo armband, alongside cameras, and voice recognition software creates a multi-sensor solution for operating rooms all connected to a device called the “TedCube”. This in turn provides surgeons with total hands-free control over the information they need during a surgical procedure. Jesus Perez-Llano, TedCas co-founder and CEO, believes that as the first generation of touchless interfaces mature, interactions between humans and medical equipment will more closely resemble human-to-human communication through voice and gesture. “With the Leap Motion Controller, not only a touchless solution is provided, but also autonomy and independence to the MD. Our device aims to validate this trend in the medical world; however, this technology is very transversal,” he says, believing 3D input has the potential to catapult many industries forward. n

Philips and Janssen to Develop New Handheld Blood Test Global Digital Health 100 (2014) honouree Philips Healthcare has announced that it has entered into a collaboration agreement with Janssen Pharmaceutical aimed at developing a new handheld blood test to provide doctors with a novel tool to improve the care of patients with neuropsychiatric disorders. The collaboration unites Philips’ expertise in point-of-care testing and monitoring applications for the hospital and the home, with Janssen’s strength in discovering and developing innovative solutions to treat brain disorders. Philips will be responsible for the development and manufacturing of the handheld test. The test will be based on Philips’ Minicare system, which is currently under development. Janssen will be responsible for the clinical studies to validate the test, as well as the commercialisation of the final product. “Our technology can play an important role in the management of chronic dis-

eases in the hospital and the home,” said Frans van Houten, CEO Royal Philips. “Better care for patients with neuropsychiatric disorders is a key driver to improve patient outcomes and lower healthcare costs. The collaboration with Janssen is a great example of our open innovation business model, combining their strength in neuroscience with the biosensor technology in our Minicare I-20 platform.” Mr. Van Houten added: “Going forward, I firmly believe that the Minicare system consisting of the analyser and application-specific cartridges and software

can be tailored to a wide range of other pharmaceuticals.” The blood test will be based on Philips’ Minicare I-20 system for immunoassays, which consists of a handheld analyser, dedicated software and a single use, disposable cartridge containing the application specific test. Using proprietary biosensor technology, the Minicare I -20 system is being developed to detect multiple target molecules at low concentrations within the same blood sample and to show the results on the analyser display within minutes. n

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