WHAT’S INSIDE
NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS
The
Journal of mHealth The Global Voice of mHealth
June 2015 | Volume 2 Issue 3
mHealth Security
Securing Information on Mobile & Digital Health Platforms INSIGHT Cyber5security
Steps for mHealth Developers
ARTICLES
REGULATION
mHealth Technology Security
European Cybersecurity Requirements for mHealth Apps
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
Editor's Comments
Welcome Cybersecurity, Data Privacy, and Information Management are always ‘Hot Topics’ for the Digital Health industry. When it comes to data in healthcare trust is paramount. We have all seen recent headlines reporting high profile data breaches at healthcare insurers and providers, and to some extent this type of intrusion is inevitable for any digitalised industry. But is there a real need for concern and what are the implications for the mobile and digital health industry as the sector grows in both reach and relevance? When it comes to the collection, management and use of health data, patients, individuals, providers, and payers – each have very different requirements and demands. This makes the task of managing the information collected, and held, within mobile and digital health platforms an inherently complex process. Ensuring that information is available, when and where it is required, in order to be useful to each particular stakeholder has to be balanced with the need to have the necessary safeguards in place to keep data protected. The growing adoption of digital health solutions among patients, consumers, providers and healthcare organisations demands that developers take a responsible and proactive approach to securing the information of users and ensuring that data is handled responsibly. This means that the best way for us to act as an industry, is to take the initiative and work together to share ideas and ensure that we deliver solutions that are effective AND use data in an appropriate way. In this issue we are pleased to be able to include a fantastic line-up of discussion, expert opinion and thought-leadership articles from leading digital health practitioners discussing the issue of data security and management on the industry, and suggesting methods for best practice. Some of the highlights include an article titled ‘Five Cybersecurity Steps mhealth Developers Should Take Now’ by Melissa Masters Head of the DeviceSecure Services for Battelle (the world’s largest non-profit research and development organisation) and Stephanie Preston of Battelle’s Cyber Innovations Team. Peter Ohnemus, CEO and Founder of the digital health solution dacadoo, discusses best practice when it comes to securing information on digital and mobile health solutions. And, we continue our series of articles considering regulatory and legal issues relating to the development and delivery of mobile and digital health devices and services with an article from Erik Vollebregt, founding partner of life sciences law firm Axon Lawyers, who provides his expert opinion on the EU cybersecurity requirements for mHealth apps and medical devices. Also inside, Jeroen Tas, CEO, Healthcare Informatics Solutions and Services, Philips discusses how the Internet of Things can empower care-givers and patients in a new, data-rich system, in the article ‘Connections that could Transform the Future of Healthcare’.
Published by Simedics Limited www.simedics.org
Editor: Matthew Driver Design: Jennifer Edwards For editorial, research and paper submissions, and advertising opportunities please contact: Matthew Driver matthew@simedics.org
+44 (0) 1756 709605 Subscribe at www.thejournalofmhealth.com The editor welcomes contributions for The Journal of mHealth. Submissions can be sent to the editor by email, images and graphics should be submitted in high resolution format. The opinions expressed in this publication are not necessarily shared by the editors nor publishers. Although the highest level of care has been taken to ensure accuracy the publishers do not accept any liability for omissions or errors or claims made by contributors or advertisers, neither do we accept liability for damage or loss of unsolicited contributions. The publishers exercise the right to alter and edit any material supplied. This publication is protected by copyright and may not be reproduced in part or in full without specific written permission of the publishers. ISSN 2055-270X © 2015 Simedics Limited
Matthew Driver Editor
The Journal of mHealth
1
Table of Contents
In This Issue 4
Five Cybersecurity Steps mHealth Developers Should Take Now In this article Melissa Masters Head of the DeviceSecure Services for Battelle (the world’s largest non-profit research and development organisation) and Stephanie Preston of Battelle’s Cyber Innovations Team, outline a range of essential security precautions for mHealth development.
18
EU Cybersecurity Requirements for mHealth Apps & Medical Devices: The Time to Act is Yesterday As the digital and mobile health landscape evolves, Erik Vollebregt, founding partner of life sciences law firm Axon Lawyers, provides his expert opinion on the EU cybersecurity requirements for mHealth apps and medical devices.
22
Connections that Could Transform the Future of Healthcare Jeroen Tas, CEO, Healthcare Informatics Solutions and Services, Philips discusses how the Internet of Things can empower care-givers and patients in a new, data-rich system.
2
June 2015
Table of Contents
Industry News
20
Health Data and Privacy: The Eternal Conundrum
21
mHealth Technology Security: Securing Information on a Digital Health Platform
6
Smartphone Microscope Diagnoses Deadly African Parasite
7
Top 5 Smart Wireless Device Developments for 2015
24
Securing Information on Mobile & Digital Health Platforms
8
Wireless Routers Could Monitor Your Breathing and Heartbeat
25
9
Boston Children’s Hospital Hosts Second Annual Innovators’ Showcase
Healthcare Organisations Recognising the Possibilities of the Apple Watch
27
Crowdsourced Tool for Depression
28
Fitbit Data Could Help Schizophrenia Sufferers Avoid Relapse
30
eHealth Week 2015: Eight European Hospitals Receive High Level Awards for Excellence in Digital Maturity
10
Digital Health Partnership Selected by USAID to Support Ebola Response Transition
11
Smartphone-based Device Could Provide Rapid, Low-cost Molecular Tumour Diagnosis
12
Collaboration Puts Medical Apps at Heart of Diabetes Treatment
31
How the NHS can become a Silicon Valley for Health
13
Revolutionary Cane Enables the Visually Impaired to Instantly Identify Friends and Family
31
2015 ATA Annual Awards: Recognising Innovators in Telemedicine
13
New Award Scheme Aims to Spark NHS Digital Revolution
32
14
Global mHealth Research Study Reveals Top Five mHealth Countries in Europe
mHealth Summit 2015 Creates Global Platform for Mobile and Connected Health
33
Winners of MaRS HealthKick 2015 Pitch Competition Announced!
MDLIVE Collaborates with Microsoft to Bring Consumers a Digital Health Experience Through Skype for Business
33
Digital Health Summer Summit
34
LifeWIRE: The “Science and Art of Communication”
16
Aseptika Releases SENSOR I App: The Clinical Version of Activ8rlives
36
MSF and Google Develop 'Ebolaproof' Tablets
16
ONC Awards Funding to Six Digital Health Pilot Projects
37
Upcoming Events
37
Advertisers Index
15
The Journal of mHealth
3
Five Cybersecurity Steps mHealth Developers Should Take Now
Five Cybersecurity Steps mHealth Developers Should Take Now By Melissa Masters and Stephanie Preston, Battelle Is there a dark side to the digital health revolution? From WiFi-enabled medical sensors to mHealth apps, digital health devices are connected to each other and to hospital networks in ways not imagined just ten years ago. But what are the risks if these devices are hacked? A growing number of hospitals are asking this question and writing cybersecurity requirements into their purchasing guidelines and contracts. Manufacturers must be prepared to address these concerns by integrating cybersecurity into their devices at every stage of development.
Why mHealth Cybersecurity Matters
Some medical devices can present direct health and safety risks for patients if they are hacked. For example, an mHealth app could provide the wrong dosage information for a patient, or a connected infusion system could be wirelessly altered to deliver medications improperly. Digital health developers have an obligation to minimize these risks to keep patients safe. But even if there is no potential for patient harm in your device, cybersecurity is critical. Unsecured medical devices can provide back-door access to hospital networks. Once inside, hackers may be able to access medical or financial records or disrupt hospital operations. An increase in cyber-attacks against the medical community in recent years, including data ransom attacks, have put hospitals on the alert. Increasingly, hospitals are seeking to protect themselves and their patients by requiring the medical devices they purchase to meet stringent cybersecurity standards.
Cybersecurity Basics, From Concept to Post-Market
4
mHealth developers can prepare themselves to meet these new purchasing requirements—and protect themselves from potential liability—by baking cybersecurity into their products from
June 2015
the start. Here are five steps every digital health manufacturer should take, from initial concept to post-market updates: 1. Pre-Development: Just as you gather end user requirements for other aspects of your product, your needs assessment should look at the cybersecurity expectations of your buyers. Some large hospital systems have developed explicit cybersecurity guidelines for medical devices. Talk to your customers, and make sure you understand their cybersecurity concerns. 2. Design Input: Medical device developers are already used to building safety standards into their product requirements. Cybersecurity should be built into your device development in the same way. mHealth developers need to think about all of the ways that their app or connected device could present risks to patient safety, data privacy or network security. Each device will have its own unique
risk profile depending on how the device sends and receives data (WiFi, Bluetooth, network ports, etc.); the kinds of data the device is capable of sending, storing, and receiving; and what the device is intended to do. These factors will dictate the cybersecurity requirements for the device. 3. Product Design and Development: Understanding and following industry best practices, such as the OWASP Top Ten, the SANS Critical Security Controls, and the NIST cybersecurity risk framework will go a long way towards mitigating cybersecurity risks. But it’s not as simple as following a checklist. Increasing the security of a device almost always has tradeoffs in terms of usability, power requirements, processing speed or other performance impacts. For example, sophisticated encryption is power-intensive and may not be practical for small battery-powered devices. Building increased security
Five Cybersecurity Steps mHealth Developers Should Take Now into an mHealth app may make it too confusing or difficult for patients to access when they need it. Digital health developers need to weigh the drawbacks against the unique risk profile of the device. A cybersecurity expert can help companies understand and evaluate these tradeoffs and make effective development decisions. 4. Product Testing and Verification: In addition to verifying that defined cybersecurity requirements have been met, cybersecurity experts will also put on their “black hats” and do their best to hack into the device. “Fuzz testing” involves flooding the device with malformed data to see what happens. Does it crash? Unlock? Open up a back door left for developers? Security engineers will also attempt more focused attacks. They may try reverse engineering the device to obtain access to the code to look for back doors and loopholes they can exploit. Finally, they will take the device apart physically to look for vulnerabilities. Are there debugging ports that could be exploited? Does the device contain chips with known weaknesses? These potential vulnerability points need to be assessed to determine if they represent an acceptable risk or need to be managed. Intelligence gathered during this phase is used to fix vulnerabilities and prepare for the FDA approval process. 5. Post-Market: To protect themselves from liability, mHealth developers need to continue to focus on cybersecurity once the product is on the market. The FDA is expected to release post-market guidance later this year. In the meantime, medical device manufacturers need to have a process in place to update software as new security issues are identified. This includes creating a rollout plan to ensure that security patches make their way to the end user. Regular security patches can go a long way towards reducing cybersecurity risks. Manufacturers should also have a responsible disclosure policy in place. These policies, commonly used in other industries, encourage security researchers and end users who find a security vulnerability in your device to notify your company—instead of anyone else. A responsible disclosure policy assures researchers that they will not be held liable for investigat-
ing your device and outlines a clear process for how they should notify you. Companies also need to establish an internal protocol for evaluating and responding to disclosures.
An Integrated Approach to Medical Device Cybersecurity
mHealth developers should take an integrated approach to cybersecurity to reduce their risks and liabilities. Battelle has developed a suite of cybersecurity services to help medical device manufacturers ensure that their connected devices meet user requirements and emerging cybersecurity regulations. Their DeviceSecure™ services incorporate vulnerability assessment, development services and anti-tampering measures to help medical device manufacturers protect patients from potential harm and minimize legal and financial risks. Over the next few years, developers can expect to see a growing focus on cybersecurity from both hospital purchasers and the FDA. Right now, these expectations and requirements are still emerging, and so far the FDA has only released premarket guidance for manufacturers. However, regulatory focus on cybersecurity is expected to grow, much as new regulations for usability and Human Centric Design (HCD) have emerged over the last decade. mHealth developers need to act now to ensure that they are ready to meet both user expectations and FDA requirements in the future.
References
1. http://www.idtheftcenter.org/ITRCSurveys-Studies/2014databreaches.html 2. http://www.modernhealthcare.com/article/20141217/NEWS/312179948 3. https://www.owasp.org/index.php/ Category:OWASP_Top_Ten_Project 4. https://www.sans.org/critical-securitycontrols/ 5. htt p://www.nist.gov/c yberframework/upload/cybersecurity-framework-021214.pdf 6. https://www.blackhat.com/ 7. http://searchsecurity.techtarget.com/ definition/fuzz-testing 8. http://en.wikipedia.org/wiki/Responsible_disclosure 9. http://www.battelle.org/our-work/ pharmaceutical-medical-devices/medicaldevices/battelle-devicesecure-services 10. http://www.fda.gov/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm356186.htm
About the Authors Melissa Masters, RAC, (B.S., Electrical & Computer Engineering) Ms. Masters is Director of Electrical, Software and Systems Engineering at Battelle and heads Battelle’s DeviceSecure Services. Ms. Masters has more than 14 years of experience in product development as a project manager, systems engineer and design engineer, serving as the project manager and lead systems engineer on medical device development and sustaining engineering programs. Ms. Masters is a voting member of the Association for the Advancement of Medical Instrumentation (AAMI) working group on cybersecurity for medical devices and contributed to the vulnerability model for AAMI’s TIR 57. She has been published and widely quoted on a variety of medical cybersecurity topics in AAMI Horizons, Mass Device, ExecutiveGov.com, and Fierce Medical Devices. In addition, Ms. Masters holds a Regulatory Affairs Certification (RAC) and has a working knowledge of domestic and international regulatory requirements for medical devices. Stephanie Preston, EIT, GIAC, CEH, (B.S., Computer and Electrical Engineering) Ms. Preston is on Battelle’s Cyber Innovations team, where she focuses on firmware reverse engineering (x86, x86_64, MIPS, 8051), as well as application development (C/C++). She also serves as the team’s intellectual property steward. Ms. Preston contributed to the IEEE guidelines for security in medical device software development and production, a step toward industry standards that will systematically secure medical devices. Ms. Preston is a registered engineer in training (EIT) in the state of Ohio, holds a (GSEC) Global Information Assurance Certification (GIAC) Security Essentials certification, and a Certified Ethical Hacker (CEH) certification. She also serves as an adjunct faculty member at the Ohio State University College of Computer Engineering. n
The Journal of mHealth
5
INDUSTRY NEWS News and Information for Digital Health Professionals
Smartphone Microscope Diagnoses Deadly African Parasite The second leading cause of infectious blindness in the world is river blindness, or onchocerciasis, caused by a parasitic worm transmitted through bites from blackflies that live and breed near fast-flowing rivers. The World Health Organization estimates at least 25 million people have the infection, primarily among sub-Saharan African countries, with a couple pockets of Latin America and the Middle East. Among those infected, 300,000 are blind and 800,000 have some visual impairment, and another 123 million people are at risk for infection. For millions of people in central Africa, being infected with the microscopic worm Loa loa is not a big deal: just a bit of mild itching and swelling. But if they take a dose of ivermectin— a drug that’s being widely distributed around the continent in an attempt to wipe out other parasites—L. loa can cause more severe complications: hemorrhaging, neurological problems, and even death. Now, for the first time, scientists have developed a prototype for a handheld, mobile phone–based platform to screen for L. loa in a matter of minutes that could help health care workers decide who can safely receive the drug. “There is screening, but it is a long, tedious business,” says physician and public health researcher Adrian Hopkins, director of the Task Force for Global Health’s Mectizan Donation Program in Decatur, Georgia, who was not involved in the new work. The number of miniscule worms in a blood sample must be counted manually by a trained technician, he says, to determine if there are enough worms to cause the serious ivermectin reaction. “There’s no way you could go into a village and do it on everyone.” For programs like his, which oversees the administration of hundreds of millions of Mectizan (ivermectin) doses per year in Africa to treat river blindness and elephantiasis— both caused by parasitic worms—that’s a problem, because of the odd and poorly understood interactions between ivermectin and loiasis.
6
Ivermectin is actually so good at killing Loa loa worms that killing them all at once in someone with too many in their blood – more than 30,000 parasites per millilitre – can
June 2015
potentially cause fatal encephalopathy, said Daniel Fletcher, a professor of bioengineering at the University of California at Berkeley. This risk has slowed or even suspended ivermectin administration programs because each person infected with river blindness or lymphatic filariasis has to be tested for Loa loa first to determine whether they can safely take the drug. That testing requires a trained technician using a conventional light microscope to manually count the Loa loa larvae in a blood smear, a process that usually takes at least a day. Researchers had previously tried developing ways to test blood for L. loa antibodies or to stain L. loa parasites for easier identification under a microscope, but the techniques were never fast, cheap, or effective enough. Fletcher wondered whether an automated computer program could instead detect the worms in blood samples by sensing their telltale wiggling. “It was really an effort to make it as simple Continued on page 8
Industry News
Top 5 Smart Wireless Device Developments for 2015 Technology analyst house, Juniper Research has released research that indicates the top 5 developments that will impact the smart wireless devices sector this year. Interestingly all of the technologies included have demonstrated particular potential for the role they are likely to play in the medical and health & wellbeing sectors. The technologies highlighted by the research are: Apple Watch Apple’s long-anticipated smartwatch launch is a game changer. Not because it offers radical new features and functions, but because it offers a best-in-class consumer experience, and forms part of a seamless ecosystem... and of course, it’s Apple! Microsoft HoloLens Microsoft’s bold announcement envisions consumer-friendly smart glasses that can bring AR experiences throughout the home, from watching football projected onto a wall, to playing Minecraft on the kitchen table. Intel’s Wearables Intel is betting hard on the smart devices sector with a range of chipsets. From Edison to Curie, these new chips are going to drive many smart wireless devices this year. The company also has co-branding partnerships with Open Ceremony - for the MICA bracelet, SMS Audio –for smart headphones, and Luxottica – for smart eyewear. GOQii Fitness GOQii aims to shake up the fitness device sector with their subscription-based service. This links a user with a ‘real’ fitness coach who helps to interpret output from the fitness device and provides motivation and context for the data - which is often lacking in the fitness wearables space. Google - TAG Heuer Smartwatch This is an exciting development for the smartwatch sector, and opens up the wider premium watch market to Android Wear and Intel chips. Together with the Apple Watch launch, this signals a new phase of development for smart wear. The impact of these developments, and more, are discussed in Juniper’s latest research, Smart Wireless Devices: CE, Enterprise, Healthcare, Fitness, Payments 2015-2019. n
The Journal of mHealth
7
Industry News and rapid as possible,” he says.
Loa, so we can look for particular sizes to further increase confidence.”
The work that followed has led to a simple device composed of a 3D-printed plastic base, with LED lights, micro controllers, gears, circuitry and a USB port, which can turn a smartphone into CellScope Loa, a mobile phone video microscope that can be used to count Loa loa worms in a blood sample in a few minutes. After a quick fingerprick, the blood sample is placed under the phone’s camera lens. An algorithm analyses the larvae wiggling in the blood and tallies the total Loa loa worms in just two minutes. Since the app prompts the user each step of the way, little training is needed.
Outlined in a proof-of-concept study published in the journal Science Translational Medicine Fletcher’s team tested the device on 33 patients in Cameroon and found the phone’s parasite count to approximately match up with the technicians’ count in a head-to-head trial. The CellScope Loa delivered no false negatives (patients with too many worms who were identified as having fewer) and two false positives (patients with a lower worm count identified as having a higher one). That made the device 100% accurate in identifying those with too many worms to receive the drug.
The Loa loa worms only venture out from the lungs into the bloodstream a few hours a day and at different times than the river blindness worms, Fletcher said. “By measuring at specific times, between 10 a.m. and 2 p.m., we can have increased confidence that we’re measuring Loa,” he said. “In addition, other moving things in blood like trypanosomes are much smaller than
The study group was small so more trials are needed, but Fletcher roughly estimates that about 15 million people living in Loa-endemic areas could safely receive river blindness treatment following use of the smartphone video microscope.
Continued from page 6
Source: UC Berkley/Forbes.com n
Wireless Routers Could Monitor Your Breathing and Heartbeat A radar-like system that fits inside a Wi-Fi box can record health data and monitor mood and activity – without you even noticing. The solution called Vital-Radio, developed at the Katabi Lab, part of the Computer Science and Artificial Intelligence Laboratory at the Massachusetts Institute of Technology, needs no sensors attached to the body, yet is nearly as accurate as conventional methods. Its measurements are wireless and even work through walls, so can keep tabs on your vital signs as you watch TV in the lounge or read or sleep in the bedroom. The team behind it believe it could be used to monitor and improve patient health in hospitals and at home. "Breathing and heart rate would be interesting in hospitals if you want to monitor people without having things on their body," says team member Fadel Adib. But the system could have a more surprising application: inferring our emotional state. What's more, it could be built into a home Wi-Fi router, making it a hub not just for internet connections but also for collecting health data.
8
Vital-Radio works a bit like radar, transmitting using a part of the radio spectrum similar to that used for
June 2015
Wi-Fi, then watching the reflected signals for imprints that indicate life. It also measures how long it takes the reflected wave to return – its "time of flight". Each object in the vicinity, people included, reflect the signals with a slightly different flight time depending on their distance from the antenna. The system then analyses the signals for the tell-tale signs that they bounced off a human – usually modulations that indicate movement. The rising and falling of our chest creates a distinct signature, and even the pulse in our neck, imperceptible to the eye, can be seen in the reflected signals. Although the obvious applications lie in remote health monitoring, the physiological signals the system picks up often betray something that computer scientists are increasingly interested in – our emotions. A modified Wi-Fi router incorporating the system might tell a laptop that the movie someone is watching is calming them down, prompting the laptop to hold off displaying alerts, except for truly urgent matters. Smart lighting or music systems could change their hue or the music they play to match or moderate our mood. Adib says the group is honing the system to the point where it can monitor
a fetus's heartbeat inside its mother. It may one day even be able to monitor the heartbeat in detail, acquiring data comparable to an electrocardiogram without the need for a hospital visit. The biggest challenge for systems like Vital-Radio, according to Changzi Li of Texas Tech University in Lubbock, is how to deal accurately with the fact that people don't sit still. "A heartbeat is 1 millimetre or smaller. Any random body motion could be much larger than the signal you want to capture," says Li. For this reason, Vital-Radio doesn't try to monitor a person's heart rate while they wander about. But the technology it relies on can be used to track you as you move around the house, for instance. It can also track specific gestures and body language. A home with the system installed and connected a remote care system could, for example, monitor elderly residents and alert carers to falls or accidents. "There's going to be a lot of applications," says Li. "Not just in home but hospitals too. If the technical problem is solved, then the first hit will be in routine health monitoring." Source: New Scientist n
Industry News
Boston Children’s Hospital Hosts Second Annual Innovators’ Showcase Boston Children’s Hospital’s hosted their second annual Innovator’s Showcase in April. Organised by the hospital’s Innovation Acceleration Program and Technology & Innovation Development Office, the event allowed researchers and clinicians to present a number of new technology-focused offerings that are currently in use or being tested at the hospital. On display was a wide-range of technologies from virtual reality goggles with gesture control to biomedical technologies. The following are a selection of the technologies from the showcase: RNSafe - Boston Children’s FastTrack Innovation in Technology (FIT) team is in the process of testing a new app, called RNSafe, which stands for Remote Nurse witness Supporting Medication Administration for Efficient Care. The app, created by nurses in the hospital, aims to help increase patient safety when administering medications. Designed to assist in the process of administering complex medications, a process which requires the verification of two nurses prior to administering the medication. RNSAFE, a bedside nurse will request verification via an iOS
device and then a “bunker nurse” will get an alert that a medication needs to be administered. Bunker nurses then use a Microsoft Surface Pro device to video chat with the bedside nurse to verify the order and do the requisite ten rights of medication giving. After this process has been completed, they sign off on it in the medical record. Currently, with RNSafe in the beta testing phase, four nurses are volunteering to sit in the “bunker” to conduct the virtual double checks. The future vision for RNSafe is to dedicate experienced nurses to the remote medication verification process—similar to the electronic intensive care unit (eICU) model in which remote intensive care specialists act as a second set of eyes in monitoring patient data. “There’s an opportunity to use digital technologies to improve safety, consistency and clinical efficiency on the medical floor,” explains Alex Pelletier, MBA, director of Digital Innovation at Boston Children’s Hospital. “RNSafe can help reduce the workload of already busy nurses dedicating their time to patient care. It’s an example of how the future of clinical care might look.” Seizure Detecting Wristwatch (empatica.com) - This wearable device for patients with epilepsy, called Embrace,
is like a “smoke alarm” for unwitnessed seizures that may potentially prevent tragic cases of sudden, unexpected death from epilepsy (SUDEP) in the future. The Bluetooth-enabled, sensor-loaded wristband, using technology developed and tested in collaboration with the MIT Media Lab, can detect the onset of a convulsive seizure based on the wearer’s movements and autonomic nervous system activity. Parents, caregivers or even roommates can wear a “companion” Embrace that vibrates an alert, so they can quickly intervene. iThermonitor a wearable wireless thermometer developed especially for children. The small comfortable non-invasive device is designed to attach easily under a child’s arm using an adhesive patch. Bluetooth technology links the iThermonitor to your smart phone or tablet, allowing you to continuously and quietly monitor your child’s temperature. AudioHub - Researchers created AudioHub, a clinical audiology app, to help audiologists record data from audiological assessments. Audiologists can use the app to document data on the iPad app, which will be sent to a patient’s EHR. The app is used by 30 audiologists at Boston Children’s who see over 1,000 patients every month. n
The Journal of mHealth
9
Industry News
Digital Health Partnership Selected by USAID to Support Ebola Response Transition Scripps Translational Science Institute will lead a consortium of four partners to develop a program to improve health outcomes for Ebola patients, increase the safety of health care workers and reduce the risk of spreading the virus to others. The program, dubbed STAMP2, short for Sensor Technology and Analytics to Monitor, Predict and Protect Ebola Patients, will test a new “precision medicine” approach using wearable, wireless health sensors, a wireless vital signs monitoring platform and advanced analytics technology to monitor and analyse multiple vital signs of patients either suspected or confirmed to be infected with the Ebola virus. The program was nominated for a grant from the U.S. Agency for International Development. The grant is part of a new program called Fighting Ebola: A Grand Challenge for Development, led by USAID in collaboration with the White House Office of Science and Technology, the Centers for Disease Control and Prevention, the Department of Defence and field experts to help health care workers provide better care.
“The new approach will provide unprecedented visibility into a patient’s physiology that we believe will be invaluable in improving care in minimising risk of exposure during an Ebola virus outbreak,” said Steven Steinhubl, M.D., director of digital medicine at Scripps Health. “This will open the door to being able to identify warning signs very early on, when potentially lifesaving care can be provided.”
Solution to Current Shortcomings
Patient data will be collected using two innovative wireless monitors that will continuously and remotely monitor and transmit multiple vital signs. By incorporating the ViSi Mobile System from Sotera Wireless and a Band Aid-type sensor — the MultiSense device from Rhythm Diagnostic Systems — into systems of care, patients will be able to be monitored at all times, so that changes in their condition can be recognised sooner, and without needless exposure to health care workers.
STAMP2 represents a potential solution to current shortcomings in the management of Ebola patients by targeting an opportunity for earlier interventions and minimising spread of the virus. The existing approach for monitoring patients suspected of an infection detects the infection only after a patient has become contagious and the virus has the opportunity to spread. Continuous monitoring of multiple vital signs, coupled with sophisticated, personalised data analytics, can lead to much earlier warning and with it, earlier intervention. For patients confirmed to be infected, continuous monitoring of multiple vital signals can detect important changes in health status immediately.
10
June 2015
Opportunity for Earlier Interventions Data from the monitors will be transmitted wirelessly to a personalised physiology analytics (PPA) platform developed
by PhysIQ, which will use advanced machine learning algorithms to detect subtle changes in a patient’s physiological profile over time, compared to the patient’s physiological baseline. The PPA will also provide automated analysis, actionable information and guidance to clinical staff for multiple patients simultaneously. This offers the opportunity to detect and act upon changes in a patient’s health status in real time, well before symptoms develop or conditions worsen. According to the CDC, the 2014 Ebola epidemic is the largest such outbreak in history, affecting multiple countries in West Africa, with more than 13,000 confirmed cases and more than 9,000 deaths. Plans to develop, validate, refine and field test the STAMP2 program are currently under way. Following the completion of these processes, it is expected that a fully functioning turnkey STAMP2 system would be made available for deployment. As currently envisioned, the system would include an appropriately scaled supply of ViSi Mobile and MultiSense wireless health monitoring devices, wireless rugged computers and smartphones and tablets with specially created apps. n
Industry News
Smartphone-based Device Could Provide Rapid, Low-cost Molecular Tumour Diagnosis Hospital-developed platform may streamline point-of -care diagnosis in limited resource settings A device developed by Massachusetts General Hospital investigators may bring rapid, accurate molecular diagnosis of tumours and other diseases to locations lacking the latest medical technology. In their report appearing in PNAS Early Edition, the researchers describe a smartphone-based device that uses the kind of technology used to make holograms to collect detailed microscopic images for digital analysis of the molecular composition of cells and tissues. “The global burden of cancer, limited access to prompt pathology services in many regions and emerging cell profiling technologies increase the need for low-cost, portable and rapid diagnostic approaches that can be delivered at the point of care,” says Cesar Castro, MD, of the MGH Cancer Center and Center for Systems Biology, co-lead author of the report. “The emerging genomic and biological data for various cancers, which can be essential to choosing the most appropriate therapy, supports the need for molecular profiling strategies that are more accessible to providers, clinical investigators and patients; and we believe the platform we have developed provides essential features at an extraordinary low cost.” The device the team has developed – called the D3 (digital diffraction diagnosis) system – features an imaging module with a battery-powered LED light clipped onto a standard smartphone that records high-resolution imaging data with its camera. With a much greater field of view than traditional microscopy, the D3 system is capable of recording data on more than 100,000 cells from a blood or tissue sample in a single image. The data can then be transmitted for analysis to a remote graphic-processing server via a secure, encrypted cloud service, and the results rapidly returned to the point of care. For molecular analysis of tumours, a sample of blood or tissue is labelled with microbeads that bind to known cancer-related molecules and loaded into the D3 imaging module. After the image is recorded and data transmitted to the server, the presence of specific molecules is detected by analysing the diffraction patterns generated by the microbeads. The use of variously sized or coated beads may offer unique diffraction signatures to facilitate detection. A numerical algorithm developed by the research team for the D3 platform is capable of distinguishing cells from beads and of analysing as much as 10 MB of data in less than nine hundredths of a second. By quantifying the number of tumour-marker-targeting microbeads bound to cells, the D3 system categorises high- and lowrisk cervical biopsy samples as well as traditional pathology does, according to the research by the Massachusetts General
Hospital Center for Systems Biology. A pilot test of the system with cancer cell lines detected the presence of tumour proteins with an accuracy matching that of the current gold standard for molecular profiling, and the larger field of view enabled simultaneous analysis of more than 100,000 cells at a time. The investigators then conducted analysis of cervical biopsy samples from 25 women with abnormal PAP smears – samples collected along with those used for clinical diagnosis – using microbeads tagged with antibodies against three published markers of cervical cancer. Based on the number of antibody-tagged microbeads binding to cells, D3 analysis promptly and reliably categorised biopsy samples as high-risk, low-risk or benign, with results matching those of conventional pathologic analysis. D3 analysis of fine-needle lymph node biopsy samples was accurately able to differentiate four patients whose lymphoma diagnosis was confirmed by conventional pathology from another four with benign lymph node enlargement. Along with protein analyses, the system was enhanced to successfully detect DNA – in this instance from human papilloma virus – with great sensitivity. In these pilot tests, results of the D3 assay were available in under an hour and at a cost of $1.80 per assay, a price that would be expected to drop with further refinement of the system. “We expect that the D3 platform will enhance the breadth and depth of cancer screening in a way that is feasible and sustainContinued on page 12
The Journal of mHealth
11
Industry News Continued from page 11
able for resource limited-settings,” says Ralph Weissleder, MD, PhD, director of the MGH Center for Systems Biology (CSB) and co-senior author of the paper. “By taking advantage of the increased penetration of mobile phone technology worldwide, the system should allow the prompt triaging of suspicious or high-risk cases that could help to offset delays caused by limited pathology services in those regions and reduce the need for patients to return for follow-up care, which is often challenging for them.” In their further development of this technology, co-senior author Hakho Lee, PhD, of the MGH-CSB notes, “The research team will: 1) investigate the D3 platform’s ability to analyse protein and DNA markers of other disease catalysts, including infectious agents and allergens; 2) integrate the software with
larger databases; and 3) conduct clinical studies in settings such as care-delivery sites in developing countries or rural settings and for home testing with seamless sharing of information with providers and/or clinical investigators.” The MGH has filed a patent application covering the D3 technology. Co-lead author Hyungsoon Im, PhD, a research fellow at the MGH-CSB, adds, “Compared with traditional analysis techniques, the D3 mobile platform generates robust biological data while being significantly more cost conscious, operable by non-specialist end users, and well-suited to point-of-care settings. We have field tested the wireless readouts in rural areas of northern New England without problems and believe this technology is poised to deliver fast, low-cost and accurate cancer and HPV diagnosis.” Source: massgeneral.org n
Collaboration Puts Medical Apps at Heart of Diabetes Treatment The care process for Swedish children with insulin-dependent diabetes is now more efficient thanks to a new digital health collaboration between Astrid Lindgrens Children’s Hospital, software firm Diabetes Tools and Karolinska University Hospital’s Innovation Center. The result of this cooperation is a first in Sweden: the addition of apps to a diabetes patient’s treatment plan. This means that staff at the Child Diabetes Unit at Astrid Lindgrens Children’s hospital, along with children and their families, can use apps to reliably calculate insulin doses from the same shared information to save time, reduce errors and inspire confidence. The new jointly created app and online service is called TriabetesClinic for Children and is supplied by Diabetes Tools. The three organisations worked together to replace a paper-based workflow with the new TriabetesClinic tablet app for staff to use on the ward and the new TriabetesGo smartphone app for children, and their families, to use at home. “Having timely and accurate information instantly available is one of the keys to treating children with diabetes. Our
12
June 2015
wish for a digital system that is portable, which facilitates patient participation and ownership, while enabling us to streamline our patients' time has been realised with TriabetesClinic,” said the initiator of the project at Karolinska University Hospital and head nurse at the Child Diabetes Unit 2 Astrid Lindgren Children's Hospital, Åsa Wallin. “Diabetes impacts family life in so many
ways. I am delighted that our TriabetesClinic apps and online decision support service can simplify the care for insulin-dependent children while taking the pressure off nurses, doctors, parents and relatives,” said Diabetes Tools’ Chief Executive Officer Anders Weilandt. “Our collaboration with Karolinska University Hospital marks an important step towards greater acceptance of mobile health techniques in Sweden.” n
Industry News
Revolutionary Cane Enables the Visually Impaired to Instantly Identify Friends and Family The ‘XploR’ mobility cane, being developed by ICT students Steve Adigbo, Waheed Rafiq and Richard Howlett, from Birmingham City University uses smartphone technology to recognise familiar faces from up to 10m away. The cane also features a GPS function to aid navigation. The University team have already presented the XploR cane to medical and science professionals in Luxembourg and France, and plan to visit organisations in Germany later this year. The students have designed the XploR cane to scan faces and vibrate when an individual is detected and recognised from a bank of images stored on an internal SD memory card. The device will guide users towards friends and family members using an ear piece and audio guidance, with the information being relayed using Bluetooth technology. The students conducted market research at the Beacon Centre for the Blind in Wolverhampton, West Midlands, to determine key features that the visually impaired would find useful in a mobility cane. “We found that high-spec technology features were essential requirements for users, as well as the need to make a cane that is fairly lightweight and easy to use”, said Waheed. “We’ll be returning to the Beacon Centre later this year to test the product as well as to develop the training and security features of the cane.”
“Medical and healthcare companies in France really liked the product, so hopefully it’ll be making a real difference to people’s lives soon”, said Waheed. The device has added importance for one of its developers, Steve Adigbo, whose grandfather is blind. Steve said: “My grandfather is blind and I know how useful this device could be for him. The smart cane incorporates facial recognition technology to alert the user when they are approaching a relative or friend. There’s nothing else out there like this at the moment.” The student project forms part of LILA, a European initiative encouraging entrepreneurship and fostering internationalisation. n
New Award Scheme Aims to Spark NHS Digital Revolution A unique partnership of patients and health professionals has launched a new awards scheme to unearth the technologies being created across the UK. The organisers will champion the best products and bring them to the attention of NHS officials – including grass-root innovations from NHS and healthcare professionals. Patients are innovating faster and more cheaply than the NHS, using digital technologies to make acute and chronic
health problems easier to live with – and saving the NHS considerable funds. Yet there is often no process to find and develop the best of these technologies. One of the founders of the unAwards, Victoria Betton, mHealth Programme Director at Leeds & York Partnership NHS Foundation Trust, says: “A group of us has come across the most amazing products, apps and digitally based services, created by ordinary people. These are not only helping patients in quite extraordinary
ways, but often saving the NHS considerable money. We want to unearth more of these technologies, encourage others to develop their ideas and help the NHS to find and use these products.” Two examples of problem-solving technologies are the patient-developed apps, Ostom-I Alert and Doc Ready. Michael Seres created Ostom-I Alert from his hospital bed following a bowel Continued on page 14
The Journal of mHealth
13
Industry News Continued from page 13
transplant. Michael had no way of knowing how quickly his stoma bag was filling, often resulting in leaks – particularly at night. He discussed the problems with 20,000 fellow sufferers on social media and produced a device for bags which sends signals to a free mobile app with alarms. It also sends information to health professionals to simplify monitoring – saving 33% of NHS costs against existing care. The financial savings mean the device is now prescribed by the NHS and has full US FDA approval. Mark Brown realised how difficult it was for young people with mental health problems to talk to their GPs and, along with a Comic Relief funded team, created the Doc Ready app. This helps young people to collect information before visiting a
GP, and takes them through what they should explain to their doctor. Launched two years ago, more than 3,000 young people have used the app. In evaluation, 77% of those using the app said they felt more able to take control and make up their own minds about their treatment. Victoria Betton explained why the unAwards: “We have all been to dozens of ‘same old’ events over the last year, where the patient is often an afterthought and the real innovations are never found. Our unAwards are free and easy to enter so we have the best chance of unearthing new talent. This approach is critical to the future of healthcare in the UK – bringing ground-up innovators to the attention of NHS officials”. The awards follow on from the People
Driven Digital Health and Wellbeing unConference for digital entrepreneurs, where Tim Kelsey, national director of patients and information at NHS England, launched a small innovation fund to develop ideas that emerged from the day. Tim Kelsey said: “We need to drive more ground-up digital innovation and help digital entrepreneurs make a difference in achieving our vision set out in Personalised Health and Care 2020. The unConference and UnAwards are a great way of harnessing the innovation already happening and making more people aware of the difference it can make to patient experience, outcomes and efficient use of resources.” Winners of the UnAwards will be announced in July. n
Global mHealth Research Study Reveals Top Five mHealth Countries in Europe More than 5,000 people participate in landmark study for mobile health app companies Denmark, Finland, The Netherlands, Sweden and the UK are the top five countries offering the best market conditions for mobile health app companies in Europe, according to a survey conducted by research2guidance in collaboration with HIMSS Europe. As part of the largest global mHealth research programme, research2guidance and HIMSS Europe have come together to analyse the market readiness of the 28 EU member states through “The EU Countries’ mHealth App Market Ranking” survey. Over 5,000 app developers, healthcare professionals and mHealth practitioners were asked to rank European countries based on five dimensions: eHealth adoption, level of digitalisation, mHealth market potential, regulations and ease of starting a business. Denmark, Finland, The Netherlands, Sweden and UK proved to have the highest market readiness and most mature market conditions, providing the best starting points for mHealth companies to succeed. Out of these five countries though, the UK emerged as the leader according to 55% of mHealth practitioners. The study revealed that this is primarily due to the openness and positive attitude many doctors in the UK have when it comes to new technology and integrating mHealth solutions into patient treatments.
14
Ralf Jahns, Managing Director at research2guidance, who
June 2015
announced the survey findings at the 2015 mHealth Summit Europe, said: “The survey is now in its sixth year and the response this time has been overwhelming becoming increasingly evident that the momentum around mHealth is growing at a rapid pace. The report is extremely valuable for anyone thinking about starting a mHealth company, as well as for government organisations in European countries that want to benefit from a flourishing mHealth ecosystem through creating highly qualified jobs, reducing national healthcare costs and ensuring high levels of quality of care.” Germany and France emerged with mixed results: on the one hand these two markets have enormous potential when it comes to the amount which has been invested in patients, doctors, hospitals and healthcare on a whole. However, rankings for eHealth and mHealth adoption in Germany and France were extremely low, showing these countries are more reluctant to embrace the digitalisation of healthcare, thus classifying themselves as “average” countries to invest in mHealth. Rainer Herzog, General Manager at HIMSS Europe added: “The survey results provide a great platform for discussion and give us an insight into how ready European countries really are to adopt mHealth and the challenges that some countries are yet to overcome, meanwhile giving entrepreneurs a head-start when deciding which country would be best to start an mHealth business.” n
Industry News
MDLIVE Collaborates with Microsoft to Bring Consumers a Digital Health Experience Through Skype for Business MDLIVE has announced a new collaboration with Microsoft that makes MDLIVE the first company to deliver digital health services to millions of healthcare consumers through the Skype platform. The collaboration follows Microsoft's acquisition of Skype and launch of Skype for Business which offers MDLIVE patients a new, secure, and seamless digital health experience. "We are excited to work with Microsoft to marry one of the best known and most secure video chat and voice call platforms with a world class network of physicians ready to deliver exceptional care to patients anywhere," said Randy Parker, Chief Executive Officer of MDLIVE. "This collaboration makes MDLIVE's highly secure service even stronger." Skype for Business is integrated into Microsoft Office Suite, making video and voice messaging simple and accessible for all users. By offering enterprise-level security, the newly redesigned platform brings the highest levels of security and privacy to the digital health experience. "In MDLIVE we see a true partner, one that understands and can deliver on the vision of transforming the healthcare experience for consumers anywhere there is an Internet connection. We are thrilled to bring the promise of telehealth to millions of patients through Skype for Business," said Dr. Dennis Schmuland, Chief Health Strategy Officer, U.S. Health and Life Sciences of Microsoft Corp. Today, 20 million Americans get some part of their healthcare remotely, and that number will grow as such services are normalised in hospitals, workplaces
and households across the nation. As more consumers embrace the benefits of virtual care, the highest level of network security, a seamless user experience and the best standard in clinical care will be essential. The collaboration between MDLIVE and Microsoft helps deliver on those expectations through a first-ofits-kind digital health experience.
will offer Surface Pro Tablets to deliver MDLIVE's digital health experience and launch the new MDLIVE app for the Windows Phone.
The collaboration will propel the cloud based solution provider to become the first company in the US to offer digital health services through Skype to health care practitioners, dispensaries and hospitals.
MDLive raised $23.6 million, at the beginning of 2014, in a round led by Heritage Group with participation from Sutter Health and Kayne Anderson Capital Advisors. The financing led to the acquisition of online therapy provider Breakthrough Behavioral at the end of last year. n
As part of its collaboration, Microsoft
Microsoft’s reinvention of Skype has been seen by industry insiders as a bid to bring the consumer facing video service more in line with business needs.
The Journal of mHealth
15
Industry News
Aseptika Releases SENSOR I App: The Clinical Version of Activ8rlives Aseptika has launched the SENSOR I App for iPads to support clinical studies in respiratory research and for those with long-term respiratory conditions who want to self-monitor and self-manage their health at home. The SENSOR suite of Apps, which were designed and trialled in collaboration with an NHS Trust, were developed as part of a clinical trial funded by NHS England. The trial, which has just been successfully completed in Hampshire, was funded through the Small Business Research Initiative (SBRI) Healthcare programme. As part of the trial volunteer patients took and recorded daily measurements, without supervision. These included: lung function using simple spirometry; blood oxygen saturation; blood pressure; heart rate; levels of physical activity; and body composition. Also recorded were answers to a number of questions that capture data routinely requested in paper-based questionnaires, these are normally only undertaken at the start, middle and end of research studies. The response of volunteers (average age 67) on the clinical trial proved highly positive. Designed for use by people of any age, the application is especially inclusive for older patients. The colourful user interface, the step-by-step instructions and motivational messages enable the user to collect 40 vital signs and questions about their daily health, all in less than 10 minutes a day. The App collects and displays the data on that day for the key vital signs and displays these to the user, the user, however, is “blinded” to the longitudinal data – useful in clinical research
studies. Data is simultaneously uploaded to Activ8rlives’ UKbased web-servers for review by a cohort of clinical teams through a dedicated clinician portal. The ownership of the data is retained by the user at all times, but can be shared (by permission of the user) with the ecosystem of care workers, supporters and family who are involved in their care. A SENSOR II App is due for release shortly in which users in future randomised controlled trials are unblinded to their longitudinal data. The aim is that this will enable them to self-monitor and self-manage their respiratory disease at home and to watch for signs of impending ill health associated with respiratory exacerbations. Kevin Auton Ph.D, Managing Director of Aseptika commented: “The release of the SENSOR I App via the Apple Store is an important milestone for Aseptika. It supports the increasing use of self-monitoring by the patient as policy makers shift the balance of care from hospitals to the home and the community throughout the EU. The SENSOR App suite provides tools which can be used to facilitate a new partnership between the patient and their clinical teams and complement the new Activ8rlives v3.0 App, which shares many of the same features as SENSOR but is designed for use by the consumer.” The SENSOR I and the Activ8rlives 3.0 Apps are free to download. There is no charge to the patient for the use of Activ8rlives to securely and confidentially store their data. The decision to share data with clinical teams remains at the sole discretion of the user. n
ONC Awards Funding to Six Digital Health Pilot Projects The ONC Market R&D Pilot Challenge was created by the Office of the National Coordinator for Health Information Technology (ONC) within the US Department of Health and Human Services (HHS), with the intent to find innovative, early-stage health IT companies and connect them with health care organisations that would host pilot programs to test their technologies. ONC is excited to announce $300,000 in funding to six winners of the challenge, who will live-test new health information technology (health IT) applications in health care settings administered by their
16
June 2015
host partners. The winning innovator-health care organisation teams are: »» ClinicalBox and Lowell General Hospital »» CreateIT Healthcare Solutions and MHP Salud »» Gecko Health Innovations and Boston Children’s Hospital »» Optima Integrated Health and University of California, San Francisco, Cardiology Division »» PhysIQ and Henry Ford Health System
»» Vital Care Telehealth Services and »» Dominican Sisters Family Health Service The ONC Market R&D Challenge launched on October 20, 2014 with a key goal to break down barriers between promising start-ups and health care stakeholders. Three in-person matchmaking events were held in January, 2015, focused on connecting innovator companies looking to pilot test their products with health care organisations. More than 300 of
Industry News these meetings were held in New York, New York; San Francisco, California; and Washington, D.C. These “speeddating” events, organised and facilitated by Health 2.0, allowed start-ups to meet face-to-face with industry stakeholders to identify common interests and goals and receive valuable exposure. To be eligible to win an award, innovators had to be an early-stage health information technology company with less than $10 million in venture capital funding and a readily available technology solution. Applications were received from 78 host-innovator teams from across the nation. The proposed pilot projects were required to focus on at least one of several ONC priority areas, of which the most commonly selected were care coordination, patient generated health data, medication management, and underserved communities. Each team will receive $50,000 to fund its pilot program, which will become operational in August. The Winners ClinicalBox and Lowell General Hospital ClinicalBox develops software for coordination and patient engagement across the surgical care continuum. Their technology, CoordinationBox, tracks patients through the care delivery pipeline and visualises critical tasks that need to be completed for the health care provider. It facilitates communication with the patient and provides them with a visual overview of the stages in their episode of care, as well as task lists and educational materials. The pilot with Lowell General Hospital will test CoordinationBox’s effi-
cacy in coordinating care and engaging patients during surgical episodes. CreateIT Healthcare Solutions and MHP Salud CreateIT Healthcare Solutions’ MyCare Communicator is a patient engagement platform used to engage a culturally, economically, and technologically diverse patient population. The platform allows healthcare providers to deliver education materials and clinically relevant messages to patients in their native language via email, SMS, and automated voice. MHP Salud will pilot the MyCare Communicator in the Texas Rio Grande Valley to enhance the impact of its Community Health Worker programming in the areas of diabetes prevention and breastfeeding. Gecko Health Innovations and Boston Children’s Hospital Gecko Health Innovations’ CareTRx uses medication sensors, mobile apps, and cloud computing to improve respiratory disease management and provide relief for asthma patients. The technology records medication use, sends reminders, tracks symptoms, and shares reports with care coordinators. In partnership with Boston Children’s Hospital, the pilot will evaluate the effectiveness of CareTRx on asthma self-management among urban school children compared to traditional self-management practices. Optima Integrated Health and University of California, San Francisco Division Optima-for-Blood Pressure (Optima4BP) is a cloud-based artificial intelligence solution that evaluates hypertensive patients’ real-time status in order to provide personalised decision
recommendations for medication treatment changes. Optima4BP analyses a variety of data to calculate the percentage improvement of potential treatment changes over the current treatment. Hosted by UCSF’s Cardiology Division and integrating with its EMR, the pilot will evaluate the efficacy of Optima4BP in improving care coordination for patients with uncontrolled hypertension. PhysIQ and Henry Ford Health System PhysIQ has developed an analytics platform that transforms sensor-generated biodata into clinically meaningful and personalised physiological insight. The solution couples machine learning physiology analytics with disposable wearables that capture and transmit bio-signal data in order to reduce hospital readmissions associated with exacerbations of chronic conditions. The pilot with Henry Ford Health System will evaluate PhysIQ’s platform’s ability to reduce hospital readmissions for heart failure and/or COPD patients and quantify changes in outcomes, operational efficiency and ROI for the care delivery organisation. Vital Care Telehealth Services and Dominican Sisters Family Health Service The Senior Total population Assisted Telehealth Services (STATS) program, created by Vital Care Telehealth Services, connects populations of seniors at the community level to preventative care and chronic disease management programs. The pilot project will test STATS efficacy in increasing access to primary and secondary prevention services on the Shinnecock Indian Health Services Clinic located on the reservation on eastern Long Island. n
Marketing & Content Publishing Packages We can publish your educational white papers, case studies, and research reports in The Journal of mHealth. We can work with you to develop engaging, creative, and informative content that will help promote the results of your work, to a targeted audience of industry professionals. Our publishing programs all include an integrated marketing plan to ensure that your content gets high exposure. Please contact matthew@simedics.org for more information.
The
Journal of mHealth The Global Voice of mHealth
The Journal of mHealth
17
EU Cybersecurity Requirements for mHhealth Apps & Medical Devices
EU Cybersecurity Requirements for mHealth Apps & Medical Devices: The Time to Act is Yesterday
By Erik Vollebregt, Partner, Axon Lawyers Introduction The FDA has recently released the final version of its guidance on cybersecurity and the EU has recently performed its biggest cybersecurity exercise ever. Proof of concept of hacking medical devices exists both in fiction and in fact. The EU is currently revising its regulation of medical devices and IVDs in order to modernise EU medical devices regulation for the coming decades. Also, there is the EU directive on personal data protection dating from before the time that internet became widely available, which imposes – among other things – security requirements aimed at ensuring data security. Finally, there is the Commission’s Green Paper on mHealth, which also concerns questions about data security of mHealth
18
June 2015
applications in the context of protection of personal data. What is the state of current and future EU law in the field of cybersecurity and how does it apply in mHealth? What would mHealth cybersecurity look like? The FDA approach to cybersecurity as set out in its recent guidance defines security measures for medical devices. This framework is based on general cybersecurity thinking as promulgated by NIST, the US National Institute of Standards and Technology. During the 2014 FDA’s workshop on cybersecurity a lot of emphasis was placed on security aspects of networks and systems, which makes much sense given the developments of the Internet of Things with respect to medical devices. Many of
the attacks on internet of things (IoT) enabled devices happen via attacks that exploit network / communication related vulnerabilities. The EU currently does not have similar guidance, but current design requirements do prescribe measures in that field. Current and future EU medical devices law There is not much direct reference to cybersecurity design requirements in Annex I of the Medical Devices Directive and IVD Directive, but there is a reasonably firm framework to be found in the different layers of regulation that imposes cybersecurity design requirements on manufacturers. The EN/IEC 62304 standard is the harmonised standard that requires in point 5.2.2 (Software requirements content) that the manufacturer defines and implements
EU Cybersecurity Requirements for mHhealth Apps & Medical Devices security measures. Also, a manufacturer of medical devices is obliged to implement the EN 14971 standard for risk management. When the performance of a device can be compromised by means of hacking, risk management dictates that security measures are implemented to prevent this. These requirements do not really look at networks and systems. Future EU medical devices law features specific design requirements for software in Annex I, point 14, but none of these specifically addresses cybersecurity although they may be supplemented at a later stage. The EU is fully betting on the contribution of IoT enabled medical devices to healthcare in its eHealth Action Plan. Not getting cybersecurity for mHealth right at this point in time is a huge missed opportunity. Yet, the draft regulations still proceed from the assumption that medical devices are mere physical widgets. Yet, medical devices are increasingly targeted by cyber-attacks. General EU security regulations and standards No device or software is an island, and the way devices are networked in actual use impacts on the cybersecurity profile. The IEC 80001 standard (Application of risk management for IT-networks incorporating medical devices) is relevant but is not a harmonised standard as the standard is directed at clinical institutions only. Another relevant standard is IEC 62443, dealing with industrial communication networks - Network and system security. This standard was flagged in the FDA cybersecurity workshop as relevant for IoT enabled devices. The proposed EU NIS directive looks like it is focused on public infrastructure security, but will also apply to medical devices that connect to the “internet of everything”. End-to-end solutions consisting of IoT enabled devices and software interacting will fall within its scope. Market operators operating a NIS are subject to the security requirements and incident notification duties. The EU currently refers to privacy regulation the most for cybersecurity requirements, and obliges companies to implement state-of-the-art and proportionate technical and organisational
security measures. A big problem with security requirements under the Data Protection Directive is that they are not harmonised, so member states have different views of what is required in terms of security. Hopefully that will be solved under the new General Data Protection Regulation that is currently in the legislative process via one or more delegated acts that address both privacy design requirements and security standards. Conclusion Cybersecurity requirements for medical devices in the EU are currently an overlapping patchwork of requirements under different statutes. With the new medical devices regulations underway the Commission is reluctant to renew guidance. Maybe DG GROWTH, the DG that is responsible for medical devices policy under the new Commission, will be able to put cybersecurity for medical devices on the agenda. References 1. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, see http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ConnectedHealth/ucm373213.htm 2. http://europa.eu/rapid/press-release_ IP-14-1227_en.htm?locale=en 3. http://www.telegraph.co.uk/science/science-news/11212777/Terrorists-couldhack-pacemakers-like-in-Homeland-saysecurity-experts.html 4. h t t p : / / g o. b l o o m b e r g . c o m / t e c h blog/2012-02-29-hacker-shows-offlethal-attack-by-controlling-wireless-medical-device/ 5. See for a case study about connected hospital medical devices the WIRED article “It’s Insanely Easy to Hack Hospital Equipment”: http://www.wired.com/2014/04/ hospital-equipment-vulnerable/ 6. See Directive 95/46, article 17 7. GREEN PAPER on mHealth, Brussels, 10.4.2014, COM (2014) 219 final, § 3.1 8. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, see http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ConnectedHealth/ucm373213.htm 9. Collaborative Approaches for Medical Device and healthcare
Cybersecurity, October 21-22, 2014, Arlington, VA. 10. Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and the Committee of the Regions-eHealth Action Plan 2012-2020-Innovative healthcare for the 21st century Brussels, 6.12.2012 COM(2012) 736 final, see http://ec.europa.eu/information_ society/newsroom/cf/dae/document. cfm?action=display&doc_id=4188 11. See http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm 12. Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning measures to ensure a high common level of network and information security across the Union, Brussels, 7.2.2013, COM(2013) 48 final, 2013/0027 (COD) 13. Article 17 (1) directive 95/46 14. 2012/0011(COD) Personal data protection: processing and free movement of data (General Data Protection Regulation) http:// www.europarl.europa.eu/oeil/popups/ ficheprocedure.do?lang=en&reference= 2012/0011(COD) About the author Erik Vollebregt is a founding partner of the boutique life sciences law firm Axon Lawyers specialising in EU legal and regulatory issues relating to medical technology. He is an expert in life sciences regulation at EU and Dutch level and is acknowledged by Chambers Europe for his work in the field of intellectual property and life sciences. Erik is a prolific writer and publishes in life sciences legal and regulatory journals on a wide variety of subjects. Additionally, he is the author of the acclaimed medical technology blog medicaldeviceslegal.com n
The Journal of mHealth
19
Health Data and Privacy: The Eternal Conundrum
Health Data and Privacy: The Eternal Conundrum
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. Here’s something provocative to start you thinking about health data security (anecdotal of course, but I’m sure the point still stands): the majority of healthcare professionals will have some sort of patient data lying around their home, in their bag or on their mobile phone. I remember when, as junior doctors, colleagues would show you the latest photos of injuries they had seen in A&E on their phones or when you would see patient lists at someone’s house with names, numbers and diagnoses strewn across kitchen tables or unshredded in bins. Your health data is frequently outside health organisation boundaries, supported on non-secure devices and transferred by non-encrypted or protected methods. Of course this is far from appropriate and the myriad institutions, guidelines and protocols in healthcare systems will state that data security, patient privacy and user experience are critical factors in the world of information governance, but what happens in theory and in reality are often very different scenarios. Because of these issues around BYOD, cloud systems, data transfer, patient identifiable data and much more, healthcare lags far behind other industries when it comes to data security, storage and transfer. Now, the topic of data and security in healthcare is so huge that we can only scratch the surface in terms of analysing this, but I’ll cover a couple of key areas that I believe are partly responsible for this antiquated process and where we can ensure that patient data as a whole becomes a much easier concept to deal with. Use vs. security the impossible spectrum Health data is much like prescribing a drug – you need the right patient, the right information, the right time and place and the right professional doing/access-
20
June 2015
ing it. Something as simple as a patient’s allergy status needs to be known by dozens of staff and be present in dozens of disparate places, not to mention the fact that the data collected is often constantly changing or being amended. But of course, while some information is fairly standard that the majority of people wouldn’t mind volunteering (demographics for example), a lot is highly confidential (past operations, psychiatric history, HIV status and so on). So we have a spectrum regarding healthcare data, either we let all the information be freely accessible and easy for professionals to use, or we put everything behind data silos, passwords and encryptions. Neither of these extremes however is feasible, and this is why the middle ground is vehemently debated. In my view, there will never be a consensus in which everyone is happy. I personally don’t mind what happens (providing it’s anonymised) to my health information at all as I think it will benefit the progress in medical research and diagnosis hugely, but others will hold opposite views which we must respect. The key in this instance I believe is to continue the improvement of secure, fast access to health data. As we refine the security gateways (through the advent of single sign-on, multi-factor authentication and biometrics) we can have the best of both worlds on the data-security spectrum. Digitisation is a challenge and an opportunity Many will say that digitising data in all its forms will lead to more issues with security as it is easier, for example, for a hacker to breach an IT system than to walk into a hospital and grab however many patient notes. This is certainly a
concern and we have seen with digitalheavy industries (e.g. personal banking) that fraud and data breaches are not unheard of. However, if you look at the status quo in many health institutions, the majority of them would likely fail the security standards they are holding digital systems up to anyway because of their paper-based systems. If you look at the examples I gave at the start, it is clear to me that paper is not a secure medium and the lack of digitisation and secure digital platforms are impeding the situation. To further illustrate, it is possible for anyone, in theory, on a ward to pick up any patient notes and start reading everything that has been done and said about them, or take the scenario where you want to show one of your seniors a patient in A&E or on the ward but they are stuck in clinic. Without a secure service, you will bite the bullet and use your own personal, and unsafe, devices for transfer. The adoption and diffusion of secure messaging, electronic notes, patient and staff portals and analytics platforms will undoubtedly cause security headaches that will need to be negotiated, but they will also alleviate a huge security problem we have at the moment in terms of capture, storage and transfer. It is clear that the debate about patient data and security is not going to be solved anytime soon and there will always be a dissenting opposition. If we look at care.data for example, we can see the magnitude of not just the technical issues but also the social and moral ones. The advent of digitisation will bring many new challenges, but with improved security solutions and patient and staff engagement, we can begin to have secure and mobile health information. n
mHealth Technology Security: Securing Information
mHealth Technology Security: Securing Information on a Digital Health Platform By Peter Ohnemus Health data is particularly sensitive personal data. As an industry, we must be focused on providing top privacy and security for the global mHealth market. Users trust us with their health data for the benefits of the digital healthcare solutions that we provide to them, in order to drive consumerization of healthcare forward. The outcome of digital health will only be trusted, if, the highest possible security and privacy is provided. The problem is that every time there is a breach in security, this trust is eroded. dacadoo is a global provider of digital Health Scoring and Lifestyle Navigation. We have been developing our Health Score Platform, since 2010, where we today have users in both, corporate healthcare, digital health providers and digital life and health insurance companies. They all trust the Health Score as the future digital health outcome supporting any device, anytime, anywhere. For dacadoo, security has always been at the forefront of our thinking, and never a mere afterthought. In this article, we outline key principles which we have developed and applied over the course of our history. The Law First and foremost, the law must be observed. dacadoo is a Swiss company. In Switzerland, the Datenschutzgesetz (Data Protection Law; DSG) applies. In this law, health data is classified as particularly sensitive data. This classification implies, among others, that users have to explicitly opt-in to any processing of their data, and that the database operated by dacadoo is registered publicly with the Federal Data Protection and Information Commissioner. In addition, the DSG mandates that dacadoo take adequate measures to protect the data. dacadoo has, since day one, decided not to license or resell any data. This is our clear advantage in the market, as people seeing their healthcare data being treated very seriously by dacadoo. In order to earn and maintain the trust of our users and partners, we have adopted a holistic approach to data security that touches on everything we do. Applicable laws vary on a countryby-country basis. Our holistic approach to data security has focal points on the right level of transparency, secure technology and best quality processes in the market. Transparency We are transparent and clear about what we do, and do not do, with user health data. As previously mentioned, dacadoo does not license or sell any end-user data – we also do not provide any advertising on the platform. As a consequence, our services
cost money. This money is paid by our users, or by third parties such as their employers, insurance companies or healthcare operators. They all have key interest in providing the best possible mHealth service and digital outcome to their clients in order to keep health conditions at the best possible level and costs as low as possible. In cases where a third party is the payer, we only provide anonymous statistics to the third party and of course inform the end user about this (opt-in). The personally identifiable data remains in the exclusive control domain of the end user/dacadoo client at all times. We give transparent control to the users. Users determine how their health data is shared. For example, we enable users to share their health data with health professionals if they desire to do so. For less sensitive data, such as workouts and the aggregate Health Score, we let users decide whether they want to keep that data private, or share it with their friends, or their groups. Or even share it publicly, on platforms such as Facebook and Twitter. This is exclusively decided by the end-user of dacadoo’s Health Score and Lifestyle Navigation Platform. Technology On the technology level, IT security starts with a secure infrastructure. Rule number one is obviously to use the most trusted Continued on page 22
The Journal of mHealth
21
Connections that Could Transform the Future of Healthcare Continued from page 21
data centers that provide adequate physical access control and privacy protection. The physical access requirement is extended by the use of VPN technology for accessing backend systems, and by requiring physical access tokens for remote access. On the network level, we use state of the art firewall technology to segregate our infrastructure into multiple zones. On the application level, we additionally apply state of the art Web Application Firewall (WAF) technology to protect our applications and services against attacks aimed at software errors, such as injection attacks. In developing our solutions, we apply best practices of software engineering, such as continuous integration and code reviews. In the software architecture of our solutions, we aim at concentrating security logic, for example in a segregated security or account server that receives special protection within a highly secured environment. Another key consideration in IT security is sourcing. No solution of relevant complexity is built entirely in-house these days. When selecting solution components, we carefully evaluate their providers with regard to their approach to security. We clearly make sure we stay on top of things in case there is a development relevant to security and privacy of our global user community. Process dacadoo has since its early beginning worked with key clients in the global healthcare industry in order to provide the best possible and professional processes in the industry. This is obviously including but not limited to background checks, policies regarding access, change control, 3rd party processes, such as media management. Regulatory Developments Regulation is at a tipping point from where it can go in two directions. In the direction we favour, regulation specifies responsibilities with regard to the protection of health data, and provides for
penalties in cases where a company fails to comply. In the adverse direction, regulation specifies what a company is allowed to do with health data and what it is not allowed to do. We do not support such regulation as it inhibits innovation and keeps the health industry in the analog age. An analogy to this would be outlawing hammers as they have occasionally been used to kill people. Luckily, our law does not outlaw hammers; it simply states one is not allowed to kill people. This is sensible. It is a statement of trust towards human beings. It is now up to all of us in the global mobile health industry to prove that we are worthy of trust, when it comes to processing healthcare data. The digital and mobile healthcare industry is forecasted to grow very rapidly over the coming years and it is up to the industry to find the right level of law, transparency, technology and processes that both, the regulatory authorities and the end-users of mHealth and digital healthcare infrastructures will fully trust. dacadoo is taking an active lead in this important movement and industry. About the author Peter Ohnemus is Founder, Chairman, President and CEO of dacadoo ag and dacadoo americas, inc. Peter has been involved in high-tech and bio-tech investments over the last 25 years. Peter Ohnemus/Network Capital Holding, his private investment firm, is currently invested in high-tech, bio-tech and sustainable energy/infrastructure startups. Peter co-founded ASSET4, the world’s leading provider of extra-financial information, in 2004, which was sold to Thomson Reuters in November of 2009. The dacadoo mobile health engagement solution enables individuals to track, manage and benchmark their health and wellbeing in an easy and fun way on their smartphones. For more information see Peter describe the dacadoo solution at https:// www.youtube.com/watch?v=krcUtW-Cx_E n
Connections that Could Transform the Future of Healthcare How the Internet of Things can empower care-givers and patients in a new, data-rich system By Jeroen Tas, CEO, Healthcare Informatics Solutions and Services, Philips In Britain, they called it a ‘major incident’. Hospitals across the country have been so inundated with patients that there was a ‘threat to the health of the community’ because proper care could not be administered by an overstretched staff. In one January week this year, more than 105,000 people were admitted into
22
June 2015
hospitals in England, one of the highest figures on record. That’s 20,000 more than the same week last year. The healthcare system in the UK is not the only one under scrutiny – there have been protests this month in France over reform plans and the Dutch government was criticised at the end of last year over a new healthcare bill. These are certainly the results of com-
plex situations and technology is by no means a panacea on its own, but it can and it should play a major role in helping to resolve these issues in the longer term. The Internet of Things (IoT) offers the potential for a more connected healthcare world, in which new technologies allow organisations to ensure the patient experience is not so fragmented and reliant on face-to-face care. There is a need for a stronger and more meaning-
Connections that Could Transform the Future of Healthcare
ful proactive engagement with patients, empowered by mobile devices and an extended care team including family and friends. A collaboration between technology, medicine and individuals.
isolation, clinicians can customise more effective treatment plans because they draw insights from a multitude of sources. They can ‘know’ their patients with an unrivalled depth of understanding.
Diagnoses can be made faster and more accurately to inform a personalised care decision, while treatment can be undertaken without the need for long queues or travel to and from hospital. By using secure cloud-based technology, we can store and analyse incredibly detailed amounts of big data made possible by the IoT and new technologies like digital pathology and genome sequencing. With the right information technology we can scale real-time monitoring capabilities to have one nurse looking at hundreds of different people at different locations at the same time.
Currently, healthcare providers have trouble accessing and utilising this information in an efficient way. Those who work in public health know there is a huge amount of waste – more than $750 billion annually in the US alone. But by individualising healthcare in this way, and empowering providers with the technological tools to store and access information from multiple sources, we can move from a system which treats chronic disease to one which personalises care. It means you can keep people well, not just encounter them when they are in more urgent need of attention, like an acute event.
Data is, of course, a crucial element of this particular healthcare revolution, seamlessly connecting healthcare professionals and patients. Not just electronic medical records, but health data garnered across the health continuum - from healthy living, prevention and diagnosis, to recovery, treatment and homecare - such as information on vital signs and physical wellbeing. This can be done through wearable technology, apps connected to home ware or devices that a patient is using within the hospital, as well as material from imaging systems and data monitors. We’re increasingly seeing examples of connectivity transforming how healthcare is delivered and coordinated. The amount of personal health data generated and tracked is exploding.
These are the liberating promises of the digital age in which we live, where complex algorithms attuned to patients’ vital signs can identify a serious situation and send an ambulance in time. Where elderly parents can still live at home together and go out safely knowing that if they fell, wherever they were, someone will be alerted to come and help immediately.
The potential is to create a world where patients and caregivers stay connected to each other, not just in the hospital. Instead of taking pieces of big data in
Let’s take heart conditions as an example. A more holistic, digital approach can mean that instead of treating the patient after a problem has occurred, tablet-enabled measurements can ensure patients take their medicine on time, help ensure calorie and alcohol intake is measured efficiently and weight is normalised. Monitors in the kitchen can provide nutritional advice, wearable technology can check the heart and record sensitive data, and video installations can link to doctors for instant checkups. All of this is designed to prevent
acute problems, give people the information they need to look after their own health and get an early warning so that medical professionals can better care for their patients and choose the optimum moment for intervention. Crossing fingers in the hope that budgets and system efficacy will improve is not an option. The system as it stands offers patients’ limited opportunities for self-management and resources are stretched evermore thinly. Healthcare systems need to be more patient-centric and a fear of radical realignment should be replaced by an enthusiasm for it. It needs leadership from the top and a new sense of collaboration. These kinds of changes can’t be made in isolation; they require strong, multi-skilled, dynamic partnerships to make a true transition into a digitally-enabled healthier world. One where sophisticated analytic solutions and advanced information technology strengthen society by offering personalised healthcare plans designed to keep people out of hospital. About the author Jeroen Tas has over 30 years of global experience as an entrepreneur and senior executive in the financial services, healthcare and information technology industries. Currently he is the CEO of the Philips Healthcare Informatics Solutions and Services Business Group. Previously he was the Group Chief Information Officer of Royal Philips, leading IT worldwide. n
The Journal of mHealth
23
Securing Information on Mobile & Digital Health Platforms
Securing Information on Mobile & Digital Health Platforms 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 here we come, I believe, to one of the crossroads we will continue to be faced with as we continue on the journey of mhealth and helping patients and consumers interact and manage their own health in the future. There are lots of blind hedges at these crossroads, some real danger that we do need to look out for and also lots of worried people that make us think the crossroads are a lot more dangerous than they might actually be. For me, there are a number of slightly different areas here and there are also probably others that I haven’t thought about either! Data management and security How do we manage the data we collect, what do we do with it, where do we store it and how secure does this need to be? Well we need to collect as much data as we can about our health, as a consumer and patient, and the more data we can get, and supply to our health providers and clinicians the better decisions we, and they, can make about the healthcare
journey we go on. We need to be sensible and store the data behind appropriate firewalls and in secure locations and we have to manage the access to that data in the same way that we would expect our bank to look after our financial details. However, we don’t need more than that. We don’t need to secure it behind a military level firewall so that nobody can ever access it even if they need to. Every day as consumers and patients we make choices about what data we let people see, what we use and what we expect to secure away. This is the same approach that we should take with our health data. Let’s also remember whose data it is – it is ours, as patients and as health consumers. Privacy Well let’s be honest here, we don’t want everybody seeing everything about us but we probably do want the people who need that data, to make better decisions about our health, to be able to see that data. After all, they already have data about us which they have looked after for years without us having any issue. But, let’s be sensible, if I can collect data
about my long term condition which helps my doctor treat me, and I am better managed, why wouldn’t I want the option to do that in the same way that I can do all my banking online and even through an app these days to make it even easier. Implications for collection and use of health data I think this represents the crossroads mentioned above. We have to act sensibly and make sure there are no cars coming down the road when we get to the crossroads and manage our data with a balanced and sensible perspective, but we shouldn’t avoid the crossroads all together because we fear something that might not and probably isn’t there at all. If it works lets go forward and not stop ourselves by over worrying about data security, management of data and storage of data. As long as we are sensible, take a balanced view and do what feels right for us as patients and consumers (and here is the really key bit for me) healthcare professionals and institutions will need to develop and move with us to support our changing healthcare 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
24
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
June 2015
Healthcare Organisations Recognising the Possibilities of the Apple Watch
Healthcare Organisations Recognising the Possibilities of the Apple Watch Apple have always had healthcare in mind as a significant market for the Apple Watch and it seems that hospitals and healthcare providers have recognised early the potential for the device. With 264 health-related apps available, at launch, for the watch platform a whole range of organisations have announced pilots and projects that make use of the device. At the recent HIMSS 2015 conference in Chicago 15 different medical based Apple Watch projects were announced. Despite similar device offerings from a range of providers, Apple’s involvement in this sector looks set to significantly increase consumer awareness. This combined with Apple’s astute strategy to seamlessly integrate device data with the company’s HealthKit and ResearchKit products helps make the platform attractive to organisations looking for ways to introduce technology-led research and service based healthcare projects. From managing chronic conditions to changing lifestyles and health related behaviours we take a look at some of the more notable early announcements: Chronic Condition Management Ochsner Health System based in New Orleans, LA, have introduced the Apple Watch as a tool to enhance the effectiveness of their Ochsner Hypertension Digital Medicine Program, a pilot program that tracks several hundred patients who are struggling to control their blood pressure. Through wireless blood pressure cuffs integrated with Apple HealthKit and Epic, Ochsner’s Electronic Medical Record (EMR), patients can regularly measure their blood pressure and heart rate at home while the data is sent directly to the clinic for monitoring. Specialised pharmacists review the data in real-time to make medication adjustments and
lifestyle recommendations as needed to ensure effective blood pressure control. Results are incorporated into MyOchsner, the system’s online patient portal, so that patients have access to their EMR and can receive progress reports on their status. Through the Apple Watch, patients can now receive medication reminders which include actual pictures of the pill; feedback from clinicians about potential side effects once a new medication is prescribed; renewal notifications for prescriptions, and activity tracking and exercise reminders. “Typically, hypertension patients see their physician a few times a year. Now, we are offering a new way to deliver care in patients with chronic diseases in which we can communicate with the patient in a more intimate way, more frequently,” explains Richard Milani, MD, Chief Clinical Transformation Officer, Ochsner Health System. “We recognise that to be impactful with this method, we need to fundamentally change behaviour. We can do this by providing continuous feedback with reminders and words of encouragement to promote lifestyle modification. What better way than to utilise the capa-
bilities of the Apple Watch to make this an easier transition.” Monitoring Chemotherapy in Cancer Patients UK based digital health solution provider Medopad have launched a chemotherapy application for monitoring cancer patients, which has been designed specifically for the Apple Watch. Developed with input from King’s College Hospital doctors, Medopad’s Apple Watch application includes three core capabilities: Medication reminders and Taptic alerts for personalised drug regimens; Real-time, one-touch symptom tracking and temperature measurement; and, Feedback on drug adherence, activity and symptoms for patients and their doctors. Effective cancer treatment relies heavily on the administration of strict drug regimens, however the complexity and potency of prescribed drugs often leads to a range of side effects. As a result, patients sometimes struggle to stay motivated, forget to take their prescriptions and see a lapse in the accurate recording of side effects. As soon as a patient Continued on page 26
The Journal of mHealth
25
Healthcare Organisations Recognising the Possibilities of the Apple Watch convenience for those who want this important information in an easy-touse and discreet form. We share Apple’s commitment to making technology more accessible, relevant and personal.”
Continued from page 25
experiences a negative reaction they can record their symptoms and the data is sent instantly and securely to doctors using the Medopad platform.
The Dexcom glucometer transmits blood glucose information to a receiver using Bluetooth Low Energy (BLE). The receiver then sends the information through the Dexcom iPhone app to the Apple Watch.
This delivers a number of powerful outcomes. Doctors can adjust drug regimens in real-time to provide even greater levels of proactive care and patients are provided chemotherapy treatment tailored specifically to them. Furthermore, connecting patients directly to doctors reduces side effect-related visits to hospitals, which in turn alleviates the pressures on medical staff and the associated financial costs. The company is in the process of making the service available to cancer patients in a number of UK NHS hospitals as well as in locations around the world. Secure Communications and Decision Support In a world where pagers and landline phones are still widely used by doctors and others to coordinate care, an effective wrist-based communication tool could have a huge impact in hospitals and clinics. Athenahealth, a major provider of electronic health records for hospitals and clinics, has announced a new care coordination and communication Watch app called AthenaText. The app, Athenahealth says, is designed to help keep health clinicians fully present in the exam room while at the same time being “connected” to whatever information they may need. The caregiver can use the Watch app to send and receive secure text messages to and from other members of the care team and support staff. Using Athenahealth’s Epocrates provider directory, the AthenaText app allows health care providers to immediately find and communicate with one another. The app also provides certain types of clinical intelligence from the Athenahealth patient record. Blood Glucose Monitoring Dexcom has launched a Watch app that will allow diabetics (and people who monitor them) to track blood glucose stats on the wrist.
26
As the industry’s first mobile-con-
June 2015
New Platform for Tele-consultations
nected system, the Dexcom Continuous Glucose Monitoring System (CGM) and its mobile apps, Share™2 and Follow, are already approved by the FDA and allow both users and “followers” to view glucose data directly on their iPhone. The Apple Watch apps from Dexcom will now enable users to monitor glucose on the Apple Watch so that people with diabetes can discreetly view their own information while parents and caregivers can conveniently view a child or loved one’s glucose data, giving them peace of mind and reassurance when they are apart. Dexcom CGM provides patients the opportunity to track their glucose levels and trends right on their wrist with the Apple Watch. Additionally, patients or “Sharers” can invite up to five people to view their glucose information and send an alert when the sharer’s glucose levels are outside the norm. “Dexcom is committed to providing our patients with access to the most current technology to better manage their diabetes,” stated Kevin Sayer, Chief Executive Office of Dexcom. “We are excited that the Dexcom CGM glucose data is now available on the Apple Watch, allowing greater
In what the company has dubbed the world’s first “Affordable-Care App” for Apple Watch, Healthtap has launched a communications app that provides patients with instant and affordable access to top U.S. doctors with just a tap on your wrist. The HealthTap DocNow App for Apple Watch connects immediately to a primary care doctor for a video consult, all at the tap of a button. With consults at just $2.99 per minute, the solution means that affordable healthcare is available to people who need instantaneous access to doctors. “We’re extremely excited to be on the forefront of the third generation of computing by offering this first-of-its-kind ‘Affordable-Care App’ via the all-new Apple Watch,” says Ron Gutman, HealthTap’s founder and CEO. “At HealthTap we’re committed to continuously innovating and continuously launch new ways to provide faster, more affordable access to trusted doctors so billions everywhere can live healthier happier lives.” n
Crowdsourced Tool for Depression
Crowdsourced Tool for Depression Peer-to-peer application outperforms conventional self-help technique for easing depression, anxiety.
“Could people get clinical benefits from it? That’s hypothesis one,” he says.
Researchers at MIT and Northwestern University have developed a new peerto-peer networking tool that enables sufferers of anxiety and depression to build online support communities and practice therapeutic techniques.
“Hypothesis two is, ‘Will people be engaged and use this regularly?’” Morris adds. “There’s a lot of great work in building web apps and mobile apps to provide psychotherapy without a therapist in the loop— as self-guided programs. There’s almost a decade of research showing that these things can produce really profound improvements for people. The problem is that, once you release them out into the wild, people just don’t use them. The way we designed our platform was to really mimic some of the interaction paradigms that underlie very engaging social programs.”
In a study involving 166 subjects who had exhibited symptoms of depression, the researchers compared their tool with an established technique known as expressive writing. The new tool yielded better outcomes across the board, but it had particular advantages in two areas: One was in training subjects to use a therapeutic technique called cognitive reappraisal, and the other was in improving the mood of subjects with more severe symptoms. “We really wanted to see two things,” says Rob Morris, who led the work as a PhD student in media arts and sciences at MIT. After graduating in February, Morris is now commercialising the technology through a New York-based company he co-founded, called Koko.
On that score, too, the results of the study were encouraging. The average subject in the control group used the expressive-writing tool 10 times over the three weeks of the study, with each session lasting about three minutes. The average subject using the new tool logged in 21 times, with each session lasting about nine minutes. Morris; his thesis advisor, Rosalind
Picard, an MIT professor of media arts and sciences; and Stephen Schueller, a clinical psychologist at Northwestern, describe the study in a paper appearing in the Journal of Medical Internet Research. Morris, who had majored in psychology as an undergrad at Princeton University, initially enrolled in a PhD program in psychology in California. But he concluded that a traditional psychology program wouldn’t grant him enough latitude in researching the therapeutic potential of information technology, a topic that quickly captured his interest. So he applied instead to do graduate work in Picard’s Affective Computing Group, which specifically investigates the intersection of computing technologies and human emotions. “I was at MIT without an engineering degree and really trying to race to learn computer programming,” Morris recalls. He found himself spending a lot of time on a programmers’ question-and-answer site called Stack Overflow. “Whenever I had a bug or was stuck on something, I would go on there, and almost miracuContinued on page 29
Fitbit Data Could Help Schizophrenia Sufferers Avoid Relapse
Fitbit Data Could Help Schizophrenia Sufferers Avoid Relapse
An early warning system for schizophrenia relapse, using Fitbit data and a smartphone app, could lead to dramatic improvements in treatment. A group of London-based doctors and software engineers is developing the experimental system at London's Bioinformatics Core of the National Biomedical Research Centre (BRC) and Dementia Unit. Working from the centre, where clinicians, software engineers and statisticians seek out patterns in vast medical datasets, the team is studying the sleep patterns of schizophrenia patients to develop a possible alert system. "It's well documented by clinicians that sleep disturbance is one of most highly self-reported factors [prior to a relapse in psychosis]," says Amos Folarin, the BRC statistician behind the trial's SleepSight app. "But it's hard to cover subjectively." "Most people use a sleep diary, but that is probably not reliable in populations of people with mental illness," adds specialist registrar in psychiatry Dr Nicholas Meyer. If there were a way to track sleep patterns in real time, share that data with a physician, and alert them as soon as anomalies in those patterns occur, patients could potentially be treated prior to a full relapse. According to project co-lead Dr Richard Dobson, patients are released fairly quickly into the community following their first "episode". As a result, an inexpensive automatic alert system could be an excellent way to keep in touch with a patient and ensure they get the treatment they need before another episode strikes. Enter the Fitbit Charge HR, which measures heart rate and movement. It will be used in an upcoming pilot trial of 20 patients (currently being recruited) to calculate how restful a wearer's sleep is. The reason for using the commercial device is simple: medical-grade equivalents are neither built for long term use, nor cost-efficient enough to be handed out to patients -- they cost around ÂŁ300-500, versus the ÂŁ120 Fitbit. "Broadly, the underlying tech is the same," says Meyer. "But Fitbit also has Bluetooth." The use of Fitbit in medical trials is gaining credibility, he
28
June 2015
adds. But it's also adding layers to trials that would otherwise have been impossible. The company has recently given researchers access to its real time data via API partnerships, and patients on the upcoming trial will sync it up with a smartphone app called SleepSight. Data from the patient’s phone will also be gathered, including accelerometer, light and battery data. The team is seeking approval to use information on messages and calls -- times and activity, rather than content. They are taking a bit of a punt with the latter, not knowing how useful the outcome will be. But, Meyer says, "this is potentially a really rich source of information about various behaviours, showing what the life of someone with mental illness is like." "When relapsing they might initiate fewer contacts, or use email or social networks less, for example. We don't know, but it could be really important information. The more variables we collect, the better." The team is also calling for the public to send in sleep data, as a means of developing a control set. The trial will continue for two months, but anyone that takes part will be given the option of keeping the Fitbit for a year and sharing that data. Meyer points out that within a five year period, 80 percent of people with psychosis relapse. Whether that statistic is due to individuals failing to take medication, or the dose no longer being sufficient, the team wants as much data as possible to be able to calculate when sleep pattern anomalies can also be helpful indicators of relapse. For the initial trial, the team will recruit "relatively stable" patients not undergoing a relapse. "Future studies will recruit more unwell patients who may have a history of not taking medication," says Meyer. "The point is to show sleep objectively and uncover the relapse signature." Meyer frequently hears from friends and families of patients that a sufferer's sleep is highly disturbed prior to a relapse -- he wants more than anecdotal evidence to prove it, and act on it in good time. In the meantime, they can also see if restless sleep corresponds with those days an individual experiences more paranoia, "even though people might not relapse fully".
Fitbit Data Could Help Schizophrenia Sufferers Avoid Relapse There is perhaps one significant issue surrounding the use of Fitbit that could feasibly be cause for concern. Many wearers find the data addictive, and behavioural changes -- though the desired outcome of such a fitness product -- can be significant. Apply that to an individual suffering from a mental illness, where paranoia and obsessive behaviours are common, and surely it would be a recipe for disaster?
at it another way," says Meyer. "If you give them a tool that they understand, and work with patients, it's something that will help you in building up a trusting alliance. Then there will be a chance people use it long-term. I hope we can show that people do use it and they have benefit, not just dispose of it when they become unwell."
Not so, says Meyer. He and the wider team strongly believe that giving patients a device, and the data that goes along with it, also gives them a sense of control over their own health and a sense of agency so frequently lacking when care is placed in the hands of senior physicians that have little time to get to know each individual.
"We want to promote the idea of self-monitoring, where they can see for themselves 'I used alcohol there and then my mental state deteriorated over the next few days'. At the moment people get relatively little feedback -- there's a top down approach of 'you must take medication because it's good for you'. But if they see the consequences of not taking medication, or not sleeping well, it works to increase insights."
"The first thing people say is 'that sounds like a crazy idea', but I look
Original article source Wired.com n
Continued from page 27
lously, this crowd of programmers would come and help me,” he says. “It was just this intuition that, just as we can get people on Stack Overflow to help us identify and fix bugs in code, perhaps we can harness a crowd to help us fix bugs in our thinking.” People suffering from depression frequently exhibit what Morris describes as “maladaptive thought patterns”: You lose your job, and you conclude that you’ll never find another one; your roommate comes home and shuts herself up in her room, and you assume it’s because of something you’ve done. Psychologists have sorted these thought patterns into categories. Predicting your future unemployability is an instance of “fortune-telling”; assuming you know your roommate’s motivations is “mind-reading.” Others include “overgeneralisation,” “catastrophising,” and “all-or-nothing thinking.” Cognitive reappraisal involves, first, identifying maladaptive thought patterns and, second, trying to recast the events that precipitated them in a different light: The job you lost offered no room for promotion and wasn’t aligned with your interests, anyway; your roommate has been having trouble at work and may have just had a fight with a colleague. A user of the new tool—which Morris calls Panoply—logs on and, in separate fields, records both a triggering event and his or her response to it. This much of the application was duplicated exactly for the expressive-writing tool used by the control group in the study. With Panoply, however, members of
the network then vote on the type of thought pattern represented by the poster’s reaction to the triggering event and suggest ways of reinterpreting it. As users demonstrate more and more familiarity with techniques of cognitive reappraisal, they graduate from describing their own experiences, to offering diagnoses of other people’s thought patterns, to suggesting reinterpretations. “We really wanted to see that people are utilising this skill over and over again, not only in response to their own stressors but also as teachers to other people,” Morris says. “We can surmise that it’s a little easier to practice some of these psychotherapeutic skills for other people before turning them toward themselves. But we don’t have data supporting that.” For their study, Morris, Picard, and Schueller recruited subjects who described themselves as under stress, something that correlates highly with depression. Volunteers were asked to complete three questionnaires. One is a depression measure that’s standard in the field. Another assesses perseverative thinking, and the third assesses skill at cognitive reappraisal. After three weeks using either Panoply or the expressivewriting tool, the subjects again completed the same three questionnaires.
Network effects To simulate a large network of users— and ensure that Panoply users would receive replies even if they were posting in the middle of the night—Morris hired online workers through Amazon’s Mechanical Turk crowdsourcing application to supplement the comments made
by study subjects. Each Mechanical Turk worker received a brief training in cognitive reappraisal, and about 1,000 contributed to the study. “It took a lot of time to figure out how to teach people these skills and give them examples of what to do in a way that is easily understood in a handful of minutes,” Morris says. “Some of them wanted to sign up afterwards. They were like, ‘Wow, I never knew I had these bugs in my thinking, too.’” “What I like about the crowdsourcing idea is that it’s sort of tackling two things in a nice way,” says James Gross, a professor of psychology at Stanford University, who has studied cognitive reappraisal. “One is that reappraisal, although powerful, can break down when you most need it. And so this is saying, ‘Hey, instead of relying on intrinsic regulation, let’s try extrinsic regulation, where we’re going to get some help from other people.’ “But the second thing is that when you’re depressed, you can withdraw from other people. So now you’ve got this double whammy, where you’ve got a high level of negative emotion, making it more difficult to reappraise, and you’re isolating yourself from other people, which means that you’re not going to be as likely to get extrinsic regulation. What they’ve done is nicely address both of these issues by saying, ‘Hey, we can help with reappraisal, even if you’re feeling a bit depressed, by helping you leverage outside input that you wouldn’t otherwise get. I think this is a promising approach.” Source: MIT News n
The Journal of mHealth
29
Conference News eHealth Week 2015: Eight European Hospitals Receive High Level Awards for Excellence in Digital Maturity ing – indicating a truly paperless hospital. These were just a few of the strengths observed amongst other examples of excellent eHealth practices. The awards were officially presented at the eHealth Week 2015 in Riga.
Radboud UMC has become the third hospital in Europe to be given the Stage 7 EMR Adoption Model (EMRAM) award by HIMSS Europe, while six further European institutions have received stage 6 validation. Radboud UMC of Nijmegen, Holland, which has 953 beds, is now Europe’s third EMRAM Stage 7 hospital and the first organisation to be given the prestigious award in more than two years. Medication safety and clinical decision support were just two noteworthy areas in which this hospital demonstrated examples of best practices. Three Turkish hospitals Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon E.A.H., İzmir Dr. Suat Seren Göğüs Hastalıkları ve Cerrahisi E.A.H., İzmir Katip Çelebi Üniversitesi Atatürk E.A.H., the Italian Istituto Di Candiolo (IRCCS) and the two Spanish Hospitals Universitario Central de Asturias (HUCA) and Hospital Universitario Son Espaces also join 28 other healthcare organisations as Stage 6 hospitals in Europe. Although geographically disperse inspectors noted common outstanding pharmaceutical governance, processes to adapt to system enhancements and also witnessed entirely paperless cod-
30
June 2015
The seven hospitals have now also been granted access to the newly founded HIMSS Stage 6&7 Club, a forum created for member organisations to share experiences and challenges and to help with the management of the European eHealth community. Hospitals can benefit from the huge pool of knowledge that this club contains and have privileged access to HIMSS Stage 6&7 events and functions. Uwe Buddrus, senior consultant for HIMSS Europe, congratulated the institutions saying “What they all share is a vision to transform healthcare by using modern means of communication, data capture and processing. They understand and use technology as an enabler, but have also tackled the equally important issues of governance, change management and clinical transformation through IT.” EMRAM has been adapted to meet the needs of European healthcare institutions as a methodology for evaluating the progress and impact of electronic medical record systems in hospitals. Tracking their progress in completing eight stages (0-7), hospitals can review the implementation and utilisation of information technology applications with the aim of reaching Stage 7, which represents a superior electronic patient record environment. For more information about the HIMSS EMRAM Stage 6 and 7 award visit http://himss.eu/emram n
Conference News
How the NHS can become a Silicon Valley for Health WIRED Health 2015 How do you disrupt the NHS – without joining a political party? "It causes a lot of trouble sometimes," admitted Tony Young, NHS England's clinical director for innovation, at WIRED Health 2015. "I'm someone who has fought against the system my whole life, and now they have asked me to come to the centre and try to change it." Young is a self-described "mad inventor", acting as disruptor-in-chief for NHS England in an attempt to create what amounts to a mini Silicon Valley located within the bureaucracy of the NHS. Young is also a working surgeon, the founder of four medical start-ups and the cofounder of the £500m Anglia Ruskin MedTech Campus.
unique opportunity, Young says – precisely because it is a unified, enormous and complex system. "If there is a place on the planet you can innovate at scale, the NHS is it… We have datasets for our population going back 25 years… What a great mine of information we have there." To use this data and opportunity effectively, NHS England and the UK as a whole need to learn to bring our own innovations to market, and not just create working models in an academic setting, Young said. "We face a real problem in our country…we are world leaders in inventing things…but on bringing them to the rest of the planet it’s done better by others, abroad, time and time again."
“We need new thinking and new action, if we are truly to do something different in health care," he told the audience at WIRED Health. "Failure in my view is when you don't learn when you get it wrong."
So what is the NHS actually going to do to innovate? "It’s all about partnerships," Young said. Those partnerships will involve allowing clinicians, academics, charities and companies to work with the NHS and transfer possible solutions.
The scale of the challenge is massive. Every 36 hours NHS England sees a million patients, and it employs more than 1.4 million people. But it's also a
MedTech innovation briefings are one example of how this works in practice. Under this system, NHS England will give guidance for young companies about
their early-stage medical products without having to deliver the result of large-scale trials, which all products need before mass adoption. There are also funding options, including prizes, a National Innovation Accelerator and a series of "test beds" between four and six areas of the NHS "where we want to be the go-to place on the planet for you to come and trial anything" Young told the health professionals and start-ups in attendance. "If we can get our culture right… making innovation everyone's business – which is not the culture at the moment. The NHS will benefit – and so will its users,” Young said. He points to examples like Cupris Health, which builds a self-diagnosis and advice tool for smartphones. The company received funding from the NHS, and is, through the partnership, leading to real benefits. So while it might sound counter-intuitive, the sheer size and complexity of the NHS in the UK is exactly what might make it one of the most innovative medical systems in the world – if everyone gets on board with Young’s disruptive way of thinking. Original article appeared on Wired.com April 2015. n
2015 ATA Annual Awards: Recognising Innovators in Telemedicine The American Telemedicine Association (ATA) announced the winners of the 2015 ATA Annual Awards. The awards recognise individuals and organisations at the forefront of healthcare technology for their significant contributions to the development of telemedicine. Winners formally accepted their awards at the ATA 2015 Annual Meeting and Trade Show, in May, at
the Los Angeles Convention Center. “We are honoured to recognise these outstanding individuals and institutions,” said Yulun Wang, PhD, President of ATA, and Chairman and CEO of InTouch Health. “Telemedicine is a tool to improve the quality, accessibility and affordability of healthcare, and these recipients serve as a testa-
ment to the field’s ability to improve each of those aspects of care.” The following awards were announced: Lifetime Distinguished Service Award Winner: Rashid L. Bashshur, PhD, Professor Emeritus, Department of Health Continued on page 32
The Journal of mHealth
31
Conference News Continued from page 31
Management and Policy, Executive Director UMHS eHealth Center, University of Michigan Health System ATA President’s Award for Individual Leadership Award supported by Jay Sanders, MD of The Global Telemedicine Group Winners: Brian Rosenfeld, MD, and Mike Breslow, MD, Philips Healthcare, Hospital to Home ATA President’s Award for Innovation in Remote Health Care Award supported by InTouch Health Winner: Sentrian, The Remote Patient Intelligence Company ATA President’s Award for Health Delivery, Quality and Transformation Award supported by AMD Global Telemedicine, Inc.
Winner: University of Mississippi Medical Center, Center for Telehealth ATA Industry Leader Award Award supported by UCLA Health Winner: Robert Jarrin, JD, Senior Director, Government Affairs, Qualcomm Incorporated Special Interest Group & Chapter Achievement Award Award supported by Validic Winner: The Telerehabilitation SIG Chair: Jana Cason, DHS, OTR/L, FAOTA Vice Chair: Tammy Richmond, MS, OTR/L, FAOTA Full write-ups about the award winners are available on the ATA 2015 website. The ATA also elected six members of distinction as new members to the ATA College of Fellows. Election as a Fellow
is a high honour that recognises achievements in telemedicine, services to the general telemedicine community and service to ATA. The new Fellows are: • Richard S. Bakalar, MD, Managing Director, Healthcare, KPMG, Lone Tree, Colo. • Edward M. Brown, MD, CEO, Ontario Telemedicine Network, Toronto, ON, Canada • A. Stewart Ferguson, PhD, Chief Technology Officer, AFHCAN, Anchorage, Alaska • Mark A. Goldberg, MD, President and Chief Operating Officer, Parexel International, Waltham, Mass. • Bernard A. Harris, Jr., MD, MBA, FACP, Director/President and CEO, Vesalius Ventures, Inc., Houston, Texas • Hon Pak, MD, FAAD, Chief Medical Officer, LongView International Technology Solutions, Clarksburg, Md. n
mHealth Summit 2015 Creates Global Platform for Mobile and Connected Health The 7th annual mHealth Summit will be held November 8-11 in the Washington, DC, area. This year's Summit has an expanded focus to better reflect the industry's emphasis on connecting providers and patients to advance consumer-drive health, wellness and prevention. This year's theme, Anytime, Anywhere: Engaging Providers and Patients, reflects a shifting focus from traditional patient care to a more dynamic, interactive and patientdriven experience. Keynote presentations, panel sessions, special events and a vibrant exhibition floor will explore existing and emerging technologies changing care delivery, including mobile devices and apps, telehealth services and personal connected health. For more information or to register visit http://www.mhealthsummit. org/ n
32
June 2015
Conference News
Winners of MaRS HealthKick 2015 Pitch Competition Announced! Building on the success of last year’s inaugural event, MaRS HealthKick 2015 brought together hundreds of members of the North American investment community, as well as key health industry leaders and ecosystem players. This year’s pitch competition also expanded to include health ventures from across Canada narrowed down to 39 of the most promising health start-ups through a rigorous application review.
PITCH COMPETITION WINNERS After a full day of pitches, the 2015 judges chose one winner from each showcase track for the $20,000 cash prize. The awards were sponsored by AstraZeneca, Amgen, Baxter, Canada Health Infoway, Medtronic and Saint Elizabeth. Here are the MaRS HealthKick 2015 winners: »» Biotechnology & Pharmaceuticals: EMERpharma, a start-up drug
development company focused on the development of efficacious, nonaddictive treatment for ADHD and treatment for addiction disorders. »» Medical Devices & Diagnostics: Mindful Scientific, developing the Halifax Consciousness Scanner (HCS), a portable medical device that rapidly assesses brain function
to aid in the diagnosis, monitoring and management of concussion and other neurological problems. »» Health IT: QoC Health, provides patient engagement solutions to support shifting care to the community. These solutions save money, improve outcomes and improve user experiences. n
Digital Health Summer Summit The fourth annual Digital Health Summer Summit, produced by Living in Digital Times and co-hosted by the Center for Digital Health Innovation at UCSF, will highlight the latest happenings in digital health. This two-day conference will connect start-ups, investors, tech innovators, healthcare practitioners and thought leaders to meet, share and disseminate the up-to-the-minute accomplishments in the digital health space.
panies face as they build and scale their businesses," said Jill Gilbert, producer of the Digital Health Summer Summit. "This premier event brings together pioneers who are reinventing health care from the frontlines."
Thought leaders and practitioners who are at the intersection of health, technology and finance will share their insights and experiences of how they are nurturing the evolution of digital health. The Summit will address some of the following topics: Ensuring that Privacy and the Security of Information is Protected; Necessary Ingredients to Accelerate Healthcare Innovation; Transformative Partnerships – Breakthrough Business Models; Funding- The Gap Between Seed Money and Institutional Funding; Technology and Mental Health; Impactful Technologies for Improving Patients' Lives
Some of the key speakers at the Digital Health Summer Summit are: »» Joe Bengfort, Chief Information Officer, UCSF »» Michael Blum, Associate Vice Chancellor for Informatics, Professor of Medicine in Cardiology, Chief Medical Information Officer »» Wainwright Fishburn, Jr., Partner Cooley LLP partner »» Karan Singh, Co-Founder, Ginger.io »» Reed V. Tuckson, President, American Telemedicine Association; Managing Director, Tuckson Health Connections; Former EVP and Chief of Medical Affairs, UnitedHealth Group »» Robert M. Wachter, MD, Professor and Associate Chair of the Department of Medicine, University of California, San Francisco
"The Digital Health Summer Summit will expose the progress made in the digital health arena as well as the challenges com-
For more information about the Digital Health Summer Summit visit www.summersummit.digitalhealthsummit.com/ n
The Journal of mHealth
33
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.
LifeWIRE: The “Science and Art of Communication” We continue our series of Global Digital Health 100 (2014) profiles with an interview with Howard Rosen, CEO of LifeWIRE. LifeWIRE’s interactive communications platform facilitates dialogue between patients and their treatment teams which has proven essential to patient compliance and improved clinical outcomes. Any interaction can be automated, delivered, interactively monitored, and customised based on patient responses. In health, corporate communication, and academia, LifeWIRE has an established track record of success among veteran and civilian populations. What were the primary objectives when developing the LifeWIRE solution? “LifeWIRE began by our focusing on the science and the art of communication. We knew we needed to create a dialogue between Providers and Patients that was engaging, efficient and effective where the technology (the “science”) was “invisible”, but at the same time dynamically customisable for the patient using their desired communication
34
June 2015
media and language (the “art”).”
Which features of the system set it apart from other interactive health communications solutions?
respond. Our solution measures and is responsive to non-responses. In all cases, based on responses (or non-responses) it can be configured to notify the care team or personal support networks, to contact the patient. We can even send notifications to third parties outside the immediate treatment team and family, such as program managers of supportive services. Fundamentally, LifeWIRE is patient driven and user-interactive. This is how it gets results!”
“It is easy to ‘blast’ information based on a theoretical agenda. LifeWIRE is about people, and people control the pace, the content, and the delivery of every interaction. With LifeWIRE, the patient dictates the means of communication, whether it is email, IVRS, call centers, text message or chat. It is highly interactive, facilitating communications with the patients, and then using those responses to parse the answers. Based on the answers, the patient receives immediate follow-up calls-to-action, referrals, information feedback such as providing insight to their response, links to websites, or warm handoffs to a care manager. Importantly, we know that a non-response is in fact a response where a user chooses not to
“All communications are permissionbased and HIPAA compliant. LifeWIRE is virtually instantaneous, and implementation does not require the installation of any software for either the Provider or the patient. It can be customised/personalised for one patient, a group of patients or a large population of patients with virtually the same effort. All the tools are in the hands of the Providers, requiring little to no programming, allowing our clients to manage as they know best. As a result it allows them to manage 1 or 10,000 with equal ease. The solution is cloud-based population management communication engine that provides our clients with the tools to mobilise their existing interactive protocols and/or validated instruments.”
“We were passionate about building a technology solution that does not dictate how or where a patient communicates with a Provider, but where the technology is invisible and ubiquitous; an enabler, not a barrier.”
In Depth with the Global Digital Health 100 How do you adapt a system of this type to deliver interactive communications tailored to the individual? “It’s one thing to have a technical means to communicate. It’s another to know how to communicate, what modality to use, what language and context, and then to have the technology to address it all. That’s what 10 years and 2,500 insights provide. That’s why this is a great question as it hits directly on what we discuss as the ‘Science and Art of Communication’.” “LifeWIRE provides both. Our team includes specialists from a number of areas, including the world of communication. We provide the means to communicate in the context of the end user augmented by the ability and insights to know how to deliver in a way that effectively communicates. Our patients say it all. We have ongoing utilisation of 92% of the patients and in some implementations users voluntarily have continued to use the service for over 4-years beyond their hospitalisation.” What are the opportunities for population health management? “We have the opportunity to change medical treatment as we currently know it. The ultimate economic solution integrates improved outcomes, decreased costs, and improved customer care by automating existing workflows and remotely monitoring patients across a wide and diverse population.” “Our clients manage diverse populations in a local geographic zone, state wide, across the US, or in some cases those deployed overseas, from a central location. Extensive data can be reported by demographic, geographic region, by condition, or by any identified and measured need. We empower our clients to not only manage wider populations, but to manage a population of 100,000 as easily as they now manage a single individual. More critically, each client is managed using individualised interactions tuned to just that individual’s need at that moment, and then adapt the treatment as they change.” “Through our “personalised population management” we automate the upload process, the set-up process, we monitor patient responses, and then categorise patients based on rule sets created by our clients. For example, for a particular client LifeWIRE automated the daily
working patient management process involving adding over 100 patients per day, reducing labour from four hours a day to 10 minutes with greater accuracy, data collection, and insight.” “Through population management, we also collect large amounts of data, which lends to health management analytics on specific issues or trend analysis.” Are there many difficulties associated with developing an interactive communications system of this type? “It’s less difficult to build a piece of software than to implement the processes to effectively motivate companies to use it well. We went about it a little differently. Typically in the IT/Tech world, you build a system and then convince management it is good for the clients. In our case, we identified the problems and issues first, then built a solution to address those needs. LifeWIRE was built for the clients, and therefore our efforts are not on “selling” a technology but helping management communicate more successfully and improving outcomes with their patients.” “If you know what you are trying to do, understand the core of what is needed, remain open to feedback from clients/ users; and work with a great team who really care about client needs, you will build a great product. What LifeWIRE is today has evolved from over 2,500 client/ user insights leading to system improvements - all key for the existing engagement. It is crucial to be able to satisfy the adaption of an effective interactive communication engine, but equally crucial to have a system that your clients will be able to use intuitively. And certainly, training is critical. We have a 1-day LifeWIRE certification training program to train our clients. By the end of the training our clients can customise LifeWIRE as they see fit. This empowers them to adapt and manage the platform using their insight to their specific population and their insights to the growth of the platform as a whole.” What are the different types of data that can be collated using the system and what meaningful insights can be derived from the analysis of this data? “Data comes from interactions with a patient, and patient interactions are developed by, and for, the client. Correspondingly, there isn’t a limit to the
kinds, type, depth, or detail of data that can be collected and collated.” “Our unique strength is not simply collecting objective data, but our ability to collect subjective data such as “How do feel today?” or “How effective was your medication?”, and then compare each response to the patient’s earlier responses. What makes LifeWIRE stand alone is not simply our ability to collect data but to empower our clients and their patients to make the determination of what is most valuable to them. We allow our clients to create their own rule set as to what they want to measure, and to then compare populations, patients within a population on how they respond, the changes in the type and range of responses and then make their own determination on future interactions and results.” What are your hopes for LifeWIRE in the future? “We recognise that we are barely at the tip of the iceberg of where we can make an impact. Any place a few individuals need to interactively communicate with a large group, LifeWIRE applies. We began in the medical field, but have already seen applications in areas as diverse as homelessness to corrections. The more the world accelerates, the more critical it is for something such as LifeWIRE to connect everyone with each other. Fifteen years ago only a few people had heard of email. Today, if a person does not use email, a large segment of the medical industry is inaccessible. We see LifeWIRE as the centre of connecting many, if not all, forms and modalities of communication. Tomorrow’s modalities may not even be envisioned today, but our modular construction will allow us to be on the cutting edge. We will continue to allow Providers to easily, effectively communicate with clients, to gain insights valuable for the Provider, but also to provide feedback for the patient.” “Technology should not limit and dictate but ultimately it should allow communication between clients and their patients provided how they want, when they want, where they want and about what they want.” We would like to thank Howard Rosen for taking the time to provide this insight into the LifeWIRE solution. You can find out more about LifeWIRE at www. lifewiregroup.com. n
The Journal of mHealth
35
MSF and Google Develop 'Ebola-proof' Tablets
MSF and Google Develop 'Ebolaproof' Tablets A unique collaboration between Médecins Sans Frontières (MSF) and Google to develop new technology for use at the height of the Ebola epidemic now offers huge promise to help improve medical care and save lives in a range of other humanitarian emergencies.
energy and uses batteries that can be quickly recharged with a generator.
As cases of Ebola reached their peak in September 2014, MSF reached out to the tech community, appealing for a way to help medical staff quickly and accurately record patients’ notes whilst in the highrisk zone of an Ebola management centre.
Built for purpose, the software is also incredibly easy for medics to use. “We had to put on full personal protective equipment to understand how difficult it was for doctors working in the high-risk zone," says Ganesh Shankar, product manager for Google.
Medics working in the West African heat could spend only an hour at a time inside the personal protective suits, and usually spent the final 10 minutes of their shift shouting basic patient notes over a fence to a colleague on the other side – as even a piece of paper leaving the high-risk zone posed an infection risk. This wasted precious time that medics wanted to spend with patients, while dictating notes across a fence at the end of an exhausting shift whilst wearing a mask was a recipe for error. At the same time, the basic notes did not always give medics enough information to provide individualised care, making it more complicated to analyse a patient’s condition over time. In response to MSF’s call for help, a group of tech volunteers* formed, who were later joined by a team from Google. The team developed a waterproof tablet that can be dropped into chlorine, sterilised and safely taken out of the high-risk zone. Tablet adapted to challenging conditions
The tablet is built to withstand humidity and storms, and is robust enough to be perfectly adapted to the challenging conditions in which MSF teams often work.
“We wanted to make sure the tablets would be as simple and as safe as possible to use. We got rid of all the sharp edges, pre-configured the technology so that it could be taken out of the box and used, and spent time thinking about the extreme environments that MSF staff often work in.” Improving the understanding of Ebola The specially developed hardware is incredibly easy for glove-wearing, timepressed medics to use. The tablet also allows staff to access a patient’s history and allows medics to collect more complete health data – such as pulse and respiration rates – to better track a patient’s progress and provide them with individually tailored care. At the same time, collecting data from a large group of Ebola patients will enable medics to better understand the disease in future outbreaks. This was a laborious and potentially error-prone process when done by hand.
The electronic tablet recharges quickly by being placed on a table – normal wirebased chargers have a sharp edge which could puncture gloves, posing an infection risk.
“In the longer term, if we are able to collect more and better information about our patients, we will also learn more about the disease and how best to treat it,” says MSF’s technology advisor, Ivan Gayton, who developed the project.
The team also developed a local network server for the tablet which is the size of a postage stamp, runs on minimal
“Although we have just treated the largest cohort of Ebola patients in human history, we still know distressingly little
36
June 2015
about the progression of the disease.” "It will take many months to file, organise and analyse the data we have collected. Now that the technology has been developed and successfully trialled, we know that data will be instantly ready for both analysis and patient care in the future.” The tablets were successfully trialled in MSF’s Ebola management centres in Sierra Leone and are now in use. Open-source technology The technology will be open-source and MSF is now appealing to the tech community to adapt the software for use in other humanitarian emergencies, such as cholera outbreaks, nutrition crises and in refugee camps – any settings where detailed medical notes will make a difference to patient care, or where data might improve medical understanding of a disease or outbreak. “In Western hospitals, doctors take detailed medical notes that allow them to build up an individualised pictures of their patients for granted - the ability to properly track a patient’s blood pressure, for example, or their breathing when they come into an emergency room,” said Dr Jay Achar, MSF’s Ebola advisor. “Finally, we have technology adapted to the challenging environments that MSF doctors have to work in, which will allow us to keep on improving the care we can provide, and ultimately allow us to save more lives.” “I think that this kind of partnership represents the future of how NGOs are going to integrate technology into the work they do,” says Ganesh Shankar, product manager for Google. “I will judge the success of the project in a year’s time when hopefully the technology has been taken up by a plethora of other non-governmental organisations, helping them with the important work that they do.” n
Upcoming Events
Upcoming Events 16-17 June
18-19 June
7 July
Digital Health and Care Congress 2015
Connected Health 2015
Digital Health Summit and Exhibition
London, UK For more information visit www.kingsfund.org.uk/events/ digital-health-and-carecongress-2015
San Diego, CA, USA For more information visit www.openmobilemedia.com/ connected-healthcare-mhealth-usa/
University of Salford, UK For more information visit www.salford.ac.uk/onecpd/courses/ digital-health-conference-andexhibition
15-17 July
2-3 September
16-18 September
Mobile World Congress Shanghai
Health and Care Innovation Expo 2015
ATA 2015 Fall Forum
Shanghai, China For more information visit www.gsma.com/events/mobileworld-congress-shanghai
Manchester, UK For more information visit www.england.nhs.uk/expo
Washington, DC, USA For more information visit www.americantelemed.org/2015ata-fall-forum
17-18 September
30-31 October
8-11 November
China Wearables & Innovation Summit 2015
ATA China Meeting
mHealth Summit 2015
Shanghai, China For more information visit www.conwayasia.com/cwis2015
Beijing, China For more information visit www.americantelemed.org
Washington, DC, USA For more information visit www.mhealthsummit.org
Advertisers Index To advertise in Consultation Plus
38
dacadoo 27 Infield Health
27
mHealth Summit 2015
32
The
Journal of mHealth The Global Voice of mHealth
Contact Matthew Driver matthew@simedics.org +44 (0)1756 709605
The Journal of mHealth
37
Consult…..connect…..engage……respond……improve In today’s fast changing health landscape understanding and responding to patient needs is becoming ever more critical. Designing healthcare services to match more closely the profile and lifestyle of your local population can bring benefits for patients and the efficiency of the health system. Consultation Plus is an online system tool that helps organisations improve their consultation exercises and encourage customer and user engagement. Designed by communications and engagement experts the system is simple to use and provides meaningful feedback to aid improved decision making via meaningful engagement. »» »» »» »» »» »» »» »» »» »» »»
Easy to use with simple ‘wizard’ menu to guide all users though the consultation and engagement process Low cost – multiple users can access the system via PCs and mobile devices to provide ongoing feedback and up to the minute information about user and customer views and experiences Feedback can be analysed demographically and geographically to give a clear picture of emerging themes and key issues Ability to manage multiple consultation exercises Upload data from meetings, web sites, or community outlets such as GP surgeries, town halls and schools Provides a clear ‘audit trail’ of activity to ensure ‘good practice’ and the meeting of legal requirements such as the ‘duty to consult’ Mapping feature shows ‘hot spots’ to identify areas where greater engagement is needed Analysis of feedback creates presentations for management and public meetings Our team can set up the system and upload an organisation’s existing databases for use in the consultation processes We can also set up and embed a new forward looking engagement approach in your organisation to improve customer and user experiences and enhance service delivery Bespoke solutions – building on the basic system we can add and tailor additional features to match customer’s exact requirements
For further information and a free demonstration email: info@consultation-plus.com