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mHealth and Home Monitoring
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Abstract for H2AD
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divestiture strategies in the ICT industry.
MHEALTH AND HOME MONITORING
ABSTRACT FOR H2AD
Index
Table of Contents
Table of Contents......................................................................................................................... i
List of Figures............................................................................................................................viii
Executive summary..................................................................................................................... 1
1
The challenge from welfare diseases .................................................................................. 3
1.1
1.1.1
The ageing world population ................................................................................ 3
1.1.2
Metabolic syndrome and lifestyle related diseases .............................................. 4
1.2
Common chronic diseases.......................................................................................... 5
1.2.1
Cardiac arrhythmia................................................................................................ 6
1.2.2
Hypertension ......................................................................................................... 7
1.2.3
Ischemic diseases ................................................................................................. 7
1.2.4
Sleep apnea .......................................................................................................... 8
1.2.5
Chronic respiratory diseases ................................................................................ 9
1.2.6
Diabetes .............................................................................................................. 12
1.2.7
Hyperlipidemia .................................................................................................... 13
1.3
2
Introduction.................................................................................................................. 3
Healthcare providers and reimbursement systems .................................................. 14
1.3.1
Healthcare in Asia-Pacific.................................................................................... 16
1.3.2
Healthcare in Europe .......................................................................................... 17
1.3.3
Healthcare in North America ............................................................................... 20
mHealth strategies of mobile operators ............................................................................ 23
2.1
Telecommunications in mHealth services................................................................. 24
2.2
mHealth market segments ........................................................................................ 25
2.3
Business models ....................................................................................................... 27
2.4
mHealth strategies of mobile operators in North America ........................................ 30
2.4.1
Verizon Communications .................................................................................... 30
2.4.2
AT&T.................................................................................................................... 32
2.4.3
Sprint ................................................................................................................... 34
2.4.4
KORE Telematics ................................................................................................ 36
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2.4.5
GreatCall.............................................................................................................. 36
2.4.6
TELUS ................................................................................................................. 38
2.4.7
SaskTel................................................................................................................ 40
2.5
Vodafone ............................................................................................................. 42
2.5.2
Deutsche Telecom .............................................................................................. 44
2.5.3
Orange Group ..................................................................................................... 45
2.5.4
Telefónica ............................................................................................................ 48
2.5.5
KPN ..................................................................................................................... 50
2.5.6
Telecom Italia ...................................................................................................... 52
mHealth strategies of mobile operators in Asia-Pacific............................................. 53
2.6.1
NTT DoCoMo ...................................................................................................... 55
2.6.2
SK Telecom ......................................................................................................... 56
2.6.3
Telstra.................................................................................................................. 57
Enabling technologies and initiatives ................................................................................ 59
3.1
Wireless M2M technology ......................................................................................... 59
3.1.1
Chipsets, modules and terminals........................................................................ 61
3.1.2
Device design and machine integration.............................................................. 64
3.1.3
M2M device value chain...................................................................................... 65
3.1.4
eDevice focuses on end-to-end M2M solutions for telehealth............................ 66
3.1.5
Qualcomm launches the 2net Platform and Hub................................................ 67
3.1.6
Wireless M2M module vendors in the mHealth market ...................................... 69
3.2
Mobile handsets ........................................................................................................ 72
3.2.1
Smartphone vendors and operating systems..................................................... 72
3.2.2
Application stores provide a new channel to the market for developers............ 75
3.2.3
Medical applications............................................................................................ 76
3.3
Personal health record initiatives............................................................................... 77
3.3.1
Google shuts down Google Health..................................................................... 78
3.3.2
Microsoft HealthVault .......................................................................................... 78
3.3.3
Dossia personal health platform ......................................................................... 80
3.3.4
PatientsLikeMe .................................................................................................... 80
3.4
ii
mHealth strategies of mobile operators in Europe.................................................... 40
2.5.1
2.6
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Industry associations................................................................................................. 81
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4
3.4.1
Continua Health Alliance..................................................................................... 81
3.4.2
The Bluetooth SIG Medical Working Group........................................................ 82
3.4.3
American Telemedicine Association ................................................................... 83
3.4.4
CTIA..................................................................................................................... 83
3.4.5
GSMA .................................................................................................................. 84
3.4.6
mHealth Alliance ................................................................................................. 84
3.4.7
West Wireless Health Institute............................................................................. 84
3.4.8
Wireless-Life Sciences Alliance........................................................................... 85
Home healthcare monitoring ............................................................................................. 87
4.1
Trends in health monitoring....................................................................................... 88
4.1.1
Going digital, going wireless............................................................................... 89
4.1.2
Distance disease management........................................................................... 91
4.1.3
Outsourcing of health monitoring ....................................................................... 92
4.2
Medical monitoring devices....................................................................................... 93
4.2.1
Cardiac monitoring.............................................................................................. 94
4.2.2
Blood pressure monitoring ................................................................................. 96
4.2.3
Blood coagulation monitoring............................................................................. 98
4.2.4
Blood oxygen level monitoring ........................................................................... 98
4.2.5
Glucose monitoring............................................................................................. 99
4.2.6
Lipid monitoring ................................................................................................ 101
4.2.7
Sleep monitoring ............................................................................................... 101
4.2.8
Breath monitoring.............................................................................................. 102
4.3
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Regulatory environment .......................................................................................... 103
4.3.1
Regulatory environment in Europe ................................................................... 103
4.3.2
Regulatory environment in the US .................................................................... 104
4.3.3
Regulatory environment on other major markets ............................................. 106
4.3.4
International standardisation............................................................................. 107
Physiological monitoring solution providers ................................................................... 109
5.1
Cardiac monitoring .................................................................................................. 111
5.1.1
Biotronik ............................................................................................................ 112
5.1.2
Boston Scientific................................................................................................ 113
5.1.3
Medtronic .......................................................................................................... 114
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5.1.4
Sorin Group....................................................................................................... 115
5.1.5
St. Jude Medical................................................................................................ 115
5.1.6
CardioNet .......................................................................................................... 117
5.1.7
LifeWatch........................................................................................................... 118
5.1.8
Corventis ........................................................................................................... 119
5.1.9
Curvus ............................................................................................................... 120
5.1.10
Q & S ................................................................................................................. 120
5.1.11
SHL Telemedicine ............................................................................................. 120
5.1.12
Vitaphone .......................................................................................................... 121
5.1.13
Zenicor .............................................................................................................. 122
5.2
Blood pressure monitoring...................................................................................... 122
5.2.1
Omron Healthcare............................................................................................. 122
5.2.2
A&D Medical...................................................................................................... 123
5.2.3
Microlife ............................................................................................................. 124
5.2.4
Rossmax............................................................................................................ 124
5.2.5
IEM .................................................................................................................... 125
5.2.6
Medisana ........................................................................................................... 125
5.3
Coagulation monitoring ........................................................................................... 126
5.3.1
Alere .................................................................................................................. 126
5.3.2
CoaguSense...................................................................................................... 127
5.3.3
International Technidyne Corporation............................................................... 128
5.4
Sleep monitoring ..................................................................................................... 128
5.4.1
Fisher & Paykel Healthcare ............................................................................... 131
5.4.2
Philips Respironics ............................................................................................ 131
5.4.3
ResMed ............................................................................................................. 132
5.4.4
Cadwell Laboratories ........................................................................................ 133
5.4.5
CareFusion ........................................................................................................ 133
5.4.6
Compumedics ................................................................................................... 134
5.4.7
Natus Medical.................................................................................................... 134
5.4.8
NovaSom........................................................................................................... 135
5.4.9
Watermark Medical ........................................................................................... 135
5.5
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Blood oxygen monitoring ........................................................................................ 136
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5.5.1
Covidien ............................................................................................................ 136
5.5.2
Masimo.............................................................................................................. 137
5.5.3
Nonin Medical ................................................................................................... 138
5.5.4
Opto Circuits ..................................................................................................... 138
5.6
Air flow monitoring................................................................................................... 138
5.6.1
Smiths Medical .................................................................................................. 139
5.6.2
Clement Clarke International............................................................................. 139
5.6.3
Medical Electronic Construction ....................................................................... 139
5.6.4
Medical International Research......................................................................... 140
5.6.5
Midmark............................................................................................................. 140
5.6.6
Ndd Medizintechnik........................................................................................... 140
5.6.7
nSpire Health..................................................................................................... 141
5.6.8
SDI Diagnostics................................................................................................. 141
5.6.9
Sibelmed ........................................................................................................... 141
5.6.10
Vitalograph ........................................................................................................ 141
5.6.11
Welch Allyn........................................................................................................ 142
5.7
Glucose level monitoring......................................................................................... 142
5.7.1
Abbott Laboratories........................................................................................... 143
5.7.2
Bayer Healthcare............................................................................................... 144
5.7.3
Johnson & Johnson .......................................................................................... 145
5.7.4
Roche ................................................................................................................ 146
5.7.5
DexCom............................................................................................................. 146
5.7.6
Telcare............................................................................................................... 147
5.7.7
Welldoc.............................................................................................................. 147
5.8
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Lipid monitoring....................................................................................................... 148
5.8.1
CardioChek ....................................................................................................... 148
5.8.2
Apex Biotechnology .......................................................................................... 148
5.8.3
Biomedix USA ................................................................................................... 149
Medication and integrated monitoring solution providers............................................... 151
6.1
Integrated telehealth solution providers .................................................................. 151
6.1.1
Bosch Healthcare.............................................................................................. 152
6.1.2
Honeywell HomMed.......................................................................................... 153
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6.1.3
Cardiocom......................................................................................................... 154
6.1.4
Philips Healthcare ............................................................................................. 155
6.1.5
Numera.............................................................................................................. 157
6.1.6
Viterion TeleHealthcare ..................................................................................... 157
6.1.7
Aerotel Medical Systems................................................................................... 158
6.1.8
American TeleCare............................................................................................ 159
6.1.9
Authentidate ...................................................................................................... 159
6.1.10
BlueLibris........................................................................................................... 160
6.1.11
BodyTel ............................................................................................................. 160
6.1.12
Grandcare Systems........................................................................................... 161
6.1.13
H2AD ................................................................................................................. 162
6.1.14
Ideal Life ............................................................................................................ 162
6.1.15
Intel-GE Care Innovations ................................................................................. 163
6.1.16
MedApps ........................................................................................................... 164
6.1.17
Medic4All ........................................................................................................... 165
6.1.18
OBS Medical...................................................................................................... 166
6.1.19
Tunstall Group................................................................................................... 166
6.1.20
Telehealth Solutions.......................................................................................... 168
6.2
7
Medication compliance monitoring ......................................................................... 168
6.2.1
Aardex Group .................................................................................................... 169
6.2.2
Bang & Olufsen Medicom ................................................................................. 169
6.2.3
Cypak ................................................................................................................ 170
6.2.4
Information Mediary Corporation ...................................................................... 170
6.2.5
Medicpen........................................................................................................... 171
6.2.6
Medsignals ........................................................................................................ 171
6.2.7
Proteus Biomedical ........................................................................................... 171
6.2.8
SIMpill................................................................................................................ 172
6.2.9
Vitality ................................................................................................................ 172
6.2.10
Vocel.................................................................................................................. 173
Market analysis and forecasts ......................................................................................... 175
7.1
7.1.1
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MHEALTH AND HOME MONITORING
Market analysis ........................................................................................................ 175
Cardiac implants comprise the bulk of RPM connections................................ 177
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7.1.2
Compliance requirements drive connectivity in the sleep therapy market....... 179
7.1.3
Lower reimbursement slows down uptake of mobile cardiac telemetry .......... 180
7.1.4
New entrants challenge leading providers of integrated telehealth solutions.. 181
7.1.5
Wireless connectivity gains momentum in several market segments .............. 183
7.1.6
Remote data transmission in other market segments ...................................... 185
7.2
Market forecasts ...................................................................................................... 187
7.3
Market drivers and barriers...................................................................................... 191
7.3.1
An ageing population ........................................................................................ 192
7.3.2
Increasing welfare disease prevalence ............................................................. 192
7.3.3
Focus on disease prevention ............................................................................ 192
7.3.4
Substitutes to medical monitoring .................................................................... 193
7.3.5
Resistance to change........................................................................................ 194
7.4
Potential market catalysts........................................................................................ 195
7.4.1
Increased monitoring during clinical trials ........................................................ 195
7.4.2
Insurance companies demanding monitoring .................................................. 196
7.4.3
New clinical evidence on cost effectiveness..................................................... 196
7.4.4
Non-prescribed monitoring and healthcare consumerism ............................... 197
7.5
Recommendations for mobile industry players....................................................... 197
Glossary .................................................................................................................................. 201
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Executive summary
eHealth is a term for healthcare practice supported by electronic processes and
communication. More recently, mHealth has begun to appear as a term for eHealth using
mobile phones or cellular networks. mHealth is a very broad term that principally involves
every kind of mobile health related communication, application or data service. This report
covers home health monitoring involving patient self-testing using medical devices and
remote transmission of the medical data to healthcare providers for disease management.
Some of the most common conditions being monitored today are chronic diseases including
cardiac arrhythmia, hypertension, ischemic diseases, sleep apnea, diabetes, hyperlipidemia,
asthma and chronic obstructive pulmonary disease (COPD). These conditions cause
substantial costs and reduce both life expectancy and quality of life. Berg Insight estimates
that more than 200 million people in the EU and the US suffer from one or several diseases
where home monitoring can become a treatment option. Applying information and
communication technologies in the healthcare industry can lead to decreased costs, more
efficient care delivery and improved sustainability of the healthcare system. However, the rate
of adoption is still slow and wireless technologies have only just begun to penetrate the
market.
At the end of 2011, around 2.2 million patients worldwide were using a home monitoring
service based on equipment with integrated connectivity. The figure does not include patients
that use monitoring devices connected to a PC or mobile phone. It only includes systems that
rely on monitors with integrated connectivity or systems that use monitoring hubs with
integrated cellular or fixed-line modems. Berg Insight forecasts that the number of home
monitoring systems with integrated communication capabilities will grow at a compound
annual growth rate (CAGR) of 18.0 percent between 2010 and 2016 to reach 4.9 million
connections globally by the end of the forecast period. The number of these devices that
have integrated cellular connectivity increased from 0.42 million in 2010 to about 0.57 million
in 2011, and is projected to grow at a CAGR of 34.6 percent to 2.47 million in 2016.
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MHEALTH AND HOME MONITORING
Several companies have developed integrated solutions for monitoring multiple chronic
diseases and other conditions. The six leading providers of integrated telehealth systems
include the major technology and electronics companies Bosch, Honeywell, Philips and
Bayer, as well as the small specialist telehealth companies Cardiocom and Numera.
Combined, these six companies account for 73.0 percent of the installed base of telehealth
hubs. The main market segments for medical devices with integrated connectivity are cardiac
rhythm management, sleep therapy and cardiac event monitoring. In these segments leading
providers such as Medtronic, Biotronik, St. Jude Medical, CardioNet, LifeWatch, ResMed,
Philips Respironics and Fisher & Paykel Healthcare today market wirelessly connected
solutions. Implantable cardiac rhythm management devices is by far the largest segment,
accounting for 74.3 percent of remotely monitored patients.
The major mobile operator groups including AT&T, Orange, Telefónica and Vodafone are
currently exploring the field and have set up business units dedicated to mHealth. The most
commonly used mode of expansion has been to establish strategic partnerships with
mHealth and eHealth solution vendors. Several operators are leveraging other vehicles for
expansion such as corporate venture capital, acquisitions and in-house development.
However, providing specialized solutions for the healthcare industry implies a significant
diversification from the core business. The challenge for mobile operators is to identify market
segments where they create most value, while at the same time limiting the potential
downsides of over-diversification.
The adoption of out-of-hospital wireless monitoring in healthcare is driven by a wide range of
incentives, related to everything from demographics and technology development to new
advancements in medical treatment. However, there are a number of barriers, including
resistance to change among healthcare organizations and clinicians, misaligned incentive
structures and the financing of wireless solutions by what is at large an underfunded
healthcare sector. Several catalysts are nevertheless likely to speed up the rate of adoption,
including increasing monitoring during clinical trials, insurance company requirements and
new clinical evidence on cost effectiveness. Significant events that will drive uptake include
the Medical Device Data Systems (MDDS) legislation in the US and the publication of the
results from the Whole System Demonstrator project in the UK.
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The challenge from chronic diseases
1.1
Introduction
During the last 50 years, the major cause of death in the Western world has shifted from
infectious to non-infectious diseases, mainly cardiovascular diseases, metabolic diseases and
cancer. The shift in disease panorama is mainly due to improved living conditions and
nutritional status of the population as well as new and improved treatments. Introduction of
vaccinations and antibiotics has attributed to this revolution. Today, life-style related diseases
are an important factor leading to illness and death.
The same pattern is seen in other areas of the world, such as China and India, when the living
conditions improve and medical treatments are made available. The World Health
Organization has concluded that by 2030, non-communicable conditions will cause over
three quarters of all deaths globally. Non-communicable diseases commonly reduce the
quality of life for many years before death results. They are associated with enormous costs,
both directly through medical treatments and consumption of healthcare as well as indirectly
by loss of productivity. Most of these diseases are related to lifestyle: smoking causing
cancer, chronic obstructive pulmonary disease (COPD) and cardiovascular disease, obesity
and inactivity causing type 2 diabetes and cardiovascular disease.
1.1.1
The ageing world population
Population ageing is the process by which older persons become a proportionally larger
share of the total population. It was first experienced by the more developed countries, but
the process has become evident in the developing world as well. In 1950, there were about
200 million persons aged 60 or over throughout the world. Fifty years later, the number of
persons aged 60 or over increased about three times to more than 600 million. Meanwhile,
the total population increased 2.4 times. The demographic transition associated with
population ageing has a substantial impact on economic and social conditions, for instance
regarding the viability of intergenerational social support and social security systems.
Population ageing also results in rising demands for health services and higher medical costs
since older people are normally more vulnerable to chronic diseases.
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MHEALTH AND HOME MONITORING
Figure 1.1: Population by age group (EU, North America and Japan 2010-2030)
Million people
EU27+2
Canada
USA
Japan
2010
All ages
514.0
34.0
310.0
127.0
88.8
4.7
40.2
29.4
17.3 %
13.8 %
13.0 %
23.1 %
All ages
527.0
38.0
341.0
123.0
Aged 65+
106.0
7.0
55.0
35.9
Share, 65+
20.1 %
18.4 %
16.1 %
29.2 %
All ages
534.0
41.0
373.0
115.0
Aged 65+
126.0
9.6
72.0
36.7
Share, 65+
23.6 %
23.4 %
19.3 %
31.9 %
Aged 65+
Share, 65+
2020
2030
Source: Berg Insight
1.1.2
Metabolic syndrome and lifestyle related diseases
Many non-communicable diseases are associated with the metabolic syndrome, defined as
obesity, elevated blood glucose levels, elevated blood lipids (hyperlipidemia), high blood
pressure and decreased sensitivity to insulin. The prevalence of metabolic syndrome in the
Western world is 20–30 percent and is steadily increasing. It is rapidly increasing in populous
countries such as China and India. There are more than 400 million obese people in the
world, defined as body mass index above 30 kg/m2 and the rates are rising. In the US, one in
three adults are obese and another third of the population is overweight (BMI 25–30 kg/m2).
In most Western countries, 10–20 percent of the adults are obese, while the level is less than
5 percent in Korea and Japan. Many Asian countries show a high growth rate in obesity.
Simplified, the rise of the metabolic syndrome is the result of three factors: an aging
population, excessive calorie intake and inadequate exercise. The two latter are avoidable, as
is smoking, which is also associated with the metabolic syndrome. However, people often do
4
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not adjust their lifestyle until it affects their quality of life considerably and it is then often too
late to reverse the effects. The metabolic syndrome is thus constituted of what is most often
chronic diseases or risk factors. Frequent or continuous monitoring of blood pressure, blood
glucose, blood lipids and heart activity improves the management of these diseases.
Smoking is a major cause of cancer, respiratory and cardiovascular disease. Many countries
have banned smoking in restaurants and public areas and tobacco taxes are being
increased. In most Western countries, smoking is declining although it is still common.
Moreover, as the effects of smoking are seen after several years of exposure, smoking-related
diseases are expected to increase, as cases of cancer and cardiovascular disease diagnosed
today are the results of smoking habits decades ago. In developing countries, the number of
smokers is increasing.
1.2
Common chronic diseases
This report focuses on monitoring of chronic diseases including cardiac arrhythmia,
hypertension, ischemic diseases, sleep apnea, diabetes mellitus, hyperlipidemia, asthma and
chronic obstructive pulmonary disease (COPD). These conditions cause substantial costs
and reduce both life expectancy and quality of life. Thus far, these conditions have attracted
most attention for home monitoring.
The economic burden of a disease is the total economic impact that the disease has on
society as a whole as well as on individuals and families. The total economic burden can be
separated into direct and indirect disease-attributable costs. Direct costs are the costs of
medical management of the disease and comorbid conditions, including inpatient care,
outpatient care and drug treatment. Indirect costs are loss of work productivity and premature
mortality, or other costs that arise from the disease.
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Figure 1.2: Direct and indirect costs of chronic welfare diseases in the US and EU
Sleep apnea
Direct
Asthma
Indirect
Cardiac arrhythmia
COPD
Diabetes
Hypertension
0
20
40
60
Source: Berg Insight
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80
100
120
140
160
180
200
€ Billion
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Medication and integrated monitoring
solution providers
6.1
Integrated telehealth solution providers
Integrated telehealth solutions enable remote monitoring and disease management for
patients at home or in assisted living facilities. The solutions available today are commonly
specialized towards a specific target market such as management of long-term conditions or
post-hospitalization discharge. The dedicated stationary device is currently the dominant form
factor with a market share of over 90 percent. However, the number of solutions featuring
more portable form factors is growing. Most providers offer their customers only one form
factor, but there is a trend towards providing users a wider variety of options.
The market for integrated telehealth solutions has been around for over a decade. Bosch and
Honeywell are today the leading providers followed by Cardiocom, Philips, Numera and
Viterion TeleHealthcare. However, there is a large number of smaller vendors and many new
companies are entering the market. Furthermore, some of the largest home care service
providers are developing proprietary solutions in-house or have acquired a telehealth solution
vendor. Some of these companies also provide their own vital sign monitors, while most use
monitors from third parties. Data transfer is provided by the monitoring hub or a connected
mobile phone, tablet or PC.
6.1.13 H2AD
H2AD is a French provider of telehealth services that was founded in 2004. The company’s
offering comprises telemedicine and telehealth services, health data hosting and remote
patient monitoring. The telemedicine and telehealth services are call center services delivered
on a 24/7 basis by a group of doctors, nurses and engineers that provide medical advice and
assistance. The company markets its health data hosting service as a secure, flexible an
reliable hosting service tailored for healthcare organizations. A part of this offering is the D2P
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platform that enables cloud-based storage of electronic medical records. A cornerstone of
H2AD’s remote patient monitoring service is the Twitoo telehealth hub, which has been
developed in collaboration with Telit, Sdataway and Locatis. Twitoo is a stationary device that
can connect with medical monitoring devices via Bluetooth and transfer the data to H2AD’s
remote server using an embedded M2M module. The Twitoo device is compatible with
monitoring devices including a blood pressure monitor and a scale designed by A&D, as well
as a pulse oximeter made by Nonin. H2AD offers the Twitoo device and associated services
to both consumers and healthcare service providers. Consumers can purchase the device
together with a four-year service contract for € 30 per month.
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of intelligence for our customers.
Other products available from Berg Insight:
Car Telematics and Wireless M2M
www.berginsight.com/m2m
Fleet Management in Europe
www.berginsight.com/m2m
Smart Metering in Europe
www.berginsight.com/m2m
The Global Wireless M2M Market
www.berginsight.com/m2m
Security Applications and Wireless M2M
www.berginsight.com/m2m
Smart Metering in North America and Asia-Pacific
www.berginsight.com/m2m
ITS in Public Transport
www.berginsight.com/m2m
LBS Insight newsletter
www.lbsinsight.com
A complete listing of Berg Insight’s current reports can be found at:
http://www.berginsight.com/reports
Berg Insight: Viktoriagatan 3, S-411 25 Gothenburg, Sweden Tel (46) 31711 30 91 www.berginsight.com