the mhealth revolution

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ADVANCED MASTER’S DEGREE IN STRATEGY AND MANAGEMENT OF INTERNATIONAL BUSINESS Presented by Bruno RAKOTOZAFY Professional Thesis Advisor: Xavier Pavie Mission Advisors: Laurent Roche & Eliane Apert The M-Health revolution: which opportunities for a medical device company? GE Healthcare

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ESSEC\’s professional thesis from Bruno Rakotozafy (2011). Following an internship at General Electric Healthcare

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Page 1: The mHealth Revolution

ADVANCED MASTER’S DEGREE IN

STRATEGY AND MANAGEMENT OF INTERNATIONAL BUSINESS

Presented by

Bruno RAKOTOZAFY

Professional Thesis Advisor: Xavier Pavie

Mission Advisors: Laurent Roche & Eliane Apert

The M-Health revolution: which opportunities for a medical device company?

GE Healthcare

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Résumé Le secteur de la santé est un secteur particulièrement complexe car il implique de nombreux acteurs et touche potentiellement tout le monde. Il est également hautement dépendant des états et des instances régulatrices ce qui le rend différent de tous les autres secteurs d’activités. C’est peut-être pour ces raisons que le secteur de la santé n’a pas encore été, ou peu, impacté par les Technologies de l’Information et de la Communication (TIC) comme l’ont été la plupart des autre activités. Cependant nous observons une tendance profonde au rapprochement entre la santé et les TIC, à l’heure où les gens apprivoisent l’usage de l’Internet et des objets connectés dans leur quotidien. Cette convergence naturelle entre une science millénaire et des technologies chamboulant l’ordre établi pourrait bien prendre son essor avec l’apparition de solutions innovantes de M-santé (santé Mobile). Instruments médicaux connectés, plateformes Internet participatives, applications santé sur smartphones, médecins connectés, téléassistance aux personnes dépendantes. Voici quelques exemples d’applications promises par la M-santé et qui pourraient révolutionner la façon dont le secteur est structuré et les soins sont prodigués. Les fabricants d’équipement médical possèdent la légitimité pour devenir les locomotives de ce mouvement en marche. C’est donc dès à présent qu’il convient, pour ces entreprises, de détecter les opportunités à saisir, d’imaginer les produits et solutions pertinentes, de construire l’écosystème associé et enfin de prévoir les modèles économiques qui seront viables.

Mot-clés : Santé, M-Santé, Equipement Médical, TIC, Internet, Smartphones, Docteurs.

Abstract The health sector is a particularly complex one because it implies lots of actors and impacts potentially everyone. It is also highly dependent on states and regulatory bodies making it be different from the other business sectors. This may be the reason why the health sector has not been stricken by Information and Communication Technologies (ICT), on the contrary to other business fields. However we can notice a convergence trend between health and ICT, while people have adopted the use of Internet and connected devices in a daily basis. This natural convergence is bringing the most promising applications with M-health solutions (Mobile health). Connected medical devices, web health platforms, smartphones’ health apps or connected physicians are some of the most encouraging solutions that could revolutionize the health sector and the way healthcare is provided. Medical devices manufacturers have the legitimacy to lead this undergoing movement. There is no more time to waste for those companies to detect opportunities, design relevant products and solutions, build associated ecosystems and overall imagine correct business models.

Keywords: Health, M-health, Medical Devices, ICT, Internet, Smartphones, Physicians.

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INTRODUCTION……………………………………………………………………..2 PART 1 -   THE HEALTH SECTOR: A CONSERVATIVE APPROACH DESPITE OF INNOVATIVE TECHNOLOGIES ................................................ 4  

1-   HEALTH CONCEPT IN THE SOCIETY.........................................................................4  a)   Sociological and demographical aspects...................................................................4  b)   Scientific aspects .......................................................................................................7  c)   Economic aspects......................................................................................................8  

2-   THE HEALTH SECTOR GATHERS A LOT OF PLAYERS...............................................10  a)   Women and men are the heart of healthcare ..........................................................10  b)   Pharmaceutical and medical equipment industries are innovation leaders .............13  c)   Payers: State is the primary payer and health insurances complete the offer.........16  d)   The patient: a forgotten end-user ............................................................................18  

3-   A BIG PICTURE OF THE HEALTH SECTOR...............................................................19  

PART 2 -   WHEN ICT MEET HEALTH.......................................................... 21  1-   FROM INFORMATION AND COMMUNICATIONS TECHNOLOGIES TO CONNECTED HEALTH TECHNOLOGIES ...........................................................................................21  

a)   A short story of communications and its recent ramping evolution..........................21  b)   Connected health technologies: E-health and M-health ..........................................24  

2-   DIFFERENT PLAYERS FROM DIFFERENT BACKGROUND IN THE M-HEALTH UNIVERSE.27  a)   Consumer electronics manufacturers ......................................................................27  b)   Infrastructure builders and telecom operators .........................................................29  c)   Healthcare stakeholders ..........................................................................................30  d)   A big picture of the M-health. ...................................................................................31  

PART 3 -   WHICH POTENTIAL MARKETS TO TARGET AND BUSINESS MODELS TO DESIGN?.................................................................................. 32  

1-   UNDERSTAND THE HEALTHCARE PATTERN AND IDENTIFY KEY CHANGING FACTORS .32  a)   Education/prevention, diagnosis, therapy, post-treatment monitoring.....................32  b)   Targeting the real challenges ..................................................................................36  c)   Home care services .................................................................................................41  d)   Patient empowerment..............................................................................................42  e)   Cost, access, clinical outcomes...............................................................................43  

2-   DESIGN A RELEVANT BUSINESS MODEL ................................................................44  a)   Why medical device companies are more likely to be leading players in M-health?44  b)   Build patient centric solutions ..................................................................................45  c)   Adaptation to the complex practice of healthcare....................................................47  d)   Build partnerships to provide fully integrated M-health solutions.............................48  e)   How to sell and monetized wireless health solution ................................................50  

3-   FORESEE ADVERSE OR COLLATERAL EFFECTS OF M-HEALTH SOLUTIONS: BE CONSCIOUS AND RESPONSIBLE INNOVATORS. .............................................................54  

a)   Ethics and health Information security.....................................................................54  b)   Reduce impact on environment and people ............................................................54  c)   Use of M-health in the developing world..................................................................55  

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Introduction

It is not abusive to say that the world has entered a new area: the connected world. This evolution has led to many changes in the society and in human activity. This movement has been supported by the emergence of Information and Communication Technologies also known as ICT. ICT is often quoted nowadays and in reality those technologies are much more present than one can expect since they are deeply impacting our daily life. These telecommunication technologies, and the consequential applications, are literally reshaping our life. In the meantime some activities stayed reluctant to these changes and have known kind of inertia. One of the obvious sectors that have remained conservative toward this trend is the health sector.

It would be crazy to think that the healthcare world will remain “disconnected” and completely separate from that revolution on the way. More and more people are now thinking about applying all those discoveries to health. And especially how applying mobile technologies to healthcare. It is still the preliminary phase of an important movement. What is sure is that the path seems to be though because of the inherent sector’s complexity but also because health is a serious matter. Yet this seriousness is also the most powerful reason to make changes happened. One significant point to highlight is that ICT technologies have radically changed the business approach in economic sectors already impacted. The shift from a selling-industrial-product approach to a providing-integrated-services one. In our case it makes sense since healthcare is basically a service.

The purpose of this work is clear. Help understanding both health and ICT sectors in order to understand how they can converge and how it would be possible to deliver relevant solutions. Understand the two universes means understand them deeply, understand their technical aspects, understand their own philosophy, understand their relationship with the people they provide and understand how the different stakeholders of both worlds could finally find a mutual interest. To be simple the problematic we are going to answer is:

“When health becomes mobile: which opportunities to catch and which business models to implement in order to provide and improve health services through mobiles devices. A natural convergence between ICT and medicine”

In order to deal with this really exciting but complicated subject it has been necessary to define the scope of such a work. Indeed it would have been pretentious trying to tackle every aspect of this challenging topic. One reason is that both health and ICT fields are extremely wide ones and include tons of different things. Another reason is that the diversity of our world make this problematic be very region-specific.

That is why first it has been chosen to focus on mature countries, and France will be our major illustration. We will sometimes consider and talk about the US because it is still one of the most innovative countries in the world and it will help us to provide more examples. Second we will treat the subject from a business point of view. Obviously we will have to deal with political, philosophical or ethical aspects but always as evidences to support the business relevancy. Finally we have decided to include in the scope a reflection about how those innovations could be responsibly designed.

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This work will be of interest especially for medical device companies which are, as we will see, the most relevant players to lead the wireless health movement. In a larger extent this report will be also useful for all actors that are involved in the healthcare and the ICT industry. The health sector is clearly undergoing main transformations and those innovations could be growth drivers in the near future. It will also be of interest for entrepreneurs who would like to take part in this revolution, because opportunities are huge and there will have space for a lot of actors.

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Part 1 - The health sector: a conservative approach despite of innovative technologies

Compared to other business fields the health sector is highly complex to approach. For our purpose, the aim is to understand how this sector is structured from a business point of view. But healthcare is much more than a simple business. Fundamentally it is even frequently assumed that healthcare is a public topic and for the Universal Declaration of Human Right1 health is recognized as a universal right (article 25).

In this particular context it is crucial to capture the full picture of the health environment. In order to do so we will first try to understand how healthcare activities are imbricate in human societies, at socio-demographic, scientific and economic levels. A second part will be dedicated to introduce the myriad of stakeholders playing a role in the healthcare universe. It will include healthcare professionals, industrial actors, payers and last but not least patients.

1- Health concept in the society

a) Sociological and demographical aspects

Humans and health

Health is a topic at the center of human existence as it is directly and indirectly linked to life and death considerations. From the first historical record discovered so far health issues have been mentioned. The first doctor known is Imhotep, an Egyptian who lived two millenaries before Christ2. Among other genius activities Imhotep left a textbook on how to treat some illness. To illustrate the importance of health and, as a direct consequence, the power obtained by persons who can master it, Imhotep was so revered that Egyptians used to worship him as a god. Medicine genesis can even be tracked before Antiquity, thanks to records of plant use for medicinal purpose.

According to the World Health Organization “health” is “a state of complete physical, mental and social well-being, and does not consist only of the absence of disease or infirmity”3. This modern definition of health put emphasize on the fact that health not only includes anatomical aspects but also psychological and mental ones. We will not try to debate about the border between well-being and being healthy because it is not relevant for our purpose. But we could be sure that as a general matter, health is a key occupation in human’s life.

Is health an individual or a group concern?

In the 1940’s a psychologist called Abraham Maslow delivered a theory to explain what motivated humans. His theory, originally presented as a hierarchical model was later simplified into a pyramidal scheme, as showed in Figure 1.

1 Déclaration universelle des droits de l'homme, 1948 (http://goo.gl/1c7kv) 2 Saari, Peggy. “Medicine And Disease – Who Was The First Doctor In History?.” History Fact Finder. Ed. Julie L. Carnagie. UXL-GALE, 2001. eNotes.com. 2006. 30 Sep, 2009 3 Preamble to the Constitution of the World Health Organization, 1946 (http://goo.gl/ZRAUF)

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This representation helps us to realize that health is a basic need. And because it is a basic need for each of us, maintaining a good level of health is a strong individual motor.

Nevertheless we can feel that health is more than an individual concern, it is also a group preoccupation.

First, the ill person often cannot treat itself. It receives treatment from another person. Answering the health need require, at least, 2 people. Second because a disease not only impact the sufferer but also its entourage. Because either the disease is contagious, or because the sick person cannot take care of itself. So quickly civilizations and society had to organized health

structures in order to manage or monitor individuals’ health. In a society this organization is often known as “public health”. According to Charles-Edward Amory

Winslow, a famous American thinker and teacher at Yale University, public health is “the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals”4. This concept was theorized quite recently but we can observe practical examples of it since ancient times. For instance Romans understood that it was necessary to control human waste diversion in order to limit diseases among urban populations.

Today public health is a major concern in western countries and in 1948 a world-scale structure were set up to tackle with this issue: the World Health Organization (WHO). In a majority of mature countries, including France, health is highly funded by governments and represents a huge part of states’ expenditures. Governments implication is justify by the fact that health is considered as a primary right. National health insurances will be described later but we can already write that health, as a group concern, is an economic subject.

So we better understand now that health is both an individual and a group concern. It is important to know that for our purpose. Indeed we will take into account this double consideration when we will talk about relevant business models to design. Mobile solutions will have to be individually accepted while promoted by opinion leader groups.

Different cultures, different health standards

As we have just seen health is a double concern. But we can also underline that health is culture-dependent. Health is closely link to cultures and religions since it concerns person’s intimacy. The science that focuses on that relationship is called medical anthropology. Herman, in 2000, defined the medical anthropology as “how people in different cultures and

4 The Untilled Fields of Public Health, C.-E. A. Winslow, 1920 (http://goo.gl/NcyPY)

Figure 1 - Maslow's hierarchy of needs

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social groups explain the cause of ill-health, the type of treatments they believe in, and to whom they turn if they do become ill”5. It is not a revelation to say that in different cultures health is considered differently. Eastern countries put emphasize on traditional and soft medicine. For them plants are the most efficient drugs. And mind is the better tool to prevent or fight illness. In some other cultures or religion, women are treated differently than men. Even if we will focus on western countries in this work, it is useful to be aware of that since populations in those mature countries are being more and more multi-cultural.

In general, health in the western world is characterized by its technical-medical approach. If we have another look at the WHO definition of health (“state of complete physical, mental and social well-being, and does not consist only of the absence of disease or infirmity”) we could say that health practice in western world is focused on “physical” and “absence of disease or infirmity”. In practice it means that health is a scientific subject that should be handled as a pragmatic, factual and empirical one. Little credit is given to non-visible, non-demonstrable solutions. Strong evidences are mandatory and it is the only valuable way to proceed.

We should keep that idea in mind because rationality will be the principal way to give value to mobile solutions. It will be necessary to provide strong evidences and measurable benefits.

Health and demography

To conclude with the importance of health in our societies it makes a point to talk about health and demography. Not only health discoveries have strongly impacted the world demography but the opposite is also true. Demographic changes influence health systems. Life expectancy has globally (but unequally) rose all along human history in parallel to health innovation that has allowed reducing mortality. As a consequence the world population has exponentially grown. Hardly 1 billion human on earth in 1800 it is assumed that we will be 9 billion in 2050. For sure those medical innovations were major improvements for humanity. But in the meantime there are side effects of this demographic explosion, indirectly impacting health of people. It will be tough to detail all factors that have been influenced by demographic changes and in return threat our health so we will just give some easy examples.

Demographic boom has increased populations’ concentration. In addition to rural exodus in mature countries during the last century it has led to a very high human density in urban areas. And this over-population not well structured can sometimes causes different issues. Among others it is a factor creating insanitary zones and promoting spreading of contagious illnesses.

Ageing population is another heavy demographic trend. Medical progress allowed people living longer but this has also brought a bunch of new diseases specific to elderly. This is particularly important in mature countries and we will see further the impact of that ageing trend.

5 Culture and Health: Applying Medical Anthropology, Michael Winkelman, 2008 (http://goo.gl/csWTu)

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b) Scientific aspects

For a better understanding of health sector it is important to exhibit a brief timeline of medical practice and technologies.

From antiquity to Middle Ages

The first proof of medical practice is dated from the new Stone Age6 with the discovery of trepanations practice. Trepanation consists in boring a hole in the skull. It is believed that trepanning was used to relieve horribly painful headaches.

As said previously Imhotep was the first physician known by name. But it is considered that the born of modern medicine came with Hippocrates, around 400 years B.C. Hippocrates (460-310 B.C) based medicine on objective observation and deductive reasoning. Galen (131-201 A.D) was considered to be the most important contributor to medicine following Hippocrates. He was personal physician to several emperors and published some 500 treatises. Up to now he is still respected for his contributions to anatomy, physiology, and pharmacology.

Persian doctor Rhazes (865-925 A.D) is famous for having pioneered pediatrics and was known to have been the first to use anesthesia before surgery. Muslims have brought a lot in the history of medicine. Avicenna (980-1037) wrote The Book of Healing and The Canon of Medicine, establishing experimental medicine and evidence-based medicine. He was the precursor of modern hospital concept in the Middle East. Those books remained a standard in European universities until the 18th century. A second Muslim, Avenzoar (1091–1161) is known to be the father of modern anesthesia.

From 16th to 18th centuries

But this is not until the early 16th century that Paracelsus, a German alchemist, pioneered the use of chemicals and minerals in medicine. Then there was a major revolution in European medicine with the release of Fabrica Corporis Humani, written by Andreas Vesalius, which corrected major Greek medical errors. In the meantime variolation (infecting people purposively with smallpox) was implemented in China7. Variolation, and inoculation in general, would further lead to vaccination’s concept.

In 1590 Janssen invented the first rudimentary microscope. This was an important milestone in medicine’s history since Anton van Leeuwenhoek (1670) used this tool to first to characterized human cells. In 1650 Sir Christopher Wren was the first to administer medications intravenously and experiments with canine blood transfusions.

Later, Edward Jenner (1749-1923) developed a method to protect people from smallpox by exposing them to the vaccine virus (a cow disease). The process became known as vaccination. Jenner is sometimes called the founding father of immunology.

The 19th century: revolution of tools

6 History of medicine, Wikipedia (http://goo.gl/HBTB7) 7 Une petite histoire de la medicine, Valentin Daucourt, 2002 (http://goo.gl/oZfi4)

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For a long time, the practice of medicine was based on patient’s descriptions of symptoms not based on hands-on experience such as examination of a patient’s body. The 19th century was a turning point for physicians thanks to innovations in medical techniques and equipment to better diagnose and treat patients.

Stethoscope (1816), ophthalmoscope (1851), laryngoscope (1859), X-ray use for medical imaging (1895), sphygmomanometer (blood pressure meter, 1896) and ECG (1901) changed the way diagnosing people, to hear, feel and see their bodies.

The first human blood transfusion (1819), the first vaccine for cholera (1879) and the first bottle of aspirin sold (1899) were major innovations to treat or prevent people.

In parallel new methods improving medicine practice appeared. Antiseptic Principle of the Practice of Surgery (1867) by Joseph Lister, convinced of the need for cleanliness in operating rooms. In the 1870’s Louis Pasteur and Robert Koch established the germ theory of disease. Before this discovery, most doctors believe diseases were caused by spontaneous generation.

The 20th century and now

Everything went faster during the 20th century. The use of technologies from other fields allowed a revolution in diagnosis. Medical imaging breakthroughs (X-ray, ultrasound, computed tomography, magnetic resonance imaging) resulted from advances in physics, mechanics and computer sciences. Biological diagnosis benefits from innovations in biology and automation. There was in the same time a revolution in treatment. Drug manufacturing benefits from chemistry and biology improvements. Equipment like intensive care units or pace makers overcome unpaired human functions. Transplantations and grafts became a reality thanks to biology advances.

Today we even go further with biotechnology and bionic sciences. We are almost able to create super-humans or living beings from scratch.

Despite of this huge step further in health technologies during the last century, practice of medicine has not evolved as fast. This prosperous era of technology improvement was a good thing for the emergence of health industry (pharmaceutical and equipment industry). But when we talk about how healthcare is provided, progresses are few. More than that, healthcare professionals have loose influence and weight in favor of the industry.

c) Economic aspects

In order to evaluate the weight of health in our society it is important to determine the economic impact. The aim of this report is to select best opportunities to be addressed by mobile solutions and it is worth understanding the most promising health sub-sectors.

The Chart 1 gives us an overview of health expenditures’ weight compare to the GDP in France. Representing 11,7% of GDP in 2009, French health expenditures are far below the USA spending around 17,4% of their GDP. Nevertheless it is above the OECD average (9,5% of GDP).

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2000 2009 Care and medical goods consumption (CMGC) 115,1 175,7

Funding pattern of CMGC: Social security 77,1% 75,5%

Local collectivities 1,2% 1,3% Complementary Organisms (Mutual fund, Private

Insurance) 12,7% 13,8% Households 9,0% 9,4%

Residential Care Facilities 2,9 7,4 Daily indemnity 8,2 11,9 Prevention 4,1 6,2 Health professionnals social coverage 1,6 2,0 Research 5,4 7,5 Training 0,8 1,3 Administration costs 11,4 15,3 National health expenditures 146,9 223,1 % of GDP 10,2% 11,7%

Chart 1 - France health expenditures, € billions (source: INSEE)

Obviously “Care and Medical Goods Consumption” is the first account but it is remarkable to notice that administrative costs ranked second, with almost 7% of the total.

Translate into per capita expenditures it gives €3600 for every French citizen. “Care and Medical Goods Consumption” is mainly financed by the Social Security with up to 75% of expenditures covered. But between 2000 and 2009 the part of households and complementary organisms in that funding rose by 1,5%.

2000 2009 Hospital care 52,7 78,0 In-town care 31,2 48,3

Physicians 15,2 22,1 Healthcare associates 6,3 11,6

Dentists 6,7 9,8 Analysis 2,8 4,5

Other 0,3 0,3 Transportation 1,9 3,6 Medications 23,6 35,4 Other medical goods (glasses, prosthesis, disabled vehicles, small equipment and bandage)

5,7 10,5

Care and Medical Goods Consumption 115,1 175,7 % of GDP 8,0% 9,2%

Chart 2 – Breaking down of Care and Medical Goods Consumption, € billions (source: INSEE)

A deep dive into the principal account of national health expenditure, “Care and Medical Goods consumption”, shows us that some categories have almost doubled (Chart 2). For instance the “healthcare associates expenditures” account, mainly represented by nurses and physical therapists rose from €6,3 to €11,6 billion. The same observation can be made about the “other medical goods” category. It could be explained by a volume increase and a price increase.

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Finally it is important to notice that the economical weight of health depends on the population’s age. Figure 2 explicitly proofs that the older the person is , the higher health expenditures are. The impact of ageing population is then obvious.

2- The health sector gathers a lot of players.

In this section will be exposed and detailed the categories of players that are involved in the health sector. The description will be based on mature countries scheme, especially on French and US ones. It will help us to determine who hold influence and decision’s powers.

In order to approach the sector easily, four groups of « involved parties » have been identified and will be set forth. First, healthcare professionals, representing the heart of healthcare service. Second, health industrial companies, including pharmaceutical and medical devices firms, providing healthcare professionals with tools and products to treat individuals. Strongly linked to the first category they often are the initiators of innovations. Then states and governments will be depicted as central players in the stakeholder map. Finally patients will be outlined. Although they are the final beneficiaries of any healthcare service it makes a point to describe this group lastly if we consider its power of influence.

a) Women and men are the heart of healthcare

The general practitioner is the common image that comes to one’s mind when the health professional word is mentioned, at least in western countries. But it would be improper to limit the healthcare workforce to this unique category of women and men.

Because « healthcare » include the word « care » it will not be surprising that the healthcare professional category includes social and paramedical occupations in addition to general and specialist physicians.

Health occupations: from medicine competencies to social activities

Healthcare professionals constitute a non-homogeneous group of people aiming at providing health services to individuals, families and communities. But their action is not limited to cure ill people as they also provide preventive, promotional or rehabilitation services. This way they also have an impact on healthy people.

Graph 1 - Health expenditure per capita by age (source IRDES)

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Physicians and pharmacists: the upper class

According to INSEE standards (French Statistics Institute)8 a first sub-group can be identified. It gathers the medical and pharmaceutical professionals. Highly knowledgeable about medicine, doctors in medicine, professors in medicine, pharmacists but also dental surgeons represent an upper class within the health workforce, since they are the most skilled. Their mission is to promote, maintain or restore human health thanks to the inquiry, diagnosis, and cure of physical disorders, diseases or mental impairments.

In almost all countries, educative paths to become medical or pharmaceutical professional are among the toughest and the most elitist ones. For instance in France a doctor is authorized to practice after 6 years of higher education at university and 3 years of internat under the responsibility of an experienced physician. A numerus clausus is applied as soon as the second year and limits the number of practitioners. If one desires to be a specialist, the internship part is again longer. Education for pharmacists or dental surgeons is roughly as long and hard.

Being a practitioner is often a vocation. The personal choice to carry out a hard educative course may be motivated by different factors but generally it has roots in the idea of helping and curing others. The Hippocratic Oath9 shows exactly that state-of-mind. Requiring a high level of knowledge for treating people and make them being in a better shape there is also a high degree of psychology in the art of medicine. The psychoanalyst Mr Balint has studied the particular physician-patient relationship and it results to 3 key points10.

i) One of modern medicine’s weak is its trend to focus more on curing a disease than treating an ill person.

ii) One third of the medicine practice is only a psychotherapist one. iii) The physician-patient relationship is based on domination and submission, linked to

the power of the physician and the weakness of the patient.

Other aspects of this physician-patient relationship will be discussed further in a part dedicated to the rebalance of the power and its acceptance for the development of health mobile services. One last point is that people (and physicians too) often considers the activity of physicians as synonymous with high ethical and integrity standards and hardly with a commercial occupation. That is also a fundamental point in the design of an acceptable business model for mobile health services.

Pharmacists are in a quite similar position than physicians in their relation with patient. Their mission is to guarantee the well distribution and selling of medication and to ensure the safe and effective use of medication. They act as intermediaries between the prescriber and the patient. In this role they share a heavy legal responsibility with physician. In France, pharmacists have also prescriptive authority. Moreover these medication specialists are often the first point-of-contact for patients and their role more and more includes the management of health. That mechanically increases their responsibility. On the contrary to physicians, the

8 INSEE, Healthcare professionals in France, 2010 (http://goo.gl/uQgjZ) 9 Hippocratic Oath, Translated by Michael North, National Library of Medicine, 2002. (http://goo.gl/yZuI3) 10 Balint M. " Le Médecin, son malade et la maladie " Trad. J.P. Valabrega,Petite collection Payot, Paris, 7ème éd. 1996

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pharmacist’s status suffers from a lack of recognition. Although they bear an enormous level of responsibility they tend to be seen like commercial professions. Plus their relations with physicians have often been conflicting when it is about to decide the limits of each other’s activity, and the share of decision power between them. The emergence of generic and over-the-counter drugs continues to create divergences. However pharmacists remain key players in health systems and a 2009 poll in France11 illustrates this statement. 55% of interviewees answered that the pharmacist is the second most viewed health professional and for 96% of the sample “the pharmacist is an essential health professional”.

All these factors have feed the idea that medical and pharmaceutical professionals are above the average persons. In a 2009 French poll title “Perception of occupations”12, the general practitioner occupation is ranked 2nd in both term of prestige (48% of interviewees answered “lot of prestige”) and term of utility (79% answered “very useful”). As a result it may be logical that a feeling of superiority appears among the medical professionals themselves. The point here is not to criticize their status and the importance of their competencies but to understand how they can feel uncomfortable faced upon major changes the mobile health revolution could bring.

Medical assistant occupations: the insiders

Besides the medical and pharmaceutical sub-group, still according to the INSEE categorization, we found medical assistant occupations. This category gathered a wide panel of health professionals including nurses, diverse therapists (physiotherapists, podiatrists, speech therapists, orthoptists, opticians or audiologists) and technicians (mainly X ray technicians). Their role is totally supplementary to the first sub-group of physicians and pharmacists in providing health services. These occupations are seen as less prestigious in modern health system. This is the case for some therapists, not considered as specialist physicians, and overall the case for nurses. The education path is for sure shorter and their scientific knowledge level is obviously lesser than physicians one. But they play a key role in the act of providing health care and support the physician or pharmacist’s activity. In general they also pay more attention to the environment and the history of patients than physicians and as a consequence are really good interlocutors for patients.

Within this group nurses and midwives represent the largest contingent. Indeed, according to 2011 WHO (World Health Organisation) statistics in (Chart 3), nurses and midwives are globally twice as much as physicians.

Physicians Pharmacists Nurses & midwives France 213 821 75 432 548 429 World 9 171 877 2 587 043 19 379 771

Chart 3- Healthcare workforce (source: WHO health report statistics, 2011)

Although they do not or hardly have prescriptive authority, medical assistant workers are key actors in the development of mobile health services for different reasons:

i) They are numerous and constitute a dense network. ii) They really are on-the-field and have the empirical knowledge of the health system

11Vision Critical, Image et attachement des Français à la profession de pharmacie, 2009 (http://goo.gl/xShto) 12 Logica-TNS Sofres, L’image des professions, 2009 (http://goo.gl/4gNDh)

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iii) In some areas they are the only health actors, especially in remote areas. iv) They are receptive to innovations that increase their recognition. v) They are interesting in solutions improving their efficiency.

b) Pharmaceutical and medical equipment industries are innovation leaders

There are two industries that are predominant in the health universe. First is the pharmaceutical industry. Second is the medical equipment one. Both of them are very powerful, scientifically and economically. The major milestones of medicine innovation have been previously explains and it showed that at the beginning initiators of breakthroughs were mostly men and women. Pharmacists were used to create drugs in their own laboratories. And ingenious people invented physical or mechanical systems to diagnose or help physicians curing diseases. Then in the last century, the health sector was deeply transformed by the industrial revolution that occurred in all the business areas. Today pharmaceutical and medical equipment firms are unavoidable and among the most influential and profitable at a global level.

The aim of this part is first to discover how these industries are organized. The second objective is to understand the exact role of those companies and how they interact with the other health actors in mature countries. A last point will raise the paradoxical situation between the purpose of a for-profit enterprise and the ethical dimension of health business.

Pharmaceutical companies

The pharmaceutical industry develops, produces, and markets drugs for use as human or veterinary medications. It is one of the most profitable industry gathering pharmaceutical laboratories and biotechnology companies.

Facts and figures

At the beginning medication used to be made by apothecaries and sold in drugstores. The first of this store known was active in the medieval Islamic world, a fertile region and period for health innovations, as previously detailed. Most of contemporary’s pharmaceutical companies were born during the chemical revolution at the end of 19th century when drugs could be synthesized.

The 2009 global pharmaceutical market was evaluated at $810 billion. The French domestic market weighted more than $40,5 billions the same year according to IMS Health13, at the fourth position after the US, Japan and Germany. The average net income for the top ten companies is around 19% according to Global 500’s Fortune ranking.

Produce a pharmaceutical product requires a lot of money and time. In addition to be one of the most profitable industries it is also the one spending the most in research and development. Overall 2009 global expenditure on discovering and developing new medicines amounted to an estimated of $70 billion14, i.e. 9% of revenues.

13 Global pharmaceutical industry and market, ABPI (http://goo.gl/NT73t) 14

Drug R&D spending fell in 2010, and heading lower, Reuters, 2011(http://goo.gl/hEBsa)

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Just to understand briefly the pharmaceutical activity it is useful to have a look at Figure 3. As showed, the development process for one drug, before being on the market, lasts between 10 and 12 years and costs in average $850 million15 according to a recent study.

Figure 2 - Development of a pharmaceutical product

Marketing expenses and compliance in the pharmaceutical industry

After R&D, the marketing and promoting effort is the most important activity for pharmaceutical firms. Worldwide pharmaceutical marketing & sales spending were of $89 billion in 2009 according to Cegedim16, a market research company. Yet this is significantly higher than R&D expenditures and it can be explain because of different factors.

The most valuable assets for a pharmaceutical company are its patents. In general a patent lasts 20 years with the possibility to extend this period for few years. A patent allows the firm to make sustainable selling of the patented drug without being threat by the competition. If we have a look to pharmaceutical firms‘ financial accounts we can observe that revenues are concentrated on the best-seller drugs, also called blockbuster. Unfortunately we are today in a period were a lot of patents are falling in the public domain, without being really replaced by new blockbusters. It is a marvelous opportunity for a new kind of pharmaceutical companies that manufacture generic drugs based on this unpatented blockbusters. In such an environment the battle occurs on the marketing and sales fields that need huge amounts of money.

Another particularity of the pharmaceutical industry is the tough regulatory frame. The Figure 3 shows that a market launching follows 2 pre-approvals and one final approval from regulatory bodies. In France the regulatory organism is called AFSSAPS. And it is never finished since during the commercialization a drug is still assessed. The phase 4, or pharmacovigilance phase, aims at evaluating the benefit/risk ratio. Some recent events in France (for instance Servier case) have showed that this continuous evaluation is both necessary for the users and critical for the companies.

15 Estimating The Cost Of New Drug Development: Is It Really $802 Million?, C. P. Adams and V.V. Brantner,2011 (http://goo.gl/MXn0U) 16

2010 Audited Pharmaceutical Marketing Expenditure Results, Cegedim Strategic Data (CSD), 2011 (http://goo.gl/i4TXe)

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Are pharmaceutical firms responsible innovators?

Up to now pharmaceutical companies have not been the most active in integrating responsibility in their innovation process and in the lifecycle of their products. For instance tough debates are tough about the animal testing during pre-clinical trials. In 1959 Russel and Burch have described the “3Rs” principle for the use of animals in research17.

i) Replacement refers to the preferred use of non-animal methods over animal methods whenever it is possible to achieve the same scientific aim.

ii) Reduction refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.

iii) Refinement refers to methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals still used.

Drug recycling channels exist but have experience issue. In France Cyclamed was created by pharmaceutical companies to cope with the collect of pharmaceutical products. These products are particularly sensitive ones since they include complex component. Unfortunately Cyclamed has to stop its recycling activity (sending of unused drugs in poor countries) in 2008 due to embezzlement problems.

Medical device companies

Medical device companies are the other health industry actors. According to the WHO a medical device means “any instrument, apparatus, implement, machine, appliance, implant, software, or material to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment of a disease or an injury”18. By definition this term covers a vast range of equipment, from simple tongue depressors to MRI machines, including wheelchairs or pacemakers. In other words this industry provides thousands of different products. It is still possible to categorize those products into different classes:

i) Diagnostic/analysis devices ii) Drug administration or surgery devices iii) Substitution/support devices iv) Monitoring devices

Facts and figures

As a consequence there are hundreds of companies operating in this market, but the majority of revenues are concentrated by thirty of the top companies, among them: Johnson & Johnson, Siemens Healthcare, Medtronic, GE Healthcare and Baxter.

According to Kalorama19, the 2009 global medical device market was valued at $290 billion, roughly a third of the pharmaceutical market. The French market is estimated at $14.6 billion by SNITEM20, representing around 5% of the global market.

17The Removal of Inhumanity: The Three R's, Russel and Burch, 1959 (http://goo.gl/jmP7C)

18 Medical device regulations: Global overview and guiding principles, WHO, 2003 (http://goo.gl/acWMP) 19 Medical Device Revenue to Top $300 Billion This Year, Kalorama, 2011 (http://goo.gl/8CNb0)

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Over the last decades medical devices technologies have experienced an impressive evolution contributing to the general improvement of healthcare. Amongst other, medical imaging companies democratized the use of today routine machine, such as MRI or CT, and continue discovering new applications every day. The diagnostic process has become considerably more precise thanks to those technologies.

In the same time the different technologies have not only converged between them but also with pharmaceutical ones. Diagnostic imaging firms, like GE Healthcare or Siemens, have acquired in vitro diagnosis ones. Laboratories like Abbot, Roche and Baxter have developed strong business segments in medical devices. Indeed medical devices technologies have key advantages over their drug counterparts. Product development process last between 3 to 5 years, compared to 10 to 12 years for a drug. Regulatory approvals are also less risky since the majority of medical devices are not invasive.

This industry has a higher potential than the pharmaceutical industry, to answer the health challenges including cost efficiency, care accessibility and diagnosis accuracy in order to deliver the most relevant treatments. And this trend is already observable in figures since the sector growth over-performs the pharmaceutical industry one21.

From a responsible innovation point of view, the medical device industry is as critical as the pharmaceutical industry. Let us remember that old thermometers were made with mercury inside. It is not before 1999, with a law forbidding marketing mercurial thermometers than device makers stopped manufacturing them. There is also a high concern about the disposable character of some medical accessories.

c) Payers: State is the primary payer and health insurances complete the offer.

As an introduction to this part we will repeat that the scope of this work is limited to mature countries and especially to France. Indeed in many countries it is left to the individual to gain access to health care goods and services by paying for them directly as out-of-pocket expenses. On the contrary, in France, health is heavily funded thanks to the national social security, up to 75% for the Care and Medical Goods expenditure as detailed previously.

The French National Health Insurance system

In France the Social Security was founded just after the WW2, in 1945. The Social Security includes 3 branches: Health Insurance, Retirement Insurance and Family Insurance. The purpose of this system is to “guarantee employees and their family with a protection against any potential risks likely to cut or suppress their income, covering maternal and family expenditures” (article 1)22. Before this date there were social insurances but they were organized by workers associations23. After 1945 those group claimed to keep the social advantages they already had.

20 Le marché en chiffres des dispositifs médicaux en France, SNITEM, 2011 (http://goo.gl/MoV2R) 21 Global medical device market outperforms drug market growth, M. Rosen, 2008 (http://goo.gl/5dIsn) 22 Ordonnance portant organisation de la securite sociale, 1945 (http://goo.gl/oUS6R) 23 Le financement du système de santé en France, WHO, 2004 (http://goo.gl/mNHup)

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The National Health Insurance system is simple in theory. Every worker and employer has to contribute via mandatory taxes to fill a national health insurance fund, as a proportion of the salary earned or spent. In return those contributors could benefit from the health insurance when he or she will need care or medications. Solidarity is an important element of the French insurance system: the more ill a person becomes, the less the person pays.

Figure 3 - Scheme of the French Health Insurance Fund in 2009

Figure 4 presents how the French Health Insurance was financed and redistributed the money in the health system in 2009. One important point is the asymmetry of this system. Indeed there are more expenses than income, and the deficit was about €11 billion in 2009. And it is a chronic problem even tough regular modifications have been made. At the beginning, in 1945, there were no taxes to fund the Health Insurance. The CSG tax, based on employee revenues, was only implemented in 1990. While expenses were still overtaking incomes the deficit had to be cover by debt. Then in 1996 the CRDS tax (Contribution to Reimburse the Social Debt) was added. The same year the French government voted different laws to help reducing health expenditures, including hospital reforms and efficiency rules.

Up to now the Health Insurance deficit remains an issue and the consequences have a real impact over the whole health system. For instance states do not hesitate to put pressure on the health industry, via regulatory agencies, in order to better control price, quality or efficiency of drugs and medical devices. Another tactic is to reduce reimbursement of some medical products or care. For instance in the 1960, dental and optical care reimbursements were strongly reduced. In that case the impacted stakeholders are patients because they have to pay out-of-pocket.

In parallel to national health insurances, usually not covering 100% of health expenditures, people have the choice to subscribe a private health insurance. In 2008 92% of French were covered by a complementary insurance, compared to only 69% in 198024 (Chart 4).

24 La complémentaire santé en France en 2008 :une large diffusion mais des inégalités d’accès, IRDES (http://goo.gl/4S0xi)

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Mutual Fund Private Insurance Contingency Fund French population

coverage 59% 24% 17% Health expenditures

coverage 7,7% 3,5% 2,5%

Chart 4 - Health complementary insurances in France (source: DREES)

In that kind of state-controlled health system with a population relying on a dominant National Health Insurance, selling a health product is not that easy. The business model should either include a solid partnership with a payer (regulatory approval or private insurance partnership) or an inexpensive product for patients. It will definitely be an important point to describe.

d) The patient: a forgotten end-user

We deliberately finish the description of health sector stakeholders with the patient since it is the end-user and final beneficiary of the health system. The word “patient” originally meant “one who suffers”. We will portray patients under different angles.

Sometimes patient, sometimes consumer

The patient is the receiver of any healthcare service, most often ill or injured. In comparison with other business sector, the patient could be considered as the counterpart of the consumer. In reality fundamental barriers exists between a consumer and a patient. By definition the consumer is the “economic agent who choose, (buy), use and consume a good or a service”. In the health system the patient systematically differs from the decision maker (generally the prescribing doctor) and very often also from the bearer of the costs (generally the health insurance system). Moreover the patient suffers from an asymmetrical level of knowledge concerning health products and is dependent on health providers. This characteristic causes divergent interests and a lack of clarity in relations between the health actors. Pharmaceutical companies focus more on healthcare professionals and state agencies than on patients (anyway advertisement toward patients is forbidden for them). The same way physicians hardly asked for patient opinions before treating them. In practice patient is a passive player with no influence power.

Things are moving and the patient role is gaining importance within the health system. Causes come from the inside and the outside. Within the system, due to pressure from the government, patients are progressively educated. Education campaigns aim at rising patient awareness in the way they receive care and consume medications. For example, the campaign to limit antibiotic usage succeeded in its purpose to control the misusage of those drugs. The reforms to improve patient health pathway gave people the responsibility to choose a general practitioner and respect the procedure in order to be fully reimbursed. More over recent health scandals, like Servier’s Mediator case in France, have contributed to increase a mistrust feeling among peoples. They claim for better transparency and communication from the health providers, the health industrials and from the healthcare system in general.

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In the same time, changes come from outside the health universe. Large adoption of Internet among households allows them to access a lot of information. They seek for information that are often more objective. It is so true that seeking for health-related information activity on the Internet is now comparable to e-mailing activity in term of spending time. Physician testimonials relate that some patients come and visit them with a pre-diagnosis or sometimes contradict their conclusion. It is obvious than people are becoming involved in the health system and are gaining weight.

The healthy, the ill and the entourage

Patient’s group is far from being a homogeneous category. Because a patient is overall an individual and because diseases are numerous it is tough to constitute sub-groups. Moreover it makes a point to include healthy people into the patient group. Indeed healthy people are contributing to the National Health Insurance fund. Indeed healthy people are also seeking for health information and are potentially future patients. For example the preventive activity is clearly dedicated to healthy people aiming at keeping them healthy. Finally the patient’s group should also include sick persons’ entourage. Indeed a health problem directly impacts the sufferer’s entourage, often its family, and they are willing to be involved. Minor diseases or injuries softly involve the entourage. But if we consider chronic diseases the entourage becomes crucial. For example an Alzheimer patient will be entirely substitute by its entourage, becoming indirect sufferers. It is remarkable that this fact is hardly take into consideration by the health system but it is a major challenging point.

3- A big picture of the health sector

Thanks to the detailed description of health players it is time to integrate them in the health system. We will use the value chain model to understand the bases of relationship and competition between suppliers and provider. It will also be an ideal representation to highlight changes and opportunities along the value chain.

A traditional healthcare value chain has been established and popularized by Lawton Burns in 2002, as represented in Figure 5.

Figure 4 - The Healthcare value chain (source: Lawton Burns)

This pattern shows 5 different categories of actors, 3 majors and 2 intermediaries. The first one is the producers’ category. We have already analyzed those actors, including pharmaceutical and medical equipment manufacturers. They are the innovation initiators and

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provide products and tools to healthcare providers. Those last, gathering hospitals (public or private), physicians but also pharmacies promote the consumption of health products. They prescribe medications and use medical equipment. They are the link between end beneficiaries, patients, and health manufacturers. They bring value to products thanks to their medical knowledge. Between producers and providers stood distributor intermediaries aiming at buying health products to the first category and sold them to the atomized providers’ category. Although healthcare providers can directly buy to producers, the intermediation of wholesalers makes possible to reduce costs of distributed goods while increase the buying power.

At the end of the chain we find patients that are the end beneficiaries. There is here a big difference with other sectors since the payment is mainly indirect. Indeed payer bodies insure an intermediary role. Those payers are mainly governments thanks to public health insurances and private insurances in complement. Based on taxes and fees patients are covered for the majority of health expenditures (medication and health care). Either they do not pay at all or they do and are reimbursed afterwards thanks to claims sent by healthcare providers. At the end it appears that some health expenditures are not entirely covered and patients have to directly pay to providers. This indirect payment pattern exists in the health sector (remember that this study is focused on mature countries) to provide health to the many and avoid disparities by increasing the power of regulation.

We can observe in this value chain that innovation goes from left to right and the money from right to left. If we refer to marketing concepts health products are more pushed by manufacturers than pulled by patients or providers.

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Part 2 - When ICT meet health

Now that the health service universe has been described this second part will explains in more detail the ICT world. ICT stands for Information and Communications Technologies. It is important to understand the evolution of these technologies and how they are knocking at the medical field’s doors. We will study in the first part the genesis of that convergence. Then the actors of this movement will be identified.

1- From Information and Communications Technologies to Connected Health Technologies

Nowadays the ICT acronym often refers to the Internet or telecommunications but as an extended definition it refers to all kind of data exchange between two or more entities. For our purpose we will obviously consider communications between humans. History of communication is as old as history of humanity. From cave paintings to 3G-mobile phones let us discover the exponential development of information and communications technologies.

a) A short story of communications and its recent ramping evolution.

Communication history milestones

From the origins, humans have communicated. For this purpose they created codes, languages and alphabets. Speech, hand signs, smoke messages, drums or written documents: everything was good to carry messages.

From the beginning: writing’s birth

Communication was first oral. It needed a constant interconnection in space and time between the transmitter and the receiver. The writing phase comes in a second time. It has allowed a disconnected communication between the transmitter and the receiver in time and space. This revolution represents the starting point of the Humanity story. Writing is the first milestone in the communication story.

Writing story corresponds to two different kind of writing: ideographic writing and alphabetical writing. The first was born in Mesopotamia probably around three thousand years before Christ. Egyptians also used this mean of communication but improved it thanks to more complex signs called hieroglyphs. Phoenicians are inventors of the alphabetical writing (around 1800 years B.C.) but we have to wait until the Greeks to witness of an efficient transcription of the spoken language. From this date, intellectual production has been deeply modified thanks to writings and information exchange improvements were keys in the golden age of antic civilizations. Knowledge was share and spread. Rhetoric was particularly emphasized under the Roman period and then become a communication technique.

Yet in antic society there were places dedicated to information and communication purpose. Agoras, temples or forums are some of them. Acta diurna were official daily publication displayed in the ancient Rome walls to let citizens updated. Transport of messages was both human (the marathon-man legend is the perfect symbol) and animal (for instance carrier pigeons).

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When the printing technology changed the world

The next breakthrough and second key milestone in the communication story was the creation of printing techniques by Gutenberg. The move from written documents to printed ones match with the end of the Middle Age, a period of intellectual and social changes. The first colored printed book was Psalmorum Codex in 1457, five years after the first printed ever: the Bible (42 line version). It is estimated that in 1470 a printed Bible was 5 times cheaper than a hand-written one. Such a drop in the cost of knowledge allowed a larger part of the population to become informed. In 1464 Louis XI institutionalized the mail service with the implementation of a royal mail enterprise. The newspaper as a source of information appeared in the early 17th century. In France, in 1631, La Gazette was the first periodic newspaper (N.B: La Gazette’s writter Théophraste Renaudot was the king’s personal doctor).

Development of newspaper was then supported by improvements in transportation. At the beginning of the 19th century the first steam vehicles appeared (boats and trains). This evolution did not solely allow people to move faster, it has also reshaped the human activity, created new kind of exchange, promoting new ways of thinking.

The first telegraph, information dematerialization

In 179225, few years after the French Revolution, the third key milestone in the history of communication is officially announced. The optical telegraph was born and its creator is named Claude Chappe. In 1844 Morse, well known for its code made of straight lines and points, sent its first telegram in the US. This period is contemporary with the emergence of international press agency such as Havas (1835), Wolff (18949) or Reuters (1851). In the same time a new communication support is invented: the photography. Two inventors are the fathers of this new technique, Daguerre (France) and Talbot (US) and it has been officially presented in 1839.

The American engineer Graham Bell leads the world to a new communication area in 1876 when he invented the telephone. Sounds can now be transmitted, remotely, through an electric wire. In the late 1880’s regular telephone communications are available. These inventions are strongly linked to the rise of electricity.

Just before 1900, the first radio message was exchanged by Marconi between England and France. This is the start for wireless communications. In 1895 the cinema was born (Lumières brothers). Information became available for crowds and the media industry grew up thanks to these new tools. Regular radio broadcasts appeared in the US in the 1920’s and the TV experience was a success for the time in 1930. Thanks to communication satellites, launched in the early 1960’s it was now possible to broadcast TV shows on both sides of the Atlantic Ocean. The world has becoming a “global village”.

Today’s communications

After a slow but continuous evolution of communication medium, we could say that ICT have risen exponentially during the last 50 years. Joseph Schumpeter, a famous economist studied the Kondratieff cycle theory to understand economic trends. Thanks to their work 5

25 Histoire des Télécommunications, L’Internaute (http://goo.gl/PhWPj)

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super-cycles have been outlined since the beginning of the industrial revolution, dozen years before 1800 (Figure 6).

Figure 5 - Kondratieff waves and Schumpeter analysis

Each of this cycle is characterized by a major technological breakthrough that has drastically changed the way human move, work, produce and exchange good and even make appears new ideologies and new ways of thinking26.

As we notice on that chronological graph, we are right now living within the fifth super-wave that started around 1992. Non-surprisingly the technological revolution that triggered this fifth cycle is the Internet27. In general, it is the booming of telecommunications that is the fundamental of the wave.

And the movement is spreading faster than never in the whole History. From simple text and information exchange trough computers too big and too expansive to be owned by Mr. Jones, we are now able to share instant videos on smartphones.

In diverse geographic areas, among different society classes, information is accessible for a continuously growing number of people. Like the other major innovations that initiated the 4th previous cycle, telecommunication revolution is changing the society, really deeply. For our purpose we will focus on 2 examples illustrating this change. Rise of social networks and nomadism.

After an era when information was pushed to people we are now in a period when people pulled it. Thanks to the Internet there is an infinite source of information available. And people have now to seek and select the relevant one. So they start to exchange data and information between them, in parallel to traditional information providers (companies, media, etc.). They are able to share, advice or critic information of interest for them. They can now express their opinion to the world. This has led to the emergence and diffusion of social networks that is the major breakthrough in mass communication over the last years. Yet many business sectors have adapted their model to this new way of communication and are trying to turn that bottom-to-top pattern into an opportunity. Surprisingly the health sector has hardly integrated that 2.0 communication scheme. But as seen before health awareness is rising and it is a real challenge to answer it.

26 Les cycles du Capital, Jean Zin, 2000 (http://goo.gl/lKTU0) 27 Tim Berners-Lee, Wikipedia (http://goo.gl/UjzYJ)

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Nomadism is a second direct consequence of ICT revolution. Today people can communicate from everywhere and quickly. The rapid diffusion of mobile phone is the best example since even in poor countries this object is being common. Improvements in the electronic field have made communication devices smaller and more powerful. In addition to give and receive calls it is now possible to surf the Internet with a mobile phone. In the future thousands of daily objects will become connected. Another promising technology is the cloud computing. It means that data are stored in remote servers and accessible from any connected device. There is no need of large storage capacity but only high-speed connection.

b) Connected health technologies: E-health and M-health

It has been only for a decade that Information and Communication Technologies have met health. It is true that the health sector is complex, as developed in the first part of this report and according to the US Institute of Medicine:

“The challenge of applying information technology to health care should not be underestimated. Health care is undoubtedly one of the most, if not the most, complex sectors of the economy. The number of types of transactions (i.e. patient needs, interactions, and services) is very large. Sizable capital investments and multi-year commitments to building systems will be required. Widespread adoption of many information technology applications will require behavioral adaptations on the part of large numbers of patients, clinicians, and organizations”.

The first step was “connected health” which focused on increase efficiency of health services through connection of healthcare providers. Like companies in other business fields, hospitals started improving their efficiency thanks to the integration of IT systems. It is often called E-health. The second wave, the core of our subject, is the rise of wireless health solutions, also known as M-health (Mobile health).

Digitation of health information: E-health

The health care system generally uses less ICT than other industries, but reports indicate that providers are increasing their investments. The main use up to now is an “administrative” application especially in hospitals that are aiming at reducing costs and facilitating communication. Those activities are also known as health information technologies. The most frequent applications are listed in the Chart 5.

Technology Definition

Picture Archiving & Communications System

(PACS)

This technology captures and integrates diagnostic and radiological images from various devices (e.g., x-ray, MRI, computed tomography scan), stores them, and disseminates them to a medical record, a clinical data repository, or other points of care.

Computerized Provider Order Entry (CPOE)

CPOE in its basic form is typically a medication ordering and fulfillment system. More advanced CPOE will also include lab orders, radiology studies, procedures, discharges, transfers, and referral.

Bar coding

Bar coding in a health care environment is similar to bar-code scanning in other environments: An optical scanner is used to electronically capture information encoded on a product. Initially, it will be used for medication (for example, matching drugs to patients by using bar codes on both the medications and patients’ arm bracelets), but other applications may be pursued, such as medical devices, lab, and radiology.

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Electronic Materials Management (EMM)

Health care organizations use EMM to track and manage inventory of medical supplies, pharmaceuticals, and other materials. This technology is similar to enterprise resource planning systems (ERP) used outside of health care.

Electronic Health Record (EHR):

EHRs were originally envisioned as an electronic file cabinet for patient data from various sources (eventually integrating text, voice, images, handwritten notes, etc.). Now they are generally viewed as part of an automated order-entry and patient-tracking system providing real-time access to patient data, as well as a continuous longitudinal record of their care.

Clinical Decision Support System (CDSS)

CDSS provides physicians and nurses with real-time diagnostic and treatment recommendations. The term covers a variety of technologies ranging from simple alerts and prescription drug interaction warnings to full clinical pathways and protocols. CDSS may be used as part of CPOE and EHR.

Chart 5 - Common Health Information Technologies (source: Medpac)

At first sight it is noticeable that technologies described in Chart 5 are more focused on improving administrative and financial processes such as patient registration, billing, and payroll, than on clinical applications. To be realistic the two last listed technologies, EHR and CDSS, which are real clinical application, are still at preliminary stages and much less diffused than the other above. In France there is a national EHR initiative called DMS28 (for Dossier Medical Personalisé) that have been launched in January 2011. Initiators for the use of ICT in healthcare were naturally large organisms like hospitals or private clinic networks. Like in other business fields, the implementation of such systems allows to gain in efficiency and as a consequence to save money. In smaller organisms it is still rarely implemented and concrete benefit evidences are few. For example a PACS system implemented in a small hospital could suffer from a lack of return due primarily to a low volume of imaging in the facility. And it is important to talk about return on investment since integrating an ICT system is very expensive.

Among physicians, data about ICT integration in health practice are limited. But in general, like hospitals, physicians are more likely to use those technologies for administrative functions. The first barrier is the cost of required infrastructures. In France with health administrative reforms, such as implementation of Carte Vitale (chip-card used to electronically record health-related transactions), almost every individual healthcare professional have installed a card-reader device to offer tele-payment. Another application of ICT in their daily practice is the use of Internet. This time it is more for clinical purpose.

Adoption of health information technologies is obviously more difficult than in other business. Indeed healthcare professionals seem to be more reluctant, or focused on other subject that could improve quality and efficiency of their activity more directly. Actually there are no real incentives and no time to integrate complex ICT systems. The main challenge will be then to adapt ICT solutions to the healthcare complex environment in order to facilitate the professional use and finally the wide diffusion.

Before continuing we could outline that E-health has bring responsible innovations to the health sector. Indeed, PACS systems have contributed to the extinction of conventional radiographies films that used to be made of toxic components (silver salts).The digitization of medical claims have helped to reduce volume of paper used.

28 Dossier medical Personnel, République Francaise (http://goo.gl/T6eAe)

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ICT technologies applied to health described so far were mostly dedicated to health professional. Does it mean that relevant patient dedicated applications are non-existent? Actually such applications exist but they are still few or still superficial (mobile apps for example). Yet this is a really important innovation’s axe since we have seen the increasing weight of patients.

Mobility of health: M-Health

Mobile health is a sub-segment of E-health because it is based on technologies described before. According to Triple Tree29, a venture capitalist firm focusing on this promising sector, M-health includes “any healthcare application or service that enables a seamless flow of information across cellular, wireless, or other mobile networks and mobile devices that improve clinical care delivery, patient-provider communications, enterprise-wide mobility, and decision support (patient, health provider, manufacturer and payer)”. We are here in the core of our subject.

The first support for mobile health solution development is the quick improvement of wireless technologies and the diffusion among population and businesses. As mentioned previously, the massive use of ICT in many aspects of our daily lives has recently help the increase of nomadism. More than many other technologies, mobile ones have the capacity to improve health systems. Major M-health solutions are for the moment mobile applications, from the simplest like diet coach apps to more technical like blood pressure add-on from Withings30. A report from Pyramid Research states that 200 million health mobile applications are available to download on the different online stores at the beginning of 2011, and that figure could triple up to 2012. Another finding of their report concludes that “70% of people worldwide are interested in having access to at least one m-health application, and they're willing to pay for it”.

To be more precise, Chart 6 identified a non-exhaustive list of potential possible health outcomes using wireless technologies.

Solutions Advantage Patient Safety

Documentation and medical safety at the bedside is a greenfield opportunity for m-health solutions. Medication and care errors at the bedside represent a multi-million dollar annual drain on the healthcare system. Solutions centered on patient identification and historical, dosage monitoring or process checking are enhanced significantly by wireless interfaces and devices that allow for ubiquitous access anywhere for inpatient and outpatient.

Tracking & Localizing

Stakeholders are beginning to leverage location-based tracking technologies providing an ability to locate medical equipment and other healthcare assets while optimizing workflows. But mobile technologies can also help to localize individuals. Tracking the location of a patient during a treatment is a critical process for inpatient care and could be improve thanks to localization tools. In the case of ambulatory care or emergency situation the challenge is to locate health providers and resources. M-health solutions are highly relevant to tackle all these localization and coordination issues.

Adherence and Compliance

Adherence is a challenge for a vast majority of patients and non-compliance to treatment is both extra costly and a threat for medication efficiency. The reasons for non- compliance are multiples and proportional to the disease/injury complexity and length. Clinical trials, that are crucial for health industrials, also suffer from non-compliance. To cope with those problems innovations like wireless-enabled pill boxes and SMS reminder can lead to better health

29 Wireless & mobile health, Triple Tree, 2009 (http://goo.gl/86o8J) 30 Blood pressure monitor, Withings (http://goo.gl/PXBjh)

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outcomes. Information Access

Mobile Internet has spread the possibility to search for everything from everywhere. Concerning health information, dedicated application could allow clinicians to easily access information to improve decision making at the point of care. For instance, secured remote connection with PACS to send patient’s X-Rays or MRI images to any physician smartphones, In parallel new mobile applications could enable people to quickly record any health-related event. Crowd-sourcing and participatory healthcare system might be a major change in the near future thanks to mobile.

Patient Monitoring

Remote patient monitoring have quickly become the poster child for M-health applications. Firms such as GE Healthcare (Joint Venture with Intel) are addressing the needs of home health monitoring. According to many industry sources, the market for those services is currently over $3 billion and will grow to over $8 billion by 2012. Opportunities are huge with the ageing population and the increase of chronic diseases and home care. Remote monitoring is based on mobile connected devices, more or less sophisticated depending on the monitored constant. It allows informing concerned people (caregivers or patient itself) in case of adverse event but also store data. In addition, advances in sensor technologies allow connecting them wirelessly. The connected mobile health device will become wearable or even implantable.

Remote Presence and Robotics

Scarcity or limited access to care providers is a persistent problem within the healthcare system, especially in remote and congested metropolitan areas. Companies are working to solve this problem through the use of remote presence. Telemedicine and telesurgery are ones of the best examples, mixing wireless connections and robotics. It will be possible for physicians to be multiple places at once, extending their reach and decreasing time to care. The other potential of smart connected robotics will be to support impaired or disabled people. Helping disabled people to move, blind to see or deaf and dumb to communicate.

Chart 6 - Potential outcomes for M-health solutions (source: Triple Tree)

Among all those M-health opportunities we will see what are the most relevant and how to design a pertinent business model. This identification will be conduct in the third part.

2- Different players from different background in the M-health universe

E-health is, by nature, aggregating players from both worlds. M-health environment is also composed of lots of actors that can be classified into 5 categories.

i) Device manufacturers ii) Infrastructure builders and telecom operators iii) Healthcare Service providers iv) Payers v) Patients

The three last actors have already been detailed in the first part of this paper so we will focus mainly on device manufacturers and telecom operators. Indeed device makers not only include medical device but also general electronic device makers. Healthcare providers, payers and patients will be quickly reviewed from a M-health point of view.

a) Consumer electronics manufacturers

We already described the medical device industry in the first part of that report and we noticed that it includes a tremendous number of products or equipment. The sector is at least ten times wider if we consider the larger group of devices and appliances. Yet in M-health sector all sort of device makers won’t be interesting. In fact the ones that could join the M-health adventures will be mainly the consumer electronics manufacturers.

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Consumer electronics are electronic equipment intended for everyday use. The first major consumer product, the broadcast receiver, appeared in the early 20th century. Later the consumer electronic industry has invented personal computers, telephones, music players, audio equipment, televisions, calculators, digital cameras or again players and recorders using video media such as DVDs. According to the Consumer Electronic Association (CEA), the 2010 global industry revenue was of $873 billion31, and is expected to grow to $964 billion in 2011, i.e. a 10% increase.

The industry is historically centered in Asia with countries that have become specialists in this particular sector like Japan or South Korea housing some of the biggest players. Giants in the sector are named Panasonic, Samsung, Mitsubishi, LG or Sony in Asia, Philips or Apple in Western countries.

Electronic devices have massively integrated the daily lives of people because they were subjected to continuous decreasing prices. Based on electronic technologies, those products follow the Moore's Law, which states that microprocessor speed doubles every 18 months. Consequently the innovation pace is faster than in any other industry with new technologies’ announcements every time. By changing the way people communicate, share information, and entertain themselves, consumer electronic products become a part of the culture. The world was different before television. It was different before radio, before cell phones, and before CD players.

Consumer electronics are today undergoing the integration of ICT technologies. The trend is to make products connected and at the end create bridges between different technologies. With each passing year, and each new generation of products introduced in the marketplace, it's getting harder and harder to differentiate companies and their products into traditional categories like telecommunications, computer hardware, and consumer electronics. Consumer electronics tends to be Swiss knifes. In addition to become connected those products are also becoming mobile, answering the fantastic evolution of human behaviors. The phone‘s history perfectly illustrates those evolutions. At the beginning phones used to be physically linked with wires to communicate between them and be supplied in energy. Then they lose the wire and became mobile, including batteries. Later they enabled people to exchange short texts. Camera technologies were soon added and image exchange was made possible. Finally they were able to be connected to the Web, sharing all kind of data including video. They are now called smartphones.

Mobile phones are obviously among the most promising products for the development of M-health. According to the International Telecommunication Union32 the mobile phone global penetration rate was of 76% in 2010 with 116% in the developed world (more than 100% means that some people owned more than one mobile phone) and 67% in the developing one. Webphones are still more promising for M-health sector and was used by 13% of the world population in 2010 (51% in developed countries, 5% in developing countries). This extraordinary diffusion will allow the mobile phone makers to vastly provide people with health-related solutions.

31 Global Consumer Electronics Retail Sales Seen Up 10% In 2011, Forbes, 2011 (http://goo.gl/hJc0t) 32 Key Global Telecom Indicators, International Telecommunication Union (http://goo.gl/FDBFK)

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Over the last years the consumer electronics industry was exposed to the issue of sustainability. Because they are widespread and based on electronic technologies those products represent an increasing part of energy consumption. For example there is a particular issue with the standby power assumed to significantly increase the energy bill. Another problem is the fast rhythm of obsolescence striking consumer electronic technologies. Integration of reusable material and recycling process are more and more taken into account by innovators.

b) Infrastructure builders and telecom operators

This category includes all the actors that are supporting the ICT sector, thanks to infrastructures (networks and storage capacity) or services (telecom operators, software providers). They are essential in M-health since they grant mobile devices to be connected.

Telecommunication network builders

Basically a telecommunication network is a collection of terminals, links and nodes which connect together to enable telecommunication between users of the terminals. Terminals are made by device makers. Links are the channels by which data is transmitted. They can be physical (copper wires, fiber-optic cables) or immaterial for the case of wireless networks. In order to be transmitted through links, messages have to be converted by terminals into different form of signal including radio frequencies, electric signals, light signals (infrared). Nodes are necessary to handle messages and route them down the correct link toward their final destination.

Protocols and standards are fundamental in networks and define how initial data is encoded then transmitted throughout the network. For example the Internet protocol is called TC/IP protocol. In mobile network there have been 4 categories of standards. The 1G network was the first automated cellular network implemented in 1979 in Tokyo. 2G standards appeared in 1991 in Finland. The 3G network was launched in 2001 in Japan too. Finally 4G standards are available since 2006 but really implemented in few countries on the edge. Each of these generations has increased the bandwidth thanks to more powerful satellites and antennas.

Telecommunication operators

Telecommunication operators are the companies performing the exploitation of networks. The first players, chronologically speaking, were the phone operators. Then Internet providers came in, rapidly acquired by phone operators. Finally they are the ones who led the invention of mobile phone networks and added this activity to the fixed phone and Internet networks’ exploitation. In reality they provide a service: they allow people to properly use the telecommunication network. And this service is worth to be paid. When we are paying for a mobile phone subscription we are actually buying the right to use a part of the network, for a certain time.

Mobile Operator Original Market Additional markets Subscribers 2010

(million) 1 China Mobile China Pakistan 627 2 Vodafone United Kingdom Middle East, Commonwealth, Europe 361 3 Telefonica Spain Latin America, Europe 227 4 America Movil Mexico Latin America 236 5 Airtel India Bangladesh, Central & Austral Africa 221

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6 Orange France West Africa, Europe, Middle East 217 7 Telenor Norway North & East Europe, South East Asia 203 8 VimpelCom Russia South East Asia 193

Chart 7 - Main mobile phone operators (source: Wikipedia)

Chart 7 lists the 8 major players worldwide. As networks are without frontiers it seems logical that the players, that are relatively young if we consider that this market did not exist before 1980, are global players. Now 3 humans out of 4 owned a mobile phone.

With access to an incredible pool of consumers, mobile phone operators could have a legitimacy to play a predominant role in M-health. This is the reason some companies have started targeting the field. For instance Orange, the 6th global player in term of subscribers, have created a dedicated branch in 2007 called Orange Healthcare. To build their strategy they particularly focus on partnerships and for example in France they partnered with GE Healthcare to deliver the biggest medical imaging connected platform for 30 hospitals around Paris.

Now that mobile broadband technologies exist (wireless Internet access) mobile phone operators provide it through additional subscription premiums. The International Telecommunication Union estimated almost 1 billion mobile Web users in 2010 and predicts this figure to double within the next 5 years, overtaking the PC as the most popular way to get on the Web.

Software providers

The mobile health sector also counts on actors that are providing the digital content. Software is the main content used on mobile devices. A software allows the machine to perform computer tasks and overall assist the user to run this task on its machine. Software will be necessary coupled with future mobile medical devices and, as we will see after, will be crucial to improve the user experience (patient or physician). Appropriate software will allow to increase ease-of-use and, as a consequence, adoption of such technologies. Microsoft is the most know software player for consumers. And IBM has become a software company when it decided to stop the selling of hardware products. Those software companies are known in the health sector to have provided enterprise management software for physicians and hospitals. Software companies are finally the ones being on the edge of M-health because they are the creators of million available health-related mobile applications.

Besides machine software we can also find Internet software that is marketed by famous companies. And those actors are highly interested by M-health since a lot of connected health devices will be linked to the Internet. For instance Google had launched the Google Health portal in 2008, offering Web-based medical records to patients. This solution has since been abandoned. Microsoft HealthVault33 by Microsoft is the same solution.

c) Healthcare stakeholders

Healthcare providers, payers and patient were all depicted in the first part but we could add some comments, related to their willingness and readiness to be active players in M-health.

33 HealthVault, Microsoft (http://goo.gl/47R0i)

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Healthcare workforce is made of individuals already using mobile solutions and the Internet on a daily basis. Technologically it won’t be a problem. A recent study commissioned by Google34 (November 2009) reveals that 86% of physicians are already using the Web for seeking health information and amongst them, 59% have performed the search on a mobile device.

Patients are again much more willing to play a role in M-health. The Internet has already given them the power to enhance their influence within the health system while improving access to information. Now they want to be able to know about their own health, in detail, and got the possibility to act by themselves, to gain autonomy. They are in huge demand.

Finally governments and payers are also expected to stand a major role to promote M-health. Actually they rule the health sector, in France especially, so nothing could be done easily without their support.

d) A big picture of the M-health.

Thanks to the previously done description of different stakeholders we are able to draft a M-health diagram (Figure 7).

Figure 6 - M-Health Environment

All the actors, Device Mobile Makers and Infrastructures and Telecom Operators have to be understood by medical devices manufacturers. Indeed they can be seen as competitors or perfect partners to take the lead on the M-health industry. We will discuss the legitimacy of those different players on the M-health battlefield further.

34 Connecting with Physicians Online: Searching for Answers, ThinkHealth with Google, 2009 (http://goo.gl/nVFXy)

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Part 3 - Which potential markets to target and business models to design?

Now that we have described in one hand the health universe and in the other hand the ICT world it is time to deal with the core of our subject. Which specific parts of the vast health system could be targeted with M-health solutions? How to build appropriate products for the concerned actors? How give value to those products? To do so we will first identify major trends, major phases susceptible to accept mobile applications. Based on this identification we will give take away about the necessary features that should be integrated in M-health solutions. We will then detail how to build integrated solutions and sell them in practice thanks to partnerships. Finally we will conclude by having a step back and look from a distance those M-health solutions. The aim of this last point is to raise awareness and make future M-health players being responsible innovators.

1- Understand the healthcare pattern and identify key changing factors

a) Education/prevention, diagnosis, therapy, post-treatment monitoring

To address a relevant health service/product integrating wireless technologies it is necessary to understand how healthcare is provided, as a complement to the healthcare system analysis that was already done. 4 different phases can be identified in the healthcare services activity.

i- Education and prevention ii- Diagnosis iii- Treatment iv- Monitoring

These phases are often performed by different health players and targeted populations are different.

Education and prevention

Education/prevention is the first mission of healthcare providers. This activity is often underestimated although it is a really crucial one. Indeed this activity represents a small part of the health costs and is hardly considered as decisive. It is probably because people think prevention or education do not have a direct impact. They just enable more healthy people to stay healthy. As a general matter, as we have seen in the first part, health in western world used to be curative more than preventive.

Prevention can be divided into 3 categories35. First prevention focuses on reducing diseases’ prevalence (vaccination for instance) and modifying population behavior (fight against alcohol or tobacco). Second prevention aims at lowering the severity of unavoidable

35 Santé et prévention en France, GSK (http://goo.gl/mGLxy)

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diseases thanks to early diagnostic. Third prevention occurs when a disease is already declared in order to limit complications.

According to those definitions, prevention/education activities imply consumption of drugs and medical equipment but overall information and communication.

In mature countries prevention is mainly supported by public health institutions. In 2009, for France, prevention cost represents €6.2 billion compared to €223 billion spent for health in general36. This general account includes mainly healthcare or medical equipment spending and information or communication activities are minor. The most important communicating and launching awareness campaign organism is INPES (Institut National de Prevention et d’Education pour la Santé). Its budget in 2009 was around €104 million37.

Prevention and information are the first actions implemented in very poor countries in order to tackle with health problem. Vaccination campaigns, awareness campaign for women, etc… In a mature country such as France, health education level is higher and prevention tries to fight other health problems like tobacco addiction or obesity. Observers noticed a rise of interest for health and well-being among population. This trend is parallel to a more general movement: people are willing to manage their life instead of remaining passive.

Health used to be an occult matter impacting lot of people but being inaccessible for crowds. Today it is a subject of high interest for the same crowds and people became active health information seekers. Just one figure, according to the 2011 Pew Internet Project38 study, 80 % of internet users look online for health information, making it the third most popular online pursuit among all those tracked, following email and using a search engine.

But prevention and education is also a relevant topic toward professional healthcare that often used to be solely informed by manufacturers themselves (pharmaceuticals and medical device). Today they are willing to share, to better understand and to be more objective face upon those manufacturers. The accurate information that a physician need obviously get more added value than information a normal person need.

At the end we understand that answering the trend of education and prevention is not the central element of mobile health solutions to be developed by medical devices companies. But it is unavoidable to integrate it.

Diagnosis

The diagnose phase appears when a symptom or an abnormality is detected and need to be identified. It comes from the greek word diagignoskein meaning to discern or distinguish. Diagnosis is the key part of a physician’s job. To perform a good diagnosis the physician possesses a high level knowledge in anatomy (body structure), physiology (body machinery), pathology (failure in anatomy and physiology) and psychology (thought and behavior). From a diagnosis it is possible to propose a treatment and plans for follow-up.

36 Dépense courante de santé en France, IRDES, 2011 (http://goo.gl/FWd3e) 37 Agences et organismes sanitaires en France, M .Bapt, 2011 (http://goo.gl/DBwOA) 38 Survey, CHCF, 2011 (http://goo.gl/Skj4u )

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This diagnosis phase has known a spectacular evolution all along the 20th century, especially thanks to advances in medical imaging and bio analytical tests. This phase is an essential target for medical devices manufacturers.

Diagnosis can be performed by simple examination of a patient or thanks to the use of basic equipment like stethoscope. This is true for simple or common disease like flu or cough. When an illness is more complex and that symptoms are not obviously visible more technical equipment is needed. We won’t detail every technique but thanks to medical imaging it is possible to obtain a precise picture of our inner. Slice imaging is able to give a 3D image of almost every kind of tissue. Coupled with biomarkers, it is now possible to see part of organs that used to be invisible. Thanks to bio analysis we are able to detect abnormalities in body’s samples (urine, blood, tissues, etc.). We called it in vitro diagnosis.

A lot of improvements have been made in the diagnosis phase for the benefit of treatment phase. It is logically comprehensible. When a disease is better distinguished, better differentiated, it is possible to address a more accurate treatment. When an abnormality is better characterized, better classified, it is possible to address a personalized cure. One of the main goals today is to diagnose as early as possible. Then treat when the disease is not too severe.

The challenge for the future will be to diagnose sooner, increase examinations efficiency and provide accurate abnormality identification for crowds. Difficult diagnosis will be still performed by on-site experienced physicians. But basic diagnostic, for common disease could be done by patients themselves or a third party, and confirm after by a physician. It opens a white space for mobile health devices.

Therapy

Therapy is the third step in the healthcare process, and it is the most visible part. Physicians are also known as therapists. Originally it is a Greek word meaning “remediation of a disease”. Synonym of treatment, the main objective of a therapy is to recover a patient from an illness or impairment. If a therapy leads to the definitive elimination of a disease or recovery of impairment it is called a cure.

In parallel to diagnosis, therapeutic tools were improved a lot during the last century. Therapeutic tools include drugs and medication but also surgery methods. This is first because of tremendous biology advances that spread our knowledge in physiology at a cellular and molecular level. The biotechnology rise is the most obvious illustration of what we can do now. The second cause of such an explosion was the rise of chemistry sciences. It was made possible to create molecule that targeted or tackled problems identified thanks to biology. Finally, electronic improvements lead to medical equipment innovations including surgery equipment and medical equipment (pace maker or stents for instance).

Therapies’ outcomes are not 100% predictable then it is important to assess what it is called the benefit/risk balance. In addition to adverse effects that are intrinsic limits to therapeutic methods there is also a risk when a treatment is not well implemented. Medication management is an identified issue and according to the International Council of Nurses39,

39 Les erreurs de médication : une étude du CII, CII, 2009 (http://goo.gl/v9g8E)

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60% to 80% of healthcare adverse effects are due to human errors. Moreover patient adherence to a treatment is also problematic. The WHO reported40 that in developed countries, only 50% of patient suffering from chronic disease follow treatment recommendations.

Medical devices are often the tools that allow administrating drugs and medication. Here is a huge opportunity for medical device manufacturers to respond the problem of medication management creating smart and connected technologies preventing errors to occur.

Post-treatment monitoring

Post-treatment monitoring aims at insuring the efficiency of a treatment, so by definition it is the last phase of healthcare service. It consists on tracking different variables that were impacted by the disease or were likely to be modified by the treatment. In this phase we also include treatment monitoring in the case of long term therapy applying for chronic diseases.

In general terms, monitoring is seen as a set of captors linked to screens or boxes, ringing when something unusual is happening. This simple vision is a quite good definition of monitoring. But this example is what we called continuous monitoring. In reality monitoring does not only implied continuously plugged devices. For example when a diabetic control his or her blood sugar level with a glucose meter it is a pinpointed monitoring. When a physician asks his or her patient to do a blood checkup once a year to control his or her cholesterol level, it is also monitoring.

Post-treatment monitoring is crucial because it allows assessing the therapy’s efficiency and in case of problems it gives the possibility to react quickly, prescribe another treatment or adjust it. Vital importance of monitoring applies mainly during and after surgical interventions and for chronic diseases. During surgery it is important to monitor how organism does react to internal modifications or anesthesia. After a surgery patients go in intensive care units, depending on the severity of the intervention, to insure vital signs stability. Concerning chronic diseases, monitoring is used to check severity evolution.

The monitoring activity involves using specific devices provided by medical equipment companies. Those tools are made of sensors or captors detecting different signals (heart beats, oxygen concentration, etc.) that are usually displayed on a screen and can be checked and interpreted by healthcare professionals. It is both constraining for patients and for healthcare providers. Today two factors are challenging monitoring device manufacturers and mobile solutions are highly relevant.

In one hand we have post-operation monitoring that need to maintain the patient in surveillance period. During this period the patient is plugged to different kind of machines, consuming time and space, until his or her state become stable. In order to reduce costs of such a service, that is a necessity and a part of health professional’s responsibility, we observe an increase of home hospitalization. In fact it means that patients return back earlier to their homes, benefiting of an in-house hospital service. In France this kind of solution is called Hospitalisation à Domicile (HAD). Obviously that kind of service required reliable and

40 Adherence to long term therapies: Evidence for action, WHO, 2003 (http://goo.gl/eQYQ9)

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connected monitoring devices transmitting information to healthcare professionals not based alongside the bed.

In another hand chronic diseases need to be better tracked and in a more uninterrupted way. But because patients suffering from chronic diseases are often mobile, monitoring devices should be adapted to their lifestyle and being less constraining. Mobility and ease of use are key arguments to deliver pertinent solutions.

b) Targeting the real challenges

In this part we will try to depict the most important issue that the health system is facing and select the ones that could be answered with mobile health solutions. First challenge for the healthcare system: there is an increasing number of people to provide care to, with limited resources (financial, human). The link between health and demography was briefly pointed out in the first part of the report. Now we will define more deeply the consequences of such unbalanced demography on the healthcare system. The second challenge is the modification of people’s behavior and the rising of health awareness changing the influencer map. The third challenge is chronic diseases that have a deep impact (qualitative and quantitative) over populations and societies.

Unbalanced demography

Baby boomers used to be the generations that were born between 1946 and 1973, after the Second World War, in mature countries (Graph XX). This exceptional birthrate boom has feed what is called the Glorious Thirty mainly in European countries. A fantastic increase of young population to rebuild those countries has led to incomparable growth until the first oil crisis in 1973. After this period birthrates have decreased and countries now hardly succeed in renewing their population.

Graph 2 - Age Structure Diagram, France 2010 (source: INSEE)

Impacts are multiple for health systems. We saw than in the health sector, expenditures are principally covered by National Health Insurance. Yet active population, i.e people who

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works, funds those insurances. Papy booming, the adverse effect of baby booming, that we are experiencing now, contribute to a reduction in the number of Health Insurance contributors. Figures from the French statistics department (INSEE) in Chart 8 are here to support that point.

Date 1960 1970 1980 1990 2000 2010 2020 2030 2040 2050 2060 Total Population

(million) 42,0 45,9 51,0 54,0 56,9 59,3 63,1 66,0 68,5 70,7 72,3

Over 65 (million) 4,7 5,3 6,2 7,5 8,0 9,6 10,7 12,7 15,2 17,4 18,2 Percentage 11,3% 11,5% 12,1% 14,0% 14,1% 16,1% 16,9% 19,2% 22,2% 24,6% 25,1%

Active population (21-65 y.o) (million) 24,7 26,0 28,1 30,1 33,2 34,6 37,1 37,5 37,5 37,5 38,0

Percentage 58,9% 56,5% 55,1% 55,7% 58,4% 58,4% 58,7% 56,9% 54,7% 52,9% 52,6% Retired/Active

Ratio 4,9 4,6 4,0 4,1 3,6 3,5 3,0 2,5 2,1 2,1 2,1

Chart 8 - French population forecast (source: INSEE)

The chart’s last line is easy to understand. It means that in 1960 5 active people used to support one retired person. At the end of the decade, the ration will fall to 3 active people for one retired people. In 2060, still according to INSEE forecasts, one retired citizen will only be financed by 2 active French workers. At the end, for every new active worker the weight of retired people funding is heavier.

To be clear demographic unbalance is a real burden for the health system and it needs to be tackled thanks to relevant solutions. After describing the health insurance system in part one we remember that it shows a deficit, bigger year over year because of debt’s interests. In one hand politics are trying to change the rules of social contribution. It means they are trying to increase incomes for the National Health Insurance while the number of contributors is shrinking. In the other hand they are focusing on reducing health expenses. Cutting health related costs is the Holy Grail for governments. For that specific financial challenge the most important thing is to improve efficiency of health services.

We already noticed that E-health solutions were particularly promising to improve hospitals and physicians efficiency. If it is still based on few evidences, there is no doubt that those technologies will positively impact the health sector, like they did for other business sectors. Mobile technologies are likely to be even more efficient.

Hospitals are like big machineries. In those places we could find a myriad of jobs and activities almost like in a common for-profit enterprise. The main purpose is obviously to provide healthcare. A hospital is a place opened to anybody. People in need of care have to be looked after by health professional. Hospitals teams are often under-staffed and then overwhelmed. Mobile solutions could be perfect tools to coordinate health workforce and manage patient and professional flows. The best example is the RFID (Radio Frequency Identification) technology. RFID tags are able to communicate wirelessly with specific receptors and could be as small as chips. Those tags, carried by patients or health workers will allow localizing their position at every moment. Information about their movements and their activities will be tracked and could be analyzed to improve workflows. The same RFID tags are already used to track equipment in hospitals, to find them easily, make inventories

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and avoid rip-off. Pilot project have also used RFID technologies to set up automated hospitals’ pharmacy.

In term of impact on health system, people over 65 years old represent 40% to 50%41 of total health expenditures in OECD countries. The real challenge will not be to reduce health costs related to old people but only to limit them. The main question is: how could we reduce the impact of elderly? With age health problems are more frequent. And old people progressively become less independent. Independence is a major problem because it implies social care. As described in the first part health associate workers guarantee this social support most of the time. Mobile solutions could support them fantastically. In fact wireless medical devices could empower dependent persons. Most of the time medical-social workers are demanded for basic problems. The idea is to developed smart equipment that could support dependent people or help entourage to perform easy cares. Smart pillboxes or connected wheelchairs are great examples. For instance a mobile digital application mixing tutorials, videos and other multimedia content installed on a touch screen device could be delivered to the dependent people and its entourage.

Undoubtedly the best way to limit age related health expenditures is to make old people being healthy as long as possible. For that purpose the best solution is to inform people and incentive them to take care of their health capital. As mentioned before, millions of mobile applications are already available. But the one dedicated to senior are still few. Help elderly to undergo regular health checkup allowing early detection and diagnosis is an example. Create remote information centers to reassure worried aged people, advise them and avoid useless consultations. For the prevention or at least stabilization of Alzheimer disease, forecasted to strike 1,3 million French42 in 2020, it has been outlined that mental exercises are really efficient. The widespread of digital tablets is excellent for the diffusion of interactive applications, scientifically designed, aiming at training Alzheimer disease subjects.

The biggest problem concerning this aged population will be to adapt devices. They are not familiar and are reluctant to use it. For them the human contact is the only valuable process. Key word will be “ease of use”.

Chronic diseases

Chronic diseases are diseases of long duration and generally slow progression. By definition such diseases have no foreseeable cure and if poorly managed typically lead to further, complicated secondary health issues. According to the WHO they are by far the leading cause of mortality in the world, representing 63% of all deaths. Out of the 36 million people who died from chronic disease in 2008, nine million were under 60. We can classify the following diseases, amongst other, as chronic ones:

• Cardio vascular disease • HIV • Chronic respiratory disease (asthma) • Severe muscle-skeleton disease • Mental disease • Mucovisci • Diabete • Tuberculosis • Blood Pressure • Multiple sclerosis

41 Dépenses de santé, quel avenir ?, L’Observateur de l’OCDE, 2001 (http://goo.gl/uhxI8) 42 RAPPORT sur la maladie d'Alzheimer et les maladies apparentées, C. Gallez, 2005 (http://goo.gl/75idv)

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• Cancer • Rheumatoid arthritis • Neuro degenerative disease

(Alzheimer, Parkinson)

In France those disease are officially classified as Affection Longue Durée (ALD) since 2004 and are specifically considered in the health system. Patient suffering from 30 short-listed chronic diseases (ALD 30) are ruled by specific laws and regimes. Those patients are 100% reimbursed for care and medication that should be taken for a long period of time. One important point is to measure the weight of those ALD patients compared to the rest of the patients.

In fact the most problematic consequence of chronic diseases is that they are really costly. Because they are long-term and often non-definitely curable, a patient suffering from a chronic disease will regularly consume medication and care, simple or complex. A 2009 report of French Health Insurance43 give figures that could help us to apprehend that importance. In December 2008, 7.9 million French suffered from ALD 30s, 3.5% more than the previous year. Those 8.3 million people represented 14% of National Health Insurance contributors while concentrating 34% of all health insurances costs (Chart 9)!

ALD Population

striken (million people)

Proportion of total insured population*

Cost (billion €)

Proportion of total Health Insurance

costs** Cardiovascular Diseases

and strokes 3,1 5,5% 21,1 12,7%

Tumors 1,7 3,0% 14,3 8,6% Diabete 1,6 2,9% 9,9 6,0%

Severe Mental Diseases 0,9 1,7% 5,3 3,2% 4 first ALDs 7,3 13,1% 50,8 30,5%

Other ALD 30 2,4 4,3% 19,2 11,5% Total ALD 30*** 7,9 14,1% 56,4 33,9%

* Estimated 56,5 million, ** €166,2 billion in 2008 *** Sums are not simple sums because some patient experience multiple ALD

Chart 9 - Weight and cost of ALD 30s for the French Health Insurance (source: CNAMTS 2008 and 2009)

Before going further the report also highlights that there is an increasing number of multiple chronic disease patients. Indeed some chronic diseases often lead to other chronic diseases. The average number of chronic diseases among ALD subjects was 1,22 in 2008 (This number explain that sums in Chart 9 are not equals).

In more detail 4 chronic diseases are particularly important and represent most of costs as mentioned in Chart 9. Is there open space for wireless health devices to help treating those chronic diseases? And how can they be relevant?

Cardiovascular diseases and strokes

Cardiovascular diseases category include different pathologies involving heart or blood vessels (arteries or veins). Although cardiovascular disease risk is individual-dependent (some people are likely to experience heart failure without any reason) the main factor leading to such a disease is the behavior. For example obesity is often assumed to be a

43 Les personnes en affection de longue durée, CNAMTS, 2009 (http://goo.gl/oK9NV)

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particular negative initiator of cardiovascular diseases. Sedentarity and unbalanced diet are also likely to provoke heart problem. Today lots of methods exist to treat heart problems or atherosclerosis ones, thanks to drugs or surgery. Pacemakers or valves implants to fix heart impairments. Stents or medications to cope with arterial problems. A stroke, also known as cerebrovascular accident, is due to disturbance in the blood supply to the brain. It results to neurological damages in brain zones that have been non-irrigated, leading to the loss of one or several human functions (speech, paralysis, etc.). Risk factors for stroke include hypertension, previous stroke, diabetes, high cholesterol and cigarette.

In the future, M-health solutions could potentially help facing cardiovascular and strokes events. Because those diseases are mainly the consequence of unhealthy behaviors, one obvious solution could be to better educated people. Mobile media could help increasing public awareness and make them adopt better way of life. As often said “the sooner the better” so one interesting target will be child and teenagers. Make health being a game is a relevant method to implicate people. With mobile health applications that are connected to social networks, people could be emulated and more motivated to practice sports, to eat well, etc.

Wireless technologies are also pertinent to improve cardiovascular treatments. For example wearable sensors could help monitoring and tracking heart beats while providing continuous records for heart insufficiency people. The same way pacemaker remotely connected will improve the monitoring of implanted patients. The first Internet connected pacemaker implant was realized two years ago, in 200944.

Finally mobile health could help for rehabilitation of strokes. Impaired functions could be better supported. For instance specific devices can allow face-paralyzed people to communicate with their entourage.

Cancer

At physiological level, a cancer is the exponential growth of disorganized cells. Sometime it take the form of a tumor, sometimes it’s hidden. Sick cells can spread in the body thanks to lymphatic system and bloodstream. Identifying cancer causes is complex, because it often involved different factors. Nevertheless many things are known to increase the risk of cancer. This is the case of tobacco use, radiation, lack of physical activity, poor diet and environmental pollutants. There are also heredity reasons, breast cancer being a perfect example. Finally age is a common factor of cancer development. With age, cells lose their ability to destroy themselves. In general cancers are multiform and result from multiple converging factors. The common characteristic for all of them is that it is a cell proliferation process.

The contribution of mobile solutions will be at different level. For medical device makers the challenge will be to diagnose cancer as early as possible. The aim is to stop cell proliferation as soon as possible and avoid malign cells spreading. Massive screening is already a reality for breast cancers. We could imagine portable appliances that allow quick detection of malign tumors. For examples skins tumors are easily accessible because they appear in surface. Smartphones coupled with a dedicated application could be used as diagnostic tool.

44 First Wi-Fi pacemaker in U.S. gives patient freedom, Reuters, 2011 (http://goo.gl/Uq2Yt)

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A patient will take a photograph of an abnormal beauty spot and get an automated diagnosis, or send the picture to a pool of specialists that will give a diagnosis.

Finally mobile applications could also help patient’s entourage. Cancers are long term illness and rise worries among families and relatives. And it has been proved that positive environment could help sufferers to fight cancer. Being able to follow the state of a loved one and support it could be positive any patient.

Diabetes

Diabetes is one of the most addressed chronic diseases so far. The daily life of a diabetic is rhythm by regular blood sugar level tests and insulin injections. The diabetes management is today mainly performed by the patient itself. Regularly the patient and its physician have to review how the disease is evolving, but the patient is autonomous in the daily practice.

Wireless solutions are definitely capable of improving this process. A portable device will easily check the blood sugar level and deliver the right level of insulin that the diabetics will have to inject. Everything could be recorded and analyzed at any moment by the physician. That kind of device, called Diabeo45, has been launched in France in 2008.

c) Home care services

In response to health expenses increase, homecare services seem to be an efficient solution. The most promising application for home care is to follow-up and recovering care. According to a 2007 comparative study from IRDES46, a HAD (Hospitalisation à Domicile) day costs in average €169 compared to €263 for similar care services in hospital. Another IRDES report47 point out clinical evidences in favor of homecare. Among others home hospitalization reduces the risk of nosocomial contaminations and has positive impact on rehabilitation length. Up to day home hospitalization represent a marginal part of all hospitalization, around 1%, but the activity has experienced a 100% and plus growth between 2005 and 200948, according to FNEHAD, the French HAD federation.

This booming market is a clear opportunity for medical equipment providers. Indeed the biggest issue is to bring a hospital into a patient’s home in order to insure the same quality of care. What are the differences between a home and a hospital environment? Actually almost everything is different. This is why all equipment should be re-designed to fit this new environment.

First of all medical equipment will have to be more mobile and rethink products to stand in “hostile” environments. Because it would be too difficult to transform a home into a hospital, equipment maker will have to transform existing hospital-standardized material into adaptive

45 Diabeo (http://goo.gl/G0ZrT) 46 L’hospitalisation à domicile, une alternative économique pour les soins de suite et de réadaptation, IRDES, 2007 http://goo.gl/8myhu) 47 L’hospitalisation à domicile, une prise en charge qui s’adresse à tous les patients, IRDES, 2009 (http://goo.gl/vFEoa) 48 L’HAD en chiffres, FNEHAD, 2010 (http://goo.gl/kpImK)

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products that can fit the diversity of homes. The material also required to be transportable easily by home care givers and be robust.

Then dedicated material should be connected. Connected to hospitals, connected to home care givers, connected to local health professional. Remote conditions imply to be highly reactive in case of adverse events. Monitoring devices capable of alarming relevant people in case of emergency is fundamental. Devices will have to be as smart and autonomous as possible. In parallel the patient must be able to contact somebody in case of inquiry about anything. Dedicated call centers could be implemented to deal those calls and redirect patients to a relevant interlocutor. Human contacts would not be suppress but optimized.

The last challenge to answer the homecare market will be to simplify appliances. The goal is to empower the patient or its entourage with easy to use and easy to understand equipment. It will decrease anxiety and threat of misuse. Before any use, the patient, its family and the nurse who will visit the outpatient regularly will be educated on installed machine. Equipment manufacturers will have to provide trainings.

d) Patient empowerment

We have already said, several times in this report, that the patient role within the health system is gaining importance. This trend will be crucial for the emergence of mobile solutions. As a matter of fact M-health application could not only target physicians or hospitals.

Even if the patient used to be a layman about health and that it is neither the prescriber of care and medication nor the payer, it is willing to know more about its health. The Internet technology has revolutionized the scheme of health-information sharing. Today boards and blogs about health are flourishing and people show an appetite to seek that kind of information. The term of “expert patient” describe non health professional that have a power of influence thanks to a personal experience of a specific disease. They spend time to share their practice in specific situation and answer to patients experiencing similar situations. They got credit because people trust them and realized that their opinion may be more objective and useful since they know exactly what they are talking about. Pew Internet49 called this trend Peer-to-Peer healthcare and is mainly based on social’s networks. It is not useless to repeat that 80% of Internet users look online for health information. Graph 3 gives more detail about what people really look for.

49 Survey, CHCF, 2011 (http://goo.gl/Skj4u )

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Graph 3 - Internet users seeking for health information (source: Pew Internet survey)

To make a link with the previous part about chronic diseases, the report states also that one in four Internet users living with a chronic condition said they have gone online to find others with similar health concerns.

Patient will want to choose the drug or the treatment they have heard of. They will want to boycott bad reputation procedures. or health industrials. In general there is a need for credible, trustworthy, understandable, concise health information that is relevant, culturally sensitive, and actionable. With the emergence of over-the-counter health products (OTC) patient are already able to treat themselves. The multiplication of downloaded health applications shows that people are willing to pay out-of-pocket if it can empower them.

Finally there is a trend in the health sector called personalized medicine. This medical model was born thanks to advances in biotechnologies and genetics especially. The concept is to characterize the molecular, genetic and metabolic profile of a patient in order to tailor an optimized treatment or again to predict probable future health events. The patients become unique. Mobile devices could perfectly be able to quickly scan some specific characteristics. In emergency situations, without access to patient health data, blood scanning could give a myriad of precious information. Obviously this info will have to remain confidential and the patient will finally have final control on it. Then mobile health solutions open large doors for customization of healthcare.

In this environment, any mobile health solution should fully integrate the patient as a central element, in addition to traditional healthcare providers. It is not natural for health industry players but it will become mandatory. The next step couldn’t be reach without patient engagement.

e) Cost, access, clinical outcomes

All the challenges outlined in the last four sections made us seen the potential opportunities for M-health technologies. Identified possibilities imply lots of different solutions, including software, application, hardware, process and so on. However they all converge to the same purposes.

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i) Reducing costs. Direct benefiting parties will be the payers. Indirectly, through national health insurance funds, it will profit for the whole society while reducing the deficit of states. For healthcare providers it will help them to answer the pressure from governments and focus more on the care delivery. Patients will be able to reduce their complementary insurance fees and spend their money into extra personal health products.

ii) Improve access to care. People are familiar with mobile device in their daily life. The fact that some health solutions will merge with already known tools will allow them to penetrate the market and make health be accessible for crowds. Dependent or remote people will be more easily integrated in the healthcare landscape.

iii) Increase clinical quality. Wireless solutions will make healthcare be more precise, more reactive and more pervasive. The amount of data, collected thanks to the multiplication of automated records, the multiplication of patient inputs, will provide material to conduct analysis and improve the quality of healthcare.

What is remarkable about those 3 purposes is that they are by nature accompanied of responsible innovations. Improving access means reshaping the way cares and physicians meet patients. M-health solutions may succeed in reducing time and space barriers that exist in the physician-patient relationship. They also enable to cut inequalities between urban area citizens able to easily reach health infrastructures and isolated people in rural areas. To be true, the most promising application of M-health will be its diffusion in emerging countries. In places where healthcare workforce is limited and people are isolated the possibility to communicate and share health information virtually bears lot of expectations.

In parallel, efforts to improve clinical quality of healthcare services would have an impact on efficient allocation of resources. Actually M-health solution could massively avoid mistakes that are problematic for patients and cause waste of time and overuse of medication.

Too often new technologies are pushed and the rapid evolution and diffusion of them can be dangerous because we do not have enough hindsight. In the case of M-health it is likely to be the contrary. The technology is ready but the system’s complexity slow down the integration process.

2- Design a relevant business model

Now that we have identified a pool of challenges and subsequent opportunities for mobile health solutions we will give some insights about key points to build appropriate business models. As mentioned in previous parts, medical device companies will have to consider new different counterparts.

a) Why medical device companies are more likely to be leading players in M-health?

Up to now we did not discuss about medical device firms’ legitimacy to be central actors and leaders for M-health movement. If we have a look back to Figure 7 (M-health diagram), we see that there is a competition between medical device companies and other device makers in one hand, but also with ICT players such as telecom companies and software innovators in the other hand.

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As of today, firsts to be on the move were the software firms that have created many mobile applications. Actually it was mainly an attempt that was supported by the large diffusion and adoption of mobile multimedia devices. However the added value of such applications is not clear yet. What is sure is that it fits a need expressed by individuals, patients and health professional, to be better informed about health topics and be able to take care themselves.

The major inconvenient of today’s solutions is that there are not linked enough to the health system. Because they are basically consumer orientated, they naturally focused on individuals. Unfortunately we have seen how the health universe is complex and that finally individuals are neither decision makers nor payers. As a consequence the use of mobile applications remains superficial. That is precisely what the medical device industry can bring to the M-health sector. Indeed it used to have strong links with all actors within health communities and a deep knowledge of interactions between them. Overall medical device firms have experience working in a purchasing environment dependent on payers and in a product development cycle that involves regulators.

From this natural advantage they will have to compensate on other aspects such as understanding consumer needs, behaviors and attitudes and turning these insights into specific product features and functions. Not only focused on clinical aspects.

b) Build patient centric solutions

When talking about M-health and patient it is interesting to differentiate different categories of patients.

i) Healthy early adopters. They are not ill or in bad shape but want to stay healthy, stay tuned about everything that is happening in the health universe. They are the ones who buy the brand new mobile health application. They are convinced that they have a role to play. Among “patient” they are relatively few. They are willing to pay for extra services.

ii) Information seekers. They represent the largest part within the category. The information seeker is the person who wants to stop smoking and looks for tips and advice. It is also the mother whom child has to be operated and who is worried. Those people are neither convinced neither reluctant. They just want transparent information and find someone to ask questions to. They are not really willing to pay, but if they see real value added and that it does not imply much money, they will agree to pay

iii) Dependent and monitored patients. This category includes chronic disease sufferers but also disabled or elderly. They are under treatment and have no choice but use the medication and equipment prescribed by physicians. They would like to gain autonomy without losing the support from healthcare givers. Their entourage is often involved. They are not willing to pay but want their lifestyles to be improved. The payers would like their costs to be reduced.

They all want the same thing: be considered and felt that a solution can help them understand better, become healthier or live better. From those common principles the key is to design patient-centric solutions. No matter how beautiful, technical, or medically sophisticated the product is, if patients don’t use it… To increase relevancy of any M-health solution, elements listed in Chart 10 should be taken into consideration.

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Characteristics Relevancy

Value to the patient

The patient should feel that the solution answers its need. That the solution will help solving its problem. In order to increase the perceived value a big marketing effort, patient-orientated, have to be made by medical device companies. The highest value for a patient may not be clinical outcomes but consciousness outcomes.

Ease of use

From sign up to cancellation, from installation to uninstallation, M-health solutions should be easy to use. The use of any mobile product or solution must meet the level of knowledge of anybody. Medical devices makers have to keep in mind that patients’ capacities are far from homogeneous and in average lower than health professional ones.

Flexibility and adaptability.

One size does not fit all. How each patient uses application will vary. M-health products must accommodate the different preferences of users. They must make people feel those tools are theirs. They must offer the possibility to be customized.

Control Users should always have control over the services they opt in to, how to receive communications, and who can access their account information. One of the main principles of the Hippocratic Oath is to respect the confidentiality of health information.

Standardization and

interoperability

People are more comfortable when they have marks. M-health solutions could eventually use multiple technologies. Adopting a new technology can be a barrier if it is too often. The challenge will be to standardized technologies in order to improve the diffusion. From a common standard all solutions will become synchronized, people will be able to connect with others and will better welcome new products. Machine to Machine (M2M) communication will be facilitated.

Feedback loop

M-health devices will allow to record huge amount of data about almost everything related to health state of a patient. In order to promote the adoption of those solutions patients will want to know what those data means. A clear and easy to interpret digest of data accessible for patient is necessary. It is simply called pedagogy.

Proactive communication

Future medical devices should be proactive. It means that the patient will agree to use mobile device in some extent but they will want to be guided to act. What is the next step? What are the options now? What to choose? How to do? Answers to those questions should be pushed without the patient have to ask for them. It is mandatory to increase autonomy and avoid the patient to not act, or worst, to make mistake.

Remote presence

Finally one of the biggest drawbacks of mobile health solution, from a patient point of view, is the lack of human contact. Yet health is often source of anxiety and worries. Any M-health solution should then integrate the possibility to ask questions every time everywhere. Call centers, hotline or real-time chat will be excellent options to support patients.

Chart 10 - Key characteristics for building patient-centric solutions (inspiration: How to profit from M-health revolution, Pamela Swingley, 2011)

As mentioned by Thomas Goetz in a recent TED’s speech50, the future of health will not be only based on technology advances but also on patients’ engagement. On the contrary to adherence or compliance to a treatment, the challenge is to make people be convinced that they are able to do understand what is important. And that they will act not because they have been told, but because they are engaged. Obviously this state of mind must be supported. Mobile solutions will have to engage thanks to two features: feedback loop and pushed communications, as seen in the Figure 8.

50 TEDMed 2010, Thomas Goetz: It's time to redesign medical data (http://goo.gl/4BHEk)

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Figure 7- Engagement Loop applied to M-Health solution

The resulting engagement cycle shows that the device-patient interface should be particularly improved. As of today, health information is often raw-displayed and unclear if you are not a physician.

c) Adaptation to the complex practice of healthcare

Although the future of M-health will be to provide patient-centric solutions, medical device makers will not have to forget healthcare professional. At the end those actors will be the prescribers, the initiators and the patients’ adviser. We could assume that the task will be even harder with physician.

We have seen in the first chapter that physicians are part of a “caste” among societies. They possess a certain image and pursue an honorable mission. This mission is to treat people and as it is often said “to save life”. The seriousness and purpose of healthcare is not to be demonstrated, but we can be sure that change mentalities will not be a simple thing. To what extend would the doctors agree to give more power to patients? To what extent would practitioners agree to let a device replace them?

In addition to those existential questions there are real barriers. Hospitals are most of the time under-staffed and workflows are complex (patient, material, administration). In such environments healthcare professionals do not have time to adopt the new technologies. They are in the present time, often in a rush. For health professional outside hospitals barriers are different. The main challenge is to deal with a fragmented population of patients located at diverse places. Patient accessibility is more difficult than in a hospital for instance. Plus healthcare workers are themselves dispersed, making interrelations more difficult. Each of them are based in facilities that have different sort of equipment. Each of them has proper habits to provide healthcare.

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All those difficulties will force M-health providers to include key characteristics in mobile solutions. Some of the features exposed for designing patient-centric solutions will be adapt to improve the diffusion among health providers. For example ease-of-use will be primordial while giving the possibility for mobile device to integrate more complex settings. For that purpose mobile solutions could allow physicians accessing complementary options, unreachable for patient. Moreover standardization and interoperability will be a critical point. Let us imagine that a practitioner is remotely following dozen of patients with different diseases then with different mobile solutions. How could he or she be efficient in providing care if all those technologies are different? How could he or she be confident in juggling with dozens of different platforms? In such cases the expected advantage of mobile solutions will not turn to be a reality.

Finally, to cope with physician’s reluctance and make them adhere to M-health solution, mobile device makers will have to emphasize on trainings and awareness campaigns. Pertinent clinical trials and witnessing from key opinion leaders will have to be conduct because it is often the only way to convinced healthcare professionals. It also important to remember that tomorrow’s physicians are now young students. And like a majority of young people they are particularly accustomed to new mobile technologies. Trained those future practitioners to use mobile devices may be a good strategy.

d) Build partnerships to provide fully integrated M-health solutions

The description of the health system, complemented by the analysis of the M-health environment, has led to the conclusion that medical devices makers are only some players within an extraordinary complex game. Yet we have also seen that mobile solutions have the capacity to reshape the whole system and set new rules. Even if medical device manufacturers are the most credible players to lead the movement (as mentioned two chapters earlier) it is obvious that they will have to find partners. First, with the ICT players. Second, with health actors.

Alliances with ICT and electronic actors

A partnership has to be seen as a win-win collaboration. The first level of partnership will be to collaborate with telecom operators and Software companies. In fact wireless health devices will have to be thought as solutions and ecosystems, not just as products.

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Figure 8 - Mobile health ecosystem, different layers that have to be linked (source: IBM)

The ecosystem represented in Figure 9 was inspired by IBM Global Business Services in a 2011 report51. Red parts represent medical device manufacturers’ field of activity. It will be essential to find partners in the other fields.

A device manufacturer will have to insure that data recorded by its products could be stored, safely. This could imply to find a company operating servers. Those servers should have the capacity to store complex data. For instance, a routine chest MRI exam contains hundreds of high quality images and weights up to 1 Gigabytes. Then the device maker will may need to collaborate with a software company that develops user interfaces. Indeed we have outlined the importance of ease-of-use and of user friendly displays. This intuitive interface will be important for the mobile device but also for the web platform associated, unavoidable back office for every M-health solution. Web giants like Google or Microsoft which have already developed such web platforms will be perfect associates. A publishing company that supplies health related information and content may be also useful to feed such a platform.

Between the servers, the web resources and the mobile devices, networks are necessary. Providers of web connection like the one presented previously (Orange Healthcare) would be approached to sign partnership. Telecom operators could also be excellent allies and would open doors of smartphones market that is up to now the most used device for health purpose (thanks to mobile applications). We could imagine that in the future, a phone subscription will be sold with a health-related package.

Finally we will focus again on the rivalry between medical device makers and mass-consumption electronic device ones. Those last can teach a lot about consumer relationship to medical devices companies. This is why it is highly relevant to create bridges between the two worlds. The widespread of electronic appliances could benefit for the penetration of mobile health device, quickly and efficiently. We have already talked about that mobile phone add-on that is dedicated to measure the blood pressure. Some others are capable of measure blood sugar level. More surprisingly, we could imagine earphones measuring body’s temperature, heart beat and blood pressure while listening to music!

51 IBM Global Business Services, The future of connected health device, 2011 (http://goo.gl/Zo2Vu)

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The convergence has no limit and the more partnership will be signed, the more solutions will emerge. We don’t even talk about alliances with garment makers (wearable devices), furniture’s sellers (smart homes), food manufacturers (co-marketing)…

In addition to invent new technologies, unions with those players will make possible to build technologies’ standards. Indeed device makers should remember that interoperability is one of the mandatory factors to allow M-health diffusion.

Partnerships with health system’s players

In this market, healthcare provider relationships will be particularly vital – not only because consumers will rely on them for recommendations, but also because the value proposition of mobile health solutions falls apart if they are unwilling to use this new data source. Depending on how a new device is sold, device makers may need to work with pharmacists’ communities as well as physicians and hospitals. The strategy will be to involve key opinion leaders that have a large influence on their counterparts. As seen before, the health professionals’ adoption will also rely on tangible proofs of efficiency. The idea will be to work with famous scientific organisms, unions or NGOs and conduct large scale trials and studies.

Making these new devices affordable may require some type of insurance reimbursement or incentive such as premium discounts. Medical devices companies may need to collaborate closely with those insurers. To help control healthcare costs, insurers may assume an increasingly prominent role in the M-Health ecosystem.

Obviously collaboration with patient communities will be highly interesting. To learn from the deep needs of the sufferers in one hand and to promote the so-designed solutions in the other hand.

Public-private partnership

We would like to highlight that the public-private partnership option is a remarkable one. As said just before, work with public hospitals will be necessary. Selecting on-the-edge institutes and implement best-in-class M-health systems would probably worth more than any other marketing campaigns. Conducting pilot experiments with local administrations could be a good choice.

Europe is also willing to partner with M-health devices makers. Through the 7th Framework Program, the European commission will invest €258 million in 2011-2012 for ICT research projects focused on health topics52. To be eligible, large companies, small companies and public institutions from different European countries have to form consortia and apply to published calls.

e) How to sell and monetized wireless health solution

Now that we have seen what the best solutions to build are and how to conceive them by partnering with other players it is time to understand how we could sell those M-health

52ICT Challenge 5: ICT for Health, Ageing Well, Inclusion and Governance, European Commission (http://goo.gl/ZpGNw)

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solutions and monetize them. We could answer this question first by identified parties willing to buy and for which expectations. Then we will decline a distribution channel for each of them and a payment process.

Business model for customer-patients

As we put emphasized on the growing role of patient all along this report we will treat this case first.

The PwC’s Health Research Institute has recently conducted a survey on consumer to get insights on their behavior relating to health-related mobile solutions53. The survey’s report concludes that 49% of interviewees will be willing to buy a mobile health solution. To be more precise 40% of respondent will agree to pay for a remote monitoring solution ($10/month for mobile phone service, $75 for a device). What is surprising is that men and healthy people are the most inclined to pay for such services. The survey shows also that customer-sold solutions would preferably be mobile phone applications or mobile-linked devices.

Thanks to those few insight we can draft beginnings of a distribution channel. Those solutions will have to be mainly linked to smartphones’ environment. Then, as mentioned sooner, the best way for selling health solutions directly to customers will be to package them as phone subscription option. Devices that would be used as smartphone add-on could be sold in high-tech or phone department in retail shops. These devices could be used indifferently with smartphones. Applications could also allow patients’ entourage to be informed of the tracked data (Figure 10).

In addition those products could be sold at hospital, at physician’s cabinet or at chemistry’s. As patient still trusted a lot those players it will be an excellent promotion for mobile health products.

In option people could request for detailed analysis of the captured data, and ask for recommendations from healthcare professionals. This service will be charged as pay-per-request and added to the phone bill.

53 Healthcare unwired: New business models delivering care anywhere, PwC Health Research Institute (http://goo.gl/8M4LV)

Figure 9 – M-health business model for consumer-patient’s solutions

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Business model for In-town care givers

A second strategy will concern mobile solutions targeting healthcare providers working in-town, as opposed to the ones working in health establishments (hospitals or clinics).

The PwC’s report gives us material to target those actors. Actually there are two things that care providers give value to: Increase the clinical outcomes for their patients, and save time. 56% of surveyed physicians answered that mobile solutions could help them to improve and shorten the decision making phase. They also outlined they are willing to track their patient at homes and would like to communicate easily with patients using mobile technologies. The last important point for them is to better interact with their counterparts.

M-health solutions could be then sold directly to physicians. Typically software including patient management capacities, with mobile communication features (virtual visits, SMS chatting) will be purchased by unique physician or community of physicians in order to replace their old patient-management software. However there is a bug in this model. Actually doctors gains revenue proportionally to volume of visits. Yet those remote solutions aim at reducing the number of visits. Possibilities are emerging.

Either patient will have to pay premiums each time they use that kind of virtual relations (may be reimbursed thanks to claims). In this case M-health providers will charge the physician proportionally to the software use, also known as SaaS model (Software as a service). Or even better, the M-health provider will take a percentage on the paid premiums. In parallel physician who will save time by using those platforms could offer a bit of its “medical time” to feed parallel platforms where people request medical advises (Figure 11).

Figure 10 - M-health business model for healthcare provider’s solutions

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Business model for health establishments

Hospitals, clinics but also elderly institute and home-care providers have in common to deal with a multitude of healthcare professionals, patients and equipment. In such organizations there is a need to improve workflows. Workflows refer obviously to care activities but also administrative and financial activities. The added value for those organisms will be to gain efficiency.

The clear interlocutors within those entities will be Chief Information Officers (CIO). A CIO is a senior executive in an entity responsible for the information technology and computer systems. They are supported by health workers using the technologies. CIO and IT decision-makers in health entities are good intermediaries. They are opened to new solutions and able to influence others parties (payers, health professional).

Figure 11 – M-health business model for health establishment’s solutions

So M-health solutions must be marketed as central solutions that have the capability to manage every workflow within a health organism. Machine to Machine communication will allow tracking all resources, recording real-time progression and abstracts of consultations and exams. They will also be relevant to improve equipment’s coordinated use, personalized relationship between patients and health providers and avoid patient being forgotten.

To sell such solutions M-health provider should consider the SaaS business model as a major source of revenue. Since those projects should be really compex to implement, the SaaS model will avoid organisms to invest huge amounts at the beginning.

Like for physician there is also here a problem of incentive since hospitals earn money based on volume of activity. The objective of improving quality and management should result in a

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decrease of activity. The game will be that payers assess the savings realized in equipped entities and give them more budgets based on efficiency objectives.

3- Foresee adverse or collateral effects of M-health solutions: be conscious and responsible innovators.

Although M-health solutions are expecting to revolutionize the healthcare system for the benefit of everybody, it makes a point to warn about some key points. The concept of responsible innovation is currently studied by people such as Xavier Pavie and must be differentiate from innovation for responsible purpose. According to him, “the responsible innovation’s stake is to integrate measures respecting the environment and the people all along the innovation process, including development and marketing phases. Even if final innovation’s purpose is not to protect environment or people, innovators should be aware of these concepts while conceiving their product or services”54.

a) Ethics and health Information security

One of the major issues raised by connected health in general is the security of health information exchange. The already mentioned PwC’s report states that 41% of interviewed physicians would be “worried about privacy and security”. From ancient times the privacy and confidentiality of health information have been an important characteristic of medicine practice. It is not surprising that this aspect is a key point of the Hippocratic Oath. Health information is part of patient’s intimacy and one will not be likely to share those with everybody. It is especially important at a time when people are able to diffuse information with a simple mouse click. If they are willing to do that for other kind of information, like photographs on social networks for instance, the willingness seems totally not true concerning health information. Imagine that an employer, an insurer or any other parties that could be interested in knowing the health state of a citizen, could access the digitalized health information is a threat for many.

Answering this issue will imply implementing high-level security processes. M-health actors should become security experts. To do so it could be interesting to take the financial services industry as a model. Actually they are on the edge in the security of data’s exchange, networks and private identification. The challenge will be hard but it will be important to establish trust and assurance with the users. Anyway regulators and governments will probably set rules, laws and certifications to guarantee health data privacy. Again partnerships and standardization will be fundamental to achieve this high-security level.

b) Reduce impact on environment and people

Massive adoption of M-health devices is assumed to improve everybody’s life, customers, physicians, governments. However, this positive vision could be spoiled by negative effects on environment or, more paradoxically, on people’s health.

Manufacturing medical devices has a direct impact on environment. Components of electronics products often include rare materials or polluting ones. Creation of those health electronic products should then integrate end-of-life management. In simple words it means

54 Innovation-responsable, Xavier Pavie, 2012 (Eyrolles)

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that devices manufacturers should consider recycling path for used-up products. It can also mean reduce polluting material or designing efficient-battery device using renewable energy.

Another problem will be the continuous use of M-health devices, especially in the case of monitoring devices. The fact that those products will be connected and used in close contact with the body raises questions. It will be of high importance for device makers to prove the inoffensive character of wireless products. For the moment the mobile phone industry is dealing with this problem but clear evidences were not found yet… Imagine a device used to track babies’ vital signs. What could be the negative effects of radiofrequencies or other infrared emissions on its brain? If M-health solutions bring more problems than solving ones, its interest could be limited.

c) Use of M-health in the developing world

The scope of our subject was clearly mature countries. But the reality is that M-health solutions are still more promising in poor countries. It could improve healthcare access for remote populations where physicians are few and often not trained well. Telemedicine could be a perfect solution. Moreover we have seen that penetration of mobile phones is definitely high in developing nations, compared to other technologies. The prevention and education of population could benefit from this mass diffusion thanks to awareness SMS campaigns or other communications.

One way for M-health solutions makers to be responsible innovators will be to design some products that could be turned down and used in developing areas. Those products should be simple, with only basic features and again more robust.

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Graphs

Graph 1 - Health expenditure per capita by age (source IRDES)............................................10  Graph 2 - Age Structure Diagram, France 2010 (source: INSEE) ...........................................36  Graph 3 - Internet users seeking for health information (source: Pew Internet survey)...........43  

Charts

Chart 1 - France health expenditures, € billions (source: INSEE) .............................................9  Chart 2 - Breaking down of Care and Medical Goods Consumption, €billions (source: INSEE)9  Chart 3- Healthcare workforce (source: WHO health report statistics, 2011)..........................12  Chart 4 - Health complementary insurances in France (source: DREES)...............................18  Chart 5 - Common Health Information Technologies (source: Medpac) .................................25  Chart 6 - Potential outcomes for M-health solutions (source: Triple Tree) ..............................27  Chart 7 - Main mobile phone operators (source: Wikipedia) ...................................................30  Chart 8 - French population forecast (source: INSEE) ............................................................37  Chart 9 - Weight and cost of ALD 30s for the French Health Insurance (source: CNAMTS 2008 and 2009) ......................................................................................................................39  Chart 10 - Key characteristics for building patient-centric solutions (inspiration: How to profit from M-health revolution, Pamela Swingley, 2011)................................................................46  

Figures

Figure 1 - Maslow's hierarchy of needs .....................................................................................5  Figure 2 - Development of a pharmaceutical product ..............................................................14  Figure 3 - Scheme of the French Health Insurance Fund in 2009 ...........................................17  Figure 4 - The Healthcare value chain (source: Lawton Burns)...............................................19  Figure 5 - Kondratieff waves and Schumpeter analysis...........................................................23  Figure 6 - M-Health Environment.............................................................................................31  Figure 7- Engagement Loop applied to M-Health solution.......................................................47  Figure 8 - Mobile health ecosystem, different layers that have to be linked (source: IBM)......49  Figure 9 – M-health business model for consumer-patient’s solutions ....................................51  Figure 10 - M-health business model for healthcare provider’s solutions ................................52  Figure 11 – M-health business model for health establishment’s solutions .............................53  

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