9.1. Introduction

One feature of the Internet of Things (IoT) is that it broadens the Internet network to include objects and places in the physical environment. The IoT is the source of a considerable increase in the quantities of data generated by the new usages associated with it, thus contributing to the supply of Big Data. An issue falling at the crossroads of technical dimensions and social usages, this has led to its definition as:

“…a network of networks which makes it possible, via standardized and unified electronic identification systems and wireless mobile devices, to identify digital entities and physical objects directly and unambiguously, and thus to be able to collect, store, transfer, and process the data attached to these entities and objects with no discontinuity between the physical and virtual worlds” [BEN 09, pp. 15–23].

In this chapter, we focus our attention on the social, political, economic and regulatory challenges of the IoT; these lie in the exponentially increased modes of access to information characteristic of “ubiquitous computing” [GRE 06], in the creation of new services, and in data exploitation conducted by means of algorithms. In its social usages, the IoT is embodied in the Web of Objects, which refers to connected objects, particularly telephones but a wide variety of other objects as well. It brings out the complexity of information and communications technologies in terms of their interoperability and the preservation of the security and reliability of data. The Web of Objects offers unforeseen possibilities in matters of communication between people and objects, direct communication between objects, and connections to centralized servers and networks of servers. However, the large amounts of data collected and the associated processing, carried out by public or private actors, raise questions of human traceability in information systems and the protection of the personal data of users of these sociotechnical systems [JUA 09, JUA 14].

Belonging to the field of Information and Communication Sciences, this chapter addresses the sociopolitical challenges and mobile information access systems encompassing the production of and access to online content and services via a portable computer terminal, focusing on mobile telephones (smartphones). The IoT’s challenges are addressed in mobile health usages and sociotechnical systems, which have destabilized the traditional health system.

Within these political and social challenges, changes in the systems of production, distribution and exchange of information generated by this “Internet of the future”¹ once again raise ethical questions concerning open access to information and to cultures in their diversity, in tandem with the protection of private life and liberties (as in the first days of the Internet’s opening to the public in the early 1990s). In this constantly evolving field, in which new equipment and techniques emerge regularly, the objective targeted is to construct an analytical framework in order to understand the policies and strategies of actors in relation to the artifacts and systems of information and mediation they implement.

We begin by presenting the specific characteristics of the hybrid field of mobile health and the social science approaches taken in studying it. The theoretical framework that joins the analysis of artifacts and innovative forms of sociotechnical mediation to the socioeconomic strategies of actors will then be discussed. Next, the strategies and socioeconomic models of the industrial actors active in the field of mobile telephony will be studied in correlation with the consequences of the changes observed in modes of access to information, particularly in the field of mobile health. We examine the way in which new forms of publication² and communication, centered on new modes of production, presentation, organization and distribution/circulation of information or knowledge, affect the production of and mobile access to content in detail. As we show, these access systems are the result of interrelations between technical innovations, socioeconomic models and modes of regulation still in development.

9.2. An interdisciplinary activity sector and field of research: between connected health and connected well-being

The uses of the terms “eHealth”, “telehealth” and “telemedicine” lend themselves to confusion, as revealed by the Haute Autorité de Sante (French National Authority for Health) in 2016 [HAU 16]. In actuality, the lines blur in the field of connected health; it is difficult to make a clear distinction between connected objects and the applications utilized in the field of well-being, of health, and in the exercise of medicine (telemedicine)³. However, the regulation of mobile health requires that its different components be defined and the regulated activities identified. Dating from the period of rapid technological development in the early 2000s, the term “eHealth” refers to a new international industrial sector combining health with information and communication technologies. The World Health Organization defines eHealth as “the use of information and communication technologies (ICT) for health” [WHO 17]. The term “mHealth”, referring to “mobile health”, was introduced in 2000 by Robert S.H. Istepanian, a researcher in electronic and electrical engineering in the context of unwired medicine (e-med), an expression which refers to “the next generation of wireless and internetable telemedicine” [IST 00]. He defined mHealth as follows in 2003:

“In general terms, m-Health can be defined as mobile computing, medical sensor, and communications technologies for health care” [IST 00, p. 405].

With mHealth gaining international scope, the World Health Organization has redefined this term by linking the technical dimension to the social uses that go along with it and to the prospective advantages they are likely to contribute:

“mHealth: use of mobile wireless technologies for public health”, reflecting the increasing importance of this resource for health services delivery and public health, given their ease of use, broad reach and wide acceptance. “mHealth” or mobile health has been shown to increase access to health information, services and skills, as well as promote positive changes in health behaviors and manage diseases [WHO 16, p. 1].

More specifically, the usages and technical systems falling under the category of mobile health include “medical and public health practices relying on mobile devices such as portable telephones, patient monitoring systems, personal digital assistants, and other wireless devices” [WHO 11, p. 6]. The technological solutions provided by mobile health “enable in particular the measurement of vital signs such as heart rhythm, blood sugar, blood pressure, body temperature, and brainwave activity”. Its applications include “communication, information, and motivation tools such as devices that remind people to take their medication and others that make recommendations regarding diet and exercise” [EUR 14, p. 3]. With a view to conducting a global analysis, the WHO has grouped mobile health services into 14 categories ranging from call centers to decision-making assistance systems, including access to information, observance assistance, appointment reminders and mobile telehealth. Its last study of 114 countries shows that mobile telemedicine, understood from the angle of communication among health professionals, belongs, along with call centers, to the four types of programs most frequently implemented in most of the nations studied. It should also be noted that the WHO’s definition includes the concept of patient monitoring [WHO 11].

Mobile health can be seen as a market and an industry [BUT 16] that raises complex issues in terms of security of information [HAN 16] and legal regulation connected to modes of utilization and data protection [THI 16]. It constitutes a hybrid domain bringing together different types of actors with the same motivations; public authorities see it as an opportunity for preventive usage [CAM 16], improved accessibility of health services (via telemedicine) and reduced public health expenditures, while health-care professions are experimenting with mobile tele-assistance and remote medical monitoring (particularly with chronic illnesses). In addition, public participation in the compiling of health data can be seen as belonging to increased autonomization, empowerment and health-related democracy. Numerous recent international studies, inventoried by the Haute Autorité de Santé, focus on the assessment of mobile health applications for smartphones. Conducted using a variety of disciplinary and thematic approaches, these have focused notably on the public and end goals (preventive medicine, medical monitoring, tele-assistance, observation, well-being, etc.), data security and management, health-related content, technical systems, utilization and use [HAU 16, pp. 8–13, 56–59]. Studies have also focused on “mobinauts” (members of the public and health-care professionals) who use and do not use these mobile applications, examining them in terms of knowledge, perceptions, uses, expectations and needs [CNO 15, pp. 15–16]. Target audiences go beyond the field of eHealth and its medical solutions with regard to the monitoring of chronic diseases and the observation or caretaking of dependents. They include users wishing to gain a better understanding and mastery of their health and well-being. Comprehensive approaches are interested in the “quantified self” in “digital self-measurement rituals” [ARR 13] and the “self-quantification” associated with sharing within communities [PHA 13].

The digital informational ecosystem continues to contribute to the destabilization of the health-care industry. Websites, forums and social networks have already caused evolutions and tensions resulting from ubiquitous information, the opening up of access to medical information and modes of communication ushering in growing public participation. The loading of health-care applications on to mobile terminals introduces specific issues connected to sociotechnical systems and new facets of intermediation, information and communication.

9.3. “Boundary objects”, socioeconomic strategies and innovative forms of sociotechnical mediation in equipped mobility

Innovations – that is, long social processes by which inventions travel along their path to users of sociotechnical objects [ALT 00] – are common in communication-related industries. By opening up remote access to the Internet in mobility situations via connected objects, computer and electronic artifacts have progressively evolved interrelationally with the public’s technological and communicational practices. The characteristics of these portable, miniaturized items of hardware combine multiple functions of electronic scheduling and communication⁴, Internet navigation via web browsers for mobile devices, file exchanges, listening and reading. Multimedia functions (text, sound, image and video) are broadened with the addition of digital reading software, MP3 audio readers, video and digital cameras. The integration of social platforms (Twitter, Facebook) has encouraged exchanges within online social networks.

Innovations occupy a central place in the highly competitive area of communication industries. The proliferation of mobile objects and interfaces has now multiplied the technical points of entry available and thus information mediation. The concept of the boundary object helps us to understand these technical, hybrid and multitasking objects that combine functions of telephony, mobile Internet and multimedia reading devices while also giving access to information. This concept has been evoked in reference to:

“concrete or abstract objects, the structure of which is sufficiently common to multiple social worlds that it ensures a minimum intersection identity while being flexible enough to adapt to the specific needs and constraints of each of these worlds” [TRO 09, p. 8].

These “boundary objects” are widely distributed in the form of netbook computers which are being progressively supplanted by smartphones and PC tablets – computer tablets equipped with touchscreens. In mobile health, a wide variety of connected objects (bathroom scales, pillboxes, watches, eyeglasses, clothing) constitute hybrid objects that fall at the intersection of multiple universes.

The social dimension of communication technologies has led to the questioning of “sociotechnical mediation” [AKR 93, JOU 93, LAT 93] and the social appropriation of connected objects, analyzed in the informational systems and practices of private or professional life. Beyond conformity to international norms and standards having to do with the “usability” of hardware and applications, the forms of sociotechnical mediation reveal that sociotechnical innovations (manufacturers of hardware and software), by joining together with new publishing practices (those who offer services and content) as well as information practices (users), are contributing to the construction of a technical and media-friendly culture. The “sociotechnical framework” [FLI 95] comes within the scope of reflection on the structuring of technical and social dimensions. Thus, the artifact becomes “a mediator, a social actor, an agent, an asset that is part of an ‘action plan’ composed of social relationships and relationships of power, law, and morality …”. Artifacts are considered as “social relationships continued by other means” [LAT 93, pp. 44–45]. Falling within the paradigm of innovation and translation theory, studies of the sociology of innovation show the social dimension of technical innovation and bring up to date the interactions and negotiations – going so far as to become confrontations – of the various actors, including the agents, that participate in it [CAL 86, LAT 89]. A digital culture is created, at the intersection of changes in the publishing practices of publishers of software and services, socioeconomic models of actors in the communication industry and the informational practices of users of the new tools and services offered [JUA 15].

In the same movement, digital technologies, by modifying the conditions of access to content, have destabilized socioeconomic balances and modes of organization in the publication of information in the health-care sector. Actors in the communications and Internet industries are playing an increasingly important role in the hybrid domain of mobile health. Intermediation focuses attention on the introduction of new actors, their status and the role they play in the mediation of information and knowledge. In the international context of the Internet of Things, the media and communications industries constitute a hybrid category that combines electronic media and technologies (the hardware industry, which includes computers, portable music players and mobile telephones), services having to do with telecommunications (the Internet, the Web and the digital services associated with it) and content in digital formats that deals with health on mobile terminals. In their relations with content publishers, hardware and software manufacturers are developing socioeconomic strategies and models, resulting in new tools and services being offered to users. We show how the socioeconomic strategies and models of these industry members are connected to cases of intervention via national and European regulations, with the whole contributing to the structuring of systems of access to information and services.

9.4. Mobile health-care service access systems: toward intermediation or disintermediation?

The scientist and futurist Joël de Rosnay, in a 2016 interview with the economic and financial newspaper La Tribune, emphasized the unforeseen possibilities opened up by digital technology and the use of sensors in personalization and personalized prevention in the health-care domain. He stated that:

“Disintermediation is underway, and it will spare neither big pharmaceutical companies, nor drugstores, nor even doctors. To what can this uberisation be credited? To the fact that small organizations are capable of creating algorithms and software, particularly on the Internet, which link supply and demand, and it is from this that they draw their shares and pay themselves. It is Uber with taxis, Airbnb with hotels, BlaBlaCar with rental cars, and Alibaba in China with business. Yet Uber owns no taxis, Airbnb owns no hotels, Alibaba has no stock. The uberisation of health care may be just as extensive and just as fast. All that is required is to lay down, atop the large and costly production and distribution systems, a thin human- and software-based structural layer and to link products and services directly with clients via proactive software. Would you resist, if you could access products and services that were cheaper, faster, less administrative, and less complicated?”⁵

The question of intermediation and disintermediation is now being raised for the mobile health market, which is one of the markets developing due to the generalization of mobile Internet access via smartphones and health-care services based on equipped mobility. Firstly, the evolution of the fixed Internet toward the development of mobile access is having an increasingly significant effect on access to information. Mobile computing technology (hybrid connected devices combining mobile telephones and pocket organizers, as well as tablets and “ultra-portable” laptops) has flooded these markets [MED 17]⁶. The success of smartphones has contributed to the development of new uses, and the number of people connecting more frequently to websites, portals and mobile applications is on the rise. This trend has gone along with access to wireless telecommunications (WiFi and Bluetooth technology; the Apple iBeacon), the use of electronic identification systems (RFID chips) and high-speed Internet. Secondly, the mobile health market is in the midst of booming growth, according to the annual report by Research 2 Guidance, a mobile application market analyst: at the end of 2015, there were 7,900 mobile health applications (mHealth apps) available worldwide (55% of these in Europe, 28% in the United States, 2% in Africa, 2% in South America and 13% in the APAC [Asia-Pacific] region), with 2,600 health practitioners using them. This market, worth more than 5 billion dollars in 2015, should reach 26 billion dollars in 2017 and 31 billion dollars by 2020, thanks mainly to the provision of services linked to applications [RES 16, p. 2, 10]. It is predominantly a European and North American industry.

However, an organization cannot communicate about a health-care product, a medication or a health-care application in the same way it communicates about a car, a hotel service or a mass market commodity. The modes of communication in terms of practices, regulation and discourse are specific to this sector⁷. However, new industrial actors from the information technology and Internet fields are investing heavily in the health-care field, considering it as a market liable to bring substantial profits rather than a scientific domain with ethical and health-related challenges.

In these large-scale industrial, strategic and technological reconfigurations, new actors in the IT and communications industry have established themselves in the mobile health market through their products and services, socioeconomic models, and business strategies. In 2015, 23% of companies publishing mobile health-care applications were IT/TECH companies; 27% were computer software developers and 5% were specialists in telehealth. On the other hand, historic health-care sector actors are a minority in the field of mobile health (7% in medical devices, 6% in the pharmaceutical sector, 4% in health insurance and 4% in hospitals) so dominated by new arrivals [RES 16, p. 1].

What are the links between the socioeconomic models used and the technological choices – in terms of both hardware and software – made by industrial actors? What are the consequences for systems of access to information? In this innovative field, material and technical aspects are very important for the user’s ability to access information. The possibilities opened up by equipped mobility and the expansion of telecommunication networks may imply that they facilitate the circulation of information to a large extent; however, the choices made, exploiting the plasticity of the informational process as they do, belong as much to strategies of opening up information as to those of access control.

On the international market, competition is quite intense among manufacturers of electronics and computer hardware and software. These companies add value to their technological innovations by associating them with the brand identity of their products. Windows Mobile, iPhone OS and Android are the principal operating systems for mobiles that share the smartphone market, while Apple Safari, Android Chrome and Microsoft IE are the major web browsers. Many of the most well-known hardware brands (Samsung, Nokia, Acer, Sony Ericsson, LG, HTC, Motorola) function on the Google Android or Microsoft Windows Phone operating systems (with a mobile Office suite in the case of the latter). Devices with keyboards or touchpads functioning on the Blackberry system by the Canadian manufacturer of the same name, whose niche strategy was aimed at a top-of-the-line business market, no longer include telephones, which ceased to be manufactured in September 2016. The various generations of Apple iPhones and iPad tablets (using the iPhone OS system) rely on the elegance of the object itself, its multimedia functions and a highly intuitive touchscreen interface, which is itself in keen competition with Google Android. The tablet market continues to attract Google and Microsoft, actors which are also opportunistically testing the market for portable connected objects designed for frequent use, following the example of Nokia, which purchased the French company Withings and is offering an innovative connected wristwatch linked to the dedicated application Withings Health Mate via smartphones. However, despite its media success, this market still lacks maturity; a number of its products often give rise to a “gadget effect”, are expensive and have problems of interoperability; moreover, their autonomy and life spans have been deemed inadequate (e.g. the withdrawal from the market of Google Glass, or the criticisms aimed at the Apple Watch, which was considered overpriced and lacking in autonomy).

In the end, three American multinational corporations (Apple, Google and Microsoft) occupy the majority of this international IT market, which is highly competitive and relies on innovative technologies. They are among the major actors of the Internet industry, often collectively nicknamed GAFA (Google, Apple, Facebook, Amazon), which, with Microsoft, represent the five largest market capitalizations whose activities rely partially on the exploitation of user data; these users are obligated to use equipped mobility hardware and software in order to access mobile health information and services.

With regard to publishers of mobile health applications, because their content is linked to software, they must comply with the norms set out by these dominant actors, which have established themselves as new intermediaries for the development and downloading of applications. Yet, an application developed for iPhone is not directly usable on Android, and vice versa. The development languages used (Objective C for Apple; Java for Android) are not the same, and differences can be seen between Java interfaces and Objective C protocols. Multiplatform publication on Android and iOS is the norm for mobile health-care publishers; 75% of them produce applications for both platforms. Non-exclusive usages of platforms are distributed among Android (88%), iOS (84%), Windows Phone (16%) and HTML5 (29%) [RES 16, p. 2].

The major Internet and communications actors, like the “boundary objects” they publish, can be characterized as “boundary organizations”; they are situated at the intersection of multiple industrial worlds and activities while still relying on their IT specialization, on the Internet and on electronic hardware. Google, renamed Alphabet, is simultaneously a search engine, an Internet access provider, an advertising agency, a publisher of resources and services (in areas of activity as wide-ranging as health and culture) as well as office suites, an online storefront, an investment fund, a health researcher and an artificial intelligence. Likewise, Apple is simultaneously a manufacturer of electronic hardware, a software publisher, a content publisher, an online storefront, an artificial intelligence researcher (voice recognition), and more. These organizations are characterized by their financial power, their established presence in multiple sectors of activity, and their high capacity for technical innovation and the absorption of innovative actors. In a highly competitive and unstable market, they deploy various development strategies which their competitive situation leads them to cause to evolve and adapt according to their competitors’ initiatives.

From a concentration-based approach, the strategy used by Apple in terms of its competitors’ practices illustrates how controlling hardware and software in mobile access enables it to cordon off access to information and services while at the same time making it necessary to purchase its devices. These limitations apply as much to mobile device application developers as to publishers of applications and users of portable devices. This “cordoning-off” or “locking” approach is applied first to developers. Since 2010, beginning with the arrival of the iPhone OS 4.0, Apple has modified its conditions of use for developers by imposing a development platform and programming language (Objective C) required for applications to function on iOS and for their authorization to be included in application sale software (the Apple Store). This situation is unprecedented in the history of information technology, as no operating system publisher has ever before insisted upon a software programming language. Conversely, Microsoft’s strategy for conquering the PC market was to allow developers the freedom to write applications, on the condition that they would be executable only under Windows and incompatible with other operating systems. Apple’s strategy seems to consist of attempting to prevent a competitor from imposing one multiplatform standard on the mobile market. The blocking of the Adobe company’s Flash software in applications and the Safari mobile web browser shows how Apple blocks its competitors and imposes its own operating system, iPhone OS⁸. The company thus capitalizes on its dominant position in different segments of the market on smartphones, particularly in eHealth, and on the success of the iPad tablet to impose its own operating system in these segments.

Because users wishing to access Apple applications for iPhone OS, or to use those applications already purchased, must buy or replace an Apple device, the company’s sales have increased all the more. The last stage of this locking-off is the diffusion, with the subtraction of a £30 commission, of subscriptions to various types of products generated via the online store (since 2011). Apple is positioned within a specific type of organizational convergence, vertical integration, in which the company controls every stage of the production line using technical lock-offs. From a proprietary perspective, it retains power through the fact that it manufactures the hardware, develops the operating system and develops or controls access to applications via its Apple Store software.

Google has made a different choice instead, playing the “open product” card. This is a horizontal concentration, not through the absorption of competitors, but via the positioning in multiple markets in the software industry and more recently in the mobile access field as well. This major industrial actor specializes in the field of software (originally its search engine) and manufactures neither tablets nor mobile telephones. It has established its place in the mobile Internet software market via an operating system for mobile telephones (Android), which is a free and open software that does not depend on a telephone. These technical characteristics mean that any mobile telephone manufacturer can use the Android system and develop applications for it in whatever technical manner they desire. Control is exercised downstream, in terms of the diffusion channel imposed via the Android Market online store. Its web browser for mobile devices, Google Chrome, is the second most-used software on mobile telephones and exceeds Apple Safari in terms of the number of users.

An analysis of the development strategies of these Internet, information technology and Web “boundary organizations” shows the methods of controlling the mobile Internet and the data collection markets they implement. These are composed of several key elements that must be controlled: the computer hardware that enables mobile access, the operating systems that pilot the mode of operation of this hardware, the mobile web browsers used for Internet access, the system of diffusion of applications that opens up access to them (according to an economic model to be defined) and the smartphone applications used by the public to access content. The locking off of modes of electronic intermediation and interoperability is central to controlling the diffusion of content and services.

The role of communication service operators, insurers and health-care professionals remains to be defined in the new intersectoral environment of mobile health. Partnerships with health-care actors such as hospitals and pharmaceutical laboratories are aimed at generating innovative projects in mobile and connected health, in which the participants would be partners. The public is participating in emerging practices such as “ubimedicine”, which is “a medical practice based on the receipt and analysis of health-care data collected on the users’ initiative at multiple times and places” outside the usual medical settings such as doctors’ offices or hospital rooms [CNO 15, p. 12]. Concerns have arisen with regard to certain partnerships, however, particularly those between insurance companies and Internet actors.

9.5. Forms of regulation of mobile health-care access: a legal, technical and sociopolitical issue under debate

Several types of organizations are involved in the development of regulations for the protection of personal data. These organizations may be institutional or technical (national, European or international): regulatory agencies, industrial interest groups or industrial stakeholders. The texts generated include public legislative acts and modes of secondary regulation consisting of technical or management norms and standards, with the whole evolving as new innovations in information and communication technology emerge [JUA 14]. Public authorities and professional health-care organizations circulate legal and regulatory provisions pertaining to hosting, the sharing of information and the processing of personal data:

“when data processed by the App/OC concerns an individual who is or can be identified, directly or indirectly […] Health-related data⁹, especially sensitive data, is subject to enhanced security measures”¹⁰ [HAU 16, p. 12].

In the field of mobile health, as specified by the Haute Autorité de Santé, the design and use of connected objects and health-related data must “conform to existing national and European legal regulations, particularly in matters of medical devices, exchange of information, and the processing of personal health-related data”. Applications liable to be qualified as medical devices are taken from article L. 5211-1 of the code of public health, in addition to those specified by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for Medicines and Health Products), or ANSM. The hosting of personal health-related data on behalf of individuals or corporations for the production or collection of said data or on behalf of the patient him/herself must comply with article L. 1111-8 of the Code of Public Health [HAU 16, p. 13]. At the European level, the 2014 Green Paper on mobile health [EUR 14] applies to medical and public health practices that make use of mobile devices.

However, it appears that mobile access is problematic with regard to the protection of personal data. Via the intermediary of applications downloaded on telephones, user information is gathered and sold for marketing purposes to advertising agencies. Data may concern the location of a telephone user, the telephone’s unique identifier (the confidentiality of which is not protected) or data about the user’s identity (age, gender, etc.). The problem stems in part from the non-obligation of application designers (downloaded via online stores such as the Apple Store or Android Market) to provide confidentiality rules regarding the manner in which personal data is used and protected. Let us also emphasize the fact that the economic model of free web browsers for mobile devices relies on user data collected by their designers, which is then relayed to advertisers.

According to a report by the CSF Santé¹¹, or The Industry Strategic Committee for Health [CSF 16], the protection of personal data remains an unresolved question to date for mHealth applications:

“[…] numerous apps do not respect the confidentiality of data collected for the needs of the application, or even use data contained in the smartphone (calendar, address book). Thus, certain certification programs for mHealth apps initiate processes that ensure the quality of the apps, but it seems that these processes did not include risk control in terms of data protection” [CSF 16, pp. 14–15]¹².

The report cites another inquiry [CSF 16, p. 15] conducted in 2015 in the United Kingdom, into applications recommended by the NHS (National Health Service) [HUC 15]. The updating by researchers of the 79 applications certified as medically reliable by the NHS led to the closure of its health-care application library site, the NHS Health Apps Library:

“Poor information privacy practices have been identified in health apps. Medical app accreditation programs offer a mechanism for assuring the quality of apps; however, little is known about their ability to control information privacy risks. […] The study revealed that 89% (n = 70/79) of apps transmitted information to online services. No app encrypted personal information stored locally. Furthermore, 66% (23/35) of apps sending identifying information over the Internet did not use encryption and 20% (7/35) did not have a privacy policy. Overall, 67% (53/79) of apps had some form of privacy policy. No app collected or transmitted information that a policy explicitly stated it would not; however, 78% (38/49) of information-transmitting apps with a policy did not describe the nature of personal information included in transmissions. Four apps sent both identifying and health information without encryption. […] Systematic gaps in compliance with data protection principles in accredited health apps question whether certification programs relying substantially on developer disclosures can provide a trusted resource for patients and clinicians. Accreditation programs should, as a minimum, provide consistent and reliable warnings about possible threats and, ideally, require publishers to rectify vulnerabilities before apps are released” [HUC 15].

Cybersecurity also constitutes a “major problem”, with multiple studies proving the existence of security flaws in connected insulin pumps and pacemakers¹³ [CSF 16, p. 16].

Moreover, numerous problems have arisen both industrial and technical in nature. These particularly concern the reliability and precision of data collected and its interpretation, as well as the question of sensor quality control. The assessment of the degree of reliability and precision of the measurements they produce is highly complex. Insofar as the applications and connected devices are liable to be part of patient care, the CSF Santé¹⁴ has defined a set of prerequisites grouped under the umbrella term of “medical reliability”:

“[…] the taking into account of connected objects or apps in the context of care, even if it is only a simple recommendation for use made to a patient by a health-care professional, requires that its harmlessness be ensured, as well as the veracity of the advice given and the measurements taken. […] Beyond fantasies, it is useful to guarantee that these devices enable the collection of correct and precise data, and that the recommendations made on the basis of the data collected be at least non-harmful. These two concepts are to be grouped under the term ‘medical reliability’” [CSF 16, p. 13].

According to these criteria, the CSF notes cases of reliable applications (such as the “Moovcare” application for monitoring patients afflicted with metastatic lung cancer), as well as those that are medically unreliable. The report cites a 2016 study [CSF 16, p. 14] concerning the “Instant Blood Pressure” application, which has been downloaded more than 100,000 times, and whose measurements are imprecise:

“Dr. Timothy Plante, a fellow in general internal medicine at Johns Hopkins, led the study in which a total of 85 participants were recruited to test the accuracy of the Instant Blood Pressure app. Participants had their blood pressure measured by both the app and a validated, standard blood pressure monitor. They found that the difference between the app and the real blood pressure was 12.4 mm Hg for systolic blood pressures and 10.1 for diastolic blood pressures. When looking at individuals with low blood pressure or high blood pressure, they found that the Instant Blood Pressure app gave falsely normal values. In other words, someone with high blood pressure who used the app would be falsely reassured their blood pressure was normal. Perhaps most striking, the sensitivity for high blood pressure was an abysmal 20%”¹⁵.

In addition, the complexity of the technical assessment of artifacts is amplified by the hybrid nature of the sociotechnical system implemented:

“Who will address the weighty question of the legitimacy of applications, devices, sensors? When does a sensor become reliable enough to propose data that makes sense? What happens if the software application you’re using is very good, but the telephone you’re using is equipped with bad sensors that distort the measurements taken? Who will tell you this? Who is responsible? You, the unaware user? The developer of the application? The manufacturer of the smartphone? Who will the family of a runner who has died of a cardiac arrest because his telephone told him that his heartbeat was optimal, when he was actually in arrhythmia, turn to?”¹⁶.

Despite the numerous problems that have cropped up, new industrial actors are now in a position to manufacture measurement instruments capable of collecting and broadcasting data on the health of users of mobile telephones and miniaturized sensors. This situation raises the question of compliance by industrial actors with standards guaranteeing the reliability of the measurements taken using these artifacts. Health data is becoming a major economic challenge in terms of innovation and the privatization of both its production and access to it. These various aspects raise questions having to do with connected objects and sensors in a rapidly evolving political and social issue. In this context, beyond the establishment of new companies, new perspectives are opening up concerning the participation of the public, which can acquire applications and equip itself with micro-sensors outside the normative context of public policies. The argument invoked, of a democratization of health care made possible by popular access to health services and microsensors, is put under debate due to numerous unresolved technical, legal, scientific and security-related questions.

Faced with the proliferation and heterogeneity of mobile health products, public bodies and professional organizations are publishing, as a complement to legislative and regulatory texts, directional documents on mobile health intended for health-care professionals, patient groups and publishers of applications. These actors are thus sharing their concerns regarding the impact of these new products or services on public health while also contributing to the understanding of users’ needs and expectations. They are also focusing on the evolution of practices toward personalized medicine that respects the principles of security of information and the protection of personal data.

In 2016, SNITEM (Syndicat national de l’industrie des technologies médicales, or the French National Union of the Medical Technology Industry) inventoried international normalization projects conducted in the field of connected objects and information security, putting two complementary approaches into perspective: “hard law” (legal tools such as laws, decrees and contracts) and “soft law” (including guidelines, charters, recommendations and norms), particularly a selection of norms in the European regulatory system [CSF 16, p. 63]. These documents also include good-practice reference documents on mobile health application and connected objects; among these are the “good practice reference document on Apps/Cos for developers and assessors (medical scholarly societies, consumer associations, or private businesses)” by the Haute Autorité de Santé, published in 2016 [HAU 16]. Likewise, the Agence française de normalisation (AFNOR), or French Agency for Normalization, published a certification reference document in September 2016. White papers and analyses of innovation and prospective strategy [CNI 14] have also been published. Several recent studies, conducted since 2013 with mobile health users, have centered on their needs, representations and usages [CNO 15]. These documents guide the practices of health-care professionals according to principles of compliance with regulations, adoption of labels and common evaluation reference documents for the profession, taking ethical considerations into account as well. The same is true at the European and international levels [HAU 16].

9.6. Conclusion and new avenues of research

Mobile access constitutes an intersectoral collective including industrial actors from the computer hardware and software industries, telephony and telecommunications, and health care. As conveyors of diverse professional cultures and socioeconomic models, they compete or join together to conquer areas of a hybrid market, composed of health-related hardware, software, services and content working in an interconnected manner. We have analyzed the mechanisms according to which technical formatting, when corresponding to market rationales, could become unfavorable in terms of access to information. Indeed, they are liable, through an excessive desire for control, to describe and compel their users in an ever more detailed way according to localized, narrow IT patterns.

Challenges having to do with the development of the production of and mobile access to information in the field of mobile health have aspects simultaneously encompassing health, industry, economics and technology. They also have social and political repercussions involving health democracy, the protection of personal data and cybersecurity on portable devices. These have led to debate and studies dealing with mobile access in its relation to communication and the circulation of health-related information and knowledge. By connecting the materiality of sociotechnical devices to modes of producing, communicating, participating in and circulating health data in the public space, it appears that technical resources facilitating the production and diffusion of information are bearers of different and even divergent ideologies which use similar means. For this reason, it is important to discuss their characteristics, the actors that convey them and the relationships of power inherent in the underlying socioeconomic models and their consequences in terms of “medical reliability” [CSF 16, p. 13], cybersecurity and respect for personal data in a critical manner.

The hybrid domain of mobile health, and more broadly the intersectoral meeting of members of the communication industries and health-care industries leading to eHealth, constitutes a vast area of investigation for those desiring to study the collaborations and competitions among its participants and the interests, ideologies and perspectives on information and resources brought out in digital environments. The democratic adaptation of new political economics of information and knowledge – its production, memorizing, processing and diffusion – to changes in informational scales introduced by digital technologies [JUA 10], and the interconnection of telecommunication networks and mobile access to health-related questions have emerged as a challenge facing society.