10.6092/issn.2038-3460/17426
Wearable sensors that allow communicating patient’s state of health to their physicians without the need for their physical presence, are offered with grand promises to both patients, doctors and other communities. This paper looks at how this technological promise is influencing policy making in the EU about future healthcare. In particular, we use knowledge assessment concepts to examine the pedigree of claims and assumptions in e-health related EU policy documents, deepening the examination of the narratives with engagement of relevant actors, i.e. those that are part of the extended peer community. We found that even if the proposal of ehealth is attractive to many, there are many disconnects about both bodies of knowledge and the apparently disjointed imaginaries about the role of these technologies to address different challenges in the healthcare sector.
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2038-3460
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Melina Breitegger
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Tecnoscienza – Italian Journal of Science & Technology Studies
techno-scientific imaginaries
Wearable Sensors. Exploring EU Policy Narratives by Engaging the Extended Peer Community
Text.Serial.Journal
https://tecnoscienza.unibo.it/
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Essays
2019-07-16
2023-06-26
2019-07-16
2023-10-05
5-27
TS
Melina Breitegger
2019/07/16
10.6092/issn.2038-3460/17426
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European Commission Joint Research Centre
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1
techno-scientific imaginaries
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27
Wearable Sensors. Exploring EU Policy Narratives by Engaging the Extended Peer Community
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                                                                                  Essay
                                                                                          5




  Wearable Sensors
  Exploring EU Policy Narratives by Engaging the
  Extended Peer Community
     Lucia                                Angela                      Melina
 Vesnic-Alujevic                      Guimaraes Pereira             Breitegger
  European Commission                     European Commission     European Commission
  Joint Research Centre                   Joint Research Centre   Joint Research Centre


    Abstract: Wearable sensors that allow communicating patient’s state of
    health to their physicians without the need for their physical presence, are
    offered with grand promises to both patients, doctors and other communi-
    ties. This paper looks at how this technological promise is influencing policy
    making in the EU about future healthcare. In particular, we use knowledge
    assessment concepts to examine the pedigree of claims and assumptions in
    e-health related EU policy documents, deepening the examination of the
    narratives with engagement of relevant actors, i.e. those that are part of
    the extended peer community. We found that even if the proposal of e-
    health is attractive to many, there are many disconnects about both bodies
    of knowledge and the apparently disjointed imaginaries about the role of
    these technologies to address different challenges in the healthcare sector.

    Keywords: E-health policy; European Union; knowledge assessment;
    wearable sensors; techno-scientific imaginaries.

    Submitted: November 13, 2017 – Accepted: March 25, 2019

    Corresponding author: Lucia Vesnic-Alujevic, European Commission
    Joint Research Centre, Rue du Champ de Mars 21, 1050 Brussels, Belgium.
    Email: lucia.vesnic-alujevic@ec.europa.eu.




1. Introduction

    Wearable sensors (WS) are a core element of wearable technologies
and devices1. WS allow activity and physiological monitoring, and as such
they are used in a wide spectrum of health-related aspects by many peo-
ple. They are already widely used for fitness and health-as-leisure purpos-
es (Piwek et al. 2016), but the growing attention is primarily due to their

TECNOSCIENZA
Italian Journal of Science and Technology Studies
10 (1) pp. 5–27 – ISSN 2038–3460
                                                      2019
www.tecnoscienza.net
6                                                           Tecnoscienza – 10 (1)

potential applications in the area of healthcare monitoring, the focus of
this paper. The literature suggests and describes the usage of these sen-
sors in medical contexts, for example, rehabilitation (Bonato 2005),
eldercare (Milligan et al. 2011), the treatment of people with chronic
medical conditions (Siddiqui et al. 2018) and the use of big (sensors’) data
for personalised healthcare (Chawla and Davis 2013). The possibility to
remotely monitor a patient’s health while collecting the patient’s data
over a long-time span nurtures the expectation that WS shall enable a
more complete medical analysis and a less cost intensive healthcare.
    The promises that these sensors come with are visible in the narratives
entrenching discourse and action of market, media, academia and policy.
People increasingly use WS, as tools for self-improvement and self-
enhancement. The moto of the Quantified Self movement2 is “self-
knowledge through numbers”. Therefore, we can say that WS may be
seen as “an extension of human senses” (Vesnic-Alujevic et al. 2016).
They also provide a feeling of more control over one’s life (Lupton
2014b).
    Optimistic imaginaries of key actors, especially those of policy makers
and industry about the potential and applications of WS to deal with
healthcare matters drive the development of these technologies. Yet, WS
growing usage in everyday life activities are blurring the existing bounda-
ries of medical and more mundane well-being practices, posing challenges
to our received notions of ‘health’, medical practice, healthcare policy
and the ethics that sustain these. Indeed, as Lupton (2014a, 1347) point-
ed out, the discussions on digital health, of which WS are a part of, rarely
address broader implications of these technologies on the meanings of
health and illness or on the medical practice and doctor and patient rela-
tionships. Furthermore, a variety of ethical issues, namely social inclusion
and social justice as well as, data ownership need to be still thoroughly in-
vestigated (Rich and Miah 2017).
    With the use of WS, individuals’ everyday practices generate data.
The transformation of activities into data is first enabled through the col-
lection of few body signals by different types of sensors and then pro-
cessed algorithmically, and communicated to different parties. This is
what Mayer-Schoenberger and Cukier (2013) called datafication of indi-
viduals’ lives. While the quantity of (big) data collected in such ways is
indeed enormous, their quality is questionable (Cai and Zhu 2015), and
more importantly, the sense that different agents make with them needs
critical interrogation (Van Dijck 2014). The “data-driven lifestyle”
(Lupton 2014b) and the emerging narrative about big data as the latest
resource to reveal ‘truths’ about us, our behaviour, our needs and expec-
tations could turn out to be the next deception.
    The potential to integrate personal data with clinical data and the
blurring line between the use of wearables for fitness or medical purposes
is raising ethical concerns, paving the way for a need for specific regula-
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                             7

tion. Governments and the European Union (EU) institutions have be-
come involved in several ways. For example, the EC has published docu-
ments, classifying WS for medical purposes (MEDDEV 2.1/6 July 2016)
trying to propose data collection regulation on health and fitness apps
(EC SWD(2014) 135 final 10.04.2014).
    In our study we are interested in understanding how different types of
knowledge inform and influence policy making in this sector, because
while looking at different discourses, we observed that policy narratives
did not seem to address different challenges to the promises of this type
of technology in addressing healthcare issues, voiced by different actors.
We applied what Funtowicz (2006) described as ‘knowledge assessment
methodologies’; in particular, we investigate whose and which knowledge
(scientific or non-scientific) on WS technology informs policy making, in
the EU context. Our main research questions are: ‘Who’ informs policy
making in the domain of wearable sensors at the European Commission?
Whose and what knowledge is reflected in the policy papers and the EC
narrative on WS technology use for healthcare?
    While looking at WS policy we found that the notion of techno-
scientific imaginary (Jasanoff and Kim 2009) to situate the EU policy nar-
ratives is critical to understand the role of actors and institutions in their
development. Our departing point is EU policy making in this domain di-
rectly or indirectly referring to WS; the analysis of those narratives helped
with situating WS in the wider context of current imaginaries of innova-
tion, helping also with identifying relevant actors. We used the notion of
pedigree, which is a key concept of ‘knowledge assessment’ to analyse
knowledge claims, assumptions and framings appearing in relevant EU
documents. The pedigree analysis is further attuned with in-depth inter-
views to identified actors. The paper offers a discussion about the pro-
duction and circulation of knowledge that sustains current policy making
in Europe with regards to WS usage in healthcare.


2. Conceptual Background: Imaginaries and Knowledge
Assessment

    Felt and Wynne (2007) argue that all key reference points in science
and governance, such as the purposes of research, ethical issues and pub-
lic concerns, are objects of collective imagination. Jasanoff and Kim
(2009) have described techno-scientific imaginaries when they studied
energy policies in the USA through the exploration of the imaginaries
that guided past energy policies in that country. This concept explains
how visions about possible futures are produced as “collectively imagined
forms of social life and social order reflected in the design and fulfilment
of nation-specific scientific and/or technological projects” (Jasanoff and
Kim 2009, 120). Hence, it is important to investigate whose and what im-
8                                                          Tecnoscienza – 10 (1)

aginaries are entertaining techno-scientific narratives and developments
and who drives the process of collective imagination. In other words,
whose values are being enacted? What and how is knowledge produced
to ground these visions of the future? How is knowledge circulated?
    Visions of future healthcare practices in EU policy circles and wider
sectors of society are informed and enacted by various actors. How these
actors are involved in the process of knowledge production (and contes-
tation), how they interact, and how knowledge circulates and how it in-
fluences decision-making helps with situating dominant healthcare inno-
vation narratives in Europe. In this context, we are referring to all the
parties, those that produce “scientific knowledge”, but also those holding
political, experiential and practical knowledge.
    It is important to understand how policy relevant knowledge is gener-
ated (Porteous 2016). ‘Knowledge assessment’ (KA) as defined by Fun-
towicz deals with “evaluating of knowledge inputs in decision-making
processes” (Funtowicz 2006, 139). In this context, knowledge is not simp-
ly understood as ‘scientific’ knowledge, but also includes other types of
knowledge produced outside the academic sphere. An important goal of
knowledge assessment is to identify and involve relevant actors in a given
debate about policy relevant science, which Funtowicz and Ravetz (1991,
6-7) called the ‘extended peer community’ – a concept from post-normal
science – i.e. a community “consisting not merely of persons with some
form or other of institutional accreditation, but rather of all those with a
desire to participate in the resolution of the issue” and produce ‘extended
facts’. In the case of healthcare WS, the extended peer community can
consist of doctors, patients, researchers, developers, policy makers, indus-
try, users (e.g. specific communities such as the quantified-self movement
–http://quantifiedself.com/) or other individuals with an interest or con-
cern about these devices and their applications.


3. Wearable Sensors in the EU Policy

    The current narratives on WS can be linked to a more general per-
spective on science and technology in the EU. At the core of the EU 2020
strategy lies the so called ‘Innovation Union’, which heralds research and
innovation as a means to bring more products to the market, with an im-
aginary of salvation of EU economy. Amongst its underlying assumptions,
the innovation narrative promises that innovation will create jobs and im-
prove quality of life (Van den Hoven et al. 2012). The narrative is pre-
sented in a salvific role, solving all the problems that we face today
(Guimarães Pereira et al. 2013). These assumptions are problematic be-
cause they can be proved wrong in many cases; economic profit does not
automatically map into improvements of quality of life and the idea that
all problems of society can be solved through technology (techno-fix) is
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                            9

obsolete and misguided. Often, by solving one problem with technology,
we generate another (Benessia and Funtowicz 2015).
    Europe’s growth strategy, Europe 2020, promotes the advances of fu-
ture and emerging technologies – and WS are among them. WS are a key
feature of what is called the Internet of Things, the largest world project
on connectivity. Policy developments in the field of telemedicine, eHealth
and ICT for healthcare are present in the Digital Agenda for Europe, the
European Innovation Partnership on Active and Healthy Ageing in Hori-
zon 2020. Hence, the proposed applications of WS do not emerge in a
vacuum but they are rather coherent with the social and technological in-
novation hype that characterises many areas of EU policy and in general,
human endeavour.
    As noted in the staff working paper on telemedicine, due to “the im-
portance of this sector and the benefits it could provide, Member States,
regional and local authorities, payers of healthcare services, industry and
the European Commission have been supporting research in the field of
telemedicine for over 20 years. However, despite the considerable level of
technical maturity of different technologies, the sector is not as well de-
veloped as could be expected” (EC SEC(2009)943 final of 30 June 2009).
    The European Commission (EC) launched several calls for proposals
for projects related to biosensors, mostly in the area of telemedicine, e-
health and active ageing during the 2000s. Research for ‘personalised
healthcare’ was funded with a budget of € 549 million in 2014, respond-
ing to the strategy to reduce the ever rising costs of healthcare in the age-
ing population of the EU. The analysis of these documents show that ex-
pectations are high. e-health and the use of big data in healthcare are ex-
pected to improve diagnostics, therapies, disease prevention and support
healthy ageing (EC 2014). The 2013 EC call for proposals describes ICT
for Health, Ageing Well, Inclusion and Governance, as one of the big
challenges of Europe. Here, ICT in health is described as a tool for em-
powering the elderly generation, that will enable them to “live inde-
pendently, delay/avoid institutionalisation and staying active as much and
as long as possible” (EC C(2012)4536, pp. 53). The empowerment could
“facilitate patient control through self-management and shared decision
making, as well as promote equitable and collaborative approaches to
healthcare and improved cost-effectiveness of care delivery” (Risling et al.
2017, 2). However, there are different views on whether patients will be
really empowered through the use of these technologies or not. For ex-
ample, Ammenwerth (2018) argues that “whether patient portals really
can have a positive impact on patient empowerment or not seems to be
quite unclear at the moment” (p. 22). Risling et al (2017) argues that the
concept of patient empowerment is still not clearly defined in the litera-
ture, although it is becoming a focus of exploration of many studies on
healthcare reform, but study of changes in health behaviour and out-
comes are still missing.
10                                                          Tecnoscienza – 10 (1)

    The cost-effectiveness ratio is an important element when evaluating
possible novelties in the healthcare systems. When it comes to WS, de-
spite the promise that eHealth would reach more people, decrease costs
and increase the effectiveness (Dobkin and Dorsch 2011), there is no
straightforward answer about the increased cost-effectiveness ratio. While
Kvedar et al (2014) state that “the increasing adoption of electronic tech-
nologies is widely recognized as a key strategy for making healthcare
more cost-effective”, improve the quality and patient satisfaction, as well
as lower costs, Mistry (2012) and De La Torre-Diez et al. (2015) argue
that there is lack of “concrete” evidence about the increasing cost-
effectiveness of telemedicine and eHealth and that it is unrealistic to
make broader generalisation about it.
    We suggest that these big promises come with high uncertainties on a
number of ethical questions that go far beyond concerns of privacy and
data protection. So far, it is not clear who will own the data, or whether
these will be open data; who would be responsible for medical decisions
that are based on data produced by WS; or what would be the social im-
plications of distant care for elderly or people with chronically ill patients
in need of continuous care? Even the reliability of such devices is still
questionable and different studies have concluded that their accuracy and
reliability are variable (Wang et al. 2017; Byun et al. 2018).
     Hence, this paper contributes to exploring whose and what
knowledge is supporting the development of policy making with regards
to development and adoption of wearable technologies in healthcare, and
what normativities are developing through the design and use of these
devices.


4. Research Design

    KA contributes to a body of research that intends to get insights about
what types of knowledge inform policy making. While some have ana-
lysed how the EU uses expert groups to inform policy making (Gornitzka
and Sverdrup 2008), the KA approach aims at tracing the pedigree of
knowledge claims. Our particular application of KA is focused on pedi-
gree analysis and the engagement of the “extended peer community”
(Funtowicz and Ravetz 1991). A pedigree analysis explores knowledge
production and circulation; in practice, by investigating where knowledge
comes from, one can establish which actors are relevant for the particular
claims and assumptions and whose narratives are voiced in the policy
process. The methodology further helps with making visible which actors
and which views are excluded through the very process of engaging a
number of relevant actors. We conducted a series of in-depth interviews
to ascertain and further explore who, what and how particular knowledge
claims get into policy documents. This methodology is particularly inter-
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                         11

esting in cases where there is genuine difficulty in having an a priori un-
derstanding about who is informing policy.

4.1 Analysis of Policy Documents

   For the purposes of this study, we identified policy documents issued
by the European Commission that are related to the use of WS in health
and wellness (see Figure 1). We selected not only documents that focus
on this field but also those that relate more broadly to the application of




WS in health. The pedigree of the policy narratives was explored by look-
ing at the sources quoted in policy documents, allowing identifying which
institutions and actors are informing policy making.

                              Figure 1 – Analysed documents



4.2 In-depth Interviews

    We conducted nine in-depth interviews with relevant actors which
were connected to WS and telemedicine policies and practices; the inter-
views focused on deepening the assessment of policy narratives, extend-
ing their review to relevant actors, bringing more insights about the con-
struction of specific visions and narratives around WS.
12                                                          Tecnoscienza – 10 (1)

    In-depth interviews are one of the major qualitative methods in order
to explore individuals’ opinions and insights about a specific issue or idea
(Kvale 2007) and useful to investigate a certain topic with more in-depth
information (Boyce and Neale 2006).
    We identified relevant actors by looking at who holds strong interests
in this particular issue and of what nature, i.e. expertise, influence in the
policy process or opinion making regarding WS. That included the au-
thorship of policy papers, scientific papers, articles in specialised media
(e.g. Wired Magazine) and persons involved in projects related to e-
health. Although policy papers are public, their authors are usually not
known. Therefore, we also asked the interviewees to recommend other
relevant actors. Five broad groups of actors were identified: policy mak-
ers, industry, academia (medical researchers, IT researchers, STS re-
searchers), media, NGOs. We contacted 20 persons in total out of which
9 agreed to be interviewed (see Figure 2). We also contacted industry but
none showed their availability to talk to us, which, we acknowledge could
have enhanced our analysis. All the interviewees were either authors of
relevant publications or known activists in the field. More interviews
weren’t necessary because, as Boyce and Neale (2006) state, the saturation
is reached when the same information is provided by different interviewees.
    The interviews were conducted in the period between 15 October
2013 and 16 December 2014 in English. They were semi-structured with
open-ended questions, lasting between 35 to 60 minutes. They were con-
ducted either in person or through electronic means by the authors. The
respondents were first approached by email to arrange the time of the in-
terview, inform them about the confidentiality, anonymity and the objec-
tives of the interview and project.
    The semi-structured interviews were centred around questions regard-
ing the interviewee’s involvement in the field of WS, the personal motiva-
tion to engage with this topic, the knowledge that was used when produc-
ing material on WS, and general questions on benefits and challenges re-
garding WS in healthcare, testing some of the claims made in policy pa-
pers. Additionally, we asked about how quality of knowledge could be as-
sured when evidence was sought for the narratives these devices are being
proposed and sold with; finally, we also enquired about which topics
were not successfully discussed in debates surrounding WS. In the inter-
views, we focused especially on the issues regarding the use of WS in
healthcare.
    The interviews were transcribed and analysed by the authors. We
used Ritchie and Spencer’s (1994) framework for analysing the inter-
views. We first ‘familiarised’ with the data by reading transcripts and lis-
tening to the audio recordings, in order to understand what the most im-
portant issues to our interviewees were. This phase helped us building a
set of preliminary codes. In the second phase, we identified a thematic
framework based on the research questions, the analysis of policy docu-
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                           13

ments, as well as the emerging themes from the interviews. We compared
codes emerged from the documents’ analysis and interviews and decided
on the most important to be kept. We then indexed and charted the data,
i.e. coded the interviews into the categories. The last phase, mapping and
interpretation meant finding patterns and making sense of the coded data.




                              Figure 2 – List of interviewees



5. A Knowledge Assessment Journey

5.1 Wearable Sensors Related Policy Documents – Journey 1

    While examining knowledge claims on the policy documents listed in
figure 1, special attention was paid to the references that are enlisted to
support major claims on the promises of wearable sensor technologies to
address challenges in the healthcare sector. We found that many of the
claims are not backed up by any reference, hence it is difficult to establish
their pedigree in the KA sense. In the Commission Staff Working Docu-
ment on the applicability of the existing EU legal framework to telemedi-
cine services it is stated that,
14                                                                    Tecnoscienza – 10 (1)


     Telemedicine can help to address major challenges faced by European
     healthcare systems. For example, telemonitoring can improve the quality
     of life of chronically ill patients through self-management solutions and
     remote monitoring from home, reducing hospitalization costs and saving
     on unnecessary emergency visits. (EC 2012)

   These are strong promises and assumptions, but they are not support-
ed with background knowledge, which could be verified. Other claims
grounded on existing publications were not faithful to the original claims:

     Telemedicine can also significantly improve access to care, by delivering
     high-quality services to patients living in remote or sparsely populated are-
     as affected by shortages of specialized healthcare professionals or by facili-
     tating across border healthcare for the benefit of citizens in the EU. (EC
     2012)

    This section cites the 2010 EU citizenship report, which deals only
with cross-border healthcare, not discussing telemedicine as a means for
better care for people living in remote areas.
    A common snag of the EC papers is self-referencing, i.e. the docu-
ments justify certain types of claims that (we argue) would require cita-
tion of expert studies or sources of evidence; instead citations of earlier




EC publications of policy nature are made. In the 2012 EC paper on tel-
emedicine, we found the following sources (figure 3): policy documents:
25 EU Directives and Regulations, 14 from the EC, 7 from European
Court of Justice; and one from academia. Whilst one can argue that the
choice to have our healthcare mediated by ICT is a social and political
one and not a technical one, it also can be expected that the reasoning of-
fered is at least of social and political nature and not based on poorly ref-
erenced technical arguments.
                   Figure 3 - Pedigree of the 2012 EC paper on telemedicine



    The green paper on mHealth (EC COM (2014) 219), has a greater va-
riety of references, although the majority is again from the EC itself: 21
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                           15

from EC, 17 from industry and consultancies (12 industry, 5 consulting),
4 from the World Health Organization, 3 from university and 1 from the
media (figure 4). Similar observations can be made for the other docu-
ments we analysed; working programmes (EC 2012, 2013, 2016) have
even less references and the Staff working document on the EU legal
framework (EC 2014) refers to the EU legislation, consisting of different
directives, only.




                       Figure 4 – Pedigree of the mHealth Green paper



5.2 Deepening the Process Through Actors Engagement –
Journey 2

Knowledge Assessment

    As previously noted, the EC is promoting e-health, m-health and WS
as important means to improve the healthcare system. We asked our in-
terviewees what their knowledge on WS builds on, especially taking into
consideration the place WS seem to have and expectations they create in
a rather complex transformation of healthcare.
    With regards to scientific and clinical studies on WS in healthcare,
three of the interviewed persons from different professional networks
(academia and healthcare) argued that there was not enough research on
WS for healthcare and a tele-health; some of them considered positive the
financing of projects in this area by the EU because there is “little aca-
demic research” in this area and although the companies show customer
satisfaction data, “this is quite different from the data that is required if
you really want to look at the medical effects of the devices” (Medical
Doctor, interview).
    Referring to an EU-funded project on sensors for monitoring and
predicting elderly people falls, our interviewees suggested that new tech-
nologies are often being pushed by the industry, although their effective-
16                                                                 Tecnoscienza – 10 (1)

ness in either improving health or reducing the healthcare costs is largely
unproven.
    The interviewees from the academia and the medical doctor we talked
to also agreed that there is a need for more large-scale studies on the use
of WS in healthcare:

      I would like to see more large-scale studies being done to really convince
     policy makers to change their funding behaviour. Whenever we want to
     study a topic, we have very small studies with a small number of partici-
     pants. This is very costly, but we really need the evidence so that people
     will listen to us. (Medical Researcher, interview)

    These views contrast with the claims in the policy documents, which
describe the economic and health related value of WS as a fact. Could the
lack of existing studies explain the WS benefits poor referencing in policy
documents?
    However, the views expressed by the researchers and the medical doc-
tor are not in line with the visions of the policy makers that we inter-
viewed. According to one of them, there is enough knowledge including
clinical evidence available on WS used as medical devices that can be
used to measure their cost-effectiveness. One of the policy makers
claimed that it only needs to be gathered in the right way to get a com-
plete picture:

     The new thing we are launching with DG CNECT tries to map out all the
     clinical evidence which is available on the market, to better measure the
     effectiveness and the cost-effectiveness of medical devices for e-health (…)
     but we look at what industry produces and everything that is in the
     Cochrane database or the Centre for Reviews and Dissemination (CRD)
     database. (…) Now [that] we have a complete picture, we will ask experts
     nominated by the Commission, a panel of experts on healthcare systems,
     to look at this. They will cast a particular eye on the quality of the litera-
     ture which is being produced. (Policy officer 1, interview, emphasis add-
     ed)

    The policy papers analysis showed that not all actors’ concerns and
their knowledge have been represented. Whilst, there seems to be a focus
on the need to involve industry in the quote above, it remained unclear
who is invited to be part of the experts panel. Also, one of the interview-
ees (social science researcher) pointed out, that their research group used
a range of methods, including discussions with different stakeholders to
draft the Forward Look on Personalized Medicine (European Science
Foundation, 2012). In the researcher’s opinion, one group was un-
derrepresented in the discussions, namely health economists.
    At the EC, policy makers often engage researchers on expert opinion
on a topic. Hence, investigating how knowledge is circulated and used in
the policy making process is needed to investigate its quality. The re-
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                            17

searchers we interviewed, raised the concern that it is often not clear to
what extent their work is being considered in the policy making process
and it is “hard” to estimate for them what impact their input has. As one
of them states: “You give your input as an expert at that level and the
hope is that somewhere downstream will inform policy” (IT Researcher,
interview). This demonstrates a certain opacity of the policy making pro-
cess, even for those who are participating in consultations, since it is not
clear to anybody whose voices really get marshalled into the policy mak-
ing process.
    Another way of understanding if the EU policy documents are well in-
formed by other actors’ visions is by asking which and whose imaginaries
and knowledge did not find its way into the policy papers. In the next
section we therefore compare visions of WS by different actors and con-
trast them with the narrative laid out by EU policy documents.

Imaginaries of Health trough Wearable Sensors and Telemedicine:
Which and Whose Knowledge Is Voiced in the Policy Narrative?

    The EC narrative on WS and e-health circles around the issues of
cost-effectiveness, improved quality of care, patient empowerment, inclu-
siveness, healthy ageing, preventive care and e-health as a promising new
market. In order to test the plausibility of the narrative with different ac-
tors we asked them: What was your motivation to engage with this topic?
To which problem are WS the solution? What types of knowledge and
sources of information did you use? What kind of impact did your work
have on policy making? Which topics concerning WS are not sufficiently
discussed at a political level?
    On question: “To which problem WS are the solution?” it was argued
that the use of WS in healthcare corresponds to the need to improve the
quality of care and at the same time decrease the costs of healthcare. In
Europe, the rising costs of healthcare are a burning topic, the current
healthcare system being unsustainable (OECD 2015). One of the inter-
viewees (IT Researcher, interview) works on a project that develops ap-
plications to predict elders falls, assess mobility and gait function; he sus-
tains that the use of WS is related to the idea that proactive healthcare
can reduce accidents and therefore reduce medical costs.
    Another element often mentioned in policy papers is that WS could
improve care of people with chronic medical conditions, by improving
the life quality of patients but also reduce costs. The interviewed policy
maker suggests that in order to decrease costs, there is a possibility to
treat some chronic patients at home instead of hospital but for that, it is
important that the medical staff can monitor them remotely.
    The idea of reduction of costs has not been proven thus far. A study
conducted by one of our interviewees showed that, the use of WS for
health monitoring actually increased the number of medical visits and
18                                                               Tecnoscienza – 10 (1)

therefore led to an increase in cost, without additional benefits for the pa-
tients.

     Actually, the results are sometimes quite surprising. We had a small study
     on diabetics in one of the cities in Finland, where glycaemic control was
     monitored using an application. What happened was that the patients who
     were monitoring their blood/glucose level themselves were using more
     healthcare services, but the end result was the same. They did not get any
     health benefit, but they used more services because when they noticed
     something problematic during their monitoring, they visited doctors and
     clinics. They used much more services, but they did not get any better
     outcomes than the other patients. (Medical Doctor, interview)

    This view is shared by a policy officer who admits that, despite the EU
strategy on e-health, whose objective is to reduce the costs of healthcare,
the evidence of the savings potential is still missing, as well as it bringing
any clinical value for patients. Our interviewees agree that it is not impos-
sible that the use of e-health could reduce costs in some instances and
“make healthcare smoother and more efficient”. Even if sometimes this
happens, “very often this does not happen (Medical Doctor, interview).
    Another vision is that WS will allow gathering a greater amount and
more “accurate” information about a person’s health status. The medical
doctor interviewed, argues that “WS provide a means to get more infor-
mation, in contrast to what we do at the moment, which is what I call
snapshot care […] when you contact your physician only after you al-
ready have a problem” (Medical Researcher, interview). Furthermore, he
states that the information collected by the sensor is more accurate than a
patient’s memory.

     If you want to know about the condition or the physiology of a patient in
     between physician visits, such as in everyday life, you have to ask the pa-
     tient. We all know that patients do not give accurate history. We get ob-
     jective information about their state of health when we use WS. We can
     get out of lab conditions in an unsupervised way. (Medical Researcher, in-
     terview)

    An interviewed policy adviser points out, that the sensors are only a
“component of a complex system” and making conclusions based on that
will produce “a huge error rate”. Hence, WS reduce a person’s health to
a few factors that can be measured by sensors. The most problematic be-
ing “because this comes from an instrument with a nice number associat-
ed with it, people will believe it” (Policy officer 2, interview). This is
shared by the medical doctor who thinks that WS and tele-care cannot be
a substitute for traditional healthcare:

     WS just provide part of our toolbox. We will never replace the physical
     person-to-person contact. This is not really our intention and we do not
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                                     19

    want to replace the nurse or physician, but rather to provide better infor-
    mation for a broader base of making better and more reliable decisions
    about the patient. (Medical Researcher, interview – emphasis added)

    Concerning the reliability and quality of the data from current devic-
es, there is still a number of technical problems to be solved. According
to the interviewed developers and IT researchers, WS are not measuring
the data with desired accuracy, and it is not proven that they provide reli-
able outputs. The positive experience of wearing a sensor is related to the
(wrong) belief that the data it produces are reliable:

    It makes you feel good to wear it because you believe that this is making a
    difference. […] [the effect] is almost psychosomatic because you think the
    number is correct, but often the number is not correct. (Medical Doctor,
    interview)

   Another important strong element of the EC narratives on WS is that
they are an empowering technology. There are different opinions on this
narrative:

    As part of the services that we have defined using WS, we can provide
    feedback with the information we have, which can improve patient self-
    management. We use the term patient empowerment. I do not really be-
    lieve that a patient can manage herself or himself completely alone, but
    this can provide support in the same way as using wearable devices when
    we go running. (Medical Researcher, interview – emphasis added)

    The concept of patient self-management and patient empowerment
raised three main issues in the interviews: responsibility, missing face-to-
face interaction with the doctor, and increasing inequalities arising from
possible digital divide. Patient self-management implies a shift of tasks
and responsibilities from the healthcare professional to the patient.
    Many of the devices are intended for eldercare. Nevertheless, certain
groups in society might have difficulty to use the devices, because “many
of the services that are provided by the Internet may be difficult for you
to use”. In this way, “e-healthcare can actually increase inequalities be-
cause it makes healthcare accessible for some, but does not help those
who probably need the services more.” (Medical Doctor, interview – em-
phasis added). While sustaining that e-health encourages alternatives to
face-to-face relationships among citizens and professional careers, an in-
terviewed policy maker agrees that there could be some ethical issues:

    I do not know whether it is an ethical issue or not. However, it is true that
    if we promote mobile health, we are also promoting a non-systematic face-
    to-face relationship between the patient or the consumer and the doctor. I
    do not know whether it is an ethical issue but anyway we need to move
20                                                                Tecnoscienza – 10 (1)

     towards this new way of delivering healthcare. That can be an ethical issue
     for some people. (Policy officer 1, interview – emphasis added)

    Also, related to the idea of empowering patients, the question arises of
whether citizens will be able to choose the healthcare they wish to enrol
with. Our interviewed researchers seem to agree that an empowering
technology needs to be based on voluntary usage. In that sense, we need
to “make sure that this participation remains an opportunity. It must not
become a burden or a duty to people” (STS Researcher, interview – em-
phasis added).
    Interestingly, these are quite contrasting narratives: choice (“an op-
portunity” vs. inevitability: “we need”). The latter is prevalent on the pol-
icy narrative.
    In addition to the mentioned contrasting views about WS for
healthcare, there is a number of other ethical issues that were pointed out
by our interviewees, which are not reflected in the policy papers, official
communications and strategies of the EC.

The Issue of Privacy and Regulation

   One of the issues that was mentioned by almost all the interviewees is
their concern for privacy.

     We will know much more about a person's mental and disease state and
     therefore we will be able to hire or fire or associate with people depending
     upon what we think we are seeing from the sensors. That is not permitted
     in most countries, at least in the Western world, but that will not stop
     people from doing it. (Policy officer 2, interview)

    Privacy is very relevant for healthcare insurance schemes; to some in-
terviewees, this could result into new normativities about our health and
healthcare and therefore constitutes an ethical issue.

     The only big concern I have is around health insurance […]. If we know
     everything about you from the day that you are born, we will know what
     burden you will be on the health system […]. It goes against the whole
     idea of insurance, which is the unknown that as a herd, we insure each
     other and some people will be unlucky and others will be lucky. Together
     we will cover the cost, but when you start to get more information about
     people and the premium changes – you can see it all happen. Some will be
     very heavily disadvantaged because they have a poor health condition and
     there is nothing they can do about it. (IT Researcher, interview)

   Moreover, the issue of privacy leads to other ethical issues, namely
property, autonomy and agency. For example, who owns the data from
these devices? This is certainly not a new discussion – e.g. in the famous
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                                    21

case of Henrietta Lacks in the 1950’s (see Skloot 2010) and that of John
Moore in the 1990s (see Moore v. Regents of the University of California
(51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479)) with regards to prop-
erty rights of their body materials and participation in research (see e.g.
Tallacchini 2015 for a discussion of these two cases). The members of the
quantified-self movement, for example, claim the right to own and also
analyse their own data. Medical data could be marketed, but this raises
ethical issues because “if you do not know where the data are going and
what people will be doing with them, terms and conditions can be
changed at will, as is often done. That is quite a big ethical issue for me.”
(Grassroots organisation, interview). The use of medical data for market-
ing purposes is currently in debate. The EC proposal for data protection
states that the data should only be used for medical purposes and “not for
purposes such as insurance or banking” (Policy officer 1, interview).
    But in times where the “open everything” paradigm is being heralded
as a key for restoration of trust, what kind of governance will protect ex-
isting rights and norms? This brings us to the issue of regulation. Given
the numerous ethical issues and uncertainties associated with present and
future uses of WS, some of the interviewees called for a need for more
regulation, because “people should control the use of their sensitive
health data. There is definitely a need for a legal framework for that.”
(Medical Doctor, interview)
    The legal framework needs to address the question of which devices
are considered medical devices, and which devices are for fitness purpos-
es. The staff working document concerning the existing EU legal frame-
work states that “there are no binding rules in the Union as to the delimi-
tation between lifestyle and wellbeing apps and a medical device or in
vitro diagnostic medical device” (EC, 2012, p.3). But our interviewees
point out that:

    This is the regulatory issue at stake. Are these WS, apps or devices consid-
    ered as medical devices or are they to be considered as consumer prod-
    ucts? At this stage, they are considered medical devices in the legislation.
    On the other hand, in other cases, they are followed up or monitored as
    consumer products. […] the information in these sensors measures health
    issues […]. They should then be considered as medical devices. They
    should then be regulated as medical devices with CE marking and so on.
    (Policy officer 1, interview)

    Another interviewee argues that:

    If you are really claiming that it provides health benefits, then you should
    have to have the same type of proof that you have for medicines, medical
    devices or medical procedures. You have to have medical data and studies
    to show that something could happen if people start to use these things.
    (Medical Doctor, interview)
22                                                                  Tecnoscienza – 10 (1)

Figure 5 summarises the divergence between the policy papers and the in-
terviews’ statements that we found while coding both sources. What this




table intends to show is not who is right or wrong, but rather to illustrate
that relevant actors in the WS field are not clear or disagree on major is-
sues concerning cost-effectiveness, the role of the patient, reliability and
the quality of the data that are produced by the sensors. These types of
uncertainty are not reflected in the policy papers, which promise that WS
and e-health will ease the burden of the health system and solve the prob-
lems of an ageing population.


      Figure 5 – Divergence between the claims in policy papers and the interview



6. Discussion

    Through pedigree analysis, a knowledge assessment methodology, rel-
evant actors in the field of WS were identified. As we have seen from the
section above, there is a disconnect between EU policy narratives and
others’. All actors are active in producing different types of knowledge
about the development, practices and policies related to the potential of
WS in addressing different aspects of human health. It seems also that not
all voices are voiced into the policy making process, given its positivist e-
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                          23

health and telemedicine narrative.
    A great deal of promises is made throughout the EU policy docu-
ments looked at in this paper (including the research calls sponsored by
the EC), especially concerning cost-effectiveness of e-health and patient
empowerment through personalised care. The underlying narrative and
expectation is that technology will fix current problems of healthcare. In
the policy papers we looked at, we found a number of issues that under-
mine their quality, namely: poor referencing for rather important claims,
self-referencing, references to poorly conducted studies, which make
knowledge claims amenable to scepticism.
    Our analysis suggests that a great deal of the knowledge used in policy
papers comes from industry and not so much from medical and
healthcare institutions, citizen led projects (e.g. Quantified self move-
ment) or academia. In fact, as one of the interviewees pointed out, indus-
try seems to dominate the imaginaries surrounding WS technology appli-
cations. While at least part of the academic knowledge might be known
to policy makers in the field, (evident from the interviews), the academic
body of knowledge is not sufficiently reflected in the policy papers. The
lack of references to sustain the big claims in the policy documents, leaves
a reader, be it any citizen or the researchers involved in consultations for
the EU, unsure about the grounds on which the EU e-health strategy is
based on.
    Moreover, policy papers that are mostly informed by visions of indus-
try leave out important alternative visions to reform the current
healthcare systems.
    By assessing knowledge production loci, one can also see that there
are disconnects between what the imagination of the current and future
uses of these sensors are. There are several spontaneous experiments of
self-care, self-veillance both by industry and citizen movements, which if
assessed could help with understanding the impacts of these objects ac-
cording to received notions of care and health. Yet the criteria with which
such monitoring would take place is also a matter of negotiation. As with
other technological developments, WS are also object of unanticipated
appropriations both by institutions and citizens. The actors’ views that we
have presented show a great number of disconnects, not only concerning
different imaginations of the role and function of these devices in health
and healthcare, but also regarding supporting evidence that these devices
can deliver what they promise to.
    Moreover, besides analysing the origin of the aforementioned discon-
nects, it seems that further research on the impact of wearable devices
and e-health on society, especially in Europe is needed; the vision articu-
lated in the policy narrative develops in specific spheres but its deeper
meanings for healthcare are in need of further investigation. Within the
framework of KA, this suggests that the ‘extended peer community’ con-
sidered thus far has been limited to few actors with strong interests on
24                                                          Tecnoscienza – 10 (1)

advancing the technology (WS) uptake by the health sector.


7. Conclusions

     All current EU narratives place science and technology at the heart of
its future but also its identity3; for some time the EU sustains a particular
innovation narrative (EC 2015). In fact, “innovation” is presented in a
salvific role, oftentimes with an imaginary of substitution, used to justify
and encourage techno-science development. WS and e-health are part of
the technological determinism and techno-scientific imaginary that sug-
gests that, through technology, health and healthcare issues can be fixed
(The Economist 2009). This expectation from technology is visible
through the narratives of patient empowerment, effective and efficient
healthcare and improved certainty (i.e. better and more complete health
related data imply tout court better diagnosis and cures). This imaginary
appears as an imperative in both policy papers and in the words of policy
makers. Simultaneously, there is a number of unknowns and concerns,
expressed diversely by different actors, e.g. unresolved ethical issues,
namely privacy, inequalities, in particular originating from digital divide,
or new ideas of care where face-to-face interaction is substituted with dig-
ital interfaces. Also, a number of uncertainties such as, quality of data and
data ownership, responsibility, inadequacy of current regulation, actual
economic effectiveness of WS deployment for health purposes, need scrutiny.
     These ‘simple’ devices are designed and delivered to us with a narra-
tive of ‘healthy’, of what needs to be shared and of what needs to be
measured, of how we should be ageing and also of how our wellness,
happiness and health are better dealt with through digital smart artefacts.
Although current WS are mainly used for fitness purposes, the narratives
around WS technology suggest that WS will become an integral part of
the medical practice, preventative medicine, personalised medicine, mo-
bile health, cure and care (Vesnic-Alujevic et al. 2016). The WS based
healthcare vision presumes cost effectiveness but it does not discuss other
social and ethical implications of the technology, such as privacy, data
ownership and patient-doctor relationships. In particular, we wonder if
the normative and performative aspects of these technologies are at all a
discussion in the policy making process. We suggest that, before the nar-
rative gets entrenched in the policy debate, that serious societal enquiry
takes place through different public engagement strategies promoted by
local, regional, national and supranational institutions, in order to under-
stand what the actual matters of concern and care are among citizens and
whether the smart innovations ‘confident’ proposal for healthcare are re-
sponsive to those. Additionally, tapping into existing public engagement
visible in existing communities’ practices, epistemologies and debate
helps policy narratives being inclusive of extended facts and societal ex-
Vesnic-Alujevic, Guimaraes Pereira & Breitegger                               25

pectations. Above all, ‘we’, collectively, need to identify by which imagi-
naries of health, including values and ethics, we wish to live and that is
only possible if spaces are made for these dialogues to take place. The in-
stitutions that lead policy initiatives should embrace this type of activity
as modus operandi.
    These types of enquiry, which fall on what we generally described
here as ‘knowledge assessment’ and the engagement of the ‘extended peer
community’ are useful beyond any geography; comparative studies across
other regions of the globe could help understanding healthcare culture
and broader contextual influences the constitution of institutional narra-
tives that contemplate adoption of WS.

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    1
      The terms wearable sensors, wearable devices or gadgets, wearables or wear-
    2
      Quantified Self is a movement of users and makers of self-tracking tools.
    3
      See e.g. the EC report The future of Europe is science, available at:
http://ec.europa.eu/archives/commission_2010-2014/president/advisory-council-
/documents/the_future_of_europe_is_science_october_2014.pdf. Or notably also
the Innovation Union strategy (http://ec.europa.eu/research/innovation-
union/index_en.cfm) or the more recent call for the digital single market
(http://ec.europa.eu/priorities/digital-single-market/index_en.htm).
