Keywords

5.1 Introduction

Prophecies made in high-impact journals identify personalised medicine—or predictive, preventive and personalised medicine (PPPM)—as the goal for global health.Footnote 1 Through the systematic combination of genomic, proteomic and digital communication technologies, the idea of personalised medicine involves the mapping of an individual’s health risk profile and the prevention of disease onset with high precision.

One reason for PPPM’s appeal is its reconciliation of two often contradicting concerns evident in two other major health trends: the quest for more scientific facts in evidence-based medicine (EBM) and the focus on patients and personal skills in person-centred care (Bohlin and Sager 2011; Bird 2011; Croft et al. 2011; Holmes et al. 2006; Torpy et al. 2009). PPPM lays claim to the area between the epidemiological subpopulations of EBM and the individual patients of person-centred care by drawing on the intensive use of information and communication technology (ICT), such as the internet, and new systematic genomic and proteomic knowledge gained from global mapping efforts (Golubnitschaja 2010; Collins et al. 2006). PPPM integrates an entire complex of emerging technologies that propel transformations at multiple levels. Some experts view these technologies, which include telemedicine, e-health and e-care, as positively influencing the social environments of patients and enhancing methods of (self-)monitoring.Footnote 2 Some prominent Science and Technology Studies (STS) scholars also have this view.Footnote 3 Pharmoeconomics is another field in which patient adherence is studied and provides knowledge that supports arguments for the reduction of the costs that non-adherence incurs both for the patient and society (cf. the journal PharmacoEconomics). There is a rapidly growing market of new and emerging diagnostic instruments with origins in pharmacogenetics, which is the science that seeks to determine how people’s genetic composition affects their responses to medicines and which offers the potential to develop a new generation of medicines that are tailored to individual needs. In addition, it is hoped that genomically based diagnostic tests will deliver reliable and rapid diagnostic data to healthcare professionals in the future (Royal Society 2005). Although pharmacogenetics has thus far had little influence on clinical practice, visions of rapid advances in both the science and the underpinning of genetic technologies strongly influence research programs, including those in Europe, where the EU’s Directorate General for Science and Innovation is a major actor in the promotion of S&T for relevant genomics, proteomics and other “-omics” developments.Footnote 4

Historically, high-tech solutions have created hype and the associated unconditional acceptance, or, in contrast, great fear, cf. gene therapy (Grankvist 2011) or stem cells (Sager 2006), none of which appear to contribute to an enhanced realisation of the desired health benefits. Because of the grand visions and rapid development in this context, the interplay of these emerging e-health technologies vis-à-vis human expertise necessitates an empirical analysis of the reconfigurations of the healthcare system.Footnote 5 How will these developments affect the physician-patient relationship and how will physician’s and patient’s identities affect the roles of emerging technologies and medical and lay expertise?

Long-standing conversations on knowledge and expertise, such as those occurring within STS, have addressed emerging health technologies (Oudshoorn 2011; Brown and Webster 2004; Cartwright 2000; Clarke et al. 2003; Webster 2006; Hindmarsh and Prainsack 2010; Salter et al. 2009). A common trait of these studies is a focus on mundane practices in close relation to political and economic infrastructures and the ramifications for the interplay between experts and patients.

Our aim is to develop a three-layered framework for the empirical study of emerging health technologies as illustrated through the example of PPPM and, in particular, telemedicine/e-health technologies. We identify three aspects of research on PPPM that we believe to be especially to both being pursued and combined. The first aspect is the governance of expertise. The last few years has witnessed an abundance of pertinent research in this area. A focus on the governance that is implicated in new distributions of expertiseFootnote 6 resulting from the mediations of emerging technologies is a vital part of any analysis of PPPM (Hedgecoe 2006; Kerr et al. 2007; Milewa 2006; Oudshoorn 2011, 2012; Weimer 2010). The second aspect is the travelling of expertise. How is the notion of expertise affected by these changes, and where is this expertise located and allocated in the new interfaces among physician, patient and e-health solutions? The final aspect is how different forms of expertise invite multiple uses, that is, their affordance.Footnote 7 The notion of affordance is commonly used in contemporary research in various ways (Bergen et al. 2010; Bloomfield et al. 2010; Leonardi 2011), but in early research, Norman (1988) defined affordance as a perceived property of an artefact that suggests how it should be used. A few years later, Pfaffenberger (1992, p. 284) adds that “Affordances are inherently multiple: Differing perceptions lead to different uses. You can drink water from a cup to quench thirst, but you can also use a cup to show you are well bred, to emphasise your taste in choosing decor, or to hold framework airplane parts”. However, this multiplicity is not unconstrained: you cannot use the cup for intercontinental travels.Footnote 8

If we combine affordance with governance, we can observe how various material cultures are utilised when expertise travels. Different materialities offer different sets of possibilities and limitations. Technological devices or genetic microarrays could be used to enhance the interaction between the healthcare system and patients, or guidelines, protocols, algorithms or even organisational forms, such as formal or informal networks, should perhaps conduct these duties. Different materialities enable, or afford, rather than determine, different relationships between actors in healthcare systems. For example, patients may be empowered and/or disempowered, or the autonomy of doctors may be confirmed and/or constrained in various new ways (Mort et al. 2009).

First, we will map key concepts, problems and areas of research in new and emerging technologies, including PPPM, telemedicine, e-health and e-care, and lastly, pharmacogenomics. Second, the developments of and the tensions between EBM and person-centred medicine, as a replacement for traditional patient-centred medicine, will be described. Against this background, we will then suggest a future mode of analysis for these considerable reconfigurations of the healthcare system. The combined concepts of the governance of expertise, travelling expertise and the affordance of technologies are presented as a helpful analytical lens for highlighting essential aspects of these developments and are employed in an illustrative case study. As will be demonstrated, the framework will enable a detailed focus on the dynamic relationships between expertise and materiality.

5.2 Powerful, Predictive, Preventive and Personalised Medicine

Leroy Hood, the inventor of the first automated DNA sequencing machine, claims that “personalized medicine is too narrow a view of what is coming” (Singer 2010). Singer states that the shift will be much broader and will involve a move from reactive medicine to proactive medicine. According to Hood, medical practice of the future is characterised by four P’s: powerfully predictive, personalised and preventive, with a focus on wellness and patient participation. Hood identifies the following technologies as important in this context:

  • Digital technology, for storing and managing medical records with genetic information (this practice will also require suitable security systems so that personal integrity will be ensured).

  • Nanotechnology, for measuring 2,500 proteins in a single drop of blood, a practice whose use is increasing [for information on the hopes and risks related to nanomedicine, see (European Commission 2007)].

  • Technology, for diagnosing and analysing a single cell so that physicians can be immediately informed of normal mechanisms and disease mechanisms in the body.

  • Computational tools.

If these expectations of Hood and other scholars are ever realised, they promise to dilute the traditional healthcare role of physicians in that nurse practitioners will assume functions that were previously performed exclusively by physicians (Royal Society 2005). Thus, there will be a sociological shift in the role that was previously dominated by physicians and that provided them with some of their authority; a new class of professionals, who undertake an increasing number of responsibilities as the new and emerging medical technologies appear online, is emerging. These new professionals may be expected to rely on technology rather than years of education and experience to diagnose and treat patients.

A critical question with regard to these developments asks whose expertise is embodied, strengthened and shifted during the redistribution of influence and the transformation of professional roles.

In addition, according to the Royal Society report, all traditional categories of professionals (doctors, nurses and pharmacists) will clearly require much stronger training in the fundamentals of human genetics so that these professionals can offer and interpret key diagnostic tests. Therefore, traditional tacit knowledge and skills will be partially replaced by new forms of tacit knowledge that are associated with genomic literacy and molecularly based disease classification systems. Furthermore, given the pursuit of more rapid and appropriate means of treatment afforded by advances in pharmacogenetics and new diagnostic methods, what expectations and values are typically associated with or projected onto this powerful technoscientific imagery (Hedgecoe and Martin 2003; Hedgecoe 2006)? Moreover, who ultimately establishes “the conventions that underlie practices, which define the criteria that turn tools and novel entities into operational components of clinical settings” (Bourret 2005, p. 41)? We suggest that the approaches to these issues require a focus on the governance that is implicated in new distributions of expertise resulting from the mediation of emerging technologies.

Multi-level transformations of PPPM (or the 4 Ps, in Hood’s terms) are visible in two paradigmatic technologies: telemedicine and pharmacogenomics. Telemedicine has a long history dating back to the American Space program after the Second World War and the need to monitor astronauts at a distance (Petersson 2011), but during recent decades has been facilitated by the advent of the Internet, mobile telephone systems and consumers’ consequent access to health information. An indirectly related technological dimension appears in genetics and biotechnology that spurs novel forms of personalised medicine, which, in turn, exert new demands on detailed information flows between patients and their physicians for both diagnosis and treatment. This trend is also related to the influence of genomics on the prescription drug market, which gives the biotechnology sector a growing share of the pharmaceutical industry as a whole if one considers the largest 25 companies in the world in terms of sales of human prescription drugs and vaccines (Camacho et al. 2009).

5.2.1 Telemedicine, E-Health and E-Care

The work of Carl R. May and colleagues (May et al. 2003) is critical to appreciating the effects of telemedicine and e-health technologies. May utilises a constructivist analysis that is associated with STS and addresses problems related to expert-patient interfaces and patient adherence in e-health systems. He poses the following question: could new technologies provide a new way to bridge the gap between the heterogeneous life-world of patients and the codified world of evidence-based medicine by combining qualitative discretionary knowledge, EBM-generated quantitative knowledge and clinical guidelines based on the latter to manage illness?

When embedded in a person-centred, preventive healthcare system, telemedicine may be viewed as a system that offers flexibility in the patient use or self-surveillance of prescribed health parameters. As a complement to traditional face-to-face encounters with physicians, such methods may—but not necessarily—increase adherence to prescribed medication routines. Flexibility and adherence are not necessarily easily combined. This tension prompts questions regarding how patient expertise may be combined with the telemedical system and what elements of this expertise are relevant in this combination. A large market targets lifestyle-related diseases; self-use toolkits are tailored to monitor vital indicators. Examples of such targeted diseases are asthma, Type 2 diabetes, hypertonia, obesity and secondary hyperlipidaemia or hypercholesterolemia.

May et al. (2006) refer to telemedical activities as a new type of clinical encounter in which non-human actors (technological aids) function as intermediaries in doctor-patient interactions to reduce hospital admissions. These authors note that “much of this field of practice is about shifting medicine and healthcare away from hospitals and back into the local community” (May et al. 2006, p. 1027). This shift prompts new practices of governance, also known as “technogovernance”, in which “intermediaries are deployed to discipline and frame the individual subjectivities of both patient and doctor […] and act to distribute accountabilities”. Furthermore, it is argued that the epistemological authority of both the doctor’s EBM-supported position and the patient’s narratives that now include accounts of technologically generated self-knowledge are enhanced. If such enhancements are attainable, the contradicting assumptions regarding the redistribution of influence as a zero-sum game become extremely interesting. In addition to redistributing roles, new technologies may add new value for all parties, although such a scenario would clearly be contingent upon circumstances in specific places.

If technologies are considered mediators between physicians and patients, a further classification may distinguish ICTs from varieties of pharmaceutical, biotechnology and therapeutic medical devices. These devices may function as mediators between a person who uses them and his or her physician. With self-managing patients, the role of the physician then shifts from deliverer of medical care to supervisor (Willems 2000).

However, whether this development entails additional democratisation because patients experience a greater amount of individualisation and person-centred care remains an unanswered question. In contrast, despite patients’ beliefs that their encounters with doctors are more democratic and participatory, could the new methods actually represent an entrenchment of the evidence paradigm in a new form? Evidence becomes inscribed in methods/technologies, and the necessary negotiations that are involved in configuring the technology are black-boxed from view.

Entrenchment might be involved in that the new technology now shapes the self-understanding of patients in parametric terms based on categories that are inscribed in the virtual world and supplied by non-human actors. In his earlier days, Jürgen Habermas might have referred to this phenomenon as a further technification of patients’ life-worlds.

At the same time, healthcare communications discourse analysts indicate the existence of a process in the other direction whereby medically literate patients develop their own expertise and colonise the physician’s world as they combine professional discourse with lay experiential discourse (Candlin 2000). For their part, physicians employ hybridised modes of speaking by interpolating discourses of patients’ life-worlds in their clinical discourses; thus, simple opposition between a patient’s life-world and a doctor’s medical world is thought to be collapsing. This shift has also been described as a shift from a white-coat model to a model of shared decision making (Camacho et al. 2009).

Thus, systems for patient self-regulation influence the epistemological questions of who may be considered an expert, who may not and why. In some of the literature on user participation in decision making regarding science and technology (sometimes referred to as technoscience), scholars claim that laypersons are experts in their own right when the technoscientific imaginaries (Jasanoff and Kim 2009) that are envisaged have a strong influence on their life conditions. Therein, it is held that the boundary between expert and lay knowledge changes. This view has also been founded on other arguments, such as those based on the role of tacit knowledge. In recent years, this same view, which is linked to discourse on the democratisation of science and technology within STS, has been challenged and countered by Harry Collins and Robert Evans (Collins and Evans 2007: see also note 5).

These authors have introduced a threefold typology of different forms of expertise. Apart from the formal propositional knowledge of a physicist or astronomer, for example, Collins and Evens identify two additional forms of expertise. One of these forms of expertise is known as “contributory expertise”, which a person possesses if s/he is fully immersed in the specialist language and specific research culture. In theory, a layperson could consequently contribute to a scientific field without formal training or credentials. It must be emphasised that this scenario is mere theory; the actual occurrence of this scenario is highly unlikely. This implausibility is why Collins has been accused of creating, or reinstating, a new demarcation in science that is scientific in spirit and possibly technocratic in practice (see note 5). However, contributory expertise is distinguished from another form of expertise. “Interactional expertise” refers to instances in which a layperson is immersed in the specialist linguistic culture of a practical domain rather than a practice itself (Collins 2004). This typology has relevant implications for analyses of the tension between evidence-based expertise that is advocated by specialists “in the know” and the personal knowledge of patients who are also “in the know” in their own ways. The previous arguments may also be extended to issues regarding individual self-regulation or the expert (outside) monitoring (with advanced technical devices) of patients. The difference here is parallel to that between an algorithmic or procedural model of expert evidencing and an enculturational model that emphasises contextual contingencies, learning and “intangibles”, such as social trust and tacit knowledge (Collins 1992: Postscript).

Thus, the embodiment and transfer of expert knowledge by telemedicine engender several possible ramifications and interpretations that require further analysis: the mutual enhancement of the epistemological authority of both patients and physicians, the technification of the life-worlds of patients, and patient and physician colonisation of one another’s “expert repertoires” and worlds.

5.2.2 Pharmacogenomics

Distance and reflexivity are necessary when seeking to understand what Lucy Suchman refers to as the moving interface between the biological and technological (i.e., bodies and machines, respectively) in modern biomedicine. In a recent anthology edited by Johnson and Berner (2010), Suchman reflects on how, through meetings among professionals, patients and their kin, medical practices are restaged as and/or transformed into bodily encounters that are crucially mediated and understood through machines (Suchman 2010). This interplay between humans and nonhumans can be found in many layers of pharmacogenomic developments.

Strong economic and political forces, as well as new and emerging technologies, drive the current trend of PPPM. A closely associated vision involves the use of pharmacogenetically based knowledge in diagnostic devices to accelerate patient throughput and tailor medical treatment to individual patient needs at the point-of-care (PoC, i.e., in clinics). Furthermore, rapid diagnoses and the individualisation of prescribed medicines promise major cost reductions, which are welcomed by health administrators. According to a BCC Market Research report, the value of the global market for personalised medicine technology was projected to equal 14.4 billion US dollars in 2009 and was expected to more than double over a 5-year period to reach 29.2 billion US dollars in 2014 (BCC Market Research 2009). Within this overall projection, it was noted that “pharmacogenomics is a major revenue generating market” and constituted 4.1 billion dollars of the total personalised medicine market in 2009 and that this segment would likely reach a market value of 9.5 billion US dollars in 2014. The next largest market segment is the PoC market, whose value was 2.7 billion US dollars in 2009 and is expected to increase to 9.5 billion dollars by 2014. Other segments that are mentioned include pharmaceutical proteomic technologies, pharmacokinetics, pharmacogenetics, pharmacodynamics, stem cell therapy and metabolomics.

Patient organisations seek more effective treatments of diseases that are associated with specific genetic characteristics (biomarkers) as a means of more durable wellness because research, for example, enables the development of medicines that are effective for a relatively small proportion of patients. In other words, a further driving force is ideational and relates to pharmacogenetics (genomics, proteomics and other “-omics”) as a powerful technoscientific imaginary envisioning possible health futures (Jasanoff and Kim 2009; Jasanoff 2011). With these changes, perceptions of disease, ontologies and epistemologies are evolving as well, as is also likely (with considerable lag) for the underpinning structures of institutional arrangements and professions that are concerned with or directly involved in healthcare.

Molecular diagnostic technologies challenge a healthcare and financial system that has long depended on visible symptoms and gross clinical classification. As diseases are (re-)classified into distinct molecular subcategories, there will be pressure to shift from traditional pharmaceutical business economic models that focus on “one-size-fits-all” drugs (Paci and Ibarreta 2009).

PoC medicine is a concept that has emerged in the literature to encompass techniques for making the correct diagnosis and beginning the appropriate treatment immediately during the first contact with a patient. Personalised medicine is the concept of customising an optimum treatment based on detailed and specific genetic information pertaining to a patient and tailoring medication to individual needs. Both the concepts and practices that they entail are accompanied by a variety of evidence-related questions. These questions must be addressed successively as pharmacogenetic tests become available so that the crucial link to personalised medicine can be provided. The process of identifying patients who are most likely to respond to a particular drug requires the (a) identification, (b) development and (c) validation of “biomarkers” for diabetes, heart disease, cancer and other illnesses. The technologies necessary for development and marketing will also meet several institutional “hurdles” before they can be adopted into mainstream medicine: regulation; reimbursement; physician education; and ethical, legal and societal concerns (European Commission 2007; Martin et al. 2006; Royal Society 2005).

PoC testing accounts for approximately one-third of the global in vitro diagnostics (IVD) market (BCC Market Research 2009). Rapid tests at the PoC by healthcare professionals or by patients in their own homes are revolutionising the diagnostic sector. Driven by the necessity of earlier, accurate diagnostic information in guiding critical clinical decisions, technology advances, including miniaturisation, are enhancing the role of diagnostic tests in healthcare systems. Products that are used in diabetes care constitute the largest segment of the PoC market. Other important segments relate to conditions such as urinary tract infections, tuberculosis, and heart failure; early distant warnings for stroke; and bladder cancer tests.

Home use tests for HIV underline the need for quality control, insurance and prevention of the misuse of such tests. Insurance companies are also making progress in the personalised medicine market. Apart from demonstrating safety and quality, testing devices must be user friendly. These devices must be convenient and simple to use while also meeting the connectivity requirements of healthcare systems.

Some studies predict a future in which new technologies will replace the traditional reliance of physicians on their senses, which include vision, hearing and touch. Molecular diagnostics require genetic literacy, and the genetic approach assists in the enhancement of doctors’ “senses” while customising treatments and prevention strategies for individual patients (Pai 2009). Furthermore, as diagnosing illnesses and monitoring patient conditions become increasingly automated and technologised, self-managed diagnostic devices place this aspect of the process in the hands of patients. Because the era of personalised medicine will evidently affect millions of people, this new type of medicine is also expected to change the perception and management of disease.

Thus, emerging health technologies, such as PPPM, not only engender grand visions but also reveal multiple possibilities and future problems whose existence depends on who is responsible and whose aims will be preferred. In addition to the combined pressures of market forces and new technologies, multiple actors, such as patient organisations, health workers at care institutions, and health administrators who want to reduce costs at the PoC in clinics, are important drivers of these developments (Martin et al. 2006; Paci and Ibarreta 2009).

Generally, the various actors who are involved have different perspectives, with pharmaceutical companies accenting potential market gains, health administrators favouring speed and efficiency in diagnostic regimens and patients and health workers in the field emphasising the validation and safety of treatments.Footnote 9 In other words, essential tensions may exist between those actors who primarily emphasise economic worth and technological efficacy and actors who place a premium on caring and view personalised medicine in terms of enabling social relations at the interface between health workers and physicians. Therefore, analyses of the interactions between value hierarchies at the institutional and personal levels are relevant to any inquiry regarding the role of new technologies as mediators between patients and those who diagnose and treat them or monitor their treatment.Footnote 10 This relevance also extends to the role of health workers with regard to the self-diagnostic capacity of patients in terms of their use of off-the-shelf diagnostic instruments on the market.

Attending to issues of knowledge production and transfer will ultimately recall the configuration of persons/patients (that is, issues of identity, politics and governance). One major barrier that health economics must consider is access to the health system, which is not necessarily equal for all potential users of healthcare and preventive medicine services for several reasons.

Another dimension that is highlighted in the policy literature is the significance of management methods and the shift from public to private-sector approaches, such as the new public management approach (Vedung 2010). Here, one finds arguments that the emphasis on competitiveness, the creation of quasi-markets in the healthcare sector and new audit cultures may have effects at the macro level (Lane 2000), and in turn, change processes at the micro and meso levels of governance and systems for patient self-regulation (van Essen 2005, 2009).

5.3 Expertise Among Evidence, Persons and Affordance

We are now in a position to return to the beginning of the chapter, and the assertions of PPPM will serve as a bridge between two significant and sometimes divergent movements within the healthcare system: evidence-based medicine and person-centred care.Footnote 11 By drawing on genetic knowledge fitted to each individual patient—rather than the average measures of large-population health benefits taken from randomised clinical trials or cohort studies—PPPM might ease conflict between evidence and persons (i.e., between allegedly hard science and soft humans).

In recent years, the term “evidence-based medicine” has been a catchword for profound changes in medical research and the provision of healthcare across the Western world. At the core of this concept, which was introduced in Canada in the early 1990s, is the idea that clinical decisions should be based on the most reliable knowledge available regarding the effects of medical interventions. Initiatives in the healthcare sector and numerous other areas are frequently justified by referring to this idea. Methods and tools that have been canonized under the banner of evidence-based medicine, such as randomised clinical trials, systematic reviews and practice guidelines, have been introduced in the fields of social work, education, psychotherapy and criminal justice. However, the application of these tools in healthcare systems and elsewhere has proved significantly more complicated than was initially anticipated by proponents of evidence-based practice.

Another recent trend is a shift from patient-centred to person-centred medicine, which is reflected, for example, in the coordinated global effort evident at a major conference in Geneva in May 2008 and, since then, in its annual follow-up conferences, as well as a new journal. The International Journal of Person Centered Medicine strives to move away from the utilitarian application of methodologically limited, biostatistically dominated studies that are conducted in epidemiological subpopulations toward a more humanistic model of care that is based on science and humanity for individuals who collectively constitute the social communities in which they are born and in which they will later die. (Miles and Mezzich 2011, p. 2).

The conference and the journal benefit from the broad-ranging participation of physicians, researchers, patient organisation representatives, social workers and other practitioners and are expected to further consolidate efforts and facilitate the development of research agendas and clinical capacity building in the same spirit (Mezzich and Miles 2011).

Clearly, the ability to bridge these two major trends within medicine is a strategic asset, if realisable. Rather than discussing how real or imagined this promise of PPPM is, at present, it is necessary to discuss this discursive space in which PPPM allegedly fits like a glove. Evidence-based medicine and person-centred care are often placed along a spectrum of trust; a greater or lesser amount of confidence may be ascribed to humans and their competences and concerns compared with technologies, standards and the removal of personal subjective elements. The spectrum has a long history, although this history appears in many guises, such as the oppositions between idiographic and nomothetic research, hermeneutics and positivism, and qualitative and quantitative studies. However, many deeply involved actors, whether they are representatives of evidence-based medicine or person-centred care, are nuanced and do not rely entirely on technologies or personal competences, respectively. However, the opposition between persons and evidence is recurring and is thus a fundamental tension in the field. This conflict contributes heavily to the space in which the discursive roles of all of these movements, including PPPM, are determined.

This discussion provides preliminary information regarding the analyses of medicine and emerging health technologies: analyses that are based on this dichotomy may reinforce existing conflicts and thus support evidence or patients. Within multi-disciplinary studies of science, technology and medicine, there have been many attempts to shift perspectives from focuses on nature versus society, humans versus nonhumans, and quantitative versus qualitative character and instead explore how technologies are constructed. Among these attempts are post-humanist approaches, such as actor-network theory, which has allocated agency symmetrically (that is, both to humans and technologies and other material, “non-human” entities). The purpose has been to examine how technologies are endowed with capacities and the various roles within medicine, for instance. Rather than discussing the opposition of technologies and people, such approaches focus on “hybrids” and the work that these hybrids perform. PPPM could be approached through such symmetrical, post-humanist methods. Through detailed studies of PPPM in action, this type of analysis could reveal how hybrids, such as pharmacogenomics and e-health/e-care, are constructed in laboratories and shifted from universities and companies to healthcare providers and patients, resulting in transformative effects for many of the involved persons.

We are inspired by these approaches. It is critical to avoid demonising or idealising either humans or technologies. It is also crucial to empirically acknowledge the plethora of hybrids and the many combinations of non-human technological solutions and human skills and values. Attending to hybrids may constitute a passable path that is certainly supported by the impressive number of detailed and informative case studies that draw on these notions. However, from the perspective of this chapter, one important reservation is connected to the particularities of the field of medicine and the ambition to overcome dichotomies: actors themselves are already at work analysing the field in these terms.

In particular, proponents of PPPM draw on the polarisation as a strategic asset when presenting PPPM as a technologically mediated solution to the dichotomy between evidence and persons. We fear that the pursuit of a post-humanist symmetry between technologies and people or between evidence and persons risks succumbing to the hype related to and the fascination with emerging technologies; this hype may be the greatest enemy of these emerging technologies. We will emphasise that there is nothing theoretically wrong with the symmetrical study of hybrids. However, the context of analysis is excessively tense because the actors themselves are greatly interested in the power of hybrids. Therefore, we suggest an “ontological fold”: a slight asymmetry in the otherwise necessary focus on hybrids and the construction of technologies.

Thus, we argue that post-humanist approaches lack an analytical space for expertise and a clear role for humans and their collective tacit knowledge. The fundamental distinction, or “human bias”, cannot be disregarded because it affects empirical analyses on several levels; this bias essentially assumes that all knowledge is primarily a matter of collective tacit knowledge that is developed and possessed communally among people. Much or most of this knowledge can be made explicit in formulas, machines and routines and publicly scrutinised through systematic investigations. In situations in which this ontological fold is overlooked either in practice or in theory, the result is excessive trust in the formulas, machines and routines that result from knowledge that was originally collective and tacit.

We claim that this result would occur with respect to PPPM if expertise is not placed at the centre of analysis. In this broader context, we need to find an analytic framework for issues concerning emerging health technologies that focuses on expertise rather than evidence—without idealising humans on behalf of technologies. Nuances are crucial. We are aware that such an attempt is a discursive minefield. The framework cannot and will not collapse into a Habermasian call against the technification of the patients’ life-worlds mentioned above because this presupposes a dichotomy between technology and people. Rather, we are inspired by Carl May’s focus on technology, patients and doctors and regard this focus as crucial to avoiding some of the pitfalls of extremist faith in evidence. Evidence always requires people. Regardless of how high-tech any health system becomes, such systems are created and used by people who are affected by such systems in their mundane daily lives. Knowledge presupposes and affects humans. Expertise is a term that refers to this essentially human element, which we believe to be crucial when studying possible enhancements of high-tech developments within the field of health and medicine.

Given the above position and arguments, how can this be turned into studies that take this into account? Below, we offer a framework that we believe will go some way towards addressing these problems. The framework is illustrated with Nelly Oudshoorn’s interesting case study of telemedicine focusing mostly on the implementation and use of three telecare devices in the Netherlands and in Germany (Oudshoorn 2011, 2012). Oudshoorn’s “multi-site” study was pursued independently of our framework and is presented most extensively in her book Telecare Technologies and the Transformation of Healthcare (2011).

5.4 Future Studies of Emerging Health Technologies: Concepts and a Framework

Considering the polarisation between evidence and persons, if we are to follow May, the next step is to monitor the transformative effects of materiality (that is, what the post-humanist approaches, such as recent Actor-Network Theory (ANT), have examined). Technologies—whether digital decision support, pharmacogenomics or e-health—afford new ways for expertise to travel, and thereby, reconfigure human relations. Expertise has an essentially human aspect, but this aspect interacts with and is altered by materiality in unpredictable ways. Thus, the three key elements of our analytical approach are in place: the affordance of technology, the travelling of expertise and the governance of expertise.

First, a pre-condition for telemedicine and pharmacogenomics, if not all technologies, is that some elements of expertise (some of which are allegedly tacit) can travel through and with non-human artefacts. In fact, expertise can travel. This ability to travel is clearly inherent in PPPM as an element of the concepts of telemedicine, e-health and pharmacogenomics and is exemplified in PoC diagnostics. PPPM exists as expertise that travels through healthcare systems from medical companies, state authorities, expert bodies and patient organisations to individual treatment decisions made among doctors, clinical teams and patients. Some elements of expertise are easily moveable, whereas other elements are ultimately not. Which elements are moveable and which elements are not? The answer to this question is crucial in understanding the fascination with emerging health technologies.

A second, equally important element involves how movements occur and in what direction they occur. Various material cultures are utilised when expertise travels. Different materialities offer different sets of possibilities and limitations. Technological devices or genetic microarrays may be used to enhance the interaction between the healthcare system and patients, or guidelines, protocols, algorithms or even organisational forms, such as formal or informal networks, should perhaps conduct these duties. According to our introduction of the concept, different materialities afford rather than determine the interaction between technologies and users.

These possibilities may be stated but must be further examined. How do various materialities, usually technologies, afford further paths of action? That technologies limit future paths is well known, but it may be hypothesised that a growing market in pharmacogenomics will sometimes limit paths more than necessary for reasons of profit. Simplification and standardisation are often profitable pursuits. However, the opposite is also true. Limitations may require enforcement to protect personal integrity, as the corporate sector (e.g., insurance companies) may identify opportunities for maximising profits by “marking” people genetically, as envisioned by Pálsson (2002), Evelyn Fox Keller (2000) and others. By attending to the affordance of technologies, analysts will be able to contribute to alternative reconfigurations by revealing cracks in the black boxes of PPPM as they are stabilised.

Third, the reason for the importance of the travelling expertise and affordance of technologies in studies of PPPM involves the relationships at stake. Who is deemed an expert? Who is allowed to influence the configurations within PPPM? Technologies afford different relationships between actors in the healthcare systems; for example, patients are empowered and/or disempowered, or doctors’ autonomy is confirmed and/or constrained in various and new ways. Many actors battle for influence. On one level, these issues are overtly democratic and relevant for all interested parties and are clearly important for analysis and deliberation. The manner in which the travelling and packaging of expertise often result in initially opaque consequences for patients, physicians and other involved parties is likely to be even more interesting for future empirical studies of emerging health technologies. Thus, the travelling of expertise and the affordance of technologies can be understood as various forms of governance, which is a composite of the materialities that are involved when knowledge is produced and initiated through healthcare systems. Of course, post facto stabilisations may be difficult to unravel or undo but remain important. In this sense, the governance of expertise is a critical issue for future studies of emerging health technologies.

5.4.1 Future Studies of Emerging Health Technologies: An Illustration

Rather than concluding on a mere conceptual level, we will end this chapter by applying our framework to a case study of telemedicine. We did not conduct this study; rather, we have borrowed it from Nelly Oudshoorn’s recent work to make our own argument. The case study will illustrate the analytical objective of the three-layered framework.

Oudshoorn (2011) has written an excellent book in which many of the expectations in telemedicine are discussed and confronted empirically. She has interviewed patients and professionals about the actual workings of existing telecare technologies, such as mobile electrocardiogram (ECG) recorders and home monitors for heart failure. She notices the common vision in telecare: the vision of overcoming distance and thereby rendering outpatient clinics redundant. Here is her retelling of the experiences of a Mr X diagnosed with heart failure:

The heart-failure nurse explained that he should use a wireless scale and blood-pressure meter daily. He thought it was a kind of magic because these instruments would send his measurements automatically to the telemedical centre, where a telenurse would control them. But since this conversation he feels rather tense. Why is he no longer allowed to visit the heart-failure nurse? She was such a kind lady and she took good care of him. And what about these instruments? He did not dare to tell the nurse, but he does not feel at ease with all the new electronic equipment in use nowadays. Why should he take his blood pressure himself? Why couldn’t the nurse do it, as she always used to do? (Oudshoorn 2011, pp. 3–4).

This particular patient did not enrol in the offered telemedical program; no scale or blood-pressure meter was placed in his home. One major and common objection expressed by patients who declined enrolment was that they did not wish to transform their homes into clinics. In one case, Oudshoorn shows how weight and blood pressure monitors become visible, audible and permanent guests of the patient’s home, occupying physical and mental space. People’s homes have been the focus of seminal geographical work on telemedicine that Oudshoorn purposely invokes (Cartwright 2000). Geography indicates the importance of place. Places are not neutral but are influenced by technologies and, in turn, influence people’s identities. Oudshoorn calls for “technogeographical” studies of care to capture these spatial aspects of telemedicine.

When following the movements of things and people between hospitals and homes, Oudshoorn finds what Paul Edwards refers to as various forms of “frictions”, that is, resistances, costs and losses when data are gathered, computed, shared and moved. According to Edwards, there are no frictionless movements (Edwards 2010; Edwards et al. 2011). Oudshoorn (2012, p. 122) claims that although literal networks are often involved in telemedicine, “the erasure of distance” or “a free flow of information and people” does not result. We call for the study of travelling expertise in the vein of geography and frictions. Expertise is not moved without frictions, despite networks and black boxes. Expertise travels within geographies that pose their own constraints on the content and shapes of expertise.

It may be possible to move expertise in heart-failure into patients’ homes, but these movements come at a cost. Costs and frictions, as well as new possibilities, are tied to the affordances of the technologies in use (Tweed 2010). Some things are enabled and allowed. Other things are not. The technological appliances promised to Mr X can speak, flash lights and display graphs. These appliances can send information themselves to the telemedical centre. The wireless scale that talks invites the interest of younger relatives visiting one patient’s home. Graphs displayed on the TV facilitate the participation of patients’ partners in caring for the patient and may also impress visiting friends. Oudshoorn finds that the blood pressure meter must be integrated into and thus transform the morning routines of both patients and their partners. However, for Mr X, the key loss introduced by the promised appliances is the skill and kindness of the nurse. These attributes are difficult to convey through the technologies but not always impossible. One example of possibilities in this area is the use of the communication program Skype between grandparents and grandchildren or between spouses who are separated for a period of time. By focusing on affordance, the view of technologies as “open-ended” is maintained without claims of limitless uses.

In another study, Oudshoorn (2012) describes how a mobile ECG monitor is used. The purpose of the monitor is to enable measurement of the heart rhythm both at home and in public places. Unfortunately, the device is designed to emit a very indiscrete sound. Because of this irritating sound, it is difficult to maintain privacy when using the device in public. The ECG monitor is designed to allow measurement in public, but, in fact, resists such use among many users because of its audible affordance. This affordance is not intrinsic, but rather, is a matter of packaging. The device could be differently designed but has not been.

In principle, the problems patients faced with the recorder’s sound script could have been solved with small changes in the artefact. Using light or vibration instead of sound as feedback could have been an appropriate solution, but the producer of the ambulatory recorder did not offer this option (interview, Jurgens, 16 December 2004). The responsibility to solve these problems were delegated to the patients, who had to put effort into “repairing” the technological script. (Oudshoorn 2012, p. 135).

Affordance is not ultimate definitive and can be changed. However, it may be more difficult to convey feelings and care than to change the sounds made by an ECG monitor.

Travelling of expertise and affordance of technologies are interesting in themselves but are not the primary focus of our approach. Most interesting in our view is the effects on responsibilities and the shifting relationship between patients/users and experts/physicians/professionals, that is, the issues of governance. In Oudshoorn’s cases, these consequences are very clear. She devotes the last part of her book to the resulting redefinitions of patients. These redefinitions include not only patients but also their kin.

It frequently happened that the partner, who was often present during our visit, joined in the conversation and told us very interesting things that we would not have noticed had we focused exclusively on the person expected to use the device. The telecare device thus redefines social relations in the home beyond the individual patient. (Oudshoorn 2012, p. 131).

The domestic relationships are transformed through the telemedical appliances. When studying technologies, the restructuring of relationships and identities is visible everywhere. According to Oudshoorn’s observations, patients become lay experts or semi-professionals:

The introduction of telecare technologies into the home thus transforms patients into ‘assistant medical personnel’, who actively participate in monitoring their own bodies (Oudshoorn 2012, p. 131).

We claim that this aspect of governance is crucial. Oudshoorn does not make this aspect as visible as it should be, as she lacks a clear vocabulary and a focus on issues of governance. On this issue we are heavily inspired by Carl May and his colleagues who explicitly draw on the body of literature on governance when studying the effects of telemedicine on patient identities:

Telehealthcare may facilitate meetings between professionals but, in so doing, do these systems also end up leaving patients out of the loop? If so, how can patients reemerge into the consultation in any meaningful way? As certain roles are inscribed and prescribed for patients, so the opportunities for opening up the governance of this sociotechnical reshaping of health care provision are, we argue, constricted. (Mort et al. 2009, p. 12).

In order to open up the technogovernance exercised through telehealthcare these authors enter into close interaction with citizens through a pilot panel where the ramifications and future configurations of medicine at a distance are directly dealt with. This is one important added value of a focus on the governance of expertise. Equally important is the connection between these mundane consequences of technologies and the economic and structural changes driving these developments. The first quote provided about Mr X from Oudshoorn’s book concludes by clarifying that whether he decides to accept the equipment now, he will finally be forced to do so. At least, this is the result for which this particular health insurer in the Netherlands hopes.

He wonders what he should do and phones his health insurer who runs the telemedical centre. He is told that in the near future he has to use their new health service because they will no longer reimburse his visits to the heart-failure policlinic. End of story, he thought. (Oudshoorn 2011, pp. 3–4).

By focusing on the governance of expertise the questions will be who attempts to decide what for whom. When reading Oudshoorn, we observe a glimpse of this aspect of governance, but this aspect is not elaborated upon. She uses the quote to display the importance of her study but does not continue down the path of the combination of multiple stakeholders in the transition to telemedicine.

By briefly re-analysing Oudshoorn’s case, we have presented a few instances in which the case study could have been enriched by using our three-layered framework. In future studies on emerging health technologies it will be key to draw on existing work on governance and combine it with the travelling of expertise and the affordance of technologies. By simultaneously studying these three aspects, we hope to find new connections. Without attending to the affordance of technologies and the travelling of expertise, studies of governance easily will lack nuances; without an eye on the issues of governance, studies of affordance of technologies and travelling of expertise are not blind but have impaired vision. We acknowledge that work, to be completed by ourselves and others, toward the combination of these elements, remains.

5.5 Concluding Remarks: Possible Re-conceptualisation?

When addressing the central questions regarding physician-patient interplay and the role of medical expertise anew, we suggest a special focus on the movements, practices and technologies of medical knowledge and the resulting emerging mutualities among actors. These aspects of medical knowledge can be and have been analysed in many ways, but here, we have suggested a specific combination of three analytical lenses. In the framework presented, we stress the prominence of expertise over materiality. In relation to post-humanist symmetry among technologies, things, evidence and people, the framework hence introduces a slight asymmetry (although there is nothing theoretically or principally wrong with symmetry). However, in studies of the affordance of emerging health technologies and governance, we need to create a clear space for human expertise and collective tacit knowledge. Without this space, we risk an unnecessary trust in pure formulas, machines and routines, for which expertise are vital every step of the way to ensuring that technologies and knowledge travel as intended.

First, medical knowledge exists as expertise that travels through healthcare systems from medical companies, state authorities, expert bodies and patient organisations to individual treatment decisions made among doctors, clinical teams and patients. Second, various material cultures are utilised when expertise travels. Perhaps technological devices or genetic microarrays are supposed to enhance the interaction between the healthcare system and patients, or perhaps guidelines, protocols, algorithms or even organisational forms, such as formal or informal networks, should conduct these duties. Different materialities afford different relationships between actors in the healthcare systems; for example, patients may be empowered or disempowered, and the autonomy of doctors may be confirmed or constrained. Third, the travelling and affordance of expertise can be understood as various forms of governance, which constitute a composite of the materialities that are involved when knowledge is produced and initiated through healthcare systems. We believe that using this heuristic scheme to identify ideal typical patterns or configurations for the purposes of conducting comparative analyses across disease categories and governance approaches in different European countries may be both interesting and policy-relevant.