Last September the Bassetti foundation had the pleasure of hosting Federica Lucivero, Senior Researcher at the Ethox Centre of the Big Data Institute of the University of Oxford and coordinator of the Digital Health Network at King’s College London. Her lecture was titled “Health apps between medicine and lifestyle”.
Federica Lucivero’s work incorporates ethics, social science and the philosophy of science with particular interest in the field of e-health, her research integrating theoretical and methodological questions into empirical research.
The foundation has made video, overview, slides and photographs of the event available.
The protagonists of the seminar were the emergent information technologies applied within the health field (health apps, wearable sensors and online portals) and the questions of responsibility and governance that arise from the normative ambiguities of devices that sit on the crossroads of health and lifestyle.
Should we see them as techno-scientific tools that belong to the domain of medicine and as such need to be regulated and calibrated through norms, practices and certification as typical in these cases? Or are we dealing with instruments that lie within the spaces between different worlds, that often take advantages of these grey areas?
As Angela Simone reminded us in the introduction to the dialogue with Federica Lucivero, this theme is enormously interesting for the Bassetti Foundation for a series of reasons. One of these is the intersection of these discussions with the debate on precision medicine – protagonist itself of the European SMART-map project that the Foundation is a partner in – that brings new actors not traditionally associated with medicine into the field, such as citizens or the big players in ICT.
The question for those interested in responsible innovation therefore becomes: which institution could carry out what the sociologist Gieryn calls boundary-work, or to draw the line between what is scientific and technological and what is not, sitting just beyond the confines? Legislators have problems keeping up with the pace of change brought by innovation in this as in other fields, and it is often the courts, brought into play by citizens, that decide if and where the line must be drawn.
m-Health: examples and definitions
Federica Lucivero guided the discussion through the normative ambiguity and governance problems connected to so-called mobile health from the perspective of three objects:
1) The well known Apple Watch, an intelligent watch fitted with sensors that register physiological parameters and for which users can download apps that monitor physical activity, hydration and other activities and states;
2) Sleepio: an app aimed at people who suffer from insomnia that can be both prescribed by a doctor or freely bought online or in pharmacists;
3) Ginger.io: an app that provides 24 hour assistance to those suffering from stress, depression or panic attacks and that can if necessary alert the emergency services and request assistance.
These are just a few examples that help us to understand how the world of mHealth (mobile health) includes self monitoring tools that are used within both the sphere of medicine and of well-being. The World Health Authority and the European Commission have both attempted to define mHealth:
“mHealth is a component of eHealth [….] medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs) and other wireless devices“.
WHO (2011), Global Observatory for eHealth
“mHealth also includes applications (hereafter apps) such as lifestyle and wellbeing apps * ”
* “lifestyle and wellbeing apps primarily include apps intended to directly or indirectly maintain or improve healthy behaviors, quality of life and wellbeing of individuals“.
European Commission (2014), GREEN PAPER on mobile Health (“mHealth”), COM (2014) 219, Brussels.
These definitions show how the field of mHealth contains a broad range of tools and strategies that differ widely, and can be used as medicine reminders, to monitor sleep, or as a support for health workers. Many of the well-being applications have been developed in order to help people change their lifestyles to improve their health: eat better, do physical exercise, sleep better, smoke less, or define the best moment for conception.
Within this context the current normative distinction of what is medical and what is not require rethinking. We are facing a problem that is anything but niche and in continuous expansion, it being enough to note that in 2017 there were about 259 thousand health and well-being application available through the app store. Public and private entities are investing heavily in these tools, also in virtue of the promises of mHealth, among which we find:
1) an improvement in the quality of healthcare, largely thanks to the continuous monitoring of chronic patients, those at high risk or in reaching patients that live in remote areas;
2) the reduction in health costs, for example through a reduction in hospital visits;
3) the democratization of the health sector through a form of self treatment of sickness, through empowerment, participation, activation and responsibilization of patients in the daily decisions and choices regarding their treatment.
Health and well-being apps are technoscientific imaginaries and many stakeholders are investing in the sector, from small to medium sized enterprises to multinationals such as Google, Apple or IBM. The UK health system (NHS) is also interested in the development and acquisition of mHealth tools as well as insurance companies, that can offer benefits and reduced rates for customers who follow a healthy lifestyle, for example connecting the insurance profile to the idea of the fidelity card used by supermarkets.
Problems of governance
During the seminar, Federica Lucivero highlighted three main difficulties for governance.
1) Security and certification.
The data must be valid and trustworthy. Some organizations, such as the FDA or CE, are working towards understanding how to certify quality. These are tools that are entering fully into the everyday life of the health system, and therefore require a certification that goes well beyond that offered to users of an app store.
2) Data protection.
These devices collect a huge amount of data in real time and raise important questions about privacy because the border between sensitive and non sensitive date is becoming ever finer, particularly in relation to the fact that lifestyle choices can be identified as factors of health risk. In a report from 2015, the Dutch Authority for Privacy reported violations following an investigation into data collection by Nike through its Nike+ Running app, but the company argued against the report stating that the sensors did not collect sensitive data on the user’s health because the analysis was conducted at an aggregate level.
3) Civil responsibility.
From the production of the device to the collection of the data, the mHelath applications involve different actors, for example producer, user and health worker. In the event of malfunction who should take responsibility? Are we dealing with a product and can we therefore hold the producer responsible? Or are we dealing with a service and shared or distributed responsibility?
These three difficulties in governance mentioned above are just a few examples that help us to understand the challenges that legislators meet and address in the regulation of health and well-being apps. The cause of these difficulties can be found in the hybrid character of these applications. The categories used until today (health and well-being) are inadequate because they are brought into discussion by the very objects that they wish to regulate.
As Anthropologist Mary Douglas sustains in her book “Purity and danger” (1966)), there is a close relationship between symbolic systems and social order, with the last based upon dichotomous concepts such as life\death, man\woman, sick\healthy, that have an epistemic and moral value. Phenomena that escape classification in the symbolic system that regulates social order – either because they fit more than one category or because they are out of place – are treated as tabù. We can think about food legislation and its relationship to normative ambiguity; or the eel, or the sea snake, between water and land, generating uncertainty. The natural hybrid is often considered unclean, often leading to bans or the strengthening of existing categories.
The same attempt to “domesticate” or to try to set the new things we have to confront into pre-existing categories also happens with technology. Wearable technology does not fit within our categories and in some ways neither within our symbolic order, that requires the medical domain, highly regulated as it is, to be different from the lifestyle, free time and play domains.
Health apps sit on the border between two categories that are normatively and morally different, that require different safety norms and security certification. But how far can we succeed in our attempt to domesticate them? Lucivero proposes another approach: that of rethinking these very categories. The governance problems and hybrid character of mHealth technology in fact share a close relationship, which requires us to think about the existing categories.
1) Security and certification.
The distinction between the medical\health domain and individual preferences (lifestyle) raises important questions in terms of the management of risk. Some apps today are fully considered medical tools, others not. The grey area created is vast, requiring us to rethink the normative criteria used until now. A new approach adopted in France and Catalonia proposes to evaluate the risks associated with such new technologies based also upon the context of the device’s use. The distinction between objective and subjective criteria loses sense and must be re-thought.
2) Civil responsibility: Medical expertise vs experience.
Until today we have used a strict distinction between experts who work within and expand a field of knowledge, taking decisions, and patients who do not possess such knowledge. Doctors have traditionally been the guardians of knowledge and clinical practice, but health and well-being apps attribute a new role to the patient, one that is much more central and proactive. Ever more frequently a patient arrives for a medical consultation with more information that that available to the medical professionals, leading in some cases to doctors adopting a role that is different from the one they have been trained for. Often they experience a distribution of roles and responsibilities, a fact that is fundamental if we speak about liability connected to the malfunctioning of the apps.
3) Data protection.
With preventative medicine, daily habit enters ever more into the sphere of health and the difference between sensitive and non sensitive data becomes ever more blurred. An apple is no longer sweet or sour, but full of vitamins; and a run becomes a certain number of calories burned. The apps that monitor our lifestyles favour the drawing in of daily life into the medical domain. Physiological data, information about hobbies, routines or residency can be used to make inference about the health of a person as the categories of health data expand almost beyond sense. Data that were not in the past considered sensitive become indicators of a healthy or unhealthy lifestyle, in an era of the constant production of data through cell phones or sensors or an era in which even a person’s shopping list can become a risk factor, personal data protection will not be guaranteed until we rethink these classifications.
A reflection on mHealth and the governance problems derived from the normative ambiguity of hybrid technologies such as apps for health and well-being is without doubt urgently needed, representing the possibility of rethinking the categories that we have used until today. We are facing important questions that require conceptual and ethical-philosophical thought, because they relate to our ideas of good, of right, of justice, of rights, obligations and responsibility.
To conclude: It is important that we realize that our symbolic order needs to be reviewed and that we use the opportunities raised by these legal challenges as the stimulus to think about these categories and their meaning in a world that is changing.
Following the lecture the web tv Triwu interviewed Federica Lucivero on the themes of the lecture: “Health Apps: la medicina del futuro alla Fondazione Bassetti. Presso la Fondazione Bassetti ha avuto luogo un incontro sul tema della medicina del futuro: tra applicazioni, big data e “democratizzazione” della salute”. 21 settembre 2017.