Abstract
In October 2010, following a two-year enquiry, the Nuffield Council on Bioethics published a report on the ethics of ‘personalized health care’. The Council's role is to examine ethical questions arising from developments in medical and biological research, to promote discussion and to make reports and recommendations. It looks for topics that are timely, where it can bring something new to the discussion and where it can have some impact on policy. This particular report takes as its starting point the convergence of a number of developments in medical technology with a set of social and political changes that seemed to the Council to have the potential to significantly transform our relationship with the health-care system. In particular, we saw an environment in which individuals are being increasingly encouraged to take more responsibility for their own health, and in which the language of ‘choice’ is emerging as a key driver in the health-care system and in service development. These developments are captured, albeit not easily, in the notions of ‘responsibilization’ and ‘consumerization’ that the report goes on to discuss.
At the same time we saw the increasing take-up of a cluster of digitally based technologies that together represent new ways of delivering health-care services, often preventive services, many of them outside of the usual setting of the general practitioner's (GP's) surgery or local hospital. These technologies, from genetic profiling to telemedicine, provide on the one hand the promise of more ‘personalized’ delivery of health care (of which more is discussed later), but at the same time opportunities for individuals to make decisions about and take greater control of their own health.
This raised the idea that one can seek information, buy diagnostic or predictive services, order medicines or other health services and keep one's own records, all without having to talk to a doctor or other health professionals. So among the questions that we wanted to ask were: How might this transform our expectations of more traditional health services? What might it mean for the NHS if people were increasingly expected to manage their own health? And what would it mean if people were to increasingly become consumers of a health system, rather than patients, or clients? And, of course, if we are going to consider these issues from an ethical perspective, what ethical principles, or framework, might we use?
This was a difficult set of ideas to bring together into a coherent ‘topic’ for a Nuffield Council report, and the process of refining the Terms of Reference, and of finding a title for the report, were extremely challenging. Nevertheless, the expert Working Party that was appointed to carry out the work, and the Council itself, were convinced that in the midst of these social, political, medical and technological changes was an issue that needed to be more fully aired. The title that was chosen, reflecting both the broad ‘personalization’ question and the case studies that we chose to examine, was Medical profiling and online medicine: the ethics of ‘personalised healthcare’ in a consumer age. The practices, terms and concepts that we were working with did not have a well-formed definition that was commonly understood by all, and the title aims to be clear about what the report would address. ‘Personalized health care’ is in quotes because the questions of whether health care was indeed becoming more personalized, and what the implications of that might be, were still very much open.
Having set out the terms that we were using, we nevertheless had to explain them. ‘Medical profiling’ is the term we use to describe new health-check services such as direct-to-consumer body imaging (e.g. computed tomography and magnetic resonance imaging scans) and personal genetic profiling for individual susceptibility to disease. ‘Online medicine’ includes developments in digital technology that offer new ways of obtaining and sharing health advice, diagnosis and medication (e.g. buying medicines online), and that provide new possibilities for storing, accessing and sharing health records, monitoring individuals' health status and communicating with health professionals and other patients.
Champions of these technologies see them as paving the way to a revolution in health care that will transform many people's lives for the better as a result of the greater possibilities they bring for individualized diagnosis and treatment and for empowering individuals over matters of health and health care. Sceptics, on the other hand, might see some of these technologies as ‘fads’, and furthermore, many are doubtful about how useful they actually are, and concerned about possible harms they may cause.
What is ‘personalized health care’?
‘Personalization’ is a multifaceted term that is becoming very widespread, with many companies, policy-makers and doctors claiming that this is the future of health care. First of all, having made clear that we were not addressing specifically the issues around the individualized therapeutics of pharmacogenetics (the subject of a 2003 Nuffield report), we identified several meanings for ‘personalized health care’:
Management or treatment that is personalized in the sense of treating each individual as a ‘whole person’, and being respectful of their particular wishes, worldview, lifestyle and health status overall, for example. Management or treatment that is personalized in the sense that it aims to provide health care as a good or commodity in ways not dissimilar to other traded products or services that are offered in response to consumer demand (however this demand has arisen or is stimulated). Medical care that is personalized in the sense that more responsibility for management of health care is primarily laid on or taken by individuals or their carers rather than on medical professionals. Personalization in this sense can arise from policies of ‘responsibilization’ from individuals' choices to manage their health care (by taking an active or even leading role in obtaining information or commissioning forms of testing or treatment), or from a mixture of the two. Technologies that are personalized in the sense that they allow better delivery of highly individualized management (prediction, prevention and treatment) more tailored or customized to each person's specific genetic, physiological or psychological characteristics.
Sometimes these four different senses of personalization can readily run together, but there are also circumstances in which the different senses of personalization can conflict, and that can lead to ethical concerns. For example, highly individualized and person-specific treatment can conflict with a ‘whole person’ approach to treatment, in that care is conducted by a number of highly specialized experts in particular areas of medicine none of whom is concerned or responsible for the whole picture.
The historical and social context of ‘personalized health care’ provided crucial background to this enquiry. In investigating ethical issues bound up with the developments under consideration in this report, we needed to explore how changes in society influence the development of technologies and, likewise, how society influences the ways in which such technologies are applied. ‘Responsibilization’ and ‘consumerization’ are two key social pressures that present particular ethical challenges. The idea of ‘responsibilization’ emerges when we consider that people are now actively encouraged to take more responsibility for their own health, to lead a healthy lifestyle and play an active role in managing their health care. ‘Consumerization’ refers to a shift towards greater emphasis on consumer-style relationships between providers and users as against those relationships based on citizenship or the fiduciary relationship between professional and client. There is nothing new about being able to select and pay for health care in the private sector, but today even public health-care services are aiming to become more user focused.
Increasing numbers of people have Internet access in their own homes and via mobile devices, such as smart phones. Many people treat the Internet as a first, or at least a major, source of information and increasingly communicate online. Public services and private companies increasingly offer information and their products and services online, some operate only online, and many others make it considerably costlier and difficult for people not able or willing to operate online.
Public policy in the UK and elsewhere has sought to encourage a switch to a ‘digital’ society and economy, with ‘e-health’ and Internet-based health services sometimes cited as one of the benefits of such a switch. But as with all such developments, those who cannot or prefer not to use such technology run the risk of becoming ‘second class citizens’ in various ways, and there is also the risk that such technologies can be used to intrude on people's privacy in ways that may be unwelcome or not fully understood.
Ethics
In keeping with previous Nuffield Council reports, we did not imagine it possible simply to superimpose on this complex problem a single approach or pre-existing ethical framework. Rather, it was more appropriate to examine the issues and concerns that arise in the specific context of the area under consideration, and to derive particular ethical values that can be applied. Working through the potential benefits and harms of the cases that we were concerned with, five values emerged as being significant:
Private information should be safeguarded; Individuals should be able to pursue their own interests in their own way; The state should act to reduce harm; Public resources should be used fairly and efficiently; Social solidarity (sharing risks and working together to protect the vulnerable) should inform public policy.
This gave us the lens through which to examine again each of the case studies, and by which to arrive at proportionate, evidence-based conclusions and recommendations. Of course, this is not a simple mechanical process, and often these ethical values conflict with one another. We took the view that no one value automatically ‘trumps’ another, and that each case needs to be examined in its own detail. Moreover, where dilemmas arise and ethical values come into conflict, we can sometimes do no better than to seek to minimize, or ‘soften’, the dilemma rather than fully resolve it. This was also consistent with the report's preference for less coercive and general interventions over more coercive and specific regulatory interventions. So, for example, if we look at online drug purchasing, we recognize both the value of people being able to pursue their own interests in their own way and the responsibility of the state to reduce harm (which might arise through non-prescribed or counterfeit drugs). The proportionate response, where there is little evidence to date of widespread harm, is not to prohibit online drug sales, but to have an adequate registration scheme for online pharmacies, and ensure people are informed about the risks of purchasing from unregistered sites.
Case study: personal genetic profiling services
The Council was reluctant to define precisely what activities constituted the imprecise concept of ‘personalized health care’, and preferred to illustrate its arguments through a number of case studies. These cases were chosen to demonstrate how, across a range of different aspects of health care, the ethical values could be played out. There may, of course, be other technologies or health-care services to which the framework could be applied. Possibly the most contentious, and most high profile of the cases studied, was that of genetic profiling.
Personal genetic profiling services are marketed by private companies to healthy people as a way of finding out about their genetic risk of developing various common diseases in the future. At a cost of up to US$2000, people can send off their DNA (a saliva sample sent by post), and receive back a list of specific risk predictions for a range of multifactorial conditions such as heart disease, diabetes and several types of cancer. As the cost of sequencing DNA falls, finding out about personal genetic information is likely to become an affordable possibility for more and more people.
Although there is some potential for people to benefit from this kind of information by enabling them to take measures to minimize future health risks, these measures are often only those that would be recommended anyway, such as a better diet, more exercise, etc. Still, people should generally be free to seek this kind of information if they wish. Nevertheless, there are also concerns about these tests for a number of reasons. For example:
their reliability can be unclear, and their results difficult to interpret; ‘good’ results might lead to complacency in lifestyles; the potential misuse of personal genetic information; people might become unnecessarily anxious, or seek unnecessary further tests through their GPs.
One can readily see how most, if not all, of the five ethical values would be operative in considering the implications of this particular development, and a balanced and proportionate response might be difficult to find. However, as with online prescribing, we found little real evidence that the ‘harms’ were actually being manifested. So our conclusion is a nuanced one that focuses on ensuring that claims about the validity and meaning of these tests are properly justified, and that people considering the tests have good information about what they might learn, how to interpret the information and what significance it might have for them.
But the overall message is perhaps less about the specific regulatory response that might be needed to each of the particular cases that we examined, and more about the direction in which we find ourselves travelling as this kind of service, offered in this kind of way, becomes increasingly prevalent.
Conclusions
Responsibilization
The developments considered in the report can lead to new obligations and expectations for the individuals who use them. For example, online personal health records systems can place new demands on individuals to check their records and ensure their security, and the availability of predictive testing might increase the pressure on people to take more responsibility for their future health. Not everybody wants this kind of responsibility, nor is everyone equally able to handle it. So we think responsibility for handling new risks associated with these developments should be in the hands of those best placed to manage it. In some cases this is the state, in some cases the medical professional and in other cases the individual. Each case needs to be considered on its own merits.
Consumerization
All the developments in medical profiling and online medicine we considered offer increased ‘personalization’ to some extent. But many of the claims for more individualized diagnosis and treatment seem to be overstated and we feel should be treated with caution at the present time. For example, commercial genetic profiling and body imaging have the potential to tailor health care to the individual, but that potential is yet to be fully realized.
All the developments considered by the report can lend themselves to the provision of health care as a consumer good. While choice is often a good thing, to work effectively in health care it needs to be accompanied by proper information and advice. We also need to find ways of balancing individual choice with the principle of social solidarity – i.e. we should share the responsibility to help people in need.
Many of the developments with which we have been concerned are ongoing. If they do go on to develop their full potential, they could transform medical practice and the social context of health care in very significant ways. Good evidence of clear benefits and harms is difficult to come by, however, and close and regular scrutiny is warranted. In the meantime, we should treat the powerful rhetoric, and sometimes exaggerated claims, with some caution.
Medical profiling and online medicine: the ethics of ‘personalised healthcare’ in a consumer age
London: Nuffield Council on Bioethics, 2010.
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