On the Ethical Implications of Personal Health Monitoring

581 Pages·2014·16.85 MB·English

by  Brent Daniel Mittelstadt

On the Ethical Implications of
Personal Health Monitoring
A Conceptual Framework for Emerging
Discourses

Thesis submitted for the degree of

Doctor of Philosophy

Centre for Computing and Social Responsibility
De Montfort University, Leicester, UK

by

Brent Daniel Mittelstadt

November 2013
Abstract
Recent years have seen an influx of medical technologies capable of remotely monitoring the
health and behaviours of individuals to detect, manage and prevent health problems. Known
collectively as personal health monitoring (PHM), these systems are intended to supplement
medical care with health monitoring outside traditional care environments such as hospitals,
ranging in complexity from mobile devices to complex networks of sensors measuring
physiological parameters and behaviours. This research project assesses the potential ethical
implications of PHM as an emerging medical technology, amenable to anticipatory action
intended to prevent or mitigate problematic ethical issues in the future.
PHM fundamentally changes how medical care can be delivered: patients can be monitored
and consulted at a distance, eliminating opportunities for face-to-face actions and potentially
undermining the importance of social, emotional and psychological aspects of medical care.
The norms evident in this movement may clash with existing standards of ‘good’ medical
practice from the perspective of patients, clinicians and institutions. By relating
utilitarianism, virtue ethics and theories of surveillance to Habermas’ concept of colonisation
of the lifeworld, a conceptual framework is created which can explain how PHM may be
allowed to change medicine as a practice in an ethically problematic way. The framework
relates the inhibition of virtuous behaviour among practitioners of medicine, understood as a
moral practice, to the movement in medicine towards remote monitoring.
To assess the explanatory power of the conceptual framework and expand its borders, a
qualitative interview empirical study with potential users of PHM in England is carried out.
Recognising that the inherent uncertainty of the future undermines the validity of empirical
research, a novel epistemological framework based in Habermas’ discourse ethics is created to
justify the empirical study. By developing Habermas’ concept of translation into a procedure
for assessing the credibility of uncertain normative claims about the future, a novel
methodology for empirical ethical assessment of emerging technologies is created and tested.
Various methods of analysis are employed, including review of academic discourses, empirical
and theoretical analyses of the moral potential of PHM. Recommendations are made
concerning ethical issues in the deployment and design of PHM systems, analysis and
application of PHM data, and the shortcomings of existing research and protection
mechanisms in responding to potential ethical implications of the technology.
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Acknowledgements
As with most any extended piece of work, behind the author there exists a vast network of
colleagues, family and friends without whom completion would be impossible. First and
foremost I would like to thank my supervisory team of Dr. N. Ben Fairweather, Dr. Neil
McBride and Mark Shaw of De Montfort University for the extensive support and dialogue that
helped develop fledgling ideas and theories into a finished piece of research. Thanks must also
be given to Prof. Simon Rogerson and Prof. Andrew Edgar for the helpful feedback and
encouragement offered during examination of thesis. I have also benefited greatly from the
supportive scholarly atmosphere cultivated by my colleagues in the Centre for Computing and
Social Responsibility at De Montfort University; the many fascinating conversations and
collaborations I’ve had the privilege of being a part of over the years have been invaluable in
developing the ideas presented here. In particular I must give thanks to the Centre’s director,
Prof. Bernd Stahl, whose advice and collaboration was critical to the development of the
epistemic approach taken here to researching emerging technologies. I would also like to
thank my family and friends back in the United States and across the world for all of their
support and well wishes—sometimes a timely reminder is needed that there’s more to life
than research about personal health monitoring. And finally, I must give me deepest thanks
and love to meine kleine Zwiebel for supporting me throughout this process—through all the
late nights and times of stress you remained understanding and supportive, and I cannot thank
you enough for it.
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Acknowledgement of Funding and Related Research
The research described in this thesis was sponsored and funded by the Centre for Computing
and Social Responsibility of De Montfort University, and was linked to the research carried out
in FP7 research projects PHM-Ethics (GA 230602) and ETICA (Ethical Issues of Emerging ICT
Applications, GA 230318). The implicit contributions of these projects are acknowledged.
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Glossary
AMI Ambient Intelligence
AT Assistive Technology
BP Blood Pressure
CCG Clinical Commissioning Group
CCSR Centre for Computing and Social Responsibility
CCTV Closed-circuit Television
COPD Chronic Obstructive Pulmonary Disease
CSO Civil Society Organisation
DH Department of Health
DMU De Montfort University
DP Data Protection
ECG Electrocardiography
ETICA Ethical Issues of Emerging ICT Applications (FP7 research project)
EU European Union
th
FP7 7 Framework Programme
GA Grant Agreement
GMC General Medical Council
GP General Practitioner
GPS Global Positioning System
HRE Human Research Ethics
ICT Information and Communication Technology
iTA Interactive Technology Assessment
NHS National Health Service
NICE National Institute for Health and Clinical Excellence
NRES National Research Ethics Service
OC Organisational Codes
PHM Personal Health Monitoring
PP (The) Precautionary Principle
RCT Randomised Clinical Trial
REC Research Ethics Committee
RFID Radio-frequency Identification
R&D Research & Development
SC Substantive Codes
TA Technology Assessment
TCA Theory of Communicative Action
Ubicomp Ubiquitous Computing
UK United Kingdom
WSD Whole System Demonstrator

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Table of Contents
Abstract ............................................................................................................................... i
Acknowledgements ............................................................................................................. ii
Acknowledgement of Funding and Related Research .......................................................... iii
Glossary ............................................................................................................................. iv
Table of Contents ................................................................................................................ v
List of Figures .................................................................................................................... xii
List of Tables ..................................................................................................................... xiii
1 Chapter 1: Introducing the Project and Associated Research ......................................... 1
1.1 Introduction ................................................................................................................... 1
1.2 Associated Research: PHM-Ethics and ETICA ................................................................ 3
1.2.1 PHM-Ethics ............................................................................................................ 4
1.2.2 ETICA ...................................................................................................................... 6
1.2.3 Ethical Assessment Methodologies ....................................................................... 7
1.2.4 Results: Initial Ethical Issues of PHM ..................................................................... 9
1.2.5 Recommendations and Outcomes ...................................................................... 10
1.2.6 Comparison of Aims, Methodologies and Outcomes .......................................... 12
1.3 Research Questions ..................................................................................................... 14
1.4 Structure of the Thesis ................................................................................................ 14
1.5 Conclusion ................................................................................................................... 16
2 Chapter 2: Defining PHM ............................................................................................ 17
2.1 Introduction ................................................................................................................. 17
2.2 Defining PHM ............................................................................................................... 18
2.3 Systematic Literature Review: Definition and Categorisation .................................... 19
2.3.1 Method ................................................................................................................ 19
2.3.1.1 Procedure ........................................................................................................ 20
2.3.1.2 Data Analysis.................................................................................................... 21
2.3.2 Results ................................................................................................................. 21
2.3.2.1 Mobile Monitors .............................................................................................. 22
2.3.2.2 Environmental Monitors.................................................................................. 24
2.3.2.3 In Vivo Monitors .............................................................................................. 25
2.3.2.4 Related Technologies ....................................................................................... 25
2.3.3 Discussion ............................................................................................................ 27
2.4 Re-Defining PHM ......................................................................................................... 31
2.5 Conclusion ................................................................................................................... 31
3 Chapter 3: Review of Ethical Implications ................................................................... 32
3.1 Systematic Literature Review: Ethical Implications ..................................................... 32
3.1.1 Defining Ethical Implications ............................................................................... 32
3.2 Results ......................................................................................................................... 35
3.2.1 Privacy.................................................................................................................. 36
3.2.1.1 Data Privacy ..................................................................................................... 36
3.2.1.1.1 Security ...................................................................................................... 38
3.2.1.1.2 Trust ........................................................................................................... 39
3.2.1.2 Personal Privacy ............................................................................................... 39
3.2.1.2.1 Surveillance ............................................................................................... 41
3.2.1.2.2 Rights ......................................................................................................... 41
3.2.2 Autonomy ............................................................................................................ 42
3.2.3 Safety ................................................................................................................... 43
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3.2.3.1 Ethical Tradeoffs based on Technological Need ............................................. 43
3.2.4 Obtrusiveness and Visibility ................................................................................ 44
3.2.5 Stigma and Identity ............................................................................................. 45
3.2.6 Social Isolation .................................................................................................... 46
3.2.7 Delivery of Care ................................................................................................... 47
3.2.8 Risk ...................................................................................................................... 48
3.2.9 Medicalisation ..................................................................................................... 49
3.3 Critical Analysis of the Discourse ................................................................................ 50
3.3.1 Technical and Demographic Limitations of Scope .............................................. 50
3.3.2 The Inevitability of Ethical Tradeoffs .................................................................. 52
3.3.2.1 Context-Sensitivity and Ethical Tradeoffs ....................................................... 54
3.3.3 Difficulties of Adapting Protection Mechanisms ................................................ 55
3.3.3.1 Informed Consent ........................................................................................... 56
3.3.3.1.1 Problems of Proxy Consent ....................................................................... 57
3.3.3.2 Data Protection Legislation ............................................................................. 57
3.3.4 Privacy and the Lack of Context-Sensitivity ........................................................ 58
3.3.4.1 Privacy Myopia in Development ..................................................................... 61
3.3.4.1.1 The Capacity to Breach Privacy Borders ................................................... 63
3.3.4.1.2 Implications of Myopia on User Awareness ............................................. 65
3.3.5 Medicalisation and Institutional Empowerment ................................................ 66
3.3.6 Conclusions ......................................................................................................... 68
3.4 Conceptual Framework to Link Discourse Themes ..................................................... 69
3.4.1 The System Lifeworld Perspective ...................................................................... 69
3.4.1.1 Colonisation of the Lifeworld .......................................................................... 71
3.4.1.2 Colonisation and Relationships ....................................................................... 73
3.4.1.3 PHM as Mediator ............................................................................................ 73
3.4.1.4 Ethical Themes as Colonisation ....................................................................... 76
3.4.2 Linkage between Ethical Themes ........................................................................ 79
3.5 Colonisation of the Lifeworld as a Framework for Further Research ......................... 81
3.5.1 Research Question .............................................................................................. 82
3.6 Conclusions ................................................................................................................. 82
4 Chapter 4 – A Conceptual Framework for PHM ........................................................... 84
4.1 Introduction ................................................................................................................ 84
4.2 Utilitarian Support for PHM ........................................................................................ 85
4.3 Virtue Ethics and Medicine as a Moral Practice ......................................................... 87
4.3.1 Virtues and Moral Practices ................................................................................ 88
4.3.1.1 Internal and External Goods ........................................................................... 89
4.3.1.2 A Narrative Life and Telos ............................................................................... 91
4.3.2 Ends of Medicine ................................................................................................. 93
4.3.2.1 Medicine as a Moral Community and the Healing Relationship..................... 94
4.3.3 Medical Virtues ................................................................................................... 98
4.3.4 Implications for PHM ........................................................................................ 100
4.3.5 Conclusions ....................................................................................................... 103
4.4 PHM as Medical Surveillance .................................................................................... 104
4.4.1 Big Brother ........................................................................................................ 104
4.4.2 The Panopticon ................................................................................................. 105
4.4.3 Social Sorting: The Power to Categorise ........................................................... 107
4.4.3.1 Bio-Power ...................................................................................................... 108
4.4.3.1.1 Risk Categorisation ................................................................................. 109
4.4.3.1.2 Implications for User Identity ................................................................. 110
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4.4.3.1.2.1 Biomedicalisation: From Clinical to Self-Care .................................. 110
4.4.3.1.3 Power Relationships ................................................................................ 111
4.4.3.1.4 The Need for Transparency ..................................................................... 112
4.4.4 Surveillance, Virtue and Colonisation ................................................................ 112
4.5 Conclusion ................................................................................................................. 114
5 Chapter 5: PHM in England ....................................................................................... 116
5.1 Introduction ............................................................................................................... 116
5.2 Strategic Support of PHM in England ........................................................................ 118
5.2.1 The Value of Information................................................................................... 119
5.2.2 Secondary Uses of Patient Data ........................................................................ 121
5.3 Diffusion of PHM ....................................................................................................... 122
5.3.1 Piloting PHM ...................................................................................................... 124
5.4 Shifting Values in Medical Relationships in England ................................................. 127
5.4.1 The Influence of Institutional Values on Care ................................................... 128
5.4.1.1 Shared Decision-Making ................................................................................ 129
5.4.1.2 Towards Self-Responsibility and Self-Care .................................................... 130
5.4.1.3 Mediation of Relationships and Duties of Good Medical Practice ................ 131
5.4.2 Conclusions ........................................................................................................ 132
5.5 Research Question ..................................................................................................... 134
5.6 Conclusion and Research Questions ......................................................................... 135
6 Chapter 6: Hermeneutics and Empirical Methodology .............................................. 138
6.1 Research Methodology .............................................................................................. 138
6.1.1 Positivism ........................................................................................................... 138
6.1.1.1 Criticisms of Positivism, Objectivity, and Objectivist Ontologies .................. 139
6.1.2 Interpretivism .................................................................................................... 140
6.1.2.1 Criticisms of Objectivist Interpretivism and Detached Observers ................. 141
6.1.3 Hermeneutics .................................................................................................... 143
6.1.3.1 Ontological Commitments ............................................................................. 145
6.1.3.1.1 Predictions of the Future and the Possibility of Hermeneutic Dialogue . 146
6.1.3.1.2 Human Experience, Meaning and Understanding as a Social Process .... 147
6.1.3.2 Epistemological Commitments ...................................................................... 148
6.1.3.2.1 Fusion of Horizons ................................................................................... 150
6.1.3.2.2 Hermeneutic Circle as a Metaphor for Research .................................... 150
6.1.3.2.3 Validity of Claims ..................................................................................... 152
6.1.3.3 Hermeneutic Dialogue ................................................................................... 153
6.1.3.3.1 Truth and the Ideal of Rational Discourse ............................................... 153
6.1.3.4 Conclusions .................................................................................................... 155
6.2 Empirical Study Design .............................................................................................. 156
6.2.1 Qualitative vs. Quantitative ............................................................................... 156
6.2.2 Case Study ......................................................................................................... 158
6.2.3 Sampling ............................................................................................................ 160
6.2.4 Data Collection .................................................................................................. 161
6.2.5 Conclusions ........................................................................................................ 162
6.3 Ensuring Research Credibility in Hermeneutic Research .......................................... 163
6.3.1 Truth, Validity and Credibility ............................................................................ 163
6.3.2 Criteria for Credibility in Hermeneutics Research ............................................. 165
6.3.2.1 Credibility and Review ................................................................................... 169
6.3.3 Generalisability in Qualitative Research ............................................................ 170
6.3.3.1 Types of Generalisations ............................................................................... 170
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6.3.3.2 Moderatum Generalisations in Ethical Assessment of Emerging Technologies
173
6.3.4 Generalisations and Credibility ......................................................................... 173
6.4 Conclusion ................................................................................................................. 174
7 Chapter 7: The Problem of Uncertainty in Ethics of Emerging Technologies ............... 176
7.1 Introduction .............................................................................................................. 176
7.2 The Integration of Empirical Data and Theory in Ethical Analysis ............................ 176
7.2.1 Moral Wisdom, Practices and Practitioners...................................................... 179
7.2.2 Practices and Empirical Ethics ........................................................................... 181
7.2.3 Alleged Meta-Ethical Fallacies of Empirical Ethics ............................................ 182
7.2.3.1 Is-Ought Problem .......................................................................................... 182
7.2.3.2 Fact-Value Gap .............................................................................................. 183
7.2.3.2.1 Criticisms of the First Version of the Fact-Value Gap ............................. 184
7.2.3.2.2 Criticisms of the Second Version of the Fact-Value Gap ........................ 185
7.2.4 Empirical Ethics and Uncertainty ...................................................................... 186
7.3 Uncertainty and the Ethics of Emerging Technologies ............................................. 187
7.3.1 Methods of Emerging Technology Assessment ................................................ 188
7.3.1.1 Uncertainty ................................................................................................... 189
7.3.1.2 Technology Foresight .................................................................................... 189
7.3.1.3 Uncertain Normative Claims ......................................................................... 190
7.3.1.4 Evidence-based Decisions under Conditions of Uncertainty ........................ 191
7.3.1.5 The Precautionary Principle .......................................................................... 192
7.3.1.6 Technology Assessment ................................................................................ 193
7.3.1.7 Problems of Normative Evaluation in TA and the PP .................................... 194
7.3.1.8 The Importance of Epistemology in Anticipatory Action and Theory Building
195
7.3.2 A Reconciliation of Norms, Facts and the Future: Discourse Ethics and the
Interpretation of Uncertain Normative Claims ................................................................. 196
7.3.2.1 Discourse Ethics as a Theoretical Foundation for Empirical Ethics under
Uncertainty ................................................................................................................... 197
7.3.2.2 Uncertain Normative Claims in Discourse .................................................... 198
7.3.2.3 Translation .................................................................................................... 200
7.3.2.4 Standards of Legitimacy ................................................................................ 202
7.3.2.5 Translation in Practice ................................................................................... 203
7.3.2.6 Responsibility for Translation ....................................................................... 206
7.3.3 Translation and Credibility in Discourse ........................................................... 206
7.4 Conclusion ................................................................................................................. 207
8 Chapter 8: Description of the Study ......................................................................... 209
8.1 Introduction .............................................................................................................. 209
8.2 Sample ....................................................................................................................... 209
8.2.1 Criteria for Participation ................................................................................... 210
8.2.2 Participant Groups ............................................................................................ 210
8.2.2.1 ‘Patient’ Groups ............................................................................................ 210
8.2.2.1.1 Dementia................................................................................................. 211
8.2.2.1.2 Diabetes Mellitus .................................................................................... 213
8.2.2.1.3 Hypertension ........................................................................................... 214
8.2.2.1.3.1 Links between Hypertension and Diabetes Mellitus ....................... 216
8.2.2.2 ‘Professional’ Groups .................................................................................... 217
8.2.2.2.1 Disease Specialists .................................................................................. 217
8.2.2.2.2 Service Officers ....................................................................................... 217
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8.2.2.2.3 Care Commissioners ................................................................................ 218
8.2.3 Summary ............................................................................................................ 218
8.3 Location ..................................................................................................................... 221
8.4 Recruitment and Research Ethics Approval .............................................................. 221
8.4.1 Criticism of NRES ............................................................................................... 226
8.4.2 Consequences for the Sample ........................................................................... 227
8.5 Data Collection .......................................................................................................... 228
8.5.1 Structure of the Interviews ................................................................................ 229
8.5.1.1 Piloting ........................................................................................................... 231
8.5.1.2 PHM Charts .................................................................................................... 232
8.5.2 Review ............................................................................................................... 233
8.6 Conclusion ................................................................................................................. 234
9 Chapter 9: Data Analysis and Results ....................................................................... 235
9.1 Introduction ............................................................................................................... 235
9.2 Data Analysis ............................................................................................................. 236
9.2.1 The Organising System ...................................................................................... 236
9.2.2 The Steps of Data Analysis ................................................................................. 237
9.2.2.1 Step 1 – Transcription .................................................................................... 238
9.2.2.2 Step 2 – Initial Reading .................................................................................. 238
9.2.2.3 Step 3 – Identification of Meaning Units ....................................................... 238
9.2.2.4 Step 4 – Organisational Coding ..................................................................... 238
9.2.2.5 Step 5 – Substantive Coding .......................................................................... 239
9.2.2.5.1 Step 5a - Translation ................................................................................ 241
9.2.2.6 Step 6 - Grouping ........................................................................................... 242
9.2.2.7 Step 7 – Final Review and Identification of Outliers ..................................... 243
9.2.3 Discussion of Analysis Method .......................................................................... 243
9.2.3.1 Reviewing Hermeneutic Interpretation ......................................................... 244
9.2.3.2 Theoretical Outliers in Coding ....................................................................... 245
9.2.4 Conclusions ........................................................................................................ 245
9.3 Results ....................................................................................................................... 246
9.3.1 Self-Care vs. Improved Care .............................................................................. 247
9.3.1.1 Patient Feedback ........................................................................................... 248
9.3.1.2 Information Overload and the Burdens of Providing Feedback .................... 249
9.3.1.3 Decontextualisation and Access to Medical Records .................................... 250
9.3.1.4 Losing the Socially Embodied Patient in Commissioning PHM ..................... 250
9.3.1.5 Improved Clinical Outcomes and Ethical Tradeoffs ....................................... 251
9.3.2 Surveillance ........................................................................................................ 252
9.3.2.1 Behaviour Modification ................................................................................. 253
9.3.2.1.1 Acclimation to PHM ................................................................................. 254
9.3.2.2 Social Sorting ................................................................................................. 255
9.3.3 Control ............................................................................................................... 255
9.3.3.1 Empowerment and Honesty .......................................................................... 256
9.3.3.2 The Need to Disable Monitoring ................................................................... 258
9.3.3.2.1 Inadvertent Monitoring ........................................................................... 259
9.3.3.3 Identity of Data Custodians ........................................................................... 259
9.3.4 Informal Care Relationships and Burdens of Monitoring .................................. 260
9.3.4.1 Lack of Choice for Carers ............................................................................... 261
9.3.4.2 Evaluations of Informal Care ......................................................................... 262
9.4 Discussion .................................................................................................................. 263
9.4.1 Cognitive Map .................................................................................................... 263
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