Ebook: Interdisciplinary Assessment of Personal Health Monitoring

Introduction

We welcome this book, which presents selected contributions to the pre-conference symposium on Personal Health Monitoring (PHM) and Ethics and future areas of Personal Health Monitoring, held in Rotterdam, prior to the 11th World Congress of Bioethics. The majority of papers present the outcomes of the European PHM-Ethics project. In addition, some further invited contributions deal with important issues strongly related to the project's primary objectives and outcomes. Therefore, the contributions in this book cover a broad spectrum, ranging from the technical set-up of PHM systems to ethical issues raised by PHM applications, and will be of interest to all those concerned with improving the provision of healthcare worldwide.

Towards Smart and Sustainable Healthcare in Europe

In Europe we are facing a paradox: while governments try to curb public spending, the demands on our healthcare systems continue to rise.

The smart use of technologies and innovation can help to address the challenges healthcare systems are facing today, such as an ageing population, a shortage of healthcare professionals and a lack of financial resources.

Information and Communication Technologies (ICT) have already made a strong contribution to these goals, but much more remains to be done. eHealth technologies such as personal health monitoring devices enable the delivery of higher quality and more efficient services to European citizens, irrespective of where they are, for the convenience of both patients and practitioners. This is made possible by granting online access to personal health information, by supporting personalised therapies and by implementing innovative telemedicine services.

The Digital Agenda for Europe, adopted by the European Commission in 2010, has defined a number of objectives, including the implementation of interoperable electronic patient records – which can be safely accessed and exchanged across the EU as well as the widespread deployment of telemedicine by 2020. To reach these objectives, the eHealth Network, which is composed of Member States' representatives, will cooperate to ensure wider use of eHealth including EU wide interoperability of electronic patient summaries.

Yet regardless of increasing evidence of the benefits technology can bring, the healthcare sector has been hesitant to embrace the digital revolution. Instead, it has stuck to its traditional methods and models.

A New eHealth Action Plan

In this context, the Commission launched a new eHealth Action Plan on 6 December 2012, which will provide a roadmap for 2012–2020 and is designed to bring the benefits of digital solutions into healthcare systems and lift the barriers that are preventing Europe from providing smarter, safer, patient-centred health services. It will also support Member States in bringing forward interoperable eHealth services within and between national healthcare systems.

In practical terms the eHealth Action Plan contains actions to give patients and key healthcare workers in the field, such as nurses, carers and doctors, the skills and confidence to use these new technologies, thus leading to more meaningful time between doctors and patients and less unnecessary appointments, thanks to the better use, among others, of ePrescription and telemonitoring. For patients, this means spending less time, effort and money on unnecessary hospital or GP visits while allowing them to take a more pro-active role in the management of their health. The plan also focuses on:

• Linking up the devices and technologies so that they can communicate with each other and spread the benefits of digital healthcare throughout the system, thus avoiding waste and repetition;

• Investing in research towards the personalised medicine of the future, so that future generations can benefit from even more patient-centric care;

• Giving small businesses a helping hand when starting up on this complex landscape by providing funding opportunities and visibility;

• Providing clarity where there is legal uncertainty: this is particularly the case for new technologies such as apps where issues such as safety, quality and transparency remain grey areas.

Health apps could prove to be an enormously important tool to promote consumer and patient empowerment and self-care. They represent an important technological tool to help inform and support patients and consumers in the self-management of their health. They bring valuable health information to our fingertips. The best of these apps enable us to act swiftly and decisively on self-care issues.

But as more and more citizens start to compile and to take control of their own health data using apps and other devices it is essential to ensure user confidence in these services and establish appropriate safeguards. Effective data protection is vital for building trust in eHealth, in particular in respect to the use of cloud computing infrastructures and services for health and wellbeing data processing.

Ethical issues need to be built into eHealth solutions, ranging from apps to remote monitoring, utilising a user-centric and user-driven innovation process. The ethical considerations that should be observed or taken into account in this domain can be deduced from binding instruments like the Charter of Fundamental Rights and the Convention on Human Rights and Biomedicine, as well as from opinions such as those of national ethics committees and the European Group on Ethics. The European Group on Ethics issued an Opinion in 1999 on the ethics of healthcare in the Information Society, emphasising the principles of privacy, confidentiality, “legitimate purpose”, consent, security, transparency, participation, and education. It is one of the points of guidance that has stood the test of time and is still relevant for those developing or deploying new technologies today. We intend to discuss issues in ethics, the law, data protection, and the internal market relevant to eHealth innovation at the eHealth Ministerial and Week in Dublin in 2013 and hope to engage with stakeholders.

The Action Plan provides a new focus on mobile health (mHealth). Building on the recommendations of the eHealth Task Force, the Commission will examine a range of issues, including quality and transparency, in this fast-moving and developing area.

To increase further legal clarity and support the wider deployment of eHealth, the plan is supported by a legal overview of how current EU legislation applies to cross border telemedicine. This overview takes the form of a Staff Working Paper, which provides responses to the main issues a healthcare practitioner would face when seeking to provide telemedicine services across-border:

• Does s/he also need to be licensed/registered in the Member State of the patient?

• What are the conditions for the legitimate processing of health data?

• Will the telemedicine act be reimbursed?

• What is the liability regime applicable in case damage arises as well as what are the relevant jurisdiction and law?

This Action Plan marks above all a commitment to change in order to better target the challenges Europe is increasingly facing. This need to change is already reflected in the European Innovation Partnership on Active and Healthy Ageing as 3000 stakeholders have committed to improve the quality of life of 4 million European senior citizens between now and 2015. This includes 20 regions of Europe which will deploy telemonitoring programmes for chronic disease management and integrated care that meet the needs of older persons and enhance system efficiency.

To do this, they are learning from the experience of others and adapting it to their own circumstances. This means that they can save time and money and avoid making expensive mistakes. As a result, thousands of people with chronic conditions and multimorbidity (but also their carers) will not have to travel back and forth between doctors, hospitals and care institutions and will be able to monitor and self-manage their own condition and health care choices.

This grass roots approach shows that even in a time of crisis, we can make smart investments towards a sustainable future. It is our responsibility to take the changes to the next level for the benefit of today's citizens and future generations.

The historical roots of IT-based monitoring in health care are described. Since the 1970ies monitoring has been spreading to more and more domains of health care and public health. Today one can observe monitoring of persons in many environments and regarding widely different questions. While these monitoring applications have been introduced ethical questions have been raised to balance the possible positive and negative outcomes of the approaches. Today IT-technology is entering many parts of our life – IT eventually became what had been coined already in the last century by IBM as “electronic dust” which one can find in every part of our environment. As most of these “dust-particles” are able to observe something one can also understand this development as a development into ubiquitous monitoring of nearly everything at any time. The foreseen ambient intelligence worlds are also spaces of ambient monitoring. This article describes this historical development. It emphasizes why ethical and data protection questions are an absolute must in most IT activities today.

The contribution briefly introduces the PHM Ethics project and the PHM methodology. Within the PHM-Ethics project, a set of tools and modules had been developed that may assist in the evaluation and assessment of new technologies for personal health monitoring, referred to as “PHM methodology” or “PHM toolbox”. An overview on this interdisciplinary methodology and its comprising modules is provided, areas of application and intended target groups are indicated.

This review gives a comprehensive overview on the technical perspective of personal health monitoring. It is designed to build a mutual basis for the project partners of the PHM-Ethics project. A literature search was conducted to screen pertinent literature databases for relevant publications. All review papers that were retrieved were analyzed. The increasing number of publications that are published per year shows that the field of personal health monitoring is of growing interest in the research community. Most publications deal with telemonitoring, thus forming the core technology of personal health monitoring. Measured parameters, fields of application, participants and stakeholders are described. Moreover an outlook on information and communication technology that foster the integration possibilities of personal health monitoring into decision making and remote monitoring of individual people's health is provided. The removal of the technological barriers opens new perspectives in health and health care delivery using home monitoring applications.

We aimed at providing a short review on already published studies addressing psycho-social issues of personal health monitoring (PHM). Both core questions addressed within this review are: What is the impact of PHM on intended psycho-social and health-related outcomes? And which psycho-social issues affected by or related to PHM have already been investigated? This descriptive review based on a literature search using various databases (Psycinfo, Psyndex, Pubmed, SSCI). Resulting 428 abstracts were coded regarding their psycho-social content. Inspection of results was carried out along the relevance of the papers regarding psycho-social issues. Research in PHM focuses on telemonitoring and smart home applications: Tele-monitoring studies are directed to outcome-related questions, smart home studies to feasibility issues. Despite of technological matters, comparability of both systems in psycho-social issues is lacking. Tele-monitoring has been proven for impact on patient groups with chronic diseases, yet smart home still lacks evidence in health-related and psycho-social matters. Smart home applications have been investigated with respect to attitudes, perceptions and concerns of end-users, telemonitoring regarding acceptance and adherence.

Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this paper. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonised medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g. the way in which hospitals are organised in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper analyses finally also how health monitoring projects may change the traditional (non-)relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require new legal rules.

In order to provide a systematic basis for communication in trans-disciplinary research projects, there is a need for taxonomies and ontologies. Our developed taxonomy of personal health monitoring (PHM) is based on a systematic literature review and an iterative adaption process with trans-disciplinary partners. The construction method of the taxonomy is an ongoing process and need regularly updates.

This chapter discusses the research undertaken in developing a comprehensive dependencies map for Personal Health Monitoring (PHM). Included is a discussion of the underlying research approach adopted and how this was operationalized. A new dependencies mapping method has been developed and this is described in detail. Illustrations of the derived tools are given using the PHM analysis undertaken. A summary of the analysis outcomes and the resulting recommendations are discussed. The chapter concludes with some suggestions of ways in which this type of data set can be used in practice to deliver fit-for-purpose PHM systems.

This contribution to an interdisciplinary methodology on Personal Health Monitoring (PHM) aims at developing a psycho-social module for health technology assessment on PHM applications. It covers important aspects that should be taken into account for conducting a health technology assessment from a psycho-social perspective. As it could be used in addition to other tools within the PHM-Ethics approach to health technology assessment it is considered as a module of the interdisciplinary methodology. As a prerequisite, we provide a conceptual framework on psycho-social issues of PHM applications. From that framework we delineate an integrated module for psycho-social health technology assessment for PHM applications, consisting of a map highlighting selective psycho-social issues that may appear when applying a PHM system. This psycho-social tool is at least twofold in its intention as a sole HTA tool on the one hand and as an integral part of the interdisciplinary PHM methodology on the other hand. It provides a quick overview on potential benefits and risks from the user's point of view.

Novel care-technologies possess a transformational potential. Future care and support may be provided via monitoring technologies such as smart devices, sensors, actors (robots) and Information and Communication Technologies. Such technologies enable care provision outside traditional care institutions, for instance in the homes of patients. Health monitoring may become “personalized” i.e. tailored to the needs of individual care recipients' but may also alter relations between care providers and care recipents, shape and form the care environment and influence values central to health-care. Starting out from a social constructivist theory of technology, an interactive ethical assessment-model is offered. The suggested model supplements a traditional analysis based on normative ethical theory (top-down approach) with interviews including relevant stakeholders (a bottom-up approach). This method has been piloted by small-scale interviews encircling stakeholder perspectives on three emerging technologies: (1) Careousel, a smart medicine-management device, (2) Robot Giraff, an interactive and mobile communication-device and (3) I-Care, a care-software that combines alarm and register system. By incorporating stakeholder perspectives into the analysis, the interactive ethical assessment model provides a richer understanding of the impact of PHM-technologies on ethical values than a traditional top-down model. If the assessment is conducted before the technology has reached the market – preferably in close interaction with developers and users – ethically sound technologies may be obtained.

The chapter undertakes a comparison of different approaches to the ethical assessment of novel technologies by looking at two recent research projects. ETICA was a FP7 sister project to PHM-Ethics, responsible for identification and ethical evaluation of information and communication technologies emerging in the next 10–15 years. The aims, methods, outcomes and recommendations of ETICA are compared to those of PHM-Ethics, with identification of linkages and similar findings. A relationship is identified between the two projects, in which the assessment methodologies developed in the projects are shown to operate at separate, but complementary levels. ETICA sought to reform EU ethics governance for emerging ICTs. The outcomes of PHM-Ethics are analyzed within the policy recommendations of ETICA, which demonstrate how the PHM-Ethics toolbox can contribute to ethics governance reform and context-sensitive ethical assessment of the sort called for by ETICA.

The Development and Implementation of PHM systems require a different approach than typical application development processes. Based on a practical example it is described how ethical and legal aspects will be considered during the development process. The result is a cohesion and adoption of different methods with defined interaction points to reiterate the solution design by legal and ethical aspects.

Individual availability of information and communications technology (ICT) has enabled “Personal Health” applications like the continuous ubiquitous telemonitoring of vital signs. The concept of Ambient Assisted Living (AAL) goes beyond health and care applications utilizing home automation technology for supporting individuals with specific needs, particularly enabling elderly to live in their accustomed home as long as possible. These users usually suffer from more than one disease and need compensation of several impairments. Most current AAL projects and products however provide insulated solutions addressing only a small selection of these user needs. For comprehensive dynamic system adaptation to changing user needs an open platform supporting interoperable components is required. While the industry-driven Continua Health Alliance developed a corresponding Personal Health ecosystem, the ongoing European project universAAL aims at a universal platform for both AAL and Personal Health applications.