Personalized health monitoring (PHM)- Interdisciplinary research to analyse the relationship between ethics, law and psychosocial as well as medical sciences

Final Report Summary - PHM-ETHICS (Personalized health monitoring - Interdisciplinary research to analyse the relationship between ethics, law and psychosocial as well as medical sciences)

Executive summary:

BACKGROUND: Information technology and medical engineering have entered a new phase of integrating systems from different areas. After a long period of isolated development in medical informatics and medical engineering, new developments incorporate a direct integration of human physiology readouts and information technology parameters. The evaluation of these developments is a big challenge which raises unique questions in the fields of ethics, law, and psychosocial impact of those new technologies.

THE PROJECT: The aim of the collaborative PHM-ETHICS research project has been to conduct scientific interdisciplinary research to analyze the dependencies between ethics, law and psychosocial sciences in personalized health monitoring in relation to the major types and steps of this very dynamic part of IT-development from a European perspective. An integrated European approach to the combined regulation of ethical, philosophical, legal and psychosocial constraints has been developed.

METHODS: In the first phase of the project a framework for the assessment of applications in personal health monitoring has been developed. This includes a taxonomy for the assessment of PHM technologies as well as a dependencies map to analyze the embedment of technologies in a broad cultural perspective. The aims of the second project phase have been to develop and test an interdisciplinary assessment methodology that allows assessing PHM technologies in terms of psychosocial and ethical implications. In addition a full analysis of the present legal context of PHM has been conducted.

RESULTS: A full methodology which includes the following five parts has been developed:

1.Dependencies Map. A multi layered, complex network of relationships that illustrates dependencies between parties involved in PHM.
2.Taxonomy. A classification system which categorizes PHM technologies and applications. It generates groups with similar characteristics and allows to makes distinctions between similar technologies.
3.Psychosocial Assessment Module. An integrated module for psycho-social health technology assessment. It consists of a map highlighting selective psycho-social issues of relevance when applying a PHM system. It covers various domains of technology perception and psychosocial outcome criteria.
4.Ethical Assessment Module. A module which allows evaluating existing and upcoming PHM technologies from an ethical point of view. Ethical values and principles are put into perspective with Personalized Health Monitoring. It provides questions in the fields of privacy, autonomy, freedom of choice, justice, and further content relevant in PHM ethical assessment.
5.Legal Framework. A comprehensive legal report that describes the legislation at the European level, regarding telemedicine and/or health monitoring. It takes into account the consequences of recent decisions by the European Court of Justice important for the project, dealing with privacy and reimbursement of monitoring systems.

CONCLUSIONS: The PHM-ETHICS project developed a methodology which can be used modularly for the assessment of various aspects regarding impact and features and impact of PHM technologies. Further work is indicated to establish the full potential of the concept in use with various upcoming PHM applications and technologies.

Project Context and Objectives:

2. Summary description of project context and objectives

2. Overview

Today's medicine is challenged by two scientific developments which have the power to change the role of the citizen and patient dramatically: genetic information and personal health monitoring - including imbedded micro- and nano-systems. In the last decade, both public concern as well as interdisciplinary bioethical research has concentrated mainly on the risks of emerging technologies, specifically of invasive technologies such as nano-technologies, genetic and stem cell research, and on ethical questions at the beginning and the end of life. By this focus on specific areas of technological development, it has remained relatively unnoticed that information technology and medical engineering in association with micro- and nano-products have recently entered a new phase of integrating systems from different areas.

2.2 Aims

The aim of this collaborative research project has been to carry out multidisciplinary research on ethical frameworks of personalized health monitoring (PHM) in relation to the major types of the technological development of PHM. 'Ethical framework' refers to guidelines for design and implementation of PHM informed by relevant values and ethical principles. The results allow to foresee and to manage the development and the complex consequences likely to emerge in its process. PHM-ETHICS has been focusing on societal embedding and implementation of new technologies in healthcare.

2.3 Main Objectives

The main objectives of PHM-ETHICS were:
1. To draw up a taxonomy of the development of personal health monitoring technologies. The taxonomy should enable one to classify existing and upcoming technologies in the context of personalized health monitoring.

2. To develop an interdisciplinary ethical methodology. It had to be based on ethical criteria; values, and in this case not least health care values, moral norms and principles. The methodology for assessing new technology should be to apply ethical principles, for example principles of respect for autonomy and privacy in the assessment.

3. To analyze the different technological lifecycles and the latency times with which psychology, ethics, medicine, and law react to challenging innovations.

4. To derive a dependencies map that delineates the interrelationship between ethics, law, psychosocial and medical sciences as a tool to foresee necessary research and to fasten product development by balancing it with early addressing non-technical issues.

5. To analyze the implementation of ethical constraints contained in EU and European/international instruments into the national laws or regulations of member states and a comparative analysis to identify areas of convergence and divergence will be conducted.

6. To identify gaps in the European legislation and ethical regulation.

7. To develop an interdisciplinary research methodology and standardized research tools to assess personalized health monitoring technologies regarding their ethical implications.

8. To develop a theoretical basis and methods for a constructive and inter-active ethical assessment of PHM.

9. To pilot test these research tools after having identified target groups and scenarios.

10. To synthesize the findings from all aspects of the study in order to provide a framework for technological innovation practice to promote and underpin innovative and participative models of technology development in Europe.

11. To promote the implementation of the results in order to provide common European rules on legal and ethical principles

12. The advantages of this common ethical approach has not only been a common European approach, but that altogether risks, costs, and implementation times of new developments shall be reduced. As a general objective, PHM-ETHICS aimed at strongly combining ethical research with technological and healthcare development so that ethics research did not run the risk of lagging behind technological development.

2.4 Methodological Steps

Objectives were attained in three phases through a series of methodological steps:

1. The aim of project phase 1 was to develop a framework of applications in tele-monitoring, starting from conventional telemonitoring to multifunctional human-machine-interactions (e.g. body area networks). For this reason, the partner UMG first described and staged the development of telemonitoring on the basis of existing European and international projects.

2. The first step of project phase 2 was to develop a combined interdisciplinary and standardized methodology that aims at assessing ethical issues in new technologies in the area of personalized health monitoring. Prominent technological innovations and target groups had been identified on different steps of the taxonomy. The methodology includes a taxonomy, a dependencies map, a ethical assessment module, a psychosocial module as well the legal report. All sub-modules of the methodology were pilot-tested and validated.

3. The aim of project phase 3 was to disseminate the methodology. Two international validation workshops and a dissemination conference have been conducted in order to review the PHM-ETHICS findings by an international expert workshop with major stakeholders from different areas: Stakeholders of European and national regulation, of information technology, legal and ethical organizations etc.

Project Results:

3. Description of the main results/foregrounds

The aim of the research project has been to develop a multidisciplinary tool box for technology assessment in the realm of personal health monitoring applications in order to both achieve new knowledge about the ethical aspects of the new technologies and to influence the direction of the emergent technologies towards realization of health care values. Disciplines involved are applied ethics, psychology, informatics, and organizational theory.

2.1 Taxonomy

2.1.1 Objective

The taxonomy consists of a series of instruments used in Personal Health Monitoring (PHM) from a technological perspective. It serves as classification tool that mirrors the current state of PHM. As the application field is continuously changing and in a dynamic phase of early adoptions and ongoing research. This applies to the proposed rules as well as to the revision of these rules.

2.1.2 Design of the PHM Taxonomy

illustrates the development of the PHM taxonomy. The taxonomy itself is based on 85 reviews that were received in a literature research. These reviews are recruited from the fields 'AAL and smart home', 'telemonitoring', 'personal health monitoring', and 'pervasive health care'. The AAL and smart home reviews covered more than 70 systems. Some systems may have been reviewed in more than one paper, thus the set of unique systems has been likely to be much smaller, but the different perspective of the reviewers on these systems may still deliver valuable information. Telemonitoring reviews dealt mainly with cardiac diseases, diabetes care or home blood pressure monitoring, cumulated to a total of 178 studies. Given the fact that most of the reviews where published within a rather short period of time, and mostly dealt with one of only three fields of application, the unique number of PHM systems is expected to be smaller.

Application view of the PHM Taxonomy

Fehler! Verweisquelle konnte nicht gefunden werden. visualises a system of concepts that allows navigating in a top-down approach to detect the concepts that are affected by a given application. In each level, ideally only one box is affected. This will most likely not be the case in most scenarios, because the scenarios cover multiple facets of the health delivery process and the relationship between patient and caregiver. Boxes in blue and grey colour show concepts that are included by PHM. Grey coloured boxes have been agreed by the project partners to be out of scope for this project in order to keep the research area manageable.

2.1.3 Technical view of the PHM Taxonomy

Specific legal, ethical, and psychosocial implications are determined by certain attributes. In order to learn which attributes coincide with the challenges of the different disciplines, they are ordered in a hierarchy that allows grouping of attributes with similar challenges. Attributes are characteristics of a concept. They vary from the respective view of disciplines.

2.1.4 Rules for using and expanding the PHM Taxonomy

Using the rules, one can detect the points that need to be investigated further. In the first step, attributes of the PHM scenario in the fields of 'ICT', 'System', 'Workflow', 'Measurement', 'Participants', 'Target Group', 'Field of Application', and 'Parameter' need to be analysed for the PHM scenario. Then these attributes are mapped with attributes in the leaves of the hierarchical tree (meaning the lowest level of nodes). If all attributes matched one leaf node of the hierarchy, and for each trunk (meaning the 1st level nodes) at least one leaf node has been matched, the PHM scenario fulfils the hierarchy's constraints ('All Attributes found? ').

2.2 Dependencies map

A comprehensive and modular dependencies map has been developed. The aim of this map is to analyse how ethics, law and psychosocial sciences are interrelated in the PHM development and to highlight and identify connections and relation of special importance.

Identification of all the dependencies is not possible. For a very high proportion of PHM technologies, however, a lot of the most important dependencies have been identified. The fact that it is an impossibility to be sure that all dependencies have been identified is no reason for failing to identify as many significant dependencies as possible. An approach which enables the identification of many of the challenges and issues associated with PHM technologies is beneficial and will reduce the likelihood of problematic implementation and use. Such an approach has the added advantage of accommodating new dependencies which are subsequently identified.

Several Dependencies maps, including sub-maps have been generated. This includes maps for:

-People
-Society
-Government
-Operation
-Law
-Medics and Allied Professionals
-Societal Scientists and Philosophers
-Health Informaticians
-Wellbeing
-PHM-Instruments.

The recommendations below lay a foundation for PHM-ETHICS and indicate the challenges for stakeholders when considering or evaluating PHM technologies. Much of what is included below reveals the need to emphasize an ethical approach to PHM that appreciates the potential impact of dependencies and their associated relationships, and which could directly influence current and future PHM development:

1. Recognise the importance of the interpretivist transdisciplinary approach which leads to deep meaning and understanding of PHM and its context: A transdiciplinary approach enables the drawing together of concepts from the disciplines to create frameworks and to break down barriers to co-operation and understanding. The interpretivist approach rejects the positivist, numbers-based world-view to allow insight and meaning to be derived from an investigation and consideration of the issues.
2. Use a common language of communication to ensure consistency of dialogue across disciplines and between key players in rolling out PHM: A transdisciplinary approach requires that in order to ensure accurate communication and understanding, a common language is adopted. A Lexicon has been provided to standardise the meaning of key words used in the dependencies map. In future PHM development, a standard or common language not only is important, but also ensures that all stakeholders are able to understand, through the minimisation of discipline-specific technical or overly-academic language.
3. Recognise that dependencies are not just between stakeholders: Dependencies may impact, or have an influence on, a wide range of areas. Whilst directly affected stakeholders are probably the most important, dependencies are also found that operate between organisations, physical artefacts (such as technical equipment), Law, Governments and wider society. For example, Law as a process facilitates business as a stakeholder. It is vital to take into account the rich diversity of dependencies when planning, developing, implementing and using PHM.
4. Recognise the dynamic nature of dependencies and relationships over time and through technological evolution: Technological evolution can often be predictable in many ways due to the largely incremental nature of development but this is not always true. However, many of the dependencies and associated relationships identified are dynamic in nature and subject to change that is less predictable than technological change. This means that PHM-ETHICS cannot be static in the way that it is either evaluated or applied.
5. Recognise the complexity and variability of dependencies and relationships: Graphical maps provide limited snapshot views for PHM-ETHICS. Through the development of the relationships table, further depth and detail has been derived. However, the complexity, variability and fluid nature of the dependencies and relationships means that it is likely that new dependencies and relationships may be discovered as new developments and changes occur within the field of influence on PHM.
6. Contextualise PHM to improve the probability of successful PHM: PHM may be used in many different contexts and for a wide range of different health conditions. Future use may also include general wellbeing and health monitoring as a preventative rather than treatment option or even as a tool for social control. It is essential therefore that the use for which the PHM system is developed, and the context in which it is to be placed, should be considered alongside the practical application of the system. This is likely to increase the probability of successful PHM implementation.
7. Prioritise the contextual issues surrounding PHM so that focus can be placed on the key elements: It is understood that PHM-ETHICS is a highly complex and dynamic area, and that there are many dependencies that could have an impact on the success or failure of PHM. Therefore, when developing PHM systems, it is important to prioritise those dependencies and relationships that are likely to have the greatest impact, whilst being aware of the potential impact that the other dependencies may have.
8. Understand the nature of relationships between dependencies: In order to be able to evaluate the impact of nodes and relationships, it is also necessary to understand the nature of the relationships identified. Relationships are better understood through an awareness of the context in which they are considered. Some nodes and their relationships may be considerably stronger and more influential than others, and so it is important to ensure that the cultural, social and political context is understood. Relationships may also vary in strength according to the specific nodes they are linked to and the context in which they are formed.
9. Make this complex system description accessible to all interested parties so that it can be used as an analytical instrument and standards compliance model for future PHM: PHM is complex and dynamic and this paper describes and explains the nature of PHM dependencies and the relationships that may impact on the development of PHM systems. However, due to its complexity, the maps, table and verb-set descriptions may not be useful analytical tools alone for PHM developers. A commercial software tool (SoDis) already exists which could be customised to be made PHM-specific. It would provide a standardized approach to identifying potential issues or problems that needed to be addressed.

2.3 Legal report

2.3.1 Objective
The legal report concerns ethical and legal aspects of personal health monitoring analyses: Law and ethics do influence each other. Based on this interaction, laws are enacted - also at the European level - that deals directly or indirectly with personal health monitoring. These laws refer to the Treaty on the Functioning of the European Union, the Data Protection Directive, the Transparency Directive, the Directive on Electronic Communications, the Medical Device Directives, the Directive on Distance Contracting, the Directive on Intellectual Property Rights, the Competition rules, the Directive on the recognition of professional qualifications as well as the Regulations on jurisdiction and the recognition and enforcement of judgements in civil and commercial matters and the Regulations concerning applicable law. The legal report also deals with the EU policy related to E-Health and personal health monitoring and with some important European Court of Justice Jurisprudence regarding to the reimbursement of healthcare services in another Member State of the European Union and with some privacy-related aspects as well.

2.3.2 Regulatory actions

Short term actions (6-18 months)

1. Medical liability legislation: The different liability legislation in the Member States hinders the application of PHM especially in case of cross border healthcare. The EU should also play a more important role with regard to liability issues since eHealth and (tele)monitoring actors are submitted to different liability schemes. In a similar way, Member States should determine the nature and modalities of mechanisms for patients to seek redress and compensation if they suffer harm as a result of receiving PHM.

2. Working conditions for healthcare professionals: The conditions under which the healthcare provider's can work in different Member States.

An important question is whether the physician who delivers healthcare at a distance has to obtain a license in the country where the patient resides. There is a need for a regulatory framework for healthcare professions, so that healthcare professionals can deliver cross-border activities without restrictions concerning cross-border licensing. One question to be considered is if the existing framework needs to be adapted or will it be necessary to develop a specific framework for Telemedicine and PHM?

3. Informed consent: In the context of new technologies patients will have to be informed not only about the diagnosis and/or the treatment plan but also about the device, the working of the device and the processing of data in case of tele-monitoring. Patient acceptance of the PHM will depend greatly on the information provided and the guidance offered.

4. Electronic health record: The cornerstone of the system for sharing information about patients between healthcare providers will be the electronic health record (EHR).

The method for documenting patients' health history and episodes of illness varies from country to country. Better and more specific provisions in the Data Protection Directive for the further use of health data are needed, as the use of such data takes place increasingly within a globalized context of health care actors.

Long term actions (18-36 months)

1. The respect of privacy: towards a revision of article 15 of the data protection directive. The question is whether or not the existing legal protection of individuals with regard to automatic processing of personal information relating to them, is sufficient. The question is also whether or not to allow PHM projects if article 15 of the Data Protection Directive is not reviewed, since nearly all processing takes place only by electronic means.

2. The relationship between health professionals and patients: A medical consultation conducted 'online' is a revolutionary concept in the physician-patient relationship. The challenge remains for national legislators to guarantee that all groups in the society have equal access to electronic health records, for example, and that discrimination is avoided. PHM and telemedicine should offer equal access to care for all patients at the national or European level.

3.3.3 Economic and organisational challenges

1. Reorganisation of the health care system: New PHM technologies entail some major changes in the whole healthcare system. These will require significant economic investment from the very beginning. Important and new legal questions will also have to be answered dealing with safeguards and medical (call) centres. One question will be whether classic hospitals will organise themselves to take care of monitoring activities or not. Will there be a possibility to delegate certain activities to non-physicians?

2. Risk of overconsumption and reimbursement of PHM projects: PHM may cause over-consumption. It will be a challenge to control the public cost of healthcare. In order to develop telemedicine and PHM, health insurance plans for funds should develop appropriate financing for shared and integrated care and should monitor cost-effectiveness issues. There are still some important legal questions with regard to the reimbursement of PHM that will need to be answered. Should the monitoring activity be reimbursed according to the rules of the Member State where the patient resides or according to the rules where the monitoring physician resides? What if the physician who is monitoring the patient is established in another country? According to which rules must the physician be authorized to practice telemedicine in order to get the activities reimbursed? Is consent of the insurer required before applying for an online consultation or a monitoring device abroad? These questions need clear answers if one wants to promote PHM with success in Europe.

3. Relationship between patient and industry: Today the producers and distributors of medicinal products have contact only with health professionals. There is in principle no direct contact between the industry and the patient. This situation will change when applying telemonitoring. Specific rules at the European level will be needed to regulate the relation between the industry and patients, for example to avoid illegal publicity of medical devices and/or medicinal products or to avoid overconsumption.

4. European legislation concerning acts that can be carried out by a physician or a nurse: Today, each Member State has its own rules concerning the requirements that must be met by certain specific healthcare practitioners before they can explore certain activities in health care. In case of PHM, it is possible that the nurses perform certain acts that may, in some Member States, be legally reserved to physicians or other healthcare professional. Defining medical treatment is a matter for the Member States. But, it would be helpful to have some European guidance on the question of which specific healthcare acts may be performed at a distance by which specific healthcare practitioner.

3.4 Ethical Assessment Methodology

2.4.1 Objective

The ethical assessment methodology focuses on the evaluation of PHM-technologies from an ethical point of view. It takes into account ethical principles and uses interview techniques and predefined questions to ensure a standardized yet flexible assessment.

A technology is not just a particular artifact but a product developed and implemented in a social context. Health care technology is part of a broad health care network. Technological development is an interactive process that can be influenced and altered. Furthermore, technology is not value neutral. Whether intended or not, values are embedded in technology that influence their use. Importantly, those values should be disclosed. In order to reveal the social impact of technology and to identify an acceptable usage, technology developers, users, care providers and other concerned parties should be considered in the developmental process of health care technology. In this way, the development process is broadened to include parties who all too often are excluded from this process.

Contrary to most ethical analyses of novel technology, an interactive ethical technology assessment has to be proactive rather than reactive. It aims to assess emerging technology and to influence research and development of technology before artifacts are established at the market. If aspects in need of modification are pointed out at the prototype stage, technology developers are more likely to alter the design than later on in the developmental process when a change is more inconvenient and costly.

Importantly, the interactive nature of the proposed assessment model respects the interests and experiences of people concerned by PHM-technology. It is a means to identify aspects crucial for how the technology is perceived by concerned parties and to identify well-funded policy recommendations. Recommendations anchored in public conceptions of the technology are likely to gain broad acceptance and their legitimacy increases with a procedure where stakeholders have been involved. Hence, a broad range of stakeholders are identified and included in assessments of PHM. A battery of questions to be addressed to PHM-technology is presented.

An interactive ethical technology assessment provides insight into the conditions of and decisions regarding PHM-technology highlighting values that should be promoted in the development and implementation of PHM-technologies. Combined with the taxonomy and dependencies map, the assessment model helps to generate research questions that are necessary in order to further explore specific technologies. Given the complexity of technological development and a priori checklist of ethical requirements is insufficient. Rather, the method must be open to 'unexpected' developments and outcomes. The suggested assessment tool offers a limited (non-exhaustive) list of values relevant for the acceptability of PHM and describes why and how such values are relevant.

2.4.2 Selected ethical aspects

In the following, some of the ethical aspects that have been touch upon will be shortly presented; privacy, freedom of choice, informed consent and the impact of PHM-technology on human relations. Importantly, issues of privacy and informed consent have also been dealt with from a legal perspective within the legal report.

1. Privacy: A recurring problem with PHM-applications has been their impact on privacy. That privacy is an important value is seldom questioned but opinions differ significantly regarding what privacy means and to what extent and how it should be protected. That which is privacy sensitive is taken to vary over time, within cultures and between individuals as well as depending on context. Suggestions as to why privacy should be protected are respect for individual's dignity, autonomy, intimacy. Some argue that we should avoid reducing privacy to one such value, rather than seeing how privacy is important for the reasons above and yet others like democracy. It has also been argued that privacy should not only be considered an individual interest but a collective such.

The case has been made that privacy protection is crucial for individuals to express their opinions and exercise their political rights. The privacy invasive potential is one of the most common controversies when it comes to ICT-based care. What intrusions consist in is a rather complex issue however, considering different dimensions of privacy such as decisional privacy, informational privacy and local privacy. The different types of PHM-based health care support affect all these PHM-ETHICS dimensions as well as care recipients' bodily privacy. Bodily privacy has to be considered as a fourth dimension (and perhaps mental privacy deserves a fifth dimension). Arguably, some dimensions of privacy may be negatively affected at the same time as other may be protected. It is commonly argued that patients' privacy is unavoidably intruded upon within hospital-based health care and hence, that the home-based care 'options' involving surveillance capable technology has a marginal effect. Informational privacy is intruded upon since patients' must release personal and health related information to health care professionals.

2. Voluntariness: To what extent then can personalized health monitoring be considered voluntary? Surveillance is typically considered to stand in contrast to voluntariness and scholars within the field of surveillance studies often discuss data subjects' resistance to such technology. Only a few scholars discuss voluntary surveillance. Freedom of choice and the chance to influence surveillance is typically held forth as aspects crucial for data subjects' acceptance of surveillance. Technology developers and care provider often emphasize that these novel types of support should be considered as voluntary complements to traditional care. But if these care solutions entail the safety and security gains that they are supposed to and if they are as cost-efficient as technology developers claim, it is not unreasonable to assume that, in time, these will make up the standard form of care. Care recipients, it is said, can freely choose to add Night Patrol as a complement to their ordinary care. But considering how often this type of care solutions are advocated as the solution to the problems related to an ageing population that health care is facing, the question of voluntariness should be further analyzed. And given this kind of development, to what extent should care recipients who express a preference for less privacy invasive and more costly forms of care e.g. home care visits by a nurse rather than camera surveillance, be accommodated? Will the preferences of extra privacy sensitive or privacy-concerned individuals be considered as expensive tastes? In a world of unlimited resources this question would not have to be raised but given the ambitions of creating a novel health care system that is better equipped to meet the ageing population and the need for prioritizations, these questions become highly relevant. If one care recipient's claim on a bigger share of the total 'cake of care resources' is accommodated, this will at least indirectly affect other care recipients' options.

3. Informed Consent: Health care should be conducted with respect for care recipients' autonomy. Personal autonomy means individuals´ ability to direct themselves and their lives. By respecting a person's right to decide in matters that concern herself, its autonomy and integrity is respected. The right to decide on matters concerning oneself however, is limited by others' equal right to such decisions. Informed consent is an instrument that has been developed within the field of medicine to guarantee patients´ the freedom of choice and to respect their autonomy and integrity. Informed consent gives the patient ultimate authority for deciding the acceptability of a particular treatment, once she has received proper information by a physician of the risks and benefits attached to the particular treatment. Thus, the patient's autonomy is respected. That is, in order for a contract between care provider and care recipient to be ethically and legally justifiable the care recipient must express her informed consent and in order for the care recipient's consent to be informed, health care professionals must provide her with necessary and relevant information, and communicate the information in such a way that she understands the content thereof and the implications of her consent. Health care professionals should present the care receiver's options in an as neutral way as possible, avoiding undue influence. Information should also be communicated in such a way that a lay-person can comprehend thereof.
4. Relations with Health Care: With sensors, cameras and robots installed in patients' homes, many aspects of health monitoring traditionally provided in hospitals are now carried out in the domestic setting. Health care offered outside the traditional care-providing institutions, is often described in terms of 'distributed care', 'self care' or 'home care'. Certainly, it makes sense to distinguish between care conducted in the patient's home and in hospitals or nursing homes and to contrast home-based care with hospital-based care. However, terms like 'distributed care' may sound as if care is transferred to the home setting whereas nothing else changes. In reality, many aspects are likely to change with this shift in where care is executed. It is important to consider what type and quality of care that is distributed, high-lighting similarities and differences.

3.4.3 Interactive Technology assessment

Interactive assessments are structured as a cycle of interviews where all stakeholders are asked to give their opinion of a certain technology but also to respond (anonymously) to opinions voiced by other participants. The interview-cycle is completed repeatedly so that a process of vicarious learning emerges. In so way the range and scope of opinions, interests and claims are mapped and consensus and disagreements are PHM-ETHICS revealed. Within iTA, agreement is both a condition of deliberation and its goal. In principle, the assessment is a never-ending process. After having interviewed the last stakeholder, the evaluator returns to the first. This method is said to prevent one party from having the last word, and by letting the stakeholders view all the opinions expressed, a broad range of perspectives is processed. The process should not be stopped until consensus is reached. Importantly, what is agreed on must be acceptable but not necessarily desirable to all parties involved. Rather than being a fixed end state, agreements should be viewed as a temporary consensus in need of renewal. In order to be ethically legitimate, the terms and conditions of reaching agreement should be transparently communicated to those involved in the assessment. Instead of working with consensus as a preset goal, the aim should be to encircle as many opinions as possible and to take potential conflicts seriously.

3.4.4 A list of ethical values and principles to serves as a basis for assessments

From the brief 'survey' of codes, field studies, guidelines and research reports relevant for the evaluation of PHM-technology, a tentative (and non-inclusive) list of values and principles have been extracted; privacy, autonomy, informed consent and freedom of choice, justice, quality of care and interpersonal relations. These served as a basis for the formulation of specific questions to be addressed the stakeholders. Importantly, the questions were subject to continuous revision and refinement throughout the process. Values and principles are:

1. Privacy: Privacy has been considered a relevant issue within all the areas consulted. Personalized healthcare implies that counseling, monitoring and care will be conducted outside the traditional institutions and that, in consequence, a larger amount of information will be transferred electronically between health care provider and health care recipient which raises demands on information security. In light of this development, it is emphasized that care recipients must be able to control others access to information about them and hence, that care providers must keep information free from unauthorized access or use. A broader understanding states that individuals should be able to control access to their personal information and to protect their own space.

2. Autonomy: It is argued that autonomy is one of the values that can gain support irrespective of what type of normative ethical theory one would 'subscribe' to. Autonomy is defined as the individual's right to decide how and for what purposes s/he is using technology. The meaning of that which normally is framed as personal autonomy in the following way: 'as a rule of thumb, individuals are the best judges of their interests, hence likely to make better decisions regarding their well-being than what others can. Irrespective if this is correct, it can be demeaning not to take action oneself.

3. Informed consent and freedom of choice: Closely related to autonomy is the principle of Informed consent, coded in the Helsinki Declaration and embraced both in medical and computer ethics. In order to be able to make autonomous and well-informed decisions, the care recipient must have a certain competence, access to reliable, non-biased and relevant information and also - have reasonable alternatives to choose between.

4. Justice: Although several aspects of justice could be discussed, the distributive aspect has received most attention in relation to PHM-technology. e-Inclusion has been emphasized that services are accessible to all user groups despite of their physical or mental deficiencies. In a similar vein the value of using public resources efficiently and fairly. Not only should public resources be spent wisely and fairly allocated but also be used to protect the vulnerable.

5. Quality of life, quality of care and interpersonal relations: Technology should be used so that it increases the quality of life without causing harm. Few empirical studies have been conducted on the impact of PHM-based home care on health care recipients. These indicate a fear among users that the technology may reduce direct, physical contact with health care providers. Hence, the relationships - health care provider and patient require attention. Values like those of presence and closeness emphasized within nursing ethics should be considered.

3.5 Psychosocial Assessment Methodology

3.5.1. Objective

The psychosocial assessment methodology on Personal Health Monitoring is an additional technology assessment tool on PHM applications. It covers important aspects that should be taken into account for conducting a health technology assessment from a psycho-social perspective. A conceptual framework on psycho-social issues of PHM applications has been generated.

The psycho-social assessment tool is linked to other tools, since the module is an integral part of the interdisciplinary PHM methodology. A general schematic model of PHM systems provides foundations for defining the core elements of PHM applications as well as their inter-relations. As a prerequisite, the model should meet the need for representing potential psycho-social issues of PHM, thus we should switch the focus from the technological system (parameters etc.) to its application in terms of interlinking persons and institutions and its integration within social systems.

In general, we first place special emphasis on the persons interrelated by or connected to the PHM device. Second we also focus on social systems (e.g. institutions), which are directly affected by the implementation of the PHM device or where the system is implemented within. In particular, psycho-social issues of PHM are related to:
(i) different persons included in or linked to the system;
(ii) connections between different parts of the system,
(iii) social/hybrid sub-systems;
(iv) social systems the PHM application is embedded within or part of;
(v) persons or social systems affected by the PHM systems.

Thus, while considering psycho-social issues of PHM applications, these technological applications should be focused as societal embedded systems, affecting individuals, collectives, social groups, institutions etc.

Establishing the framework, relevant constructs and concepts were mapped from a variety of sources regarding PHM and related technologies based on a variety of input sources. Different strategies were combined by comparing conceptual based top-down analysis with 'empirical' based bottom-up approach. Starting from a more abstract level, this conceptual structure became more differentiated by mapping each of the sources against the already established structure. In order to handle the complexity, finally several attributes to higher order domains were merged.

The following paragraphs introduce the concepts identified. The main categories outlined had been delineated along the time scale of operating a PHM application in direction of its progression within time, which is implementation, processing, and outcome. Here, we are in the heart of the topic that matters. Sources in parenthesis are just selected examples, referring to the most valuable publications in terms of included psycho-social content.

3.5.2 Content dimensions

Implementation (Expectations)

Within the process of implementation of a PHM application it is common to investigate the so called 'acceptance' of (potential) end-users, simply by asking for their needs, preferences, attitudes, perceptions and experiences. Domains identified are assigned to two different classes - those related to the user and those related to the implementation of the respective technical application.

-Issues related to the user within the context of implementation are 'perceived need' and 'perceived relevance'. Perceived need could be assumed as the most important and principle factor for adopting a PHM application. Noteworthy, balancing needs and concerns related to the use of PHM technologies had been stressed frequently in research. Further specific aspects within this 'cloud', each of them interconnected to each other, are those labeled perceived relevance (priority) and acceptance in terms of 'willingness' or adoption to technology.
-Issues related to the implementation of a PHM technology cover different requirements for the use of the system, namely affordability, demand on effort and sustainability.

Processing (Experiences)

Interaction refers to any kind of interaction with another person (whether or not it is technically mediated) or a technological device (whether or not it is operated by humans). For social (human) interactions, one could draw a meaningful distinction between interactions with private persons and interactions with professional persons.

-It makes sense to distinguish between technology-related and monitoring-related issues. Technology related aspects primary addressing the performance of man-machine-interactions. Thus, focus is directed to aspects such as function, reliability or design of the respective technological application.
-By contrast, monitoring-related issues primarily refer to the impact of data transmission settings of a PHM application. This might raise more ethical questions concerning principles and values such as privacy, surveillance, trust, freedom of choice as well as monitoring of other people.

Outcomes (Evaluations)

Assessing outcomes usually is processed for evaluation purposes. Conventional target criterions used in telemonitoring studies are e.g. quality of life (patient-related), workload (provider-related), or mortality (clinical). Some of them could not be transferred to all PHM-relevant technological systems. For instance, PHM applications from the area of 'Smart Homes' or 'Ambient Assisted Living' are often primarily intended to be used for assistive and enabling purposes, rather than for health care purposes in a narrower sense of the term. Besides the generic or overall judgements related to health status, quality of life, satisfaction with health outcome, two main clusters of specific psycho-social aspects were identified:

-A first main cluster of issues refers to ' (health-related) quality of life' and 'well-being', comprising facets such as physical, mental and social well-being as well as role-functioning aspects from the area of daily life activities and work life. This is in line with conventional conceptualizations of quality of life and well-being.
-A second main 'cluster' of psycho-social issues is related to maintain and enhance function and independence covering facets like 'autonomy' and 'security/safety', control and comfort. Here it should become evident, that the use of health-related quality of life measures (e.g. SF-36) as somewhat regarded as a 'gold standard' aiming at evaluating the intended positive impact of subjective outcomes in telemedical (and especially in telemonitoring applications) settings often fail at covering some of the most relevant target criteria these systems are intended to be used for. This holds even truer for PHM applications not primarily intended to maintain or enhance health instead of maintaining or enhancing functioning and independence in older and disabled people instead of patients (especially ambient-assistive PHM technologies). Thus, rather than just a health-related attribute of subjective outcome, quality of life within PHM context primarily captures domains such as 'in/dependence' and 'in/security'. 'In/dependence' refers to the extent to which a PHM application enables one to live a life as it should be lived, to gaining/losing autonomy, or to the extent that PHM is seen as a symbol of loss of autonomy. 'In/Security' refer to feelings of being un/safe and cognitions of perceived in/security and gaining in/confidence. Security and safety are the most important reasons to recommend a respective PHM technology (here: Smart Homes). Further aspects mentioned are related to convenience.

3.5.3 Structural Dimensions

Reflecting on the established framework, two general dimensions had been identified that are inherent to the dimensions already outlined above. These dimensions do not share the same conceptual level, since they are inherent to all content of the framework, namely the dimension of impact itself as well as the dimension of assessment. In the following, both dimensions are introduced briefly.

Dimension of impact: Structural attributes of impact

The dimension of impact refers to characteristics of the impact being under consideration, according to the following four attributes: perspective, evaluation, intention and attribution.

-Evaluation of impact (positive vs. negative): The impact of using a PHM application should be assessed regarding positive as well as negative aspects. This refers to the pros and cons of using the respective PHM application under examination. Although it might be obvious, it is worthwhile to highlight this issue here for several important reasons: (i) health technology assessment naturally is directed to primarily cover negative impact, detecting concerns, risks or hazards. In doing so, addressing or identifying positive impact in terms of benefits is biased in this context. In the round, in outcome research, target criteria are assessed, regularly addressing intended positive outcomes using PHM applications (and therefore, outcome assessment is biased against identifying negative impact). Moreover (ii) this module aims at addressing positive and negative associated attitudes, experiences and evaluations in terms of aspirations vs. concerns, risk vs. potentials, or benefits vs. constraints with respect to the (intended) use of PHM applications. In addition, (iii) most psycho-social attributes covered by the module could be labelled 'positive' or 'negative', depending on the respective subjective connotation, evaluation or judgement of the user. Most aspects are not 'positive' or 'negative' by nature. One should also consider (iv) the methodological obstacle caused by the direction of question wording in terms of so-called protrait and contrait items. That is, it could make a difference in answering a question whether or not the wording of the item is in the 'direction' of the construct of interest. Finally, (v) including pro- and contrait items allows for investigating the dimensional nature of a construct under examination.

-Intention of impact (intended vs. unintended): It seems obvious, to distinguish between intended and unintended impact. But this distinction adds up some value if considered while preparing an assessment because PHM applications do implicate at least two directions of including unintended effects despite of unintended effects as usual.

First,(i) several monitoring applications (especially from the area of ambient monitoring) could include persons that are not intended to be monitored. Moreover,
(ii) as every data could be linked, a further noteworthy impact could be related to the natural unintended linkage of data.

-Attribution of impact (related to application vs. not related to application): A sometimes neglected, yet often quite difficult task, is to distinguish between different attributes of PHM impact. This is, whether or not a change in something is attributed to the implementation of a PHM application or not. Whilst preparing the assessment this distinction has to borne in mind.

Dimension of assessment: Methodological attributes of assessment

-Focus of assessment (technology-, monitoring-, or outcome-related): While considering assessing the impact of PHM applications, one should bear in mind the distinction between technology assessment and outcome assessment. Moreover, one should distinguish between technology assessment and monitoring assessment. Although both issues are strongly interdependent, it's valuable to draw a distinction here, since a specific technological application is not necessarily limited to a specific monitoring usage and vice versa. Moreover, concerns about technology are primarily related to 'intrusiveness' and 'reliability', whereas concerns about monitoring are primarily directed to privacy and 'data security'.

-Time point of assessment (before, within, or after implementation): Not just from a scientific point of view, it's important to note, that the time point of the assessment may have a huge impact on the issues under consideration. Obviously, this holds true for studies to be conducted in the future, but one should not neglect to consider this distinction with respect to PHM related studies that have already been conducted. It does make a difference if people are asked before, within or after experiencing PHM on their own. Depending on the point of time of the monitoring implementation, questions will be addressed to people's attitudes (before), experiences (within) or evaluations (after).

-Perspective of assessment (self-, proxy-report): Further emphasis has to be put on the person responding for another person. In best case, one should implement a wide range of perspectives and thus participants, although the single-perspective trial will be the most widely used in reality. It is recommended to include the person concerned (usually the user/patient/consumer) at least with self-reporting, since understanding of his or her subjective experiences are of primary intent and these could not be achieved by other means. Thus, a proxy-report provided by a relative (e.g. family member) should focus on user's experiences instead of on their own experiences.

Potential Impact:

4. Impact and the main dissemination activities and exploitation of results

4.1 General impact

PHM-ETHICS aimed to derive a general methodological tool-box to ethical questions of new challenging technologies - usable both in the European and the national contexts of its member countries. The impact of PHM-ETHICS will increase with growing practicability of its outcome - this means that the work program - by the state of scientific research - is condensing the results of the initial analyses into more and more practically relevant tools.

PHM-ETHICS developed a toolbox of how to handle and address the difficult ethical and legal questions of monitoring of humans and can be a generic model of how to proceed in similar cases. The procedure is not too complex and can be applied to many challenging technologies. It can serve as a reference system for public discussions - facilitating efficient democratic discussions of all individuals involved.

The methodology may be established within the area of PHM, and will be potentially applicable for other technologies as well. Not only risks, but also positive aspects of the development of PHM have been investigated. These balanced controversial positions of technological pioneers and representatives of ethics committees and law schools - which tend to either, overestimate the positive or the negative effects of a new challenging technological development.

Moreover, PHM-ETHICS provided research tools that allow studying future PHM applications concerning their consequences. A knowledge base on techno-ethical issues has been set up to serve both internal and external dissemination purposes. Finally, PHM-ETHICS will provide input to EU and national institutions for techno-ethical monitoring in order to highlight risks and advantages of the development of PHM. More specifically, the project will provide a platform of PHM applications that allows industrial developers and healthcare providers to anticipate and analyse ethical consequences in initial stages of the development. The expected impact will also contribute positively to the quality of research in the field of ethics of new technologies and to the early identification of ethical issues and the effectiveness of future EU policy.

A missing code of conduct regarding early inclusion of legal and ethical aspects into challenging technological developments is especially problematic in technological fields which are extremely dynamic - that means are early in their historical development cycle - e.g. micro-IT-technology, sensor-technology, nano-technology etc. These technologies have many connections which open a wide range of possible fascinating but also ethically challenging perspectives. Because of the width of the possible development space it is impossible to deal with each sub-development as such - it is necessary to derive general procedural codes of typical examples - as PHM. The impact of such a code of good practice will allow to save resources on the one hand and to push more resources in promising developments on the other hand.

There are many historical examples that the EU reached international leadership in technical developments - e.g. smart card technology - but was not able to bring products widely into the market. Impact on European policies may be substantial since such a regulation of development procedures will alleviate the development of market relevant technologies considerably and on the other hand will help to save resources for ethical technological developments that highlight major problems from an ethical point of view.

4.2 Development of the project's website

An official PHM-ETHICS website (http://ethics.p-h-m.org online for further details) was designed and put online by EMAUG. The website introduces the project and its research partners and provides news about the latest progress of the research. Relevant articles and publications are to be downloaded at the website in the future.

4.3 Scientific Community and Research

4.3.1 Publications and published abstracts

In order to reach and inform the scientific audience numerous publication activities took place in the course of the project. The following scientific articles have already been published in scientific journals and books:

-Collste, G. (2011). Under my Skin: The Ethics of Ambient Computing for Personal Health Monitoring, InSharlene Nagy and Hesse-Biber (Eds.), The Handbook of Emergent Technologies in Social Research (pp 89-111). Oxford: University Press.
-Kalis, A. and Nijsingh, N. (2011). Leefstijlinterventies. (Life style interventions). To be published in Mariette van den Hoven, Carla Kessler (red.) Preventie en Ethiek (Prevention and Ethics). Amsterdam: Boom.
-Krieg, T., Muehlan, H., Schmidt, S. and The European PHM Ethics Group (2009). PHM-ETHICS: Personal-health-monitoring in ethics, law, psychology and medicine. In T. Kubiak and H. Weber (Eds.), Ambulatory Assessment: Bridging the gap (p.90). Lengerich: Pabst Science Publishers.
-Muehlan, H. and Schmidt, S. (2011). Psycho-soziale Aspekte des ambulanten und ambienten Gesundheitsmonitorings in modernen Anwendungskontexten. In: Deutsches Zentrum fur Altersfragen (DZGA) (Hrsg.), 10. Kongress fur Gesund-heitspsychologie 'Gesundheit im sozialen Wandel', 31.08.2011.-02.09.2011 Berlin. Informationsdienst Altersfragen (S. 116), Sonderheft.
-Nordgren, A. (2011). The web-rhetoric of companies offering home-based personal health monitoring. Health Care Analysis. DOI 10.1007/s10728-011-0174-z
-Nubbeck, G., (2010). Reduktion des Implementationsrisikos von Telemonitoring durch eine Taxonomie-gestutzte Risikoanalyse. In: B. Bockmann, et al. (Hrsg.), 1. Nationaler Fachkongress Telemedizin (S. 14-20). Berlin: TMF - Technologie- und Methoden plattform für die vernetzte medizinische Forschung e.V.
-Nubbeck, G., Gok, M. and Rienhoff, O. (2010). Systematik Assistiver Systeme in Versorgung und Forschung. EHEALTHCOM, 4, 52-53.
-Palm, E. (2010) Nar varden flyttar hem till dig den mobila vardens etikk. Etikk I praksis 2/2010, 71-92.
-Rhode, D. (2011). Personal(ized) Health Monitoring, Personalization, and Personality. Journal of Technology in Human Services, 29, 83-100.
-Rhode, D., Muehlan, H. and Schmidt., S. (in Druck). Personalisiertes Gesundheits-monitoring: Psychosoziale Aspekte und interindividuelle Unterschiede. In F. Duesberg (Hrsg.), E-Health 2012. Informationstechnologien und Telematik im Gesundheitswesen. Medical Future Verlag.
-Rogerson, S. and Haines, J. (2010). Healthy ICT. IMIS Journal, 20.
-Schmidt, S., Muhlan, H. and Rhode, D. (subm.). Personalized health monitoring - Interdisciplinary research to analyse the relationship between ethics, law and psychosocial as well as medical sciences. Technological Forecasting and Social Change.
-Verweij, M. (2011). Volksgezondheid en preventie: een ethische beschouwing (Public health and prevention, and ethical discussion). To be published in Mariette van den Hoven, Carla Kessler (red.) Preventie en Ethiek (Prevention and Ethics). Amsterdam: Boom.

4.3.2 Scientific presentations on conferences

Interdisciplinary Conference 'Chances and Riscs (in) Modern Medicine', October 18-19, 2011, Berlin, Germany

-Holger Muehlan, Vom medizinischen Telemonitoring zum alltäglichen Gesund-heitsmonitoring. Praktischer Nutzen eines konzeptuellen Rahmenmodells von Chancen und Risiken von Anwendungen des 'Personal Health Monitoring' aus psycho-sozialer Perspektive. (From medical tele-monitoring to health-monitoring in everyday life: Practical benefit of a conceptual framework on chances and risks of personal health-monitoring technologies from a psycho-social perspective). Poster presentation.
-Dieter Rhode, Akzeptanz von Gesundheitsmonitoring-Technologien aus Sicht des Nutzers (Acceptance of health-monitoring technologies from the user's perspective). Poster presentation.

Workshop 'Distributed Healthcare - Making Technology Work for Patient Benefit', October 13, 2011, Linkoping, Sweden

-Goran Collste, Personalized Health Monitoring - Ethics. Paper presentation.
Final conference of the Nordic Network for Philosophy of Medicine and Medical Ethics, October 5-7 2011, Vilnius, Lithuania
-Anders Nordgren, The web-advertisement of companies offering personal health monitoring. Paper presentation.
-Elin Palm, Informal care in the light of Personal Health Monitoring Technology. Paper presentation.
Bi-Annual Conference of Health Psychology, 'Health and Social Change', August 31 - September 2, 2011, Berlin, Germany
-Holger Muehlan and Silke Schmidt, Psycho-soziale Aspekte des ambulanten und ambienten Gesundheitsmonitorings in modernen Anwendungskontexten. (Psycho-social issues of ambulatory and ambient health monitoring in emerging areas of application). Poster presentation.
Annual Conference of Societas Ethica (The European Society for Research in Ethics), 'The Future of Medicine', August 25-28, 2011, Lugano, Switzerland
-Anders Nordgren, A technology for the future? An ethical analysis of the web-advertisement of companies offering personal health monitoring. Paper presentation.
-Goran Collste, The Ethics of Personal Health Monitoring. Paper presentation.
-Elin Palm, To be handled with care - personal health Monitoring Technology. Paper presentation.

List of Websites:

http://www.p-h-m.org

Final Report Summary - PHM-ETHICS (Personalized health monitoring - Interdisciplinary research to analyse the relationship between ethics, law and psychosocial as well as medical sciences)

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