“Interdisciplinary research to analyse the relationship between ethics, law and psychosocial as well as medical sciences”

No. Deliverable name WP no.

Delivery date

1 First report 1 29.02.2011
2 Final report 1  
3 Consortium Agreement 1 06.01.2010
4 Project Fact Sheet 1 24.08.2009
5 Report on Review 2 02.02.2010
6 1st version of the Taxonomy 3 02.02.2010
7 2nd version of the taxonomy after intergrating the evaluation of international workshop 1 3,4 17.06.10
8 1st  version of dependencies map 4 02.02.2010
9 2nd  version of dependencies map after integrating the evaluation of international workshop 1 4,3 07.10.2010
10 Report on analysis of ethical and legal constraints 5 31.10.2010
11 Ethical assessment methodology 6 11.04.2011
12 Ethical assessment methodology integrating recommendation/ evaluation of international workshop 2 7,8,9  
13 Report on validation results 7,8  
14 Final implementation plan and outcome of international dissemination conference 10



Project Fact Sheet (WP 1)
Deliverable No. 4 – delivered: 26.08.2009
The project fact sheet serves as an information tool, presenting the aims of the project, as well as the main project phases and an overview of the project partners in compact form.
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Consortium Agreement (WP 1)
Deliverable No. 3 – delivered: 06.01.2010
The Consortium Agreement lays down the rules for the participation of undertakings, research centres and universities in actions under the Seventh Framework Programme and for the dissemination of research results within the interdisciplinary consortium of the PHM-ethics project.
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Report on Review (WP 2)
Deliverable No. 5 – delivered: 02.02.2010
A short review on already published studies addressing psycho-social issues of personal health monitoring (PHM) was provided. 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 in a first step. For evaluating the impact of PHM devices on outcome measures we laid a main focus on (reviews about) randomized control studies.
It was observed, that research so far strongly focuses on Tele-Monitoring and Smart Home applications. Moreover, focus of research differs between different types of PHM: Tele-Monitoring studies are usually directed to outcome-related questions; Smart Home studies focus on feasibility issues. Both applications strongly differ, as they are developed for different purposes. Thus, despite of various technological issues, comparability of both systems regarding psycho-social issues is lacking. Tele-Monitoring has been proven for impact on various patient groups with chronic diseases, whereas Smart Homes still lack evidence on their impact on health-related and psycho-social indicators, although some first studies have been conducted. Psycho-social topics in Smart Home applications have mainly been investigated with respect to attitudes, perceptions and concerns of end-users; Tele-Monitoring was more likely to be investigated regarding acceptance and adherence.
In conclusion, there is a need for more research regarding the impact of PHM devices on psycho-social issues.
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Taxonomy (WP 3+4)
1st-Version: Deliverable No. 6 – delivered: 02.02.2010
2nd-Version: Deliverable No. 7 – delivered: 17.06.2010
The taxonomy serves as classification tool that mirrors the current state of PHM. It is to serve as a framework for research and describes major types and stages of development from the combined perspectives of medical informatics, medicine, psychosocial sciences, ethics and law. It focuses on the interrelationships of the different disciplines. With the taxonomy one should be able to foresee ethical problems in the development and implementation of PHM.
The taxonomy is based on an extensive literature review. The design has been tested and validated with several case scenarios. It provides a systematical view of the PHM area as well as a distinct basis for communication and analyses in and between different disciplines. The taxonomy will be used in the PHM-Ethics project as ground work for the dependencies map. Jointly, taxonomy and dependencies map build the foundation of the ethical assessment tool. The interdisciplinary taxonomy alone will help to systematize the development of research institutions, industry, and funding agencies and organizations including the EC.
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Dependencies Map (WP 3+4)
1st-Version: Deliverable No. 8 – delivered: 02.02.2010
2nd-Version: Deliverable No. 9 – delivered: 07.10.2010
The dependencies map was developed as a tool to improve product development and at the same time to address relevant non technical-issues just on time. It delineates the interrelationship between ethics, law, psychosocial and medical sciences. One of the key objectives was to carry out this development on a European level and to initiate steps and measures to enable this common approach of ethical evaluation.
The dependencies map is as important as the taxonomy. It covers prime research about the impact of new challenging technical developments on legal and ethical discussions and codifications. Currently, the latency times are so substantial that some legal road blocks only pop up and delay new developments after many years of early technical developments.
The dependencies map will allow technical developers to address the positive side of options for ethical and legal regulation. As well it will allow legal and ethical representatives to enter the discourse early with positive and negative arguments. It aims at analyzing different psychosocial and sociological issues in terms of the fields and stages when ethics, law, and psychosocial sciences are relevant. The map is interrelated in the implementation of technological innovations and closely bond to the taxonomy.
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Report on analysis of ethical and legal constraints (WP 5)
Deliverable No. 10 – delivered: 31.10.2010
This report concerns the legal and ethical aspects of personal health monitoring analyses.
The analysis of existing European legislation and jurisprudence dealt with legal issues of health monitoring. Ethical regulations of international instruments in the national laws or regulations of the European Union’s member states were analyzed in order to identify areas of convergence and divergence. A comparative analysis on these regulations from both a legal and ethical point of view was conducted. Legal and ethical gaps were defined in the short term and regarded due to their relation to PHM. A list of proposals for the European legislator and the member states to solve the gaps was to be drafted.
Another aim of this legal work was to carry out implications and an overview of the legislation on the European level regarding telemedicine and personal health monitoring. This analysis pictured the impact of law on healthcare and was targeted on the long term of health monitoring.
Specific attention was drawn for legislation that is directly or indirectly important for e-health. The analysis should take into account the consequences of recent decisions that might be of importance for the project and dealt with aspects like medical liability and (future) reimbursement of monitoring systems.
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First Report (WP 1)
Deliverable No. 1 – delivered: 28.02.2011
The first reporting period spans project phase 1 and the first half of project phase 2.
In the project phase 1 the development of PHM was reviewed to identify core steps that delineate major changes from an ethical, legal and psychosocial point of view. At the end of project phase 1, the taxonomy and dependencies map were validated. Overall one can say that during project phase 1 a framework of applications in personal health monitoring had to be developed. The work programme needed to guarantee that the dynamic development of recent and future applications and healthcare settings with personal health monitoring was capable of being integrated. For this reason, the subproject partner UMG described and staged the development of personal health monitoring devices on the basis of existing evidence in technology. Future developments were already taken into account. Case scenarios were created to open a gateway for later research and empirical analyses.
The proposed taxonomy was required in order to foresee ethical issues that might come up when PHM technologies are implemented into healthcare and in societal structures.
For reasons of practicability the consortium agreed in September 2009 upon a focus on medical and technological aspects with regard to ethical and psycho-social topics. A second key aspect of project phase 1 research was to analyze psychosocial issues in PHM. The dependencies map, the third key aspect of project phase 1, involves the perspective of ethics, law, psychosocial and medical sciences. In addition, a major work step of project phase 1 was to analyse the different legal and ethical regulations towards the implementation of personal health monitoring technologies across Europe, and to identify convergences and divergences in these approaches. The aims of the second project phase are to develop and test the interdisciplinary assessment tool that allows assessing PHM technologies regarding their consequences on specific steps of the taxonomy, thereby taking into account dependencies as they are described in the dependencies map. Finally the development of a combined interdisciplinary and standardized methodology aims at assessing, foreseeing and potentially regulating ethical issues in new technologies in the area of PHM.
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Ethical Assessment Methodology (WP 6)
Deliverable No. 11 – delivered: 11.04.2011
The development of a combined interdisciplinary and standardized methodology aims at assessing, foreseeing and potentially regulating ethical issues in new technologies in the area of PHM. The ethical assessment tool, including its sub-modules, will be pilot-tested and validated in current European projects that reflect different stages of the development. In addition to testing the quality of the expert instruments, pilot-testing of the interdisciplinary methodology developed will be carried out in European projects on personal health monitoring involving patients, stratified for different age groups and further socio-economic characteristics, and providers. The results will be analyzed in terms of the differences between development stages as well as differences in impact of culture, gender, age and socio-economic status on perceived personal consequences. The evaluative modules of the PHM methodology include an interactive ethical assess­ment tool, as well as the psycho-social module.
The ethical assessment tool, as core of the project’s work, aims at assessing PHM technologies regarding their ethical, legal and psychosocial consequences on specific steps of the taxonomy. The taxonomy elaborated in WP3 and the review of WP2 together with the dependencies map of WP4, which highlight non-technical interactions within PHM, are the groundwork for the ethical assessment tool. An interactive ethical technology assessment can provide an idea of what problems PHM-technology carries and who is affected thereby. It may also help to avoid certain problems and generate solutions as to how to alleviate/avoid or reduce the negative impact of the technology at hand. Furthermore, it may contribute to a fair distribution of benefits and drawbacks. Importantly, not only users benefit from ethical technology assessment but technology developers and care providers as well.
Next to the ethical assessment tool, a psycho-social health technology assessment tool on PHM applications has been developed. 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. The development of the tool is divided into three main steps, namely: con­structing, framing and staging the tool. The deliverable consisted of a map highlighting selective psycho-social issues that may appear when applying a PHM system.
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