Abstract:

The aspects to be considered in human-centered technology development extend to ethical as well as legal and social implications (ELSI). In such an approach, future users are involved in the development process from the very beginning to align the technology with the end-users’ needs. This constitutes an important educational process of both understanding how end-users interact with new technologies and how developers can tune their design to increase usability and acceptance. In this context, the transnational project PerHeart, funded under the ERAPerMed program, involves end-users and consortium partners in a common learning experience which puts heart failure (HF) patients at the very center of developing a personalized information and communication technology (ICT) solution. The solution aims to reduce re-hospitalization rates in discharged HF-patients and to detect specific risk factors by addressing all four aspects of personalized medicine (PMed): predictive, preventive, personalized and participatory (4P). Values such as privacy, well-being, user-friendliness, informed consensus, autonomy, equity of access and trust, and even gender aspects as part of the ethical implications, are to be systematically considered in the design and incorporated into the development of the PerHeart platform. The ethical technology assessment relates not only to the individual perspective of the users, but also to aspects on societal and organizational level. The different ethical perspectives with sometimes conflicting moral needs and requirements reveal the complexity of the area.

PerHeart educates and supports HF patients in self-managing their disease and in adhering to therapy and lifestyle changes while providing real-time personalized feedback for patients and caregivers. In addition to this, specific risk factors for readmission are elucidated by revealing new physiological targets or characteristic patient profiles for focused intervention. By making this data freely available to the research community, PerHeart strives to ensure a long-term educational impact also for the medical community.

Given the enormous individual as well as overall societal importance of health data, ELSI are among the focuses of the PerHeart project and of particular relevance for vulnerable user groups like HF patients. For this reason, an ELSI criteria catalog is formulated within the framework of the project by learning about the needs and requirements of the user groups through social science research methods and expert discussions. An overview of the PerHeart platform and initial results towards the project’s final ELSI criteria catalogue are presented in this paper.

Keywords:

Learning experience, reduce re-hospitalization, personalized medicine.