The ongoing transformation of health systems around the world aims at personalized, preventive, predictive, participative precision medicine, supported by technology. It considers individual health status, conditions, and genetic and genomic dispositions in personal, social, occupational, environmental and behavioral contexts. In this way, it transforms health and social care from art to science by fully understanding the pathology of diseases and turning health and social care from reactive to proactive. The challenge is the understanding and the formal as well as consistent representation of the world of sciences and practices, i.e., of multidisciplinary and dynamic systems in variable context. This enables mapping between the different disciplines, methodologies, perspectives, intentions, languages, etc., as philosophy or cognitive sciences do. The approach requires the deployment of advanced technologies including autonomous systems and artificial intelligence. This poses important ethical and governance challenges. This paper describes the aforementioned transformation of health and social care ecosystems as well as the related challenges and solutions, resulting in a sophisticated, formal reference architecture. This reference architecture provides a system-theoretical, architecture-centric, ontology-based, policy-driven model and framework for designing and managing intelligent and ethical ecosystems in general and health ecosystems in particular.

1st Medical Faculty Charles University of Prague 11000 Staré Město Czech Republic

Department of Biomedical Informatics University of Arkansas for Medical Sciences Little Rock AR 72205 USA

eHealth Competence Center Bavaria Deggendorf Institute of Technology 94469 Deggendorf Germany

Faculty of Information Technology and Communication Sciences Tampere University 33100 Tampere Finland

IBM Retired Tucson AZ 85750 USA

Informatics Institute Federal University of Rio Grande do Sul Porto Alegre 90040 060 Brazil

Medical Faculty University of Regensburg 93053 Regensburg Germany

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Principles and Standards for Designing and Managing Integrable and Interoperable Transformed Health Ecosystems