Abstract

Healthcare systems around the world are undergoing an organizational, methodological, and technological transformation towards personalized, preventive, predictive, and participative precision (5P) medicine ecosystems. These ecosystems consider individual health status, conditions, and genetic and genomic dispositions in personal social, occupational, environmental, and behavioral contexts. For designing and managing the resulting highly interdisciplinary, complex, distributed, and dynamic ecosystem, we must formally and consistently represent the system and its components at necessary granularity levels from the perspective of all actors, including the subject of care. As those actors from different domains have different education, skills, and experiences, using different methodologies, languages, and terminologies, communication and cooperation, i.e., interoperability, must advance from the data level (data sharing) to the knowledge level (knowledge sharing). To understand the business system, it must formally represent each used case structurally and functionally. Therefore, the design, implementation, and management of intelligent and ethically transformed ecosystems must be realized using a system-theoretical, architecture-centered, ontology-based, and policy-driven approach developed by the author over the last 30 years.

Meanwhile, the related model and framework have been standardized as the ISO 23903 Interoperability and Integration Reference Architecture, defined as mandatory for any specification or project at ISO, CEN, IEEE, OMG, etc., addressing more than one domain. Thereby, it also manages security, privacy, and trust in detail. The Keynote introduces necessary standards and methodologies for designing and managing 5P medicine ecosystems and practical examples.