Principles and standards for managing healthcare transformation towards personalized, preventive, predictive, participative precision medicine ecosystems

For realizing pervasive and ubiquitous health and social care services, health and social care system have to undergo an organizational, methodological and technological transformation towards personalized, participative, preventive, predictive precision medicine. For designing and managing the resulting highly complex, distributed and dynamic ecosystem, we must consistently and formally represent the system and its components from the perspective of all actors from different domains including the subject of care, using different methodologies, knowledge, language and experiences. The granularity level of the considered components may range from elementary particles up to the society and universe. This must be done, using a system-theoretical, architecture-centered, ontology-based and policy-driven approach. Over the last 30 years, the author developed the necessary model and framework, and meanwhile also the related standard ISO 23903 Interoperability and Integration Reference Architecture. The approach has been defined as mandatory for any specification or project at ISO, CEN, IEEE, etc. addressing more than one domain. The presented approach enables design, implementation and management of intelligent and ethical health and social care systems as well as knowledge-based communication and cooperation of all actors involved. Thereby, it manages also security, privacy and trust in detail. The Keynote introduces necessary standards and methodologies for designing and managing 5P medicine ecosystems as well as practical examples.