Health and social care systems around the world undergo a transformation towards personalized, preventive, predictive, participative precision medicine (5PM), considering the individual health status, conditions, genetic and genomic dispositions in personal, social, occupational, environmental and behavioral context. For enabling communication and cooperation between actors from different domains using different methodologies, languages and ontologies based on different education, experiences, etc., we have to advance design and management of the resulting complex and highly dynamic ecosystem from data to knowledge level. The aforementioned transformation is strongly supported by technologies such as micro- and nanotechnologies, advanced computing, artificial intelligence, edge computing, etc. Beside their opportunities, those advanced technologies also bear risks to be managed. Beside the relationships between technology and human actors, the behavior of intelligent and autonomous systems must be considered from a humanistic, moral and ethical perspective. The challenge is the consistent, correct and formalized representation of the transformed health ecosystem from the perspectives of all domains involved including the legal and ethical ones, representing and managing them based on related ontologies. The resulting business view of the real-world ecosystem must be interrelated using the ISO/IEC 21838 Top Level Ontologies standard. Thereafter, the outcome can be transformed into implementable solutions. The different viewpoint are represented using viewpoint-specific ICT ontologies. The necessary model and framework has been developed by the author and meanwhile standardized as ISO 23903 Interoperability and Integration Reference Architecture. The formal representation of any ecosystem and its development process including examples of practical deployment of the approach are presented in detail. This includes correct systems and standards integration and interoperability solutions.

Bernd Blobel received a multi-disciplinary education, covering mathematics, physics, systems engineering, electronics, medicine, informatics and medical informatics, including habilitations in medicine and informatics. He was Head of the Institute for Biometrics and Medical Informatics at the University of Magdeburg, and then Head of the Health Telematics Project Group at the Fraunhofer IIS in Erlangen. Thereafter, he acted until his retirement as Head of the German National eHealth Competence Center at the University of Regensburg. He was leadingly involved in many countries health digitalization as well as electronic health record strategy. He was and is still engaged in international standardization at ISO, CEN, HL7, OMG, IEEE etc. Furthermore, he still engaged in international higher education. His publications can be found at https://epub.uni-regensburg.de/view/people/Blobel=3ABernd=3A=3A.html