The Representational Challenge for Designing and Managing 5P Medicine Ecosystems.

Health and social care systems around the globe currently undergo a transformation towards personalized, preventive, predictive, participative precision medicine (5PM), considering the individual health status, conditions, genetic and genomic dispositions, etc., in personal, social, occupational, environmental and behavioral context. This transformation is strongly supported by technologies such as micro- and nanotechnologies, advanced computing, artificial intelligence, edge computing, etc. 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 understand the transformed health ecosystems and all its components in structure, function and relationships in the necessary detail ranging from elementary particles up to the universe. That way, we advance design and management of the complex and highly dynamic ecosystem from data to knowledge level. The challenge is the consistent, correct and formalized representation of the transformed health ecosystem from the perspectives of all domains involved, 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 using the ISO/IEC 10746 Open Distributed Processing Reference Model. Model and framework for this system-oriented, architecture-centric, ontology-based, policy-driven approach have been developed by the first author and meanwhile standardized as ISO 23903 Interoperability and Integration Reference Architecture.

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

The advancement of sciences and technologies, economic challenges, increasing expectations, and consumerism result in a radical transformation of health and social care around the globe, characterized by foundational organizational, methodological, and technological paradigm changes. The transformation of the health and social care ecosystems aims at ubiquitously providing personalized, preventive, predictive, participative precision (5P) medicine, considering and understanding the individual's health status in a comprehensive context from the elementary particle up to society. For designing and implementing such advanced ecosystems, an understanding and correct representation of the structure, function, and relations of their components is inevitable, thereby including the perspectives, principles, and methodologies of all included disciplines. To guarantee consistent and conformant processes and outcomes, the specifications and principles must be based on international standards. A core standard for representing transformed health ecosystems and managing the integration and interoperability of systems, components, specifications, and artifacts is ISO 23903:2021, therefore playing a central role in this publication. Consequently, ISO/TC 215 and CEN/TC 251, both representing the international standardization on health informatics, declared the deployment of ISO 23903:2021 mandatory for all their projects and standards addressing more than one domain. The paper summarizes and concludes the first author's leading engagement in the evolution of pHealth in Europe and beyond over the last 15 years, discussing the concepts, principles, and standards for designing, implementing, and managing 5P medicine ecosystems. It not only introduces the theoretical foundations of the approach but also exemplifies its deployment in practical projects and solutions regarding interoperability and integration in multi-domain ecosystems. The presented approach enables comprehensive and consistent integration of and interoperability between domains, systems, related actors, specifications, standards, and solutions. That way, it should help overcome the problems and limitations of data-centric approaches, which still dominate projects and products nowadays, and replace them with knowledge-centric, comprehensive, and consistent ones.

An ontological approach to manage and harmonize document types.

Working interoperability when consuming resources of different document types requires a harmonized understanding of their structures and contents. But sometimes, a specification has not made the underlying model explicit which would enable a coherent understanding. This paper analyses the commonly used structures of different document types and proposes an ontological structure resulting in the so-called Document Type Ontology (DTO). This solution is based on the Generic Component Model (GCM) as an architectural framework and the Communication Standards Ontology (CSO) and Basic Formal Ontology (BFO) presented earlier.

A system-theoretical, architecture-based approach to ontology management.

Comprehensive interoperability between distributed eHealth/pHealth environments requires that the systems involved are based on a common architectural framework and share common knowledge. The paper deals with the representation of systems by related ontologies. Therefore, the architectural principles ruling the system design and the interrelations of its components also rule the design of those ontologies and their management as exemplified.

Modeling digital health systems to foster interoperability.

Information systems are a complex thing, and they are mostly not used stand-alone anymore. In that context, many different issues must be considered. It starts with defining the system's purpose, includes the use cases and scenarios in combination with the necessary data ideally separated into distinct domains. Furthermore, it requires the selection of an appropriate set of supporting components/tools and a development environment including some technology to enable continuous integration. And the endeavor does not come to an end with the development of the system itself. To manage those challenges, thinking about design and architectural principles becomes a mandatory element. The situation gets more complicated with growing expectations regarding communication and cooperation between the more and more complex and dynamic ecosystem's actors. The resulting information system has to adhere to different, sometimes contradictory principles and requirements, frequently controlled by different authorities. This paper focuses less on developing information systems in general but concentrates on the aspects that must be considered when multiple requirements from different stakeholders for data exchange and knowledge sharing for advanced interoperability must be met. The latter is commonly underspecified due to missing proper verification of the correct interpretation of data. One intent of the paper is to promote the deployment of information models as a common basis to derive data exchange specifications establishing advanced interoperability. However, it also addresses the necessity to guarantee that the information models and implementable artifacts correctly represent the intended functions and objectives as well as the underlying concepts of the business system in its prevailing context. Therefore, we cannot limit our considerations on the data and information viewpoints.

Transformation of Health and Social Care Systems-An Interdisciplinary Approach Toward a Foundational Architecture.

Objective: For realizing pervasive and ubiquitous health and social care services in a safe and high quality as well as efficient and effective way, health and social care systems have to meet new organizational, methodological, and technological paradigms. The resulting ecosystems are highly complex, highly distributed, and highly dynamic, following inter-organizational and even international approaches. Even though based on international, but domain-specific models and standards, achieving interoperability between such systems integrating multiple domains managed by multiple disciplines and their individually skilled actors is cumbersome. Methods: Using the abstract presentation of any system by the universal type theory as well as universal logics and combining the resulting Barendregt Cube with parameters and the engineering approach of cognitive theories, systems theory, and good modeling best practices, this study argues for a generic reference architecture model moderating between the different perspectives and disciplines involved provide on that system. To represent architectural elements consistently, an aligned system of ontologies is used. Results: The system-oriented, architecture-centric, and ontology-based generic reference model allows for re-engineering the existing and emerging knowledge representations, models, and standards, also considering the real-world business processes and the related development process of supporting IT systems for the sake of comprehensive systems integration and interoperability. The solution enables the analysis, design, and implementation of dynamic, interoperable multi-domain systems without requesting continuous revision of existing specifications.

Character sets: an invisible pre-requisite towards cross-border interoperability?

Working interoperability not only requires harmonized system's architectures, but also the same interpretation of technical specifications in order to guide the development process. This paper analyzes the role individual characters play as the bearer of data in general and information in specific. This aspect of interoperability is especially important in the context of cross-border communication and collaboration.

A formal analysis of HL7 version 2.x.

Working interoperability not only requires harmonized system's architectures, but also the same interpretation of technical specifications in order to guide the development processes. But sometimes a specification has not made the underlying model explicit which would enable a coherent understanding. This paper analyses the structures of the HL7 Version 2.x communication standard's family and presents an UML class diagram for it.

Harmonizing the semantics of technical terms by the generic component model.

Working interoperability not only requires harmonized system's architectures, but also the same interpretation of technical specifications in order to guide the development process. This paper analyzes the commonly used terms to introduce different kinds of coded concepts by an alignment with the Generic Component Model (GCM).

A communication standards ontology using basic formal ontologies.

Working interoperability not only requires harmonized system's architectures, but also the same interpretation of technical specifications in order to guide the development process. This paper analyses the commonly used structures of communication standards elaborated with HL7 Version 3 and proposes an ontological structure resulting in the so-called Communication Standards Ontology (CSO). As such a solution has to be developed within an architectural framework, the approach is aligned with the Generic Component Model (GCM).

What is missing in health informatics standardization for pHealth?

Health systems turn everywhere, but with different speed, from organization-centered to personalized eHealth or pHealth, i.e. ubiquitous care delivery independent of time and location of the resources involved. As interoperability is an important issue in such distributed, fully integrated, intelligent and individualized environment, pHealth solutions have to comply with advanced architectural solutions based on international standards. Representing concepts and their interrelations, such architectural framework perspectives' system architecture, domains, and development process can be described by the domains' ontologies. Therefore, advanced interoperability approaches have to refer to ontology principles, finally resulting in ontology-driven approaches to semantically interoperable and sustainable health information systems. The paper investigates functional requirements, interoperability levels, architectural approaches to pHealth systems, thereby analyzing and classifying related existing or emerging standards.

The role of architecture and ontology for interoperability.

Turning from organization-centric to process-controlled or even to personalized approaches, advanced healthcare settings have to meet special interoperability challenges. eHealth and pHealth solutions must assure interoperability between actors cooperating to achieve common business objectives. Hereby, the interoperability chain also includes individually tailored technical systems, but also sensors and actuators. For enabling corresponding pervasive computing and even autonomic computing, individualized systems have to be based on an architecture framework covering many domains, scientifically managed by specialized disciplines using their specific ontologies in a formalized way. Therefore, interoperability has to advance from a communication protocol to an architecture-centric approach mastering ontology coordination challenges.

The need for standardised documents in continuity of care: results of standardising the eNursing summary.

Continuity of care is a concept that is defined as the uninterrupted and coordinated care provided to a patient and that includes an informational dimension which describes the information exchange between the parties involved. In nursing, the nursing summary is the main instrument to ensure informational continuity of care. The aim of this paper is to present an HL7 Clinical Document Architecture based document standard for the eNursing Summary and to discuss the need for harmonizing these results at international level. The eNursing Summary proposed in this paper was developed on the basis of several internationally accepted concepts, primarily the nursing process, the ISO 18104 Reference Terminology Model for Nursing and various data sets. The standardisation process embraced several phases of involving nursing experts for validating its structure and content. It was finally evaluated by a network of 100 healthcare organizations. We argue that the eNursing Summary is a good starting point for standardising nursing discharge and transfer documents on a global level. However, further work is needed to bring together the different national and international strands in standardisation. .

The Value of Domain Information Models for Achieving Interoperability.

The value of data models in general and information models in specific has been evaluated by many scientific papers. UML as one modelling notation has documented its value as a foundation for precise specifications. Analyzing implementation guides for data exchange, they rarely include or are based on information models but simple data sets, if at all, as simple technical representation thereof. This paper wants to argue in favor of information models as a basis for creating interoperability specifications using a quite simple example and to include - or at least reference - them when providing implementation guides. The reader is invited to transfer this example to even more complex scenarios.

Why Interoperability at Data Level Is Not Sufficient for Enabling pHealth?

Multidisciplinary and highly dynamic pHealth ecosystems according to the 5P Medicine paradigm require careful consideration of systems integration and interoperability within the domains knowledge space. The paper addresses the different aspects or levels of knowledge representation (KR) and management (KM) from cognitive theories (theories of knowledge) and modeling processes through notation up to processing, tooling and implementation. Thereby, it discusses language and grammar challenges and constraints, but also development process aspects and solutions, so demonstrating the limitation of data level considerations. Finally, it presents the ISO 23903 Interoperability and Integration Reference Architecture to solve the addressed problems and to correctly deploy existing standards and work products at any representational level including data models as well as data model integration and interoperability.

Autonomous Systems and Artificial Intelligence in Healthcare Transformation to 5P Medicine - Ethical Challenges.

The paper introduces a structured approach to transforming healthcare towards personalized, preventive, predictive, participative precision (P5) medicine and the related organizational, methodological and technological requirements. Thereby, the deployment of autonomous systems and artificial intelligence is inevitably. The paper discusses opportunities and challenges of those technologies from a humanistic and ethical perspective. It shortly introduces the essential concepts and principles, and critically discusses some relevant projects. Finally, it offers ways for correctly representing, specifying, implementing and deploying autonomous and intelligent systems under an ethical perspective.

Ontology-driven health information systems architectures.

Following an architecture vision such as the Generic Component Model (GCM) architecture framework, health information systems for supporting personalized care have to be based on a component-oriented architecture. Representing concepts and their interrelations, the GCM perspectives system architecture, domains, and development process can be described by the domains' ontologies. The paper introduces ontology principles, ontology references to the GCM as well as some practical aspects of ontology-driven approaches to semantically interoperable and sustainable health information systems.

Semantic interoperability between health communication standards through formal ontologies.

The paper shortly analyses the HL7 communication standards for resolving the gap between them by developing a set of ontologies reflecting the concepts and relationships which is exemplified with the incompatible HL7 versions 2.x and 3. Bridging between the different ontologies is performed by introducing a reference ontology to which a mapping is defined. The paper discusses problems and solutions which appeared during the development process.

HL7 Version 2.x Goes FHIR.

Although HL7 v2.x has been in use for more than 25 years and is thus probably the most widely used data exchange standard in the healthcare domain, there are still ongoing discussions about technical terminology, i.e., how exactly individual specifications are to be interpreted. This has led to the idea of modernizing the specification/standard without requiring any change in implementations. In other words, formalize the standard using words that are easier to understand. In parallel, the coexistence with the upcoming FHIR standard triggers modifications within HL7 v2.x. This paper explores the interaction between the modernization of HL7 v2.x and the convergence with FHIR.

Data Modeling Challenges of Advanced Interoperability.

Progressive health paradigms, involving many different disciplines and combining multiple policy domains, requires advanced interoperability solutions. This results in special challenges for modeling health systems. The paper discusses classification systems for data models and enterprise business architectures and compares them with the ISO Reference Architecture. On that basis, existing definitions, specifications and standards of data models for interoperability are evaluated and their limitations are discussed. Amendments to correctly use those models and to better meet the aforementioned challenges are offered.