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.

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.

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.

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.

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.

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.

Requirements and Solutions for Personalized Health Systems.

Organizational, methodological and technological paradigm changes enable a precise, personalized, predictive, preventive and participative approach to health and social services supported by multiple actors from different domains at diverse level of knowledge and skills. Interoperability has to advance beyond Information and Communication Technologies (ICT) concerns, including the real world business domains and their processes, but also the individual context of all actors involved. The paper introduces and compares personalized health definitions, summarizes requirements and principles for pHealth systems, and considers intelligent interoperability. It addresses knowledge representation and harmonization, decision intelligence, and usability as crucial issues in pHealth. On this basis, a system-theoretical, ontology-based, policy-driven reference architecture model for open and intelligent pHealth ecosystems and its transformation into an appropriate ICT design and implementation is proposed.

Compliance or Conformance: What Should Interoperability Focus on?

Using communication standards is normally combined with the expectation that interfaces implementing them are interoperable. This paper examines why this is not the case and what must be done to overcome this problem. It ends with a conclusion and recommendations for future developments.

How to Work with Vocabulary Correctly, Exemplified with Gender Coding?

Popular data exchange standards facilitate the use of vocabulary in different ways. Quite often, the usage is based on, and in favor of, simple implementations not considering reality. In most cases the vocabulary is assembled in form of simple code lists. Well-known bad practice is neither to define proper concept descriptions for the individual codes leaving their interpretation to the developer nor to identify the underlying vocabulary domain resulting in a mixture of something. This paper takes the gender use case and analyses the use of codes within some data exchange standards and makes recommendations for improvements in handling and managing code systems correctly.

The importance of architectures for interoperability.

The paradigm changes health systems are faced with result in highly complex and distributed systems requiring flexibility, autonomy, but first of all advanced interoperability. In that context, understanding the architecture of the system to be supported as well as the process to meet the intended business objectives is crucial. Unfortunately, there is a lot of confusion around the term architecture, which doesn't facilitate the integration of systems. Using a reference architecture model and framework, relevant existing architectural approaches are analyzed, compared and critically discussed, but also harmonized using a reference architectural model and framework.

Why do we need and how can we realize a multi-disciplinary approach to health informatics?

Like no other area, health and social care are characterized by a multi-disciplinary nature. This development gets even stronger by the move towards a personalized, predictive, preventive and participative care paradigm as well as by organizational and technological changes leading to highly distributed care setting realized by multiple stakeholder communities from different policy domains. Those paradigm changes result in growing interoperability challenges when enabling communication and cooperation of all the different actors based on shared knowledge and skills. For meeting those challenges, a systems-oriented, architecture-centric, ontology-based and policy-driven approach in health informatics education, but also in modeling, implementing and maintaining health informatics interoperability is inevitable. The paper introduces the aforementioned concepts.

Representing the Glasgow Coma Scale in IT: Proper Specification is Required for Assessment Scales.

In healthcare a huge amount of assessment scales and score systems are in use to abbreviate and summarize the results of clinical observations to interpret a patient's condition in a valid and reliable manner. It is challenging to convey the information in a semantic interoperable form to other systems. A bad approach would be to invent individual models for each of them. Within this paper we would like to demonstrate that a generic model is sufficient by demonstrating the realization with the Glasgow Coma Scale.

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.

Establishing semantic interoperability between HL7 v2. x and V3: a communication standards ontology (CSO) / Estabelecer a interoperabilidade semântica entre HL7 v2.x e V3: uma ComunicaçãoOntology Standards (CSO) / Establecimiento de la interoperabilidad semántica entre HL7 v2.x y v3: una Comunicación Normas deOntología (OSC)

Different communication standards in healthcare - esp. HL7 version 2.x and v3 - lack inter- and intra-family compatibility. Bridging between those to establish semantic interoperability using a formal ontology as a mediator in a mapping process has demonstrated that both communication standards have in principle the same underlying architecture. This paper shortly analyses this structure in order to create a communication standards ontology (CSO) based on (basic) formal ontologies (BFO/FO) which is presented thereafter. The paper discusses problems which appeared during the development process and the established solution.

Diferentes padrões de comunicação em saúde como o HL7 versão 2 e a versão 3, falham em compatibilidade inter e intrafamiliar. Unificações entre a interoperabilidade semântica estabelecida usando uma ontologia formal como um mediador no processo de mapeamento tem demonstrado que os padrões de comunicação tem em princípio, a mesma arquitetura de apoio. Este artigo analisa brevemente esta estrutura para criar um padrão de ontologia de comunicação baseado em ontologias formais apresentadas. O artigo discute problemas que surgiram durante o processo de desenvolvimento e a solução estabelecida.

Los diferentes patrones de comunicación para la salud como la versión 2 de HL7 y la versión 3, no a la compatibilidad inter e intra-familiar. Unificaciones entre la interoperabilidad semántica realiza mediante una ontología formal como médico en el proceso de asignación ha demostrado que los patrones de comunicación son, en principio, compatibles con la arquitectura misma. En este artículo se considera que esta estructura para crear una ontología estándar de la Comunicación basados en ontologías formales presentadas. El artículo analiza los problemas que surgieron durante el proceso de desarrollo y el conjunto de soluciones.

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.

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.