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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.

Background: The lack of an international standard for assessing and communicating health app quality and the lack of consensus about what makes a high-quality health app negatively affect the uptake of such apps. At the request of the European Commission, the international Standard Development Organizations (SDOs), European Committee for Standardization, International Organization for Standardization, and International Electrotechnical Commission have joined forces to develop a technical specification (TS) for assessing the quality and reliability of health and wellness apps., Objective: This study aimed to create a useful, globally applicable, trustworthy, and usable framework to assess health app quality., Methods: A 2-round Delphi technique with 83 experts from 6 continents (predominantly Europe) participating in one (n=42, 51%) or both (n=41, 49%) rounds was used to achieve consensus on a framework for assessing health app quality. Aims included identifying the maximum 100 requirement questions for the uptake of apps that do or do not qualify as medical devices. The draft assessment framework was built on 26 existing frameworks, the principles of stringent legislation, and input from 20 core experts. A follow-up survey with 28 respondents informed a scoring mechanism for the questions. After subsequent alignment with related standards, the quality assessment framework was tested and fine-tuned with manufacturers of 11 COVID-19 symptom apps. National mirror committees from the 52 countries that participated in the SDO technical committees were invited to comment on 4 working drafts and subsequently vote on the TS., Results: The final quality assessment framework includes 81 questions, 67 (83%) of which impact the scores of 4 overarching quality aspects. After testing with people with low health literacy, these aspects were phrased as "Healthy and safe," "Easy to use," "Secure data," and "Robust build." The scoring mechanism enables communication of the quality assessment results in a health app quality score and label, alongside a detailed report. Unstructured interviews with stakeholders revealed that evidence and third-party assessment are needed for health app uptake. The manufacturers considered the time needed to complete the assessment and gather evidence (2-4 days) acceptable. Publication of CEN-ISO/TS 82304-2:2021 Health software - Part 2: Health and wellness apps - Quality and reliability was approved in May 2021 in a nearly unanimous vote by 34 national SDOs, including 6 of the 10 most populous countries worldwide., Conclusions: A useful and usable international standard for health app quality assessment was developed. Its quality, approval rate, and early use provide proof of its potential to become the trusted, commonly used global framework. The framework will help manufacturers enhance and efficiently demonstrate the quality of health apps, consumers, and health care professionals to make informed decisions on health apps. It will also help insurers to make reimbursement decisions on health apps., (©Petra Hoogendoorn, Anke Versluis, Sanne van Kampen, Charles McCay, Matt Leahy, Marlou Bijlsma, Stefano Bonacina, Tobias Bonten, Marie-José Bonthuis, Anouk Butterlin, Koen Cobbaert, Thea Duijnhoven, Cynthia Hallensleben, Stuart Harrison, Mark Hastenteufel, Terhi Holappa, Ben Kokx, Birgit Morlion, Norbert Pauli, Frank Ploeg, Mark Salmon, Kyma Schnoor, Mary Sharp, Pier Angelo Sottile, Alpo Värri, Patricia Williams, Georg Heidenreich, Nicholas Oughtibridge, Robert Stegwee, Niels H Chavannes. Originally published in JMIR Formative Research (https://formative.jmir.org), 23.01.2023.)

In addition to the meaning as Health Informatics Society of Australia, HISA is the acronym used for the new European Standard: Health Informatics - Service Architecture. This EN 12967 standard has been developed by CEN - the federation of 29 national standards bodies in Europe. This standard defines the essential elements of a Service Oriented Architecture and a methodology for localization particularly useful for large healthcare organizations. It is based on the Open Distributed Processing (ODP) framework from ISO 10746 and contains the following parts: Part 1: Enterprise viewpoint. Part 2: Information viewpoint. Part 3: Computational viewpoint. This standard is now also the starting point for the consideration for an International standard in ISO/TC 215. The basic principles with a set of health specific middleware services as a common platform for various applications for regional health information systems, or large integrated hospital information systems, are well established following a previous prestandard. Examples of large scale deployments in Sweden, Denmark and Italy are described.

Information and Communication Technology (ICT) in healthcare represents a fundamental and highly qualifying pre-requisite for enabling the interoperability of information systems, the continuity of the caring process to the patient over the territory, the creation of an integrated electronic healthcare record, as well as the monitoring and optimisation of the organisational and economical aspects of healthcare enterprises. This paper presents a European architectural strategy for healthcare information systems, capable of facilitating the evolution of the existing procedures and their smooth integration into a homogeneous information and functional infrastructure, without requiring major modifications in already existing modules and protecting, therefore, previous investments.

The management of clinical data is a complex task. Patient related information reported in patient folders is a set of heterogeneous and structured data accessed by different users having different goals (in local or geographical networks). XML language provides a mechanism for describing, manipulating, and visualising structured data in web-based applications. XML ensures that the structured data is managed in a uniform and transparent manner independently from the applications and their providers guaranteeing some interoperability. Extracting data from the healthcare record and structuring them according to XML makes the data available through browsers. The MIC/MIE model (Medical Information Category/Medical Information Elements), which allows the definition and management of healthcare records and used in CADMIO, a HISA based project, is described in this paper, using XML for allowing the data to be visualised through web browsers.

Objectives: This paper reports on the integration work required to support the delivery of healthcare. Specifically, four elements are included being: the DHE (a standards based distributed healthcare environment), Synapses which is a patient record server, XML as a technology to deliver records, and finally two client applications that facilitate structured data entry (SDE) and the remote booking of specialist services., Methods: A general motivation for the work is presented and augmented on hand of a clinical scenario. Additionally, the adoption of a middleware approach is reviewed. The role of computerised patient records is described followed by an account of a federated record server. The approach favoured by standards bodies in utilising XML is covered and the tailoring to suit the needs of the integration is explained. The main practical challenges in achieving integration are presented, one of these being the mapping between the DHE data model and the Synapses server record architecture., Results: The described environment has been demonstrated to provide the functionality that is required and in addition it has been shown that the engineering challenges can be met in a controlled and orderly manner., Conclusions: The role of the DHE middleware component acting as an 'anchor' has been shown to be a valid one onto which other specialised components can be added to provide a richer service environment. Additionally, it has been demonstrated that XML is a good candidate technology that facilitates connectivity to client applications over an extranet. The demands inherent in both the clinical scenario and the computerised patient record can be met by the computing environment described in the paper.

This paper highlights the scenario implemented by the hospitals of the Copenhagen Hospital Corporation (H:S), for allowing the integration and interoperability of legacy and new systems, based on the establishing of a common and open information asset according to the CEN HISA standard and on top of the DHE middleware.

Middleware is now a commonly used expression and anyone building distributed applications is referring to 'middleware services'. Nevertheless this notion lacks of sound theoretical foundation. This paper tries to clarify the relationship between the components of distributed environments, especially in healthcare and to establish some classification aiming at gaining a common understanding of the functionality and interdependency of the existing modules of distributed environments. A case study is presented and the potential benefits of using a middleware approach are discussed.

The integration and evolution of existing systems represents one of the most urgent problems facing those responsible for healthcare information systems so that the needs of the whole organisation are addressed. The management of the healthcare record represents one of the major requirements in the overall process, however it is also necessary to ensure that the healthcare record and other healthcare information is integrated within the context of an overall healthcare information system. The CEN ENV 12967-1 'Healthcare Information Systems Architecture' standard defines a holistic architectural approach where the various, organisational, clinical, administrative and managerial requirements co-exist and cooperate, relying on a common heritage of information and services. This paper reviews the middleware-based approach adopted by CEN ENV 12967-1 and the specialisation necessary for the healthcare record based on CEN ENV 12265 'Electronic Healthcare Record Architecture'.

Middleware is now a commonly used expression and anyone building distributed applications is referring to "middleware services". Nevertheless this notion lacks of sound theoretical foundation. This paper tries to clarify the relationship between the components of distributed environments, especially in healthcare, and to establish some classification aiming at gaining a common understanding of the functionalities and interdependency of the existing modules of distributed environments.

The Electronic Healthcare Record will increasingly lie at the heart of the Healthcare Information Systems of the future, and the ability to share safely and meaningfully patient records between Hospital Information Systems depends crucially on an agreed architecture for EHCR. This paper describes the approach to providing access to Federated Healthcare Records as proposed by Synapses, a pan-European project funded under the EU Health Telematics Programme, through the use of a record server. The positioning of this server within the Healthcare Information Systems Architecture is discussed together with some suitable candidate technologies for implementation.