Evaluation of ISO EN 13606 as a result of its implementation in XML.

The five parts of the ISO EN 13606 standard define a means by which health-care records can be exchanged between computer systems. Starting within the European standardisation process, it has now become internationally ratified in ISO. However, ISO standards do not require that a reference implementation be provided, and in order for ISO EN 13606 to deliver the expected benefits, it must be provided not as a document, but as an operational system that is not vendor specific. This article describes the evolution of an Extensible Markup Language (XML) Schema through three iterations, each of which emphasised one particular approach to delivering an executable equivalent to the printed standard. Developing these operational versions and incorporating feedback from users of these demonstrated where implementation compromises were needed and exposed defects in the standard. These are discussed herein. They may require a future technical revision to ISO EN 13606 to resolve the issues identified

An electronic healthcare record server implemented in PostgreSQL

This paper describes the implementation of an Electronic Healthcare Record server inside a PostgreSQL relational database without dependency on any further middleware infrastructure. The five-part international standard for communicating healthcare records (ISO EN 13606) is used as the information basis for the design of the server. We describe some of the features that this standard demands that are provided by the server, and other areas where assumptions about the durability of communications or the presence of middleware lead to a poor fit. Finally, we discuss the use of the server in two real-world scenarios including a commercial application

Archetype development and governance methodologies for the electronic health record

[ES] La interoperabilidad semántica de la información sanitaria es un requisito imprescindible para la sostenibilidad de la atención sanitaria, y es fundamental para afrontar los nuevos retos sanitarios de un mundo globalizado. Esta tesis aporta nuevas metodologías para abordar algunos de los aspectos fundamentales de la interoperabilidad semántica, específicamente aquellos relacionados con la definición y gobernanza de modelos de información clínica expresados en forma de arquetipo. Las aportaciones de la tesis son: - Estudio de las metodologías de modelado existentes de componentes de interoperabilidad semántica que influirán en la definición de una metodología de modelado de arquetipos. - Análisis comparativo de los sistemas e iniciativas existentes para la gobernanza de modelos de información clínica. - Una propuesta de Metodología de Modelado de Arquetipos unificada que formalice las fases de desarrollo del arquetipo, los participantes requeridos y las buenas prácticas a seguir. - Identificación y definición de principios y características de gobernanza de arquetipos. - Diseño y desarrollo de herramientas que brinden soporte al modelado y la gobernanza de arquetipos. Las aportaciones de esta tesis se han puesto en práctica en múltiples proyectos y experiencias de desarrollo. Estas experiencias varían desde un proyecto local dentro de una sola organización que requirió la reutilización de datos clínicos basados en principios de interoperabilidad semántica, hasta el desarrollo de proyectos de historia clínica electrónica de alcance nacional.[CA] La interoperabilitat semàntica de la informació sanitària és un requisit imprescindible per a la sostenibilitat de l'atenció sanitària, i és fonamental per a afrontar els nous reptes sanitaris d'un món globalitzat. Aquesta tesi aporta noves metodologies per a abordar alguns dels aspectes fonamentals de la interoperabilitat semàntica, específicament aquells relacionats amb la definició i govern de models d'informació clínica expressats en forma d'arquetip. Les aportacions de la tesi són: - Estudi de les metodologies de modelatge existents de components d'interoperabilitat semàntica que influiran en la definició d'una metodologia de modelatge d'arquetips. - Anàlisi comparativa dels sistemes i iniciatives existents per al govern de models d'informació clínica. - Una proposta de Metodologia de Modelatge d'Arquetips unificada que formalitza les fases de desenvolupament de l'arquetip, els participants requerits i les bones pràctiques a seguir. - Identificació i definició de principis i característiques de govern d'arquetips. - Disseny i desenvolupament d'eines que brinden suport al modelatge i al govern d'arquetips. Les aportacions d'aquesta tesi s'han posat en pràctica en múltiples projectes i experiències de desenvolupament. Aquestes experiències varien des d'un projecte local dins d'una sola organització que va requerir la reutilització de dades clíniques basades en principis d'interoperabilitat semàntica, fins al desenvolupament de projectes d'història clínica electrònica d'abast nacional.[EN] Semantic interoperability of health information is an essential requirement for the sustainability of healthcare, and it is essential to face the new health challenges of a globalized world. This thesis provides new methodologies to tackle some of the fundamental aspects of semantic interoperability, specifically those aspects related to the definition and governance of clinical information models expressed in the form of archetypes. The contributions of the thesis are: - Study of existing modeling methodologies of semantic interoperability components that will influence in the definition of an archetype modeling methodology. - Comparative analysis of existing clinical information model governance systems and initiatives. - A proposal of a unified Archetype Modeling Methodology that formalizes the phases of archetype development, the required participants, and the good practices to be followed. - Identification and definition of archetype governance principles and characteristics. - Design and development of tools that provide support to archetype modeling and governance. The contributions of this thesis have been put into practice in multiple projects and development experiences. These experiences vary from a local project inside a single organization that required a reuse on clinical data based on semantic interoperability principles, to the development of national electronic health record projects.This thesis was partially funded by the Ministerio de Economía y Competitividad, ayudas para contratos para la formación de doctores en empresas “Doctorados Industriales”, grant DI-14-06564 and by the Agencia Valenciana de la Innovación, ayudas del Programa de Promoción del Talento – Doctorados empresariales (INNODOCTO), grant INNTA3/2020/12.Moner Cano, D. (2021). Archetype development and governance methodologies for the electronic health record [Tesis doctoral]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/16491

Using the ResearchEHR platform to facilitate the practical application of the EHR standards

Possibly the most important requirement to support co-operative work among health professionals and institutions is the ability of sharing EHRs in a meaningful way, and it is widely acknowledged that standardization of data and concepts is a prerequisite to achieve semantic interoperability in any domain. Different international organizations are working on the definition of EHR architectures but the lack of tools that implement them hinders their broad adoption. In this paper we present ResearchEHR, a software platform whose objective is to facilitate the practical application of EHR standards as a way of reaching the desired semantic interoperability. This platform is not only suitable for developing new systems but also for increasing the standardization of existing ones. The work reported here describes how the platform allows for the edition, validation, and search of archetypes, converts legacy data into normalized, archetypes extracts, is able to generate applications from archetypes and finally, transforms archetypes and data extracts into other EHR standards. We also include in this paper how ResearchEHR has made possible the application of the CEN/ISO 13606 standard in a real environment and the lessons learnt with this experience. © 2011 Elsevier Inc..This work has been partially supported by the Spanish Ministry of Science and Innovation under Grants TIN2010-21388-C02-01 and TIN2010-21388-C02-02, and by the Health Institute Carlos in through the RETICS Combiomed, RD07/0067/2001. Our most sincere thanks to the Hospital of Fuenlabrada in Madrid, including its Medical Director Pablo Serrano together with Marta Terron and Luis Lechuga for their support and work during the development of the medications reconciliation project.Maldonado Segura, JA.; Martínez Costa, C.; Moner Cano, D.; Menárguez-Tortosa, M.; Boscá Tomás, D.; Miñarro Giménez, JA.; Fernández-Breis, JT.... (2012). Using the ResearchEHR platform to facilitate the practical application of the EHR standards. Journal of Biomedical Informatics. 45(4):746-762. doi:10.1016/j.jbi.2011.11.004S74676245

Applying an Archetype-Based Approach to Electroencephalography/Event-Related Potential Experiments in the EEGBase Resource

PURPOSE: The purpose of this study is to investigate the feasibility of applying openEHR (an archetype-based approach for electronic health records representation) to modeling data stored in EEGBase, a portal for experimental electroencephalography/event-related potential (EEG/ERP) data management. The study evaluates re-usage of existing openEHR archetypes and proposes a set of new archetypes together with the openEHR templates covering the domain. The main goals of the study are to (i) link existing EEGBase data/metadata and openEHR archetype structures and (ii) propose a new openEHR archetype set describing the EEG/ERP domain since this set of archetypes currently does not exist in public repositories. METHODS: The main methodology is based on the determination of the concepts obtained from EEGBase experimental data and metadata that are expressible structurally by the openEHR reference model and semantically by openEHR archetypes. In addition, templates as the third openEHR resource allow us to define constraints over archetypes. Clinical Knowledge Manager (CKM), a public openEHR archetype repository, was searched for the archetypes matching the determined concepts. According to the search results, the archetypes already existing in CKM were applied and the archetypes not existing in the CKM were newly developed. openEHR archetypes support linkage to external terminologies. To increase semantic interoperability of the new archetypes, binding with the existing odML electrophysiological terminology was assured. Further, to increase structural interoperability, also other current solutions besides EEGBase were considered during the development phase. Finally, a set of templates using the selected archetypes was created to meet EEGBase requirements. RESULTS: A set of eleven archetypes that encompassed the domain of experimental EEG/ERP measurements were identified. Of these, six were reused without changes, one was extended, and four were newly created. All archetypes were arranged in the templates reflecting the EEGBase metadata structure. A mechanism of odML terminology referencing was proposed to assure semantic interoperability of the archetypes. The openEHR approach was found to be useful not only for clinical purposes but also for experimental data modeling

Clinical information modeling processes for semantic interoperability of electronic health records: systematic review and inductive analysis

This is a pre-copyedited, author-produced PDF of an article accepted for publication in Journal of the American Medical Informatics Association following peer review. The version of record is available online at: http://dx.doi.org/10.1093/jamia/ocv008[EN] [Objective] This systematic review aims to identify and compare the existing processes and methodologies that have been published in the literature for defining clinical information models (CIMs) that support the semantic interoperability of electronic health record (EHR) systems. [Material and Methods] Following the preferred reporting items for systematic reviews and meta-analyses systematic review methodology, the authors reviewed published papers between 2000 and 2013 that covered that semantic interoperability of EHRs, found by searching the PubMed, IEEE Xplore, and ScienceDirect databases. Additionally, after selection of a final group of articles, an inductive content analysis was done to summarize the steps and methodologies followed in order to build CIMs described in those articles. [Results] Three hundred and seventy-eight articles were screened and thirty six were selected for full review. The articles selected for full review were analyzed to extract relevant information for the analysis and characterized according to the steps the authors had followed for clinical information modeling. [Discussion] Most of the reviewed papers lack a detailed description of the modeling methodologies used to create CIMs. A representative example is the lack of description related to the definition of terminology bindings and the publication of the generated models. However, this systematic review confirms that most clinical information modeling activities follow very similar steps for the definition of CIMs. Having a robust and shared methodology could improve their correctness, reliability, and quality. [Conclusion] Independently of implementation technologies and standards, it is possible to find common patterns in methods for developing CIMs, suggesting the viability of defining a unified good practice methodology to be used by any clinical information modeler.This research has been partially funded by the Instituto de Salud Carlos III (Platform for Innovation in Medical Technologies and Health), grant PT13/0006/0036 and the Spanish Ministry of Economy and Competitiveness, grants TIN2010-21388-C02-01 and PTQ-12-05620.Moreno-Conde, A.; Moner Cano, D.; Da Cruz, WD.; Santos, MR.; Maldonado Segura, JA.; Robles Viejo, M.; Kalra, D. (2015). Clinical information modeling processes for semantic interoperability of electronic health records: systematic review and inductive analysis. Journal of the American Medical Informatics Association. 22(4):925-934. https://doi.org/10.1093/jamia/ocv008S925934224Goossen W Goossen-Baremans A van der Zel M . Detailed clinical models: a review. Healthc Inform Res. 2010;16:201.Beeler, G. W. (1998). HL7 Version 3—An object-oriented methodology for collaborative standards development1Presented at the International Medical Informatics Association Working Group 16 Conference on Standardisation in Medical Informatics—Towards International Consensus and Cooperation, Bermuda, 12 September, 1997.1. International Journal of Medical Informatics, 48(1-3), 151-161. doi:10.1016/s1386-5056(97)00121-4Dolin, R. H., Alschuler, L., Boyer, S., Beebe, C., Behlen, F. M., Biron, P. V., & Shabo (Shvo), A. (2006). HL7 Clinical Document Architecture, Release 2. Journal of the American Medical Informatics Association, 13(1), 30-39. doi:10.1197/jamia.m1888Fast Health Interoperability Resources (FHIR). http://www.hl7.org/fhir/. Accessed July 18, 2014.Beale T . Archetypes: constraint-based domain models for futureproof information systems. OOPSLA 2002 Workshop Behav Semant. 2002.ISO 13606:2008 - Health informatics - Electronic health record communication. 2008. www.iso.org/iso/catalogue_detail.htm?csnumber=40784.OpenEHR. http://www.openehr.org/. Accessed July 18, 2014.Clinical Information Modeling Initiative (CIMI). http://www.opencimi.org/. Accessed July 18, 2014.Goossen WT . Using detailed clinical models to bridge the gap between clinicians and HIT. Stud Health Technol Inf. 2008;141:3–10.Oniki TA Coyle JF Parker CG . Lessons learned in detailed clinical modeling at Intermountain Healthcare. J Am Med Inform Assoc. 2014. Advance access published; doi:10.1136/amiajnl-2014-002875.Jacobson I Booch G Rumbaugh J . The Unified Software Development Process. Massachusetts, USA: Addison-Wesley Reading; 1999.Ahn, S., Huff, S. M., Kim, Y., & Kalra, D. (2013). Quality metrics for detailed clinical models. International Journal of Medical Informatics, 82(5), 408-417. doi:10.1016/j.ijmedinf.2012.09.006Kalra D . Editorial principles for the development of standards for the structure and content of health records. 2012. https://www.rcplondon.ac.uk/sites/default/files/documents/editorial-principles-for-the-development-of-record-standards.pdf. Accessed July 16, 2014.Moher, D., Liberati, A., Tetzlaff, J., & Altman, D. G. (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ, 339(jul21 1), b2535-b2535. doi:10.1136/bmj.b2535Transparent reporting of systematic reviews and meta-analyses (PRISMA). http://www.prisma-statement.org/. Accessed July 18, 2014.US National Library of Medicine. http://www.pubmed.gov. Accessed July 18, 2014.IEEE Xplore Digital Library. http://ieeexplore.ieee.org/. Accessed July 18, 2014.ScienceDirect. http://www.sciencedirect.com/. Accessed July 18, 2014.Elo, S., & Kyngäs, H. (2008). The qualitative content analysis process. Journal of Advanced Nursing, 62(1), 107-115. doi:10.1111/j.1365-2648.2007.04569.xRinner C Kohler M Hübner-Bloder G . Creating ISO/EN 13606 archetypes based on clinical information needs. In: Proceedings of EFMI Special Topic Conference, 14–15 April 2011, Lǎsko, Slovenia e-Health Across Borders Without Boundaries. 2011:14–15.Muñoz Carrero A Romero Gutiérrez A Marco Cuenca G . Manual práctico de interoperabilidad semántica para entornos sanitarios basada en arquetipos. Unidad de investigación en Telemedicina y e-Salud. Instituto de Salud Carlos III - Ministerio de Economía y Competitividad. 2013.Kalra D . Editorial principles for the development of standards for the structure and content of health records. 2012. https://www.rcplondon.ac.uk/sites/default/files/documents/editorial-principles-for-the-development-of-record-standards.pdf . Accessed July 18, 2015.Yuksel, M., & Dogac, A. (2011). Interoperability of Medical Device Information and the Clinical Applications: An HL7 RMIM based on the ISO/IEEE 11073 DIM. IEEE Transactions on Information Technology in Biomedicine, 15(4), 557-566. doi:10.1109/titb.2011.2151868Nagy M Hanzlicek P Precková P . Semantic interoperability in Czech healthcare environment supported by HL7 version 3. Methods Inf Med. 2010;49:186.LOPEZ, D., & BLOBEL, B. (2009). A development framework for semantically interoperable health information systems. International Journal of Medical Informatics, 78(2), 83-103. doi:10.1016/j.ijmedinf.2008.05.009Lopez DM Blobel B . Enhanced semantic interoperability by profiling health informatics standards. Methods Inf Med. 2009;48:170–177.Lopez DM Blobel B . Enhanced semantic interpretability by healthcare standards profiling. Stud Health Technol Inform. 2008;136:735.Knaup, P., Garde, S., & Haux, R. (2007). Systematic planning of patient records for cooperative care and multicenter research. International Journal of Medical Informatics, 76(2-3), 109-117. doi:10.1016/j.ijmedinf.2006.08.002Goossen, W. T. F., Ozbolt, J. G., Coenen, A., Park, H.-A., Mead, C., Ehnfors, M., & Marin, H. F. (2004). Development of a Provisional Domain Model for the Nursing Process for Use within the Health Level 7 Reference Information Model. Journal of the American Medical Informatics Association, 11(3), 186-194. doi:10.1197/jamia.m1085Anderson, H. V., Weintraub, W. S., Radford, M. J., Kremers, M. S., Roe, M. T., Shaw, R. E., … Tcheng, J. E. (2013). Standardized Cardiovascular Data for Clinical Research, Registries, and Patient Care. Journal of the American College of Cardiology, 61(18), 1835-1846. doi:10.1016/j.jacc.2012.12.047Jian, W.-S., Hsu, C.-Y., Hao, T.-H., Wen, H.-C., Hsu, M.-H., Lee, Y.-L., … Chang, P. (2007). Building a portable data and information interoperability infrastructure—framework for a standard Taiwan Electronic Medical Record Template. Computer Methods and Programs in Biomedicine, 88(2), 102-111. doi:10.1016/j.cmpb.2007.07.014Spigolon, D. N., & Moro, C. M. C. (2012). Arquétipos do conjunto de dados essenciais de enfermagem para atendimento de portadoras de endometriose. Revista Gaúcha de Enfermagem, 33(4), 22-32. doi:10.1590/s1983-14472012000400003Späth, M. B., & Grimson, J. (2011). Applying the archetype approach to the database of a biobank information management system. International Journal of Medical Informatics, 80(3), 205-226. doi:10.1016/j.ijmedinf.2010.11.002Smith, K., & Kalra, D. (2008). Electronic health records in complementary and alternative medicine. International Journal of Medical Informatics, 77(9), 576-588. doi:10.1016/j.ijmedinf.2007.11.005Bax, M. P., Kalra, D., & Santos, M. R. (2012). Dealing with the Archetypes Development Process for a Regional EHR System. Applied Clinical Informatics, 03(03), 258-275. doi:10.4338/aci-2011-12-ra-0074Moner D Moreno A Maldonado JA . Using archetypes for defining CDA templates. Stud Health Technol Inform. 2012;180:53–57.Moner D Maldonado JA Boscá D . CEN EN13606 normalisation framework implementation experiences. In: Seamless Care, Safe Care: The Challenges of Interoperability and Patient Safety in Health Care: Proceedings of the EFMI Special Topic Conference, June 2–4, 2010; Reykjavik, Iceland. IOS Press; 2010: 136.Marcos, M., Maldonado, J. A., Martínez-Salvador, B., Boscá, D., & Robles, M. (2013). Interoperability of clinical decision-support systems and electronic health records using archetypes: A case study in clinical trial eligibility. Journal of Biomedical Informatics, 46(4), 676-689. doi:10.1016/j.jbi.2013.05.004Leslie H . International developments in openEHR archetypes and templates. Health Inf Manag J. 2008;37:38.Kohl CD Garde S Knaup P . Facilitating secondary use of medical data by using openEHR archetypes. Stud Health Technol Inform. 2009;160:1117–1121.Garde, S., Hovenga, E., Buck, J., & Knaup, P. (2007). Expressing clinical data sets with openEHR archetypes: A solid basis for ubiquitous computing. International Journal of Medical Informatics, 76, S334-S341. doi:10.1016/j.ijmedinf.2007.02.004Garcia D Moro CM Cicogna PE . Method to integrate clinical guidelines into the electronic health record (EHR) by applying the archetypes approach. Stud Health Technol Inform. 2012;192:871–875.Duftschmid, G., Rinner, C., Kohler, M., Huebner-Bloder, G., Saboor, S., & Ammenwerth, E. (2013). The EHR-ARCHE project: Satisfying clinical information needs in a Shared Electronic Health Record System based on IHE XDS and Archetypes. International Journal of Medical Informatics, 82(12), 1195-1207. doi:10.1016/j.ijmedinf.2013.08.002Dias, R. D., Cook, T. W., & Freire, S. M. (2011). Modeling healthcare authorization and claim submissions using the openEHR dual-model approach. BMC Medical Informatics and Decision Making, 11(1). doi:10.1186/1472-6947-11-60Buck, J., Garde, S., Kohl, C. D., & Knaup-Gregori, P. (2009). Towards a comprehensive electronic patient record to support an innovative individual care concept for premature infants using the openEHR approach. International Journal of Medical Informatics, 78(8), 521-531. doi:10.1016/j.ijmedinf.2009.03.001Puentes, J., Roux, M., Montagner, J., & Lecornu, L. (2012). Development framework for a patient-centered record. Computer Methods and Programs in Biomedicine, 108(3), 1036-1051. doi:10.1016/j.cmpb.2012.06.007Liu, D., Wang, X., Pan, F., Yang, P., Xu, Y., Tang, X., … Rao, K. (2010). Harmonization of health data at national level: A pilot study in China. International Journal of Medical Informatics, 79(6), 450-458. doi:10.1016/j.ijmedinf.2010.03.002Liu, D., Wang, X., Pan, F., Xu, Y., Yang, P., & Rao, K. (2008). Web-based infectious disease reporting using XML forms. International Journal of Medical Informatics, 77(9), 630-640. doi:10.1016/j.ijmedinf.2007.10.011Kim, Y., & Park, H.-A. (2011). Development and Validation of Detailed Clinical Models for Nursing Problems in Perinatal care. Applied Clinical Informatics, 02(02), 225-239. doi:10.4338/aci-2011-01-ra-0007Khan, W. A., Hussain, M., Afzal, M., Amin, M. B., Saleem, M. A., & Lee, S. (2013). Personalized-Detailed Clinical Model for Data Interoperability Among Clinical Standards. Telemedicine and e-Health, 19(8), 632-642. doi:10.1089/tmj.2012.0189Jing, X., Kay, S., Marley, T., Hardiker, N. R., & Cimino, J. J. (2012). Incorporating personalized gene sequence variants, molecular genetics knowledge, and health knowledge into an EHR prototype based on the Continuity of Care Record standard. Journal of Biomedical Informatics, 45(1), 82-92. doi:10.1016/j.jbi.2011.09.001Hsu, W., Taira, R. K., El-Saden, S., Kangarloo, H., & Bui, A. A. T. (2012). Context-Based Electronic Health Record: Toward Patient Specific Healthcare. IEEE Transactions on Information Technology in Biomedicine, 16(2), 228-234. doi:10.1109/titb.2012.2186149Hoy D Hardiker NR McNicoll IT . Collaborative development of clinical templates as a national resource. Int J Med Inf. 2009;78:S3–S8.Buyl, R., & Nyssen, M. (2009). Structured electronic physiotherapy records. International Journal of Medical Informatics, 78(7), 473-481. doi:10.1016/j.ijmedinf.2009.02.007D’Amore JD Mandel JC Kreda DA . Are Meaningful Use Stage 2 certified EHRs ready for interoperability? Findings from the SMART C-CDA Collaborative. J Am Med Inform Assoc. 2014. Advance access published; doi:10.1136/amiajnl-2014-002883.Kalra D Tapuria A Austin T . Quality requirements for EHR archetypes. In: MIE; 2012: 48–52.Garde S Hovenga EJ Gränz J . Managing archetypes for sustainable and semantically interoperable electronic health records. Electron J Health Inform. 2007;2:e9.Madsen M Leslie H Hovenga EJS . Sustainable clinical knowledge management: an archetype development life cycle. Stud Health Technol Inform. 2010;151:115–132.Kohl CD Garde S Knaup P . Facilitating the openEHR approach-organizational structures for defining high-quality archetypes. Stud Health Technol Inform. 2008;136:437.Stroetmann VN Kalra D Lewalle P . Semantic interoperability for better health and safer healthcare. European Commission, Directorate-General Information Society and Media; 2009. http://dx.doi.org/10.2759/38514

A Two-Level Identity Model To Support Interoperability of Identity Information in Electronic Health Record Systems.

The sharing and retrieval of health information for an electronic health record (EHR) across distributed systems involves a range of identified entities that are possible subjects of documentation (e.g., specimen, clinical analyser). Contemporary EHR specifications limit the types of entities that can be the subject of a record to health professionals and patients, thus limiting the use of two level models in healthcare information systems that contribute information to the EHR. The literature describes several information modelling approaches for EHRs, including so called “two level models”. These models differ in the amount of structure imposed on the information to be recorded, but they generally require the health documentation process for the EHR to focus exclusively on the patient as the subject of care and this definition is often a fixed one. In this thesis, the author introduces a new identity modelling approach to create a generalised reference model for sharing archetype-constrained identity information between diverse identity domains, models and services, while permitting reuse of published standard-based archetypes. The author evaluates its use for expressing the major types of existing demographic reference models in an extensible way, and show its application for standards-compliant two-level modelling alongside heterogeneous demographics models. This thesis demonstrates how the two-level modelling approach that is used for EHRs could be adapted and reapplied to provide a highly-flexible and expressive means for representing subjects of information in allied health settings that support the healthcare process, such as the laboratory domain. By relying on the two level modelling approach for representing identity, the proposed design facilitates cross-referencing and disambiguation of certain demographics standards and information models. The work also demonstrates how it can also be used to represent additional clinical identified entities such as specimen and order as subjects of clinical documentation