DETAILED CLINICAL MODELS AND THEIR RELATION WITH ELECTRONIC HEALTH RECORDS

Tesis por compendio[EN] Healthcare domain produces and consumes big quantities of people's health data. Although data exchange is the norm rather than the exception, being able to access to all patient data is still far from achieved. Current developments such as personal health records will introduce even more data and complexity to the Electronic Health Records (EHR). Achieving semantic interoperability is one of the biggest challenges to overcome in order to benefit from all the information contained in the distributed EHR. This requires that the semantics of the information can be understood by all involved parties. It has been stablished that three layers are needed to achieve semantic interoperability: Reference models, clinical models (archetypes), and clinical terminologies. As seen in the literature, information models (reference models and clinical models) are lacking methodologies and tools to improve EHR systems and to develop new systems that can be semantically interoperable. The purpose of this thesis is to provide methodologies and tools for advancing the use of archetypes in three different scenarios: - Archetype definition over specifications with no dual model architecture native support. Any EHR architecture that directly or indirectly has the notion of detailed clinical models (such as HL7 CDA templates) can be potentially used as a reference model for archetype definition. This allows transforming single-model architectures (which contain only a reference model) into dual-model architectures (reference model with archetypes). A set of methodologies and tools has been developed to support the definition of archetypes from multiple reference models. - Data transformation. A complete methodology and tools are proposed to deal with the transformation of legacy data into XML documents compliant with the archetype and the underlying reference model. If the reference model is a standard then the transformation is a standardization process. The methodologies and tools allow both the transformation of legacy data and the transformation of data between different EHR standards. - Automatic generation of implementation guides and reference materials from archetypes. A methodology for the automatic generation of a set of reference materials is provided. These materials are useful for the development and use of EHR systems. These reference materials include data validators, example instances, implementation guides, human-readable formal rules, sample forms, mindmaps, etc. These reference materials can be combined and organized in different ways to adapt to different types of users (clinical or information technology staff). This way, users can include the detailed clinical model in their organization workflow and cooperate in the model definition. These methodologies and tools put clinical models as a key part of the system. The set of presented methodologies and tools ease the achievement of semantic interoperability by providing means for the semantic description, normalization, and validation of existing and new systems.[ES] El sector sanitario produce y consume una gran cantidad de datos sobre la salud de las personas. La necesidad de intercambiar esta información es una norma más que una excepción, aunque este objetivo está lejos de ser alcanzado. Actualmente estamos viviendo avances como la medicina personalizada que incrementarán aún más el tamaño y complejidad de la Historia Clínica Electrónica (HCE). La consecución de altos grados de interoperabilidad semántica es uno de los principales retos para aprovechar al máximo toda la información contenida en las HCEs. Esto a su vez requiere una representación fiel de la información de tal forma que asegure la consistencia de su significado entre todos los agentes involucrados. Actualmente está reconocido que para la representación del significado clínico necesitamos tres tipos de artefactos: modelos de referencia, modelos clínicos (arquetipos) y terminologías. En el caso concreto de los modelos de información (modelos de referencia y modelos clínicos) se observa en la literatura una falta de metodologías y herramientas que faciliten su uso tanto para la mejora de sistemas de HCE ya existentes como en el desarrollo de nuevos sistemas con altos niveles de interoperabilidad semántica. Esta tesis tiene como propósito proporcionar metodologías y herramientas para el uso avanzado de arquetipos en tres escenarios diferentes: - Definición de arquetipos sobre especificaciones sin soporte nativo al modelo dual. Cualquier arquitectura de HCE que posea directa o indirectamente la noción de modelos clínicos detallados (por ejemplo, las plantillas en HL7 CDA) puede ser potencialmente usada como modelo de referencia para la definición de arquetipos. Con esto se consigue transformar arquitecturas de HCE de modelo único (solo con modelo de referencia) en arquitecturas de doble modelo (modelo de referencia + arquetipos). Se han desarrollado metodologías y herramientas que faciliten a los editores de arquetipos el soporte a múltiples modelos de referencia. - Transformación de datos. Se propone una metodología y herramientas para la transformación de datos ya existentes a documentos XML conformes con los arquetipos y el modelo de referencia subyacente. Si el modelo de referencia es un estándar entonces la transformación será un proceso de estandarización de datos. La metodología y herramientas permiten tanto la transformación de datos no estandarizados como la transformación de datos entre diferentes estándares. - Generación automática de guías de implementación y artefactos procesables a partir de arquetipos. Se aporta una metodología para la generación automática de un conjunto de materiales de referencia de utilidad en el desarrollo y uso de sistemas de HCE, concretamente validadores de datos, instancias de ejemplo, guías de implementación , reglas formales legibles por humanos, formularios de ejemplo, mindmaps, etc. Estos materiales pueden ser combinados y organizados de diferentes modos para facilitar que los diferentes tipos de usuarios (clínicos, técnicos) puedan incluir los modelos clínicos detallados en el flujo de trabajo de su sistema y colaborar en su definición. Estas metodologías y herramientas ponen los modelos clínicos como una parte clave en el sistema. El conjunto de las metodologías y herramientas presentadas facilitan la consecución de la interoperabilidad semántica al proveer medios para la descripción semántica, normalización y validación tanto de sistemas nuevos como ya existentes.[CA] El sector sanitari produeix i consumeix una gran quantitat de dades sobre la salut de les persones. La necessitat d'intercanviar aquesta informació és una norma més que una excepció, encara que aquest objectiu està lluny de ser aconseguit. Actualment estem vivint avanços com la medicina personalitzada que incrementaran encara més la grandària i complexitat de la Història Clínica Electrònica (HCE). La consecució d'alts graus d'interoperabilitat semàntica és un dels principals reptes per a aprofitar al màxim tota la informació continguda en les HCEs. Açò, per la seua banda, requereix una representació fidel de la informació de tal forma que assegure la consistència del seu significat entre tots els agents involucrats. Actualment està reconegut que per a la representació del significat clínic necessitem tres tipus d'artefactes: models de referència, models clínics (arquetips) i terminologies. En el cas concret dels models d'informació (models de referència i models clínics) s'observa en la literatura una mancança de metodologies i eines que en faciliten l'ús tant per a la millora de sistemes de HCE ja existents com per al desenvolupament de nous sistemes amb alts nivells d'interoperabilitat semàntica. Aquesta tesi té com a propòsit proporcionar metodologies i eines per a l'ús avançat d'arquetips en tres escenaris diferents: - Definició d'arquetips sobre especificacions sense suport natiu al model dual. Qualsevol arquitectura de HCE que posseïsca directa o indirectament la noció de models clínics detallats (per exemple, les plantilles en HL7 CDA) pot ser potencialment usada com a model de referència per a la definició d'arquetips. Amb açò s'aconsegueix transformar arquitectures de HCE de model únic (solament amb model de referència) en arquitectures de doble model (model de referència + arquetips). S'han desenvolupat metodologies i eines que faciliten als editors d'arquetips el suport a múltiples models de referència. - Transformació de dades. Es proposa una metodologia i eines per a la transformació de dades ja existents a documents XML conformes amb els arquetips i el model de referència subjacent. Si el model de referència és un estàndard llavors la transformació serà un procés d'estandardització de dades. La metodologia i eines permeten tant la transformació de dades no estandarditzades com la transformació de dades entre diferents estàndards. - Generació automàtica de guies d'implementació i artefactes processables a partir d'arquetips. S'hi inclou una metodologia per a la generació automàtica d'un conjunt de materials de referència d'utilitat en el desenvolupament i ús de sistemes de HCE, concretament validadors de dades, instàncies d'exemple, guies d'implementació, regles formals llegibles per humans, formularis d'exemple, mapes mentals, etc. Aquests materials poden ser combinats i organitzats de diferents maneres per a facilitar que els diferents tipus d'usuaris (clínics, tècnics) puguen incloure els models clínics detallats en el flux de treball del seu sistema i col·laborar en la seua definició. Aquestes metodologies i eines posen els models clínics com una part clau del sistemes. El conjunt de les metodologies i eines presentades faciliten la consecució de la interoperabilitat semàntica en proveir mitjans per a la seua descripció semàntica, normalització i validació tant de sistemes nous com ja existents.Boscá Tomás, D. (2016). DETAILED CLINICAL MODELS AND THEIR RELATION WITH ELECTRONIC HEALTH RECORDS [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/62174TESISCompendi

Detailed Clinical Models Governance System in a Regional EHR Project

The final publication is available at Springer via http://dx.doi.org/ 10.1007/978-3-319-00846-2_313In this work we present the Concept Oriented Repository (ROC), a system developed for the management of clinical information models, also known as detailed clinical models (DCM). It has been developed to be used in the Electronic Health Record project of the Valencia regional health agency (AVS). The system uses DCMs as a way to define clinical models independently of the healthcare standard chosen by the organization. These definitions create a framework where different actors can come to agreements on which information has to be represented and managed in the project. These concepts can be used later for the definition of technical artifacts (archetypes, templates, forms or message definitions) to be used by AVS information systemsThis work has been funded by Electronic Health History project from Valencia Health Agency (HSEAVS).Boscá Tomás, D.; Marco Ruiz, L.; Moner Cano, D.; Maldonado Segura, JA.; Insa, L.; Robles Viejo, M. (2013). Detailed Clinical Models Governance System in a Regional EHR Project. En XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013. Springer. 1266-1269. doi:10.1007/978-3-319-00846-2_313S1266126

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

Automatic generation of computable implementation guides from clinical information models

Clinical information models are increasingly used to describe the contents of Electronic Health Records. Implementation guides are a common specification mechanism used to define such models. They contain, among other reference materials, all the constraints and rules that clinical information must obey. However, these implementation guides typically are oriented to human-readability, and thus cannot be processed by computers. As a consequence, they must be reinterpreted and transformed manually into an executable language such as Schematron or Object Constraint Language (OCL). This task can be diffi- cult and error prone due to the big gap between both representations. The challenge is to develop a methodology for the specification of implementation guides in such a way that humans can read and understand easily and at the same time can be processed by computers. In this paper, we propose and describe a novel methodology that uses archetypes as basis for generation of implementation guides. We use archetypes to generate formal rules expressed in Natural Rule Language (NRL) and other reference materials usually included in implementation guides such as sample XML instances. We also generate Schematron rules from NRL rules to be used for the validation of data instances. We have implemented these methods in LinkEHR, an archetype editing platform, and exemplify our approach by generating NRL rules and implementation guides from EN ISO 13606, openEHR, and HL7 CDA archetypes. 2015 Elsevier Inc. All rights reserved.Boscá Tomás, D.; Maldonado Segura, JA.; Moner Cano, D.; Robles Viejo, M. (2015). Automatic generation of computable implementation guides from clinical information models. Journal of Biomedical Informatics. 55:143-152. doi:10.1016/j.jbi.2015.04.002S1431525

Can OpenEHR, ISO 13606, and HL7 FHIR Work Together? An Agnostic Approach for the Selection and Application of Electronic Health Record Standards to the Next-Generation Health Data Spaces

In order to maximize the value of electronic health records (EHRs) for both health care and secondary use, it is necessary for the data to be interoperable and reusable without loss of the original meaning and context, in accordance with the findable, accessible, interoperable, and reusable (FAIR) principles. To achieve this, it is essential for health data platforms to incorporate standards that facilitate addressing needs such as formal modeling of clinical knowledge (health domain concepts) as well as the harmonized persistence, query, and exchange of data across different information systems and organizations. However, the selection of these specifications has not been consistent across the different health data initiatives, often applying standards to address needs for which they were not originally designed. This issue is essential in the current scenario of implementing the European Health Data Space, which advocates harmonization, interoperability, and reuse of data without regulating the specific standards to be applied for this purpose. Therefore, this viewpoint aims to establish a coherent, agnostic, and homogeneous framework for the use of the most impactful EHR standards in the new-generation health data spaces: OpenEHR, International Organization for Standardization (ISO) 13606, and Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR). Thus, a panel of EHR standards experts has discussed several critical points to reach a consensus that will serve decision-making teams in health data platform projects who may not be experts in these EHR standards. It was concluded that these specifications possess different capabilities related to modeling, flexibility, and implementation resources. Because of this, in the design of future data platforms, these standards must be applied based on the specific needs they were designed for, being likewise fully compatible with their combined functional and technical implementation