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[Objective] This paper introduces a privacy-preserving federated machine learning (ML) architecture built upon Findable, Accessible, Interoperable, and Reusable (FAIR) health data. It aims to devise an architecture for executing classification algorithms in a federated manner, enabling collaborative model-building among health data owners without sharing their datasets., [Materials and methods] Utilizing an agent-based architecture, a privacy-preserving federated ML algorithm was developed to create a global predictive model from various local models. This involved formally defining the algorithm in two steps: data preparation and federated model training on FAIR health data and constructing the architecture with multiple components facilitating algorithm execution. The solution was validated by five healthcare organizations using their specific health datasets., [Results] Five organizations transformed their datasets into Health Level 7 Fast Healthcare Interoperability Resources via a common FAIRification workflow and software set, thereby generating FAIR datasets. Each organization deployed a Federated ML Agent within its secure network, connected to a cloud-based Federated ML Manager. System testing was conducted on a use case aiming to predict 30-day readmission risk for chronic obstructive pulmonary disease patients and the federated model achieved an accuracy rate of 87%., [Discussion] The paper demonstrated a practical application of privacy-preserving federated ML among five distinct healthcare entities, highlighting the value of FAIR health data in machine learning when utilized in a federated manner that ensures privacy protection without sharing data., [Conclusion] This solution effectively leverages FAIR datasets from multiple healthcare organizations for federated ML while safeguarding sensitive health datasets, meeting legislative privacy and security requirements.

Results of two major projects funded by the European Union are taken into consideration: Fair4Health regarding the possibility of sharing clinical data in various environments applying FAIR principles and 1+Million Genome for the in-depth study of the human genome in Europe. Specifically, the Gaslini hospital plans to move on both areas joining the Hospital on FHIR initiative matured within the fair4health project and also collaborate with other Italian healthcare facilities through the implementation of a Proof of Concept (PoC) in the 1+MG. The aim of this short paper is to evaluate the applicability of some of the tools of the fair4health project to the Gaslini infrastructure to facilitate its participation in the PoC. One of the aims is also to prove the possibility of reuse the results of well-performed European funded projects to boost routine research in qualified healthcare facilities.

[Background] The FAIR principles, under the open science paradigm, aim to improve the Findability, Accessibility, Interoperability and Reusability of digital data. In this sense, the FAIR4Health project aimed to apply the FAIR principles in the health research field. For this purpose, a workflow and a set of tools were developed to apply FAIR principles in health research datasets, and validated through the demonstration of the potential impact that this strategy has on health research management outcomes., [Objective] This paper aims to describe the analysis of the impact on health research management outcomes of the FAIR4Health solution., [Methods] To analyse the impact on health research management outcomes in terms of time and economic savings, a survey was designed and sent to experts on data management with expertise in the use of the FAIR4Health solution. Then, differences between the time and costs needed to perform the techniques with (i) standalone research, and (ii) using the proposed solution, were analyzed., [Results] In the context of the health research management outcomes, the survey analysis concluded that 56.57% of the time and 16800 EUR per month could be saved if the FAIR4Health solution is used., [Conclusions] Adopting principles in health research through the FAIR4Health solution saves time and, consequently, costs in the execution of research involving data management techniques.

[Background] Sharing health data is challenging because of several technical, ethical, and regulatory issues. The Findable, Accessible, Interoperable, and Reusable (FAIR) guiding principles have been conceptualized to enable data interoperability. Many studies provide implementation guidelines, assessment metrics, and software to achieve FAIR-compliant data, especially for health data sets. Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) is a health data content modeling and exchange standard., [Objective] Our goal was to devise a new methodology to extract, transform, and load existing health data sets into HL7 FHIR repositories in line with FAIR principles, develop a Data Curation Tool to implement the methodology, and evaluate it on health data sets from 2 different but complementary institutions. We aimed to increase the level of compliance with FAIR principles of existing health data sets through standardization and facilitate health data sharing by eliminating the associated technical barriers., [Methods] Our approach automatically processes the capabilities of a given FHIR end point and directs the user while configuring mappings according to the rules enforced by FHIR profile definitions. Code system mappings can be configured for terminology translations through automatic use of FHIR resources. The validity of the created FHIR resources can be automatically checked, and the software does not allow invalid resources to be persisted. At each stage of our data transformation methodology, we used particular FHIR-based techniques so that the resulting data set could be evaluated as FAIR. We performed a data-centric evaluation of our methodology on health data sets from 2 different institutions., [Results] Through an intuitive graphical user interface, users are prompted to configure the mappings into FHIR resource types with respect to the restrictions of selected profiles. Once the mappings are developed, our approach can syntactically and semantically transform existing health data sets into HL7 FHIR without loss of data utility according to our privacy-concerned criteria. In addition to the mapped resource types, behind the scenes, we create additional FHIR resources to satisfy several FAIR criteria. According to the data maturity indicators and evaluation methods of the FAIR Data Maturity Model, we achieved the maximum level (level 5) for being Findable, Accessible, and Interoperable and level 3 for being Reusable., [Conclusions] We developed and extensively evaluated our data transformation approach to unlock the value of existing health data residing in disparate data silos to make them available for sharing according to the FAIR principles. We showed that our method can successfully transform existing health data sets into HL7 FHIR without loss of data utility, and the result is FAIR in terms of the FAIR Data Maturity Model. We support institutional migration to HL7 FHIR, which not only leads to FAIR data sharing but also eases the integration with different research networks.

Background: Clinical Practice Guidelines (CPGs) provide healthcare professionals with performance and decision-making support during the treatment of patients. Sometimes, however, they are poorly implemented. The IDE4ICDS platform was developed and validated with CPGs for type 2 diabetes mellitus (T2DM). Objective: The main objective of this paper is to present the results of the clinical validation of the IDE4ICDS platform in a real clinical environment at two health clinics in the Andalusian Public Health System (SSPA) in the southern Spanish region of Andalusia. Methods: National and international knowledge sources on T2DM were selected and reviewed and used to define a diabetes CPG model on the IDE4ICDS platform. Once the diabetes CPG was configured and deployed, it was validated. A total of 506 patients were identified as meeting the inclusion criteria, of whom 130 could be recruited and 89 attended the appointment. Results: A concordance analysis was performed with the kappa value. Overall agreement between the recommendations provided by the system and those recorded in each patient's EHR was good (0.61 - 0.80) with a total kappa index of 0.701, leading to the conclusion that the system provided appropriate recommendations for each patient and was therefore well-functioning. Conclusions: A series of possible improvements were identified based on the limitations for the recovery of variables related to the quality of these recolected variables, the detection of duplicate recommendations based on different input variables for the same patient, and clinical usability, such as the capacity to generate reports based on the recommendations generated. Nevertheless, the project resulted in the IDE4ICDS platform: a Clinical Decision Support System (CDSS) capable of providing appropriate recommendations for improving the management and quality of patient care and optimizing health outcomes. The result of this validation is a safe and effective pathway for developing an

[Background] Digital transformation in healthcare and the growth of health data generation and collection are important challenges for the secondary use of healthcare records in the health research field. Likewise, due to the ethical and legal constraints for using sensitive data, understanding how health data are managed by dedicated infrastructures called data hubs is essential to facilitating data sharing and reuse., [Methods] To capture the different data governance behind health data hubs across Europe, a survey focused on analysing the feasibility of linking individual-level data between data collections and the generation of health data governance patterns was carried out. The target audience of this study was national, European, and global data hubs. In total, the designed survey was sent to a representative list of 99 health data hubs in January 2022., [Results] In total, 41 survey responses received until June 2022 were analysed. Stratification methods were performed to cover the different levels of granularity identified in some data hubs’ characteristics. Firstly, a general pattern of data governance for data hubs was defined. Afterward, specific profiles were defined, generating specific data governance patterns through the stratifications in terms of the kind of organization (centralized versus decentralized) and role (data controller or data processor) of the health data hub respondents., [Conclusions] The analysis of the responses from health data hub respondents across Europe provided a list of the most frequent aspects, which concluded with a set of specific best practices on data management and governance, taking into account the constraints of sensitive data. In summary, a data hub should work in a centralized way, providing a Data Processing Agreement and a formal procedure to identify data providers, as well as data quality control, data integrity and anonymization methods.

The current availability of electronic health records represents an excellent research opportunity on multimorbidity, one of the most relevant public health problems nowadays. However, it also poses a methodological challenge due to the current lack of tools to access, harmonize and reuse research datasets. In FAIR4Health, a European Horizon 2020 project, a workflow to implement the FAIR (findability, accessibility, interoperability and reusability) principles on health datasets was developed, as well as two tools aimed at facilitating the transformation of raw datasets into FAIR ones and the preservation of data privacy. As part of this project, we conducted a multicentric retrospective observational study to apply the aforementioned FAIR implementation workflow and tools to five European health datasets for research on multimorbidity. We applied a federated frequent pattern growth association algorithm to identify the most frequent combinations of chronic diseases and their association with mortality risk. We identified several multimorbidity patterns clinically plausible and consistent with the bibliography, some of which were strongly associated with mortality. Our results show the usefulness of the solution developed in FAIR4Health to overcome the difficulties in data management and highlight the importance of implementing a FAIR data policy to accelerate responsible health research.

[Background] Due to an increase in life expectancy, the prevalence of chronic diseases is also on the rise. Clinical practice guidelines (CPGs) provide recommendations for suitable interventions regarding different chronic diseases, but a deficiency in the implementation of these CPGs has been identified. The PITeS-TiiSS (Telemedicine and eHealth Innovation Platform: Information Communications Technology for Research and Information Challenges in Health Services) tool, a personalized ontology-based clinical decision support system (CDSS), aims to reduce variability, prevent errors, and consider interactions between different CPG recommendations, among other benefits., [Objective] The aim of this study is to design, develop, and validate an ontology-based CDSS that provides personalized recommendations related to drug prescription. The target population is older adult patients with chronic diseases and polypharmacy, and the goal is to reduce complications related to these types of conditions while offering integrated care., [Methods] A study scenario about atrial fibrillation and treatment with anticoagulants was selected to validate the tool. After this, a series of knowledge sources were identified, including CPGs, PROFUND index, LESS/CHRON criteria, and STOPP/START criteria, to extract the information. Modeling was carried out using an ontology, and mapping was done with Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT; International Health Terminology Standards Development Organisation). Once the CDSS was developed, validation was carried out by using a retrospective case study., [Results] This project was funded in January 2015 and approved by the Virgen del Rocio University Hospital ethics committee on November 24, 2015. Two different tasks were carried out to test the functioning of the tool. First, retrospective data from a real patient who met the inclusion criteria were used. Second, the analysis of an adoption model was performed through the study of the requirements and characteristics that a CDSS must meet in order to be well accepted and used by health professionals. The results are favorable and allow the proposed research to continue to the next phase., [Conclusions] An ontology-based CDSS was successfully designed, developed, and validated. However, in future work, validation in a real environment should be performed to ensure the tool is usable and reliable.

[Background] Owing to the nature of health data, their sharing and reuse for research are limited by legal, technical, and ethical implications. In this sense, to address that challenge and facilitate and promote the discovery of scientific knowledge, the Findable, Accessible, Interoperable, and Reusable (FAIR) principles help organizations to share research data in a secure, appropriate, and useful way for other researchers., [Objective] The objective of this study was the FAIRification of existing health research data sets and applying a federated machine learning architecture on top of the FAIRified data sets of different health research performing organizations. The entire FAIR4Health solution was validated through the assessment of a federated model for real-time prediction of 30-day readmission risk in patients with chronic obstructive pulmonary disease (COPD)., [Methods] The application of the FAIR principles on health research data sets in 3 different health care settings enabled a retrospective multicenter study for the development of specific federated machine learning models for the early prediction of 30-day readmission risk in patients with COPD. This predictive model was generated upon the FAIR4Health platform. Finally, an observational prospective study with 30 days follow-up was conducted in 2 health care centers from different countries. The same inclusion and exclusion criteria were used in both retrospective and prospective studies., [Results] Clinical validation was demonstrated through the implementation of federated machine learning models on top of the FAIRified data sets from different health research performing organizations. The federated model for predicting the 30-day hospital readmission risk was trained using retrospective data from 4.944 patients with COPD. The assessment of the predictive model was performed using the data of 100 recruited (22 from Spain and 78 from Serbia) out of 2070 observed (records viewed) patients during the observational prospective study, which was executed from April 2021 to September 2021. Significant accuracy (0.98) and precision (0.25) of the predictive model generated upon the FAIR4Health platform were observed. Therefore, the generated prediction of 30-day readmission risk was confirmed in 87% (87/100) of cases., [Conclusions] Implementing a FAIR data policy in health research performing organizations to facilitate data sharing and reuse is relevant and needed, following the discovery, access, integration, and analysis of health research data. The FAIR4Health project proposes a technological solution in the health domain to facilitate alignment with the FAIR principles.

Due to the nature of health data, its sharing and reuse for research are limited by ethical, legal and technical barriers. The FAIR4Health project facilitated and promoted the application of FAIR principles in health research data, derived from the publicly funded health research initiatives to make them Findable, Accessible, Interoperable, and Reusable (FAIR). To confirm the feasibility of the FAIR4Health solution, we performed two pathfinder case studies to carry out federated machine learning algorithms on FAIRified datasets from five health research organizations. The case studies demonstrated the potential impact of the developed FAIR4Health solution on health outcomes and social care research. Finally, we promoted the FAIRified data to share and reuse in the European Union Health Research community, defining an effective EU-wide strategy for the use of FAIR principles in health research and preparing the ground for a roadmap for health research institutions. This scientific report presents a general overview of the FAIR4Health solution: from the FAIRification workflow design to translate raw data/metadata to FAIR data/metadata in the health research domain to the FAIR4Health demonstrators' performance.

The current availability of electronic health records represents an excellent research opportunity on multimorbidity, one of the most relevant public health problems nowadays. However, it also poses a methodological challenge due to the current lack of tools to access, harmonize and reuse research datasets. In FAIR4Health, a European Horizon 2020 project, a workflow to implement the FAIR (findability, accessibility, interoperability and reusability) principles on health datasets was developed, as well as two tools aimed at facilitating the transformation of raw datasets into FAIR ones and the preservation of data privacy. As part of this project, we conducted a multicentric retrospective observational study to apply the aforementioned FAIR implementation workflow and tools to five European health datasets for research on multimorbidity. We applied a federated frequent pattern growth association algorithm to identify the most frequent combinations of chronic diseases and their association with mortality risk. We identified several multimorbidity patterns clinically plausible and consistent with the bibliography, some of which were strongly associated with mortality. Our results show the usefulness of the solution developed in FAIR4Health to overcome the difficulties in data management and highlight the importance of implementing a FAIR data policy to accelerate responsible health research.

Background: The evidence-based medicine (EBM) paradigm requires the development of health care professionals' skills in the efficient search of evidence in the literature, and in the application of formal rules to evaluate this evidence. Incorporating this methodology into the decision-making routine of clinical practice will improve the patients' health care, increase patient safety, and optimize resources use. Objective: The aim of this study is to develop and evaluate a new tool (KNOWBED system) as a clinical decision support system to support scientific knowledge, enabling health care professionals to quickly carry out decision-making processes based on EBM during their routine clinical practice. Methods: Two components integrate the KNOWBED system: a web-based knowledge station and a mobile app. A use case (bronchiolitis pathology) was selected to validate the KNOWBED system in the context of the Paediatrics Unit of the Virgen Macarena University Hospital (Seville, Spain). The validation was covered in a 3-month pilot using 2 indicators: usability and efficacy. Results: The KNOWBED system has been designed, developed, and validated to support clinical decision making in mobility based on standards that have been incorporated into the routine clinical practice of health care professionals. Using this tool, health care professionals can consult existing scientific knowledge at the bedside, and access recommendations of clinical protocols established based on EBM. During the pilot project, 15 health care professionals participated and accessed the system for a total of 59 times. Conclusions: The KNOWBED system is a useful and innovative tool for health care professionals. The usability surveys filled in by the system users highlight that it is easy to access the knowledge base. This paper also sets out some improvements to be made in the future.

FAIR4Health, an EU’s funded project, promotes the application of FAIR principles (Findable, Accessible, Interoperable, Reusable) in data derived from publicly funded health research initiatives to share and reuse them in the European Union Health Research community, defining an effective EU-wide strategy for the use of FAIR in Health. This paper analyses how to apply FAIR principles to “trust” in the context of the open-source software development of FAIR4Health. The FAIRification process and TRUST principles are discussed and related. The paper tries to open a new view on the trustworthiness of data access using open-source software., Work performed in the framework of FAIR4Health project, with funding from the European Union’s Horizon 2020 programme under grant agreement number 824666. In addition, work presented in this paper has been partially supported by the Generalitat de Catalunya (2017 SGR 1749)., Peer Reviewed, Postprint (published version)

The aim of this study is to build an evaluation framework for the user-centric testing of the Data Curation Tool. The tool was developed in the scope of the FAIR4Health project to make health data FAIR by transforming them from legacy formats into a Common Data Model based on HL7 FHIR. The end user evaluation framework was built by following a methodology inspired from the Delphi method. We applied a series of questionnaires to a group of experts not only in different roles and skills, but also from various parts of Europe. Overall, 26 questions were formulated for 16 participants. The results showed that the users are satisfied with the capabilities and performance of the tool. The feedbacks were considered as recommendations for technical improvement and fed back into the software development cycle of the Data Curation Tool.

[Background] The evidence-based medicine (EBM) paradigm requires the development of health care professionals’ skills in the efficient search of evidence in the literature, and in the application of formal rules to evaluate this evidence. Incorporating this methodology into the decision-making routine of clinical practice will improve the patients’ health care, increase patient safety, and optimize resources use., [Objective] The aim of this study is to develop and evaluate a new tool (KNOWBED system) as a clinical decision support system to support scientific knowledge, enabling health care professionals to quickly carry out decision-making processes based on EBM during their routine clinical practice., [Methods] Two components integrate the KNOWBED system: a web-based knowledge station and a mobile app. A use case (bronchiolitis pathology) was selected to validate the KNOWBED system in the context of the Paediatrics Unit of the Virgen Macarena University Hospital (Seville, Spain). The validation was covered in a 3-month pilot using 2 indicators: usability and efficacy., [Results] The KNOWBED system has been designed, developed, and validated to support clinical decision making in mobility based on standards that have been incorporated into the routine clinical practice of health care professionals. Using this tool, health care professionals can consult existing scientific knowledge at the bedside, and access recommendations of clinical protocols established based on EBM. During the pilot project, 15 health care professionals participated and accessed the system for a total of 59 times., [Conclusions] The KNOWBED system is a useful and innovative tool for health care professionals. The usability surveys filled in by the system users highlight that it is easy to access the knowledge base. This paper also sets out some improvements to be made in the future.

Este trabajo consiste en un análisis del comercio exterior del sector automotor de Castilla y León durante el periodo 2007-2016. Para comenzar, se definirá la base de datos de la que obtendremos toda la información necesaria para el estudio y más tarde la industria automotriz, así como las partes que la forman. A continuación, el trabajo se desarrollará en tres capítulos principales. En el primero de ellos estudiaremos el comercio exterior del sector de manera agregada, en el que hallaremos una serie de indicadores globales de comercio exterior. En el segundo, lo estudiaremos de manera desagregada, es decir, analizando los subsectores comprendidos dentro del sector. Además, también se incluirá en este último el cálculo de tres índices para medir la especialización y el comercio intraindustrial, Por último y en el tercer capítulo, se realizará un análisis geográfico de manera que podamos conocer el grado de concentración existente en el comercio exterior del sector y la identidad de los principales proveedores y clientes para nuestra región. Para finalizar el trabajo, terminaremos el documento con unas conclusiones extraídas de los datos obtenidos a lo largo de su elaboración.

Background and goal: Health information systems are increasingly sophisticated and developing them is a challenge for software developers. Software engineers usually make use of UML as a standard model language that allows defining health information system entities and their relations. However, working with health system requires learning HL7 standards, that defines and manages standards related to health information systems. HL7 standards are varied, however this work focusses on v2 and v3 since these are the most used one on the area that this work is being conducted. This works aims to allow modeling HL7 standard by using UML. Methods: Several techniques based on the MDE (Model-Driven Engineering) paradigm have been used to cope with it. Results: A useful reference framework, reducing final users learning curve and allowing modeling maintainable and easy-going health information systems. Conclusions: By using this approach, a software engineer without any previous knowledge about HL7 would be able to solve the problem of modeling HL7-based health information systems. Reducing the learning curve when working in projects that need HL7 standards.

[Background and goal] Health information systems are increasingly sophisticated and developing them is a challenge for software developers. Software engineers usually make use of UML as a standard model language that allows defining health information system entities and their relations. However, working with health system requires learning HL7 standards, that defines and manages standards related to health information systems. HL7 standards are varied, however this work focusses on v2 and v3 since these are the most used one on the area that this work is being conducted. This works aims to allow modeling HL7 standard by using UML., [Methods] Several techniques based on the MDE (Model-Driven Engineering) paradigm have been used to cope with it., [Results] A useful reference framework, reducing final users learning curve and allowing modeling maintainable and easy-going health information systems., [Conclusions] By using this approach, a software engineer without any previous knowledge about HL7 would be able to solve the problem of modeling HL7-based health information systems. Reducing the learning curve when working in projects that need HL7 standards.

Este trabajo consiste en un análisis del comercio exterior del sector automotor de Castilla y León durante el periodo 2007-2016. Para comenzar, se definirá la base de datos de la que obtendremos toda la información necesaria para el estudio y más tarde la industria automotriz, así como las partes que la forman. A continuación, el trabajo se desarrollará en tres capítulos principales. En el primero de ellos estudiaremos el comercio exterior del sector de manera agregada, en el que hallaremos una serie de indicadores globales de comercio exterior. En el segundo, lo estudiaremos de manera desagregada, es decir, analizando los subsectores comprendidos dentro del sector. Además, también se incluirá en este último el cálculo de tres índices para medir la especialización y el comercio intraindustrial, Por último y en el tercer capítulo, se realizará un análisis geográfico de manera que podamos conocer el grado de concentración existente en el comercio exterior del sector y la identidad de los principales proveedores y clientes para nuestra región. Para finalizar el trabajo, terminaremos el documento con unas conclusiones extraídas de los datos obtenidos a lo largo de su elaboración.

El presente trabajo fin de grado (en adelante TFG) se presenta como un gran reto ingenieril para el estudiante en una de las tecnologías más en auge en este momento. Se trata de la realización del diseño de una capa de comunicaciones para una plataforma modular de redes de sensores inalámbricas basada en el chip CC2520. El chip CC2520 es un transceptor de radiofrecuencia en la banda ISM sin licencia de 2.4 GHz compatible con el estándar IEEE 802.15.4 y que soporta la implementación de la tecnología ZigBee. Esta tecnología se caracteriza por su baja tasa de datos, su bajo consumo, su flexibilidad de red y su facilidad de implementación. Es por estas cuatro cualidades por las cuales esta tecnología es la más utilizada en el campo de las redes de sensores inalámbricas. El estándar IEEE 802.15.4 y ZigBee son protocolos que se basan en el modelo OSI (Open System Interconnection) para su definición, un modelo que divide en 7 capas el proceso de transmisión de la información de un dispositivo a otro en una red de comunicaciones. De los siete niveles que componen esta estructura, el estándar IEEE 802.15.4 define el nivel físico y el control de acceso al medio (MAC) mientras que ZigBee define el resto de capas superiores. Tras un periodo de estudio de la herramienta, se procedió a realizar el diseño del esquemático. Para ello, se tomó como modelo de referencia el esquemático proporcionado por el fabricante, aunque se buscaron mejoras a realizar tanto en el esquemático realizado en la anterior capa de comunicaciones como con las opiniones encontradas en internet de personas que lo habían implantado. Indicar que tuvieron que hacerse modificaciones debido a las características típicas de la plataforma modular Cookie. Se definió su tamaño a 40x60mm para que coincidiese con el resto de capas y su añadieron los conectores situados a ambos lados, teniendo especial importancia la situación de estos para que la placa encajase con el resto. Además se modificó el conector SMA de conexi