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Background: The future European Health Research and Innovation Cloud (HRIC), as fundamental part of the European Health Data Space (EHDS), will promote the secondary use of data and the capabilities to push the boundaries of health research within an ethical and legally compliant framework that reinforces the trust of patients and citizens., Objective: This study aimed to analyse health data management mechanisms in Europe to determine their alignment with FAIR principles and data discovery generating best. practices for new data hubs joining the HRIC ecosystem. In this line, the compliance of health data hubs with FAIR principles and data discovery were assessed, and a set of best practices for health data hubs was concluded., Methods: A survey was conducted in January 2022, involving 99 representative health data hubs from multiple countries, and 42 responses were obtained in June 2022. Stratification methods were employed to cover different levels of granularity. The survey data was analysed to assess compliance with FAIR and data discovery principles. The study started with a general analysis of survey responses, followed by the creation of specific profiles based on three categories: organization type, function, and level of data aggregation., Results: The study produced specific best practices for data hubs regarding the adoption of FAIR principles and data discoverability. It also provided an overview of the survey study and specific profiles derived from category analysis, considering different types of data hubs., Conclusions: The study concluded that a significant number of health data hubs in Europe did not fully comply with FAIR and data discovery principles. However, the study identified specific best practices that can guide new data hubs in adhering to these principles. The study highlighted the importance of aligning health data management mechanisms with FAIR principles to enhance interoperability and reusability in the future HRIC., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

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 IDE 4 ICDS 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 IDE 4 ICDS 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 IDE 4 ICDS 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 IDE 4 ICDS 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 and adopting digital transformation at the regional scale of the use of biomedical knowledge in real healthcare., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Carlos Luis Parra-Calderón reports financial support was provided by Ministerio de Economía y Competitividad. Carlos Luis Parra-Calderon reports a relationship with Andalusian Health Service that includes: employment. Carlos Luis Parra-Calderon reports a relationship with Andalusian Public Foundation for Health Research Management in Seville that includes: non-financial support. Esther Román Villarán reports a relationship with Andalusian Public Foundation for Health Research Management in Seville that includes: employment. Celia Alvarez Romero reports a relationship with Andalusian Public Foundation for Health Research Management in Seville that includes: employment. Alicia Martínez García reports a relationship with Andalusian Public Foundation for Health Research Management in Seville that includes: employment. Germán Antonio Escobar Rodríguez reports a relationship with Andalusian Public Foundation for Health Research Management in Seville that includes: employment. Maria Asunción Martínez-Brocca reports a relationship with Andalusian Health Service that includes: employment. Julián Alberto García García reports a relationship with University of Seville that includes: employment. María José Escalona Cuaresma reports financial support was provided by Ministerio de Economía y Competitividad. María José Escalona Cuaresma reports a relationship with University of Seville that includes: employment., (Copyright © 2023 Elsevier B.V. All rights reserved.)

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., (© 2023. The Author(s).)

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., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

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., (©Esther Román-Villarán, Celia Alvarez-Romero, Alicia Martínez-García, German Antonio Escobar-Rodríguez, María José García-Lozano, Bosco Barón-Franco, Lourdes Moreno-Gaviño, Jesús Moreno-Conde, José Antonio Rivas-González, Carlos Luis Parra-Calderón. Originally published in JMIR Formative Research (https://formative.jmir.org), 02.08.2022.)

Medical data science aims to facilitate knowledge discovery assisting in data, algorithms, and results analysis. The FAIR principles aim to guide scientific data management and stewardship, and are relevant to all digital health ecosystem stakeholders. The FAIR4Health project aims to facilitate and encourage the health research community to reuse datasets derived from publicly funded research initiatives using the FAIR principles. The 'FAIRness for FHIR' project aims to provide guidance on how HL7 FHIR could be utilized as a common data model to support the health datasets FAIRification process. This first expected result is an HL7 FHIR Implementation Guide (IG) called FHIR4FAIR, covering how FHIR can be used to cover FAIRification in different scenarios. This IG aims to provide practical underpinnings for the FAIR4Health FAIRification workflow as a domain-specific extension of the GoFAIR process, while simplifying curation, advancing interoperability, and providing insights into a roadmap for health datasets FAIR certification.

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., Competing Interests: No competing interests were disclosed., (Copyright: © 2022 Alvarez-Romero C et al.)

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.

Clinical evidence demonstrates that BRCA 1 and BRCA2 mutations can develop a gynecological cancer but genetic testing has a high cost to the healthcare system. Besides, several studies in the literature indicate that performing these genetic tests to the population is not cost-efficient. Currently, our physicians do not have a system to provide them the support for prescribing genetic tests. A Decision Support System for prescribing these genetic tests in BRCA1 and BRCA2 and preventing gynecological cancer risks has been designed, developed and deployed in the Virgen del Rocío University Hospital (VRUH). The technological architecture integrates a set of open source tools like Mirth Connect, OpenClinica, OpenCDS, and tranSMART in addition to several interoperability standards. The system allows general practitioners and gynecologists to classify patients as low risk (they do not require a specific treatment) or high risk (they should be attended by the Genetic Council). On the other hand, by means of this system we are also able to standardize criteria among professionals to prescribe these genetic tests. Finally, this system will also contribute to improve the assistance for this kind of patients.

Clinical Decision Support Systems (CDSS) are software applications that support clinicians in making healthcare decisions providing relevant information for individual patients about their specific conditions. The lack of integration between CDSS and Electronic Health Record (EHR) has been identified as a significant barrier to CDSS development and adoption. Andalusia Healthcare Public System (AHPS) provides an interoperable health information infrastructure based on a Service Oriented Architecture (SOA) that eases CDSS implementation. This paper details the deployment of a CDSS jointly with the deployment of a Terminology Server (TS) within the AHPS infrastructure. It also explains a case study about the application of decision support to thromboembolism patients and its potential impact on improving patient safety. We will apply the inSPECt tool proposal to evaluate the appropriateness of alerts in this scenario.

This paper introduces the evaluation report after fostering a Standard-based Interoperability Framework (SIF) between the Virgen del Rocío University Hospital (VRUH) Haemodialysis (HD) Unit and 5 outsourced HD centres in order to improve integrated care by automatically sharing patients' Electronic Health Record (EHR) and lab test reports. A pre-post study was conducted during fourteen months. The number of lab test reports of both emergency and routine nature regarding to 379 outpatients was computed before and after the integration of the SIF. Before fostering SIF, 19.38 lab tests per patient were shared between VRUH and HD centres, 5.52 of them were of emergency nature while 13.85 were routine. After integrating SIF, 17.98 lab tests per patient were shared, 3.82 of them were of emergency nature while 14.16 were routine. The inclusion of a SIF in the HD Integrated Care Process has led to an average reduction of 1.39 (p=0.775) lab test requests per patient, including a reduction of 1.70 (p=0.084) in those of emergency nature, whereas an increase of 0.31 (p=0.062) was observed in routine lab tests. Fostering this strategy has led to the reduction in emergency lab test requests, which implies a potential improvement of the integrated care.

Introduction: Social networks applied through Web 2.0 tools have gained importance in health domain, because they produce improvements on the communication and coordination capabilities among health professionals. This is highly relevant for multimorbidity patients care because there is a large number of health professionals in charge of patient care, and this requires to obtain clinical consensus in their decisions. Our objective is to develop a tool for collaborative work among health professionals for multimorbidity patient care. We describe the architecture to incorporate decision support functionalities in a social network tool to enable the adoption of shared decisions among health professionals from different care levels. As part of the first stage of the project, this paper describes the results obtained in a pilot study about acceptance and use of the social network component in our healthcare setting., Methods: At Virgen del Rocío University Hospital we have designed and developed the Shared Care Platform (SCP) to provide support in the continuity of care for multimorbidity patients. The SCP has two consecutively developed components: social network component, called Clinical Wall, and Clinical Decision Support (CDS) system. The Clinical Wall contains a record where health professionals are able to debate and define shared decisions. We conducted a pilot study to assess the use and acceptance of the SCP by healthcare professionals through questionnaire based on the theory of the Technology Acceptance Model., Results: In March 2012 we released and deployed the SCP, but only with the social network component. The pilot project lasted 6 months in the hospital and 2 primary care centers. From March to September 2012 we created 16 records in the Clinical Wall, all with a high priority. A total of 10 professionals took part in the exchange of messages: 3 internists and 7 general practitioners generated 33 messages. 12 of the 16 record (75%) were answered by the destination health professionals. The professionals valued positively all the items in the questionnaire. As part of the SCP, opensource tools for CDS will be incorporated to provide recommendations for medication and problem interactions, as well as to calculate indexes or scales from validated questionnaires. They will receive the patient summary information provided by the regional Electronic Health Record system through a web service with the information defined according to the virtual Medical Record specification., Conclusions: Clinical Wall has been developed to allow communication and coordination between the healthcare professionals involved in multimorbidity patient care. Agreed decisions were about coordination for appointment changing, patient conditions, diagnosis tests, and prescription changes and renewal. The application of interoperability standards and open source software can bridge the gap between knowledge and clinical practice, while enabling interoperability and scalability. Open source with the social network encourages adoption and facilitates collaboration. Although the results obtained for use indicators are still not as high as it was expected, based on the promising results obtained in the acceptance questionnaire of SMP, we expect that the new CDS tools will increase the use by the health professionals., (Copyright © 2013 Elsevier Inc. All rights reserved.)