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INTRODUCTION: Seamless interoperability of ophthalmic clinical data is beneficial for improving patient care and advancing research through the integration of data from various sources. Such consolidation increases the amount of data available, leading to more robust statistical analyses, and improving the accuracy and reliability of artificial intelligence models. However, the lack of consistent, harmonized data formats and meanings (syntactic and semantic interoperability) poses a significant challenge in sharing ophthalmic data. METHODS: The Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR), a standard for the exchange of healthcare data, emerges as a promising solution. To facilitate cross-site data exchange in research, the German Medical Informatics Initiative (MII) has developed a core data set (CDS) based on FHIR. RESULTS: This work investigates the suitability of the MII CDS specifications for exchanging ophthalmic clinical data necessary to train and validate a specific machine learning model designed for predicting visual acuity. In interdisciplinary collaborations, we identified and categorized the required ophthalmic clinical data and explored the possibility of its mapping to FHIR using the MII CDS specifications. DISCUSSION: We found that the current FHIR MII CDS specifications do not completely accommodate the ophthalmic clinical data we investigated, indicating that the creation of an extension module is essential.
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Interoperabilidade da Informação em Saúde , Humanos , Interoperabilidade da Informação em Saúde/normas , Registros Eletrônicos de Saúde/normas , Alemanha , Aprendizado de Máquina , Nível Sete de Saúde/normas , Oftalmopatias/terapia , OftalmologiaRESUMO
INTRODUCTION: For an interoperable Intelligent Tutoring System (ITS), we used resources from Fast Healthcare Interoperability Resources (FHIR) and mapped learning content with Unified Medical Language System (UMLS) codes to enhance healthcare education. This study addresses the need to enhance the interoperability and effectiveness of ITS in healthcare education. STATE OF THE ART: The current state of the art in ITS involves advanced personalized learning and adaptability techniques, integrating technologies such as machine learning to personalize the learning experience and to create systems that dynamically respond to individual learner needs. However, existing ITS architectures face challenges related to interoperability and integration with healthcare systems. CONCEPT: Our system maps learning content with UMLS codes, each scored for similarity, ensuring consistency and extensibility. FHIR is used to standardize the exchange of medical information and learning content. IMPLEMENTATION: Implemented as a microservice architecture, the system uses a recommender to request FHIR resources, provide questions, and measure learner progress. LESSONS LEARNED: Using international standards, our ITS ensures reproducibility and extensibility, enhancing interoperability and integration with existing platforms.
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Interoperabilidade da Informação em Saúde , Nível Sete de Saúde , Unified Medical Language System , Humanos , Aprendizado de Máquina , Instrução por Computador/métodosRESUMO
In Germany, the standard format for exchange of clinical care data for research is HL7 FHIR. Graph databases (GDBs), well suited for integrating complex and heterogeneous data from diverse sources, are currently gaining traction in the medical field. They provide a versatile framework for data analysis which is generally challenging for raw FHIR-formatted data. For generation of a knowledge graph (KG) for clinical research data, we tested different extract-transform-load (ETL) approaches to convert FHIR into graph format. We designed a generalised ETL process and implemented a prototypic pipeline for automated KG creation and ontological structuring. The MeDaX-KG prototype is built from synthetic patient data and currently serves internal testing purposes. The presented approach is easy to customise to expand to other data types and formats.
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Registros Eletrônicos de Saúde , Humanos , Nível Sete de Saúde , Alemanha , Bases de Dados FactuaisRESUMO
Our novel Intelligent Tutoring System (ITS) architecture integrates HL7 Fast Healthcare Interoperability Resources (FHIR) for data exchange and Unified Medical Language System (UMLS) codes for content mapping.
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Nível Sete de Saúde , Unified Medical Language System , Interoperabilidade da Informação em Saúde , Integração de Sistemas , HumanosRESUMO
The Survivorship Passport (SurPass) for childhood cancer survivors provides a personalized treatment summary together with a care plan for long-term screening of possible late effects. HL7 FHIR connectivity of Electronic Health Record (EHR) systems with the SurPass has been proposed to reduce the burden of collecting and organizing the relevant information. We present the results of testing and validation efforts conducted across six clinics in Austria, Belgium, Germany, Italy, Lithuania, and Spain. We also discuss ways in which this experience can be used to reduce efforts for the SurPass integration in other clinics across Europe.
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Sobreviventes de Câncer , Registros Eletrônicos de Saúde , Humanos , Criança , Europa (Continente) , Nível Sete de Saúde , Neoplasias/terapia , Interoperabilidade da Informação em SaúdeRESUMO
This paper explores the challenges and lessons learned during the mapping of HL7 v2 messages structured using custom schema to openEHR for the Medical Data Integration Center (MeDIC) of the University Hospital, Schleswig-Holstein (UKSH). Missing timestamps in observations, missing units of measurement, inconsistencies in decimal separators and unexpected datatypes were identified as critical inconsistencies in this process. These anomalies highlight the difficulty of automating the transformation of HL7 v2 data to any standard, particularly openEHR, using off-the-shelf tools. Addressing these anomalies is crucial for enhancing data interoperability, supporting evidence-based research, and optimizing clinical decision-making. Implementing proper data quality measures and governance will unlock the potential of integrated clinical data, empowering clinicians and researchers and fostering a robust healthcare ecosystem.
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Nível Sete de Saúde , Registros Eletrônicos de Saúde , Interoperabilidade da Informação em Saúde , Alemanha , Integração de Sistemas , Humanos , Registro Médico Coordenado/métodosRESUMO
The efficient direct integration of real-time medical device data is a promising approach to improve patient care enabling a direct and eminent intervention. This study presents a comprehensive approach for integrating real-time medical device data into clinical environments using the HL7® FHIR® standards and IEEE 11073 Service-Oriented Device Connectivity (SDC). The study proposes a conceptual framework and an opensource proof-of-concept implementation for real-time data integration within the Medical Data Integration Center (MeDIC) at UKSH. Key components include a selective recording mechanism to mitigate storage issues and ensure accurate data capture. Our robust network architecture utilizes Kafka brokers for seamless data transfer in isolated networks. The study demonstrates the selective capturing of real-time data within a clinical setting to enable medical device data for a down-stream processing and analysis.
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Nível Sete de Saúde , Integração de Sistemas , Pesquisa sobre Serviços de Saúde , Humanos , Registros Eletrônicos de SaúdeRESUMO
The ONCO-FAIR project's initial experimentation aims to enhance data interoperability in oncology chemotherapy treatments, adhering to the FAIR principles. This study focuses on integrating the HL7 FHIR standard to address interoperability challenges within chemotherapy data exchange. Collaborating with healthcare institutions in Rennes, the research team assessed the limitations of current standards such as PN13, mCODE, and OSIRIS, leading to the customization of twelve FHIR resources complemented by two chemotherapy-specific extensions. The methodological approach follows the Integrating the Healthcare Enterprise (IHE) framework, organizing the process into four key stages to ensure the effectiveness and relevance of health data reuse for research. This framework facilitated the identification of chemotherapy-specific needs, the evaluation of existing standards, and data modeling through a FHIR implementation guide. The article underscores the importance of upstream interoperability for aligning chemotherapy software with clinical data warehouse infrastructure, showcasing the proposed solution's capability to overcome interoperability barriers and promote data reuse in line with FAIR principles. Furthermore, it discusses future directions, including extending this approach to other oncology data categories and enhancing downstream interoperability with health data sharing platforms.
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Interoperabilidade da Informação em Saúde , Humanos , Interoperabilidade da Informação em Saúde/normas , Antineoplásicos/uso terapêutico , Oncologia/normas , Nível Sete de Saúde/normas , Registros Eletrônicos de Saúde , Neoplasias/tratamento farmacológico , Data WarehousingRESUMO
While pilots and production use of software based on the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard are increasing in clinical research, we lack consistent evaluative data on important outcomes, such as data accuracy. We compared the accuracy of EHR collected, FHIR® extracted data (called EHR-to-eCRF data collection) to traditional clinical trial data collection. The accuracy rate for EHR-collected data was significantly higher than for the same data collected through traditional methods. It is possible that EHR-collected (FHIR® extracted) data can substantially improve data quality in clinical studies while decreasing the burden on study sites.
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Ensaios Clínicos como Assunto , Registros Eletrônicos de Saúde , Interoperabilidade da Informação em Saúde , Humanos , Confiabilidade dos Dados , Nível Sete de SaúdeRESUMO
The Austrian research project Linked Care explored digitalization in mobile care, focusing on streamlining the medication process to save nursing staff time. A FHIR R5-based workflow was developed to support medication ordering by nurses, prescriptions by practitioners, and dispensing by pharmacies. Key FHIR resources were profiled and published in an HL7 Austria Member Implementation Guide (IG). The IG includes specifications and technical details for implementation and was the first member-contributed IG approved by the HL7 Austria FHIR community in early 2024. These specifications are now being implemented and will be tested in late 2024.
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Nível Sete de Saúde , Sistemas de Registro de Ordens Médicas , Áustria , Humanos , TelemedicinaRESUMO
This work presents the Fast Healthcare Interoperability Resources (FHIR®) specification of the NFDI4Health Metadata schema based on FHIR Version 4: We created 16 profiles to facilitate the integration of clinical, epidemiological, and public health study data. Despite challenges arising from the extensive MDS as well as missing concepts in semantic standards, it marks a significant advance in applying information technology standards to health research.
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Interoperabilidade da Informação em Saúde , Nível Sete de Saúde , Metadados , Humanos , Registros Eletrônicos de Saúde , Estudos Epidemiológicos , Saúde Pública , Pesquisa BiomédicaRESUMO
The design of digital health information systems around a conflated gender/sex binary contributes to health inequities. Lack of specific information that supports affirming communication lead to inappropriate care, disrespectful encounters with healthcare staff, and avoidance of health services by clients who have been harmed by misgendering, deadnaming and being outed. The HL7 International Gender Harmony Model (HL7 GHM) supports the design, implementation and use of DHIS that enable affirming clinical interactions and care. This case study will demonstrate how applying the HL7 GHM can address the harms reported in a recently published account of one patient in Canada.
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Informática em Enfermagem , Humanos , Feminino , Masculino , Canadá , Nível Sete de Saúde , Identidade de GêneroRESUMO
BACKGROUND: The prevalence of chronic diseases has shifted the burden of disease from incidental acute inpatient admissions to long-term coordinated care across healthcare institutions and the patient's home. Digital healthcare ecosystems emerge to target increasing healthcare costs and invest in standard Application Programming Interfaces (API), such as HL7 Fast Healthcare Interoperability Resources (HL7 FHIR) for trusted data flows. OBJECTIVES: This scoping review assessed the role and impact of HL7 FHIR and associated Implementation Guides (IGs) in digital healthcare ecosystems focusing on chronic disease management. METHODS: To study trends and developments relevant to HL7 FHIR, a scoping review of the scientific and gray English literature from 2017 to 2023 was used. RESULTS: The selection of 93 of 524 scientific papers reviewed in English indicates that the popularity of HL7 FHIR as a robust technical interface standard for the health sector has been steadily rising since its inception in 2010, reaching a peak in 2021. Digital Health applications use HL7 FHIR in cancer (45 %), cardiovascular disease (CVD) (more than 15 %), and diabetes (almost 15 %). The scoping review revealed that references to HL7 FHIR IGs are limited to â¼ 20 % of articles reviewed. HL7 FHIR R4 was most frequently referenced when the HL7 FHIR version was mentioned. In HL7 FHIR IGs registries and the internet, we found 35 HL7 FHIR IGs addressing chronic disease management, i.e., cancer (40 %), chronic disease management (25 %), and diabetes (20 %). HL7 FHIR IGs frequently complement the information in the article. CONCLUSIONS: HL7 FHIR matures with each revision of the standard as HL7 FHIR IGs are developed with validated data sets, common shared HL7 FHIR resources, and supporting tools. Referencing HL7 FHIR IGs cataloged in official registries and in scientific publications is recommended to advance data quality and facilitate mutual learning in growing digital healthcare ecosystems that nurture interoperability in digital health innovation.
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Interoperabilidade da Informação em Saúde , Nível Sete de Saúde , Humanos , Doença Crônica/terapia , Gerenciamento ClínicoRESUMO
OBJECTIVES: Designing a framework representing radiology results in a standards-based data structure using joint Radiological Society of North America/American College of Radiology Common Data Elements (CDEs) as the semantic labels on standard structures. This allows radiologist-created report data to integrate with artificial intelligence-generated results for use throughout downstream systems. MATERIALS AND METHODS: We developed a framework modeling radiology findings as Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) observations using CDE set/element identifiers as standardized semantic labels. This framework deploys CDE identifiers to specify radiology findings and attributes, providing consistent labels for radiology report concepts-diagnoses, recommendations, tabular/quantitative data-with built-in integration with RadLex, SNOMED CT, LOINC, and other ontologies. Observation structures fit within larger HL7 FHIR DiagnosticReport resources, providing output including both nuanced text and structured data. RESULTS: Labeling radiology findings as discrete data for interchange between systems requires two components: structure and semantics. CDE definitions provide semantic identifiers for findings and their component values. The FHIR observation resource specifies a structure for associating identifiers with radiology findings in the context of reports, with CDE-encoded observations referring to definitions for CDE identifiers in a central repository. The discussion includes an example of encoding pulmonary nodules on a chest CT as CDE-labeled observations, demonstrating the application of this framework to exchange findings throughout the imaging workflow, making imaging data available to downstream clinical systems. DISCUSSION: CDE-labeled observations establish a lingua franca for encoding, exchanging, and consuming radiology data at the level of individual findings, facilitating use throughout healthcare systems. IMPORTANCE: CDE-labeled FHIR observation objects can increase the value of radiology results by facilitating their use throughout patient care.
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Elementos de Dados Comuns , Interoperabilidade da Informação em Saúde , Semântica , Humanos , Sistemas de Informação em Radiologia/organização & administração , Sistemas de Informação em Radiologia/normas , Nível Sete de Saúde , Inteligência Artificial , Diagnóstico por Imagem , Registros Eletrônicos de SaúdeRESUMO
BACKGROUND: Evidence-based medicine (EBM) has the potential to improve health outcomes, but EBM has not been widely integrated into the systems used for research or clinical decision-making. There has not been a scalable and reusable computer-readable standard for distributing research results and synthesized evidence among creators, implementers, and the ultimate users of that evidence. Evidence that is more rapidly updated, synthesized, disseminated, and implemented would improve both the delivery of EBM and evidence-based health care policy. OBJECTIVE: This study aimed to introduce the EBM on Fast Healthcare Interoperability Resources (FHIR) project (EBMonFHIR), which is extending the methods and infrastructure of Health Level Seven (HL7) FHIR to provide an interoperability standard for the electronic exchange of health-related scientific knowledge. METHODS: As an ongoing process, the project creates and refines FHIR resources to represent evidence from clinical studies and syntheses of those studies and develops tools to assist with the creation and visualization of FHIR resources. RESULTS: The EBMonFHIR project created FHIR resources (ie, ArtifactAssessment, Citation, Evidence, EvidenceReport, and EvidenceVariable) for representing evidence. The COVID-19 Knowledge Accelerator (COKA) project, now Health Evidence Knowledge Accelerator (HEvKA), took this work further and created FHIR resources that express EvidenceReport, Citation, and ArtifactAssessment concepts. The group is (1) continually refining FHIR resources to support the representation of EBM; (2) developing controlled terminology related to EBM (ie, study design, statistic type, statistical model, and risk of bias); and (3) developing tools to facilitate the visualization and data entry of EBM information into FHIR resources, including human-readable interfaces and JSON viewers. CONCLUSIONS: EBMonFHIR resources in conjunction with other FHIR resources can support relaying EBM components in a manner that is interoperable and consumable by downstream tools and health information technology systems to support the users of evidence.
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Medicina Baseada em Evidências , Interoperabilidade da Informação em Saúde , Medicina Baseada em Evidências/normas , Humanos , Interoperabilidade da Informação em Saúde/normas , COVID-19 , Nível Sete de SaúdeRESUMO
The care model Hospital@Home offers hospital-level treatment at home, aiming to alleviate hospital strain and enhance patient comfort. Despite its potential, integrating digital health solutions into this care model still remains limited. This paper proposes a concept for integrating laboratory testing at the Point of Care (POC) into Hospital@Home models to improve efficiency and interoperability. METHODS: Using the HL7 FHIR standard and cloud infrastructure, we developed a concept for direct transmission of laboratory data collected at POC. Requirements were derived from literature and discussions with a POC testing device producer. An architecture for data exchange was developed based on these requirements. RESULTS: Our concept enables access to laboratory data collected at POC, facilitating efficient data transfer and enhancing interoperability. A hypothetical scenario demonstrates the concept's feasibility and benefits, showcasing improved patient care and streamlined processes in Hospital@Home settings. CONCLUSIONS: Integration of POC data into Hospital@Home models using the HL7 FHIR standard and cloud infrastructure offers potential to enhance patient care and streamline processes. Addressing challenges such as data security and privacy is crucial for its successful implementation into practice.
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Nível Sete de Saúde , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , Serviços de Assistência Domiciliar , Computação em Nuvem , Testes Imediatos , Serviços Hospitalares de Assistência Domiciliar , Integração de SistemasRESUMO
BACKGROUND: Approximately 40% of all recorded deaths in Austria are due to behavioral risks. These risks could be avoided with appropriate measures. OBJECTIVES: Extension of the concept of EHR and EMR to an electronic prevention record, focusing on primary and secondary prevention. METHODS: The concept of a structured prevention pathway, based on the principles of P4 Medicine, was developed for a multidisciplinary prevention network. An IT infrastructure based on HL7 FHIR and the OHDSI OMOP common data model was designed. RESULTS: An IT solution supporting a structured and modular prevention pathway was conceptualized. It contained a personalized management of prevention, risk assessment, diagnostic and preventive measures supported by a modular, interoperable IT infrastructure including a health app, prevention record web-service, decision support modules and a smart prevention registry, separating primary and secondary use of data. CONCLUSION: A concept was created on how an electronic health prevention record based on HL7 FHIR and the OMOP common data model can be implemented.
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Registros Eletrônicos de Saúde , Nível Sete de Saúde , Áustria , Humanos , Prevenção PrimáriaRESUMO
BACKGROUND: Clinical trials (CTs) are foundational to the advancement of evidence-based medicine and recruiting a sufficient number of participants is one of the crucial steps to their successful conduct. Yet, poor recruitment remains the most frequent reason for premature discontinuation or costly extension of clinical trials. METHODS: We designed and implemented a novel, open-source software system to support the recruitment process in clinical trials by generating automatic recruitment recommendations. The development is guided by modern, cloud-native design principles and based on Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) as an interoperability standard with the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) being used as a source of patient data. We evaluated the usability using the system usability scale (SUS) after deploying the application for use by study personnel. RESULTS: The implementation is based on the OMOP CDM as a repository of patient data that is continuously queried for possible trial candidates based on given clinical trial eligibility criteria. A web-based screening list can be used to display the candidates and email notifications about possible new trial participants can be sent automatically. All interactions between services use HL7 FHIR as the communication standard. The system can be installed using standard container technology and supports more sophisticated deployments on Kubernetes clusters. End-users (n = 19) rated the system with a SUS score of 79.9/100. CONCLUSION: We contribute a novel, open-source implementation to support the patient recruitment process in clinical trials that can be deployed using state-of-the art technologies. According to the SUS score, the system provides good usability.
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Ensaios Clínicos como Assunto , Computação em Nuvem , Humanos , Nível Sete de Saúde , Software , Seleção de Pacientes , Interoperabilidade da Informação em SaúdeRESUMO
OBJECTIVE: To evaluate the real-world performance of the SMART/HL7 Bulk Fast Health Interoperability Resources (FHIR) Access Application Programming Interface (API), developed to enable push button access to electronic health record data on large populations, and required under the 21st Century Cures Act Rule. MATERIALS AND METHODS: We used an open-source Bulk FHIR Testing Suite at 5 healthcare sites from April to September 2023, including 4 hospitals using electronic health records (EHRs) certified for interoperability, and 1 Health Information Exchange (HIE) using a custom, standards-compliant API build. We measured export speeds, data sizes, and completeness across 6 types of FHIR. RESULTS: Among the certified platforms, Oracle Cerner led in speed, managing 5-16 million resources at over 8000 resources/min. Three Epic sites exported a FHIR data subset, achieving 1-12 million resources at 1555-2500 resources/min. Notably, the HIE's custom API outperformed, generating over 141 million resources at 12 000 resources/min. DISCUSSION: The HIE's custom API showcased superior performance, endorsing the effectiveness of SMART/HL7 Bulk FHIR in enabling large-scale data exchange while underlining the need for optimization in existing EHR platforms. Agility and scalability are essential for diverse health, research, and public health use cases. CONCLUSION: To fully realize the interoperability goals of the 21st Century Cures Act, addressing the performance limitations of Bulk FHIR API is critical. It would be beneficial to include performance metrics in both certification and reporting processes.
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Troca de Informação em Saúde , Nível Sete de Saúde , Software , Registros Eletrônicos de Saúde , Atenção à SaúdeRESUMO
With the increasing need for timely submission of data to state and national public health registries, current manual approaches to data acquisition and submission are insufficient. In clinical practice, federal regulations are now mandating the use of data messaging standards, i.e., the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard, to facilitate the electronic exchange of clinical (patient) data. In both research and public health practice, we can also leverage FHIR® â and the infrastructure already in place for supporting exchange of clinical practice data â to enable seamless exchange between the electronic medical record and public health registries. That said, in order to understand the current utility of FHIR® for supporting the public health use case, we must first measure the extent to which the standard resources map to the required registry data elements. Thus, using a systematic mapping approach, we evaluated the level of completeness of the FHIR® standard to support data collection for three public health registries (Trauma, Stroke, and National Surgical Quality Improvement Program). On average, approximately 80% of data elements were available in FHIR® (71%, 77%, and 92%, respectively; inter-annotator agreement rates: 82%, 78%, and 72%, respectively). This tells us that there is the potential for significant automation to support EHR-to-Registry data exchange, which will reduce the amount of manual, error-prone processes and ensure higher data quality. Further, identification of the remaining 20% of data elements that are "not mapped" will enable us to improve the standard and develop profiles that will better fit the registry data model.