Synthetic Data Generation in Hematology - Paving the Way for OMOP and FHIR Integration.

This study advances the utility of synthetic study data in hematology, particularly for Acute Myeloid Leukemia (AML), by facilitating its integration into healthcare systems and research platforms through standardization into the Observational Medical Outcomes Partnership (OMOP) and Fast Healthcare Interoperability Resources (FHIR) formats. In our previous work, we addressed the need for high-quality patient data and used CTAB-GAN+ and Normalizing Flow (NFlow) to synthesize data from 1606 patients across four multicenter AML clinical trials. We published the generated synthetic cohorts, that accurately replicate the distributions of key demographic, laboratory, molecular, and cytogenetic variables, alongside patient outcomes, demonstrating high fidelity and usability. The conversion to the OMOP format opens avenues for comparative observational multi-center research by enabling seamless combination with related OMOP datasets, thereby broadening the scope of AML research. Similarly, standardization into FHIR facilitates further developments of applications, e.g. via the SMART-on-FHIR platform, offering realistic test data. This effort aims to foster a more collaborative research environment and facilitate the development of innovative tools and applications in AML care and research.

Integrating FHIR and UMLS in an Intelligent Tutoring System.

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.

Leveraging FHIR in Federated Learning Environments: A Data Harmonization Framework for Cohort Studies.

MyDigiTwin is a scientific initiative for the development of a platform for the early detection and prevention of cardiovascular diseases. This platform, which is supported by prediction models trained in a federated fashion to preserve data privacy, is expected to be hosted by the Dutch Personal Health Environments (PGOs). Consequently, one of the challenges for this federated learning architecture is ensuring consistency between the PGOs data and the reference datasets that will be part of it. This paper introduces a novel data harmonization framework that streamlines an efficient generation of FHIR-based representations of multiple cohort study data. Furthermore, its applicability in the integration of Lifelines' cohort study data into the MiDigiTwin federated research infrastructure is discussed.

HeXEHRS: FHIR-Based Cloud EHR Services to Support Healthcare in Depopulated Areas Driven by Digital Twin.

HeXEHRS is a FHIR-based cloud EHR service designed to support healthcare in depopulated areas, powered by digital twin technology. Its core functionalities encompass standard EHR tasks including data exchange for healthcare processes. In the first year of this national project, we present the design and define the functionalities of the system.

Assessment of HL7 FHIR Interoperability Between EHR Systems and the Survivorship Passport v2.0 Platform to Generate Treatment Summaries for Childhood Cancer Survivors in Six Clinics: Preliminary Testing Results.

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.

Reformatted Crosswalk-Tables Between Annual ICD-10-Versions for Cross Version Data Analysis.

The International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) is internationally used for coding diagnoses, with the ICD-10 German Modification (GM) being prescribed for morbidity coding in Germany. ICD-10-GM is subject to annual revisions. This can lead to backward compatibility issues leading to undesirable consequences for cross-version data analysis. A study of annual crosswalk-tables concerning 21 ICD-10-GM versions showed that the ratio of difficult transitions from an older to a newer version (0.89 %) and vice versa (0.48 %) is not particularly significant but should nevertheless not be neglected. In this paper we present two solutions (Neo4J database and FHIR ConceptMaps) for the automated handling of different ICD-10-GM versions.

Childhood Cancer Survivorship Passport Challenges in the European Health Data Space.

Innovation in cancer therapy has increased childhood cancer survival rates. However, survivors are still at risk of developing late effects. In the digital transformation of the health sector, the Survivorship Passport (SurPass) can support long-term follow-up care plans. Gaps in seamless connectivity among hospital departments, primary care, combined with the time of health professionals required to collect and fill-in health data in SurPass, are barriers to its adoption in daily clinical practice. The PanCareSurPass (PCSP) project was motivated to address these gaps by a new version of SurPass (v2.0) that supports semi-automatic assembly from organizational Electronic Health Record (EHR) systems of the treatment summary data using HL7 FHIR, to create SurPass, and to link it to regional or national digital health infrastructures in six European countries. In this paper we present the methodology used to develop the SurPass technical implementation strategy with special focus on the European Health Data Space (EHDS). The recently provisionally approved EHDS regulation instruments a digital health data ecosystem with opportunities for cost-effective SurPass implementation across Europe. Moving forward, a European HL7 FHIR SurPass Implementation Guide along with synthetic data sets, and validation tools can enrich the European Electronic Health Record Exchange Format (EEHRxF) with use cases on health & wellness of childhood cancer survivors.

Developing a Sustainable Shared Child's Health Record in Low Resources Setting, Lao PDR.

Lao PDR's Ministry of Health has problem with fragmented data, lack of standardization, and inability to interoperate hinder child health data collection. Electronic health information exchange (HIE) could improve data quality and shared child health records (SCHR). In this study we developed the SCHR by interoperating with existing healthcare systems. The FHIR IPS standards were customized based on data elements. 14 experts from the technical working group (TWG) had determined the minimum dataset for data transactions and system testing was analyzed on the HAPI FHIR server. Used FHIR IPS standards for interoperability within Client Registry (CR-DHIS2), Electronic Immunization Record (EIR-DHIS2) and Electronic Medical Record (EMR) works well for data transactions. The initial result of the SCHR could be able to provide a real target child and to monitor full vaccination. However, prior to the actual deployment of the system, it is necessary to validate it and guarantee the confidentiality and safety of the data.

GameBus on FHIR.

The interoperability of healthcare data across various systems remains a big challenge, largely attributable to the disparate data schemas and APIs in use. This study showcases the integration of a FHIR layer into GameBus, a gamified health platform, aiming to enhance its interoperability. Traditionally, GameBus has relied on proprietary data schemas and REST APIs, which restricted data exchange with other platforms. The incorporation of the FHIR standard significantly mitigates these constraints. The FHIR layer, constructed with open-source technologies - including the Google HCLS Data Harmonization tool for data transformation and the HAPI FHIR framework for RESTful services - allows GameBus to engage in data sharing using standardized FHIR formats and APIs. Implemented as a standalone microservice, this layer requires no alterations to the pre-existing architecture of GameBus. Furthermore, the design and implementation of the FHIR layer illustrate a generic method for achieving interoperability across diverse healthcare platforms.

Advancing Healthcare Research Through Live-Data Integration: Implementing IEEE 11073 and FHIR in Clinical Environment.

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.

ONCO-FAIR Project: Improving Data Interoperability in Oncology Chemotherapy Treatments for Data Reuse.

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.

Data Standardization in the Medical Field Through FHIR and FAIR Implementation: A Systematic Review.

The authors investigate in this paper the current situation of the FHIR resources adoption in order to FAIRify data in the medical research field. By aligning with the FAIR data principles, data becomes easier to share and reuse. This review aims to analyze how integrating the FHIR resources improved the findability, accessibility, interoperability, and reusability of datasets. By searching for the state-of-art situation in this field, we want to emphasize the significant role that FAIR data occupies in the medical research community, by also providing directions for further development and improved interoperability.

From Syntactic to Semantic Interoperability Using a Hyperontology in the Oncology Domain.

Interoperability is crucial to overcoming various challenges of data integration in the healthcare domain. While OMOP and FHIR data standards handle syntactic heterogeneity among heterogeneous data sources, ontologies support semantic interoperability to overcome the complexity and disparity of healthcare data. This study proposes an ontological approach in the context of the EUCAIM project to support semantic interoperability among distributed big data repositories that have applied heterogeneous cancer image data models using a semantically well-founded Hyperontology for the oncology domain.

Using Health IT Standards to Facilitate Metadata Exchange Between Research Data Management Systems.

The National Research Data Infrastructure for Personal Health Data (NFDI4Health) uses Local Data Hubs (LDHs) to manage locally research studies, documents and sensitive personal data to support controlled data sharing. While research data management (RDM) systems facilitate the storage and preparation of data and metadata as well as organizational access, they often lack support for interoperability standards of the application domain. To support the exchange with external registries of research studies, we chose 17 attributes to characterize the most relevant aspects of clinical trials (in the following named "metadata profile"). We implemented the metadata profile in the RDM system FAIRDOM SEEK using core attributes and SEEK's extended metadata feature and created a mapping conforming to the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard version R4. Finally, we implemented a prototype application interface for exports in FHIR-JSON format. We plan to extend the interface to serve central registries and support specific FHIR Implementation Guides from various use cases.

Development of an Austrian HL7 Member FHIR IG Supporting Medication Ordering, Prescription and Dispense Processes.

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.

Quality Assessment Framework of Clinical Routine Data for Secondary Use.

To systematically and comprehensively identify data issues in large clinical datasets, we adopted a harmonized data quality assessment framework with Python scripts before integrating the data into FHIR® for secondary use. We also added a preliminary step of categorizing data fields within the database scheme to facilitate the implementation of the data quality framework. As a result, we demonstrated the efficiency and comprehensiveness of detecting data issues using the framework. In future steps, we plan to continually utilize the framework to identify data issues and develop strategies for improving our data quality.

TermX: A Game Changer in the Healthcare Interoperability.

The necessity for robust, enduring, and relevant healthcare interoperability is universal across all clinical domains. However, we identified a gap in the availability of open-source, no-cost, high-quality tools that offer multilingual support and an advanced graphical interface. To address this, we developed TermX, an open-source platform to harmonise terminology and support interoperability between healthcare institutions and systems. TermX incorporates a terminology server, a Wiki, a model designer, a transformation editor, and tools for authoring and publishing. TermX is designed to develop terminology and implementation guides for healthcare systems at both the national and regional levels. It aims to ensure open, standardised access to published data and guarantee semantic interoperability based on the FHIR standard.

OMOP-on-FHIR: A FHIR Server Development to Facilitate Data Interaction with the OMOP-CDM and FHIR for PGHD.

This paper introduces the concept of the implementation of a FHIR server for bidirectional data exchange with the OMOP-CDM. Leveraging FHIR as a metamodel, the implementation aims to promote a more interconnected and patient-centric healthcare ecosystem. The methodology involves utilizing the Java HAPI FHIR API for server architecture and validating the solution through patient data exchange with a FHIR reference implementation server. This initiative signifies a significant advancement in healthcare data interoperability, promising improved patient care quality and clinical research vigor.

Improving Healthcare Quality with a LHS: From Patient-Generated Health Data to Evidence-Based Recommendations.

One approach to enriching the Learning Health System (LHS) is leveraging vital signs and data from wearable technologies. Blood oxygen, heart rate, respiration rates, and other data collected by wearables (like sleep and exercise patterns) can be used to monitor and predict health conditions. This data is already being collected and could be used to improve healthcare in several ways. Our approach will be health data interoperability with HL7 FHIR (for data exchange between different systems), openEHR (to store researchable data separated from software but connected to ontologies, external terminologies and code sets) and maintain the semantics of data. OpenEHR is a standard that has an important role in modelling processes and clinical decisions. The six pillars of Lifestyle Medicine can be a first attempt to change how patients see their daily decisions, affecting the mid to long-term evolution of their health. Our objective is to develop the first stage of the LHS based on a co-produced personal health recording (CoPHR) built on top of a local LLM that interoperates health data through HL7 FHIR, openEHR, OHDSI and terminologies that can ingest external evidence and produces clinical and personal decision support and, when combined with many other patients, can produce or confirm evidence.

Advancing Healthcare Through Interoperability: Implementing Scalable Solutions for Patient Data Integration.

Healthcare faces significant challenges in exchanging and utilizing health information across diverse providers, necessitating innovative solutions for improved interoperability. This study presents a comprehensive exploration of scalable technical and semantic solutions for patient care integration, emphasizing the implementation of these solutions within the framework of the Fast Healthcare Interoperability Resources (FHIR) standard. Our approach revolves around the development and deployment of Technical Interoperability Suite (TIS) and Semantic Interoperability Suite (SIS) technology solutions to disparate health information systems, predominantly Electronic Health Records (EHRs) into a unified Patient Care Platform, fostering comprehensive data exchange and utilization. The integration process involves importing data from various EHR systems and transforming imported patient data into FHIR-standardized formats. The provided solution supports various functionalities, including automatic and manual importation of patient data, through standard computer-readable templates. The integration of TIS and SIS solutions is underpinned by a robust technological framework, incorporating technologies such as Typescript, Deno, and document-oriented databases such as MongoDB. The effectiveness of our interoperability solutions was validated through deployment in multinational EU projects: ADLIFE and CAREPATH. The scalability and generalizability of our approach underscore its potential for diverse healthcare settings.