FHIR Research Articles

Trending in the right direction: critical access hospitals increased adoption of advanced electronic health record functions from 2018 to 2023

Abstract Objectives We analyzed trends in adoption of advanced patient engagement and clinical data analytics functionalities among critical access hospitals (CAHs) and non-CAHs to assess how historical gaps have changed. Materials and Methods We used 2014, 2018, and 2023 data from the American Hospital Association Annual Survey IT Supplement to measure differences in adoption rates (ie, the “adoption gap”) of patient engagement and clinical data analytics functionalities across CAHs and non-CAHs. We measured changes over time in CAH and non-CAH adoption of 6 “core” clinical data analytics functionalities, 5 “core” patient engagement functionalities, 5 new patient engagement functionalities, and 3 bulk data export use cases. We constructed 2 composite measures for core functionalities and analyzed adoption for other functionalities individually. Results Core functionality adoption increased from 21% of CAHs in 2014 to 56% in 2023 for clinical data analytics and 18% to 49% for patient engagement. The CAH adoption gap in both domains narrowed from 2018 to 2023 (both P < .01). More than 90% of all hospitals had adopted viewing and downloading electronic data and clinical notes by 2023. The largest CAH adoption gaps in 2023 were for Fast Healthcare Interoperability Resources (FHIR) bulk export use cases (eg, analytics and reporting: 63% of CAHs, 81% of non-CAHs, P < .001). Discussion Adoption of advanced electronic health record functionalities has increased for CAHs and non-CAHs, and some adoption gaps have been closed since 2018. However, CAHs may continue to struggle with clinical data analytics and FHIR-based functionalities. Conclusion Some crucial patient engagement functionalities have reached near-universal adoption; however, policymakers should consider programs to support CAHs in closing remaining adoption gaps.

Establishing Medical Intelligence-Leveraging Fast Healthcare Interoperability Resources to Improve Clinical Management: Retrospective Cohort and Clinical Implementation Study.

FHIR (Fast Healthcare Interoperability Resources) has been proposed to enable health data interoperability. So far, its applicability has been demonstrated for selected research projects with limited data. This study aimed to design and implement a conceptual medical intelligence framework to leverage real-world care data for clinical decision-making. A Python package for the use of multimodal FHIR data (FHIRPACK [FHIR Python Analysis Conversion Kit]) was developed and pioneered in 5 real-world clinical use cases, that is, myocardial infarction, stroke, diabetes, sepsis, and prostate cancer. Patients were identified based on the ICD-10 (International Classification of Diseases, Tenth Revision) codes, and outcomes were derived from laboratory tests, prescriptions, procedures, and diagnostic reports. Results were provided as browser-based dashboards. For 2022, a total of 1,302,988 patient encounters were analyzed. (1) Myocardial infarction: in 72.7% (261/359) of cases, medication regimens fulfilled guideline recommendations. (2) Stroke: out of 1277 patients, 165 received thrombolysis and 108 thrombectomy. (3) Diabetes: in 443,866 serum glucose and 16,180 glycated hemoglobin A1c measurements from 35,494 unique patients, the prevalence of dysglycemic findings was 39% (13,887/35,494). Among those with dysglycemia, diagnosis was coded in 44.2% (6138/13,887) of the patients. (4) Sepsis: In 1803 patients, Staphylococcus epidermidis was the primarily isolated pathogen (773/2672, 28.9%) and piperacillin and tazobactam was the primarily prescribed antibiotic (593/1593, 37.2%). (5) PC: out of 54, three patients who received radical prostatectomy were identified as cases with prostate-specific antigen persistence or biochemical recurrence. Leveraging FHIR data through large-scale analytics can enhance health care quality and improve patient outcomes across 5 clinical specialties. We identified (1) patients with sepsis requiring less broad antibiotic therapy, (2) patients with myocardial infarction who could benefit from statin and antiplatelet therapy, (3) patients who had a stroke with longer than recommended times to intervention, (4) patients with hyperglycemia who could benefit from specialist referral, and (5) patients with PC with early increases in cancer markers.

A Generic Transformation Approach for Complex Laboratory Data Using the Fast Healthcare Interoperability Resources Mapping Language: Method Development and Implementation.

Reaching meaningful interoperability between proprietary health care systems is a ubiquitous task in medical informatics, where communication servers are traditionally used for referring and transforming data from the source to target systems. The Mirth Connect Server, an open-source communication server, offers, in addition to the exchange functionality, functions for simultaneous manipulation of data. The standard Fast Healthcare Interoperability Resources (FHIR) has recently become increasingly prevalent in national health care systems. FHIR specifies its own standardized mechanisms for transforming data structures using StructureMaps and the FHIR mapping language (FML). In this study, a generic approach is developed, which allows for the application of declarative mapping rules defined using FML in an exchangeable manner. A transformation engine is required to execute the mapping rules. FHIR natively defines resources to support the conversion of instance data, such as an FHIR StructureMap. This resource encodes all information required to transform data from a source system to a target system. In our approach, this information is defined in an implementation-independent manner using FML. Once the mapping has been defined, executable Mirth channels are automatically generated from the resources containing the mapping in JavaScript format. These channels can then be deployed to the Mirth Connect Server. The resulting tool is called FML2Mirth, a Java-based transformer that derives Mirth channels from detailed declarative mapping rules based on the underlying StructureMaps. Implementation of the translate functionality is provided by the integration of a terminology server, and to achieve conformity with existing profiles, validation via the FHIR validator is built in. The system was evaluated for its practical use by transforming Labordatenträger version 2 (LDTv.2) laboratory results into Medical Information Object (Medizinisches Informationsobjekt) laboratory reports in accordance with the National Association of Statutory Health Insurance Physicians' specifications and into the HL7 (Health Level Seven) Europe Laboratory Report. The system could generate complex structures, but LDTv.2 lacks some information to fully comply with the specification. The tool for the auto-generation of Mirth channels was successfully presented. Our tests reveal the feasibility of using the complex structures of the mapping language in combination with a terminology server to transform instance data. Although the Mirth Server and the FHIR are well established in medical informatics, the combination offers space for more research, especially with regard to FML. Simultaneously, it can be stated that the mapping language still has implementation-related shortcomings that can be compensated by Mirth Connect as a base technology.

CIC 2023: Enhancing Referrals to the Supplemental Nutrition Assistance Program (SNAP) through Clinical Integration of a Standards-Based Decision Support System.

The Supplemental Nutrition Assistance Program (SNAP) is one of the most successful national programs to reduce poverty and improve health outcomes, but millions of Americans who qualify still do not have access to SNAP, and limited data is available to determine how referrals to the program can be completed successfully. We aimed to design and develop a standards-based digital care coordination platform to support closed-loop social services referrals between patients and social and health care providers; and demonstrate the feasibility to screen, diagnose, plan, and complete interventions with selected patients in real-settings. We partnered with community members to design the platform through Community Engagement Studios and with a Federally Qualified Health Center, Local Mental Health Authority, and Food Bank to determine the features and workflow requirements of the platform design. We customized currently available systems to use Fast Healthcare Interoperability Resources (FHIR) Application Programming Interfaces (APIs) that could exchange information in real-time across providers and participants. The platform was successfully demonstrated through a pilot where patients were recruited in clinical settings and referred to a Food Bank that provided SNAP application assistance to study participants. We translated the requirements of the platform to national standards and required workflows of providers and patients. Study participants were notified electronically of the specific steps to follow to complete their SNAP applications while receiving support from specialists from the Food Bank. The pilot demonstrated the feasibility of collecting granular social service referral information that can be used to better address gaps in social care. The pilot also highlighted the importance of further coordination on the usage and harmonization of needs assessment nationally and that current digital systems are still not ready to fully utilize national Social Determinants of Health (SDOH) data standards.

Bridging Data Models in Health Care With a Novel Intermediate Query Format for Feasibility Queries: Mixed Methods Study.

To advance research with clinical data, it is essential to make access to the available data as fast and easy as possible for researchers, which is especially challenging for data from different source systems within and across institutions. Over the years, many research repositories and data standards have been created. One of these is the Fast Healthcare Interoperability Resources (FHIR) standard, used by the German Medical Informatics Initiative (MII) to harmonize and standardize data across university hospitals in Germany. One of the first steps to make these data available is to allow researchers to create feasibility queries to determine the data availability for a specific research question. Given the heterogeneity of different query languages to access different data across and even within standards such as FHIR (eg, CQL and FHIR Search), creating an intermediate query syntax for feasibility queries reduces the complexity of query translation and improves interoperability across different research repositories and query languages. This study describes the creation and implementation of an intermediate query syntax for feasibility queries and how it integrates into the federated German health research portal (Forschungsdatenportal Gesundheit) and the MII. We analyzed the requirements for feasibility queries and the feasibility tools that are currently available in research repositories. Based on this analysis, we developed an intermediate query syntax that can be easily translated into different research repository-specific query languages. The resulting Clinical Cohort Definition Language (CCDL) for feasibility queries combines inclusion criteria in a conjunctive normal form and exclusion criteria in a disjunctive normal form, allowing for additional filters like time or numerical restrictions. The inclusion and exclusion results are combined via an expression to specify feasibility queries. We defined a JSON schema for the CCDL, generated an ontology, and demonstrated the use and translatability of the CCDL across multiple studies and real-world use cases. We developed and evaluated a structured query syntax for feasibility queries and demonstrated its use in a real-world example as part of a research platform across 39 German university hospitals.

Enhancing the Functionalities of Personal Health Record Systems: Empirical Study Based on the HL7 Personal Health Record System Functional Model Release 1.

The increasing demand for personal health record (PHR) systems is driven by individuals' desire to actively manage their health care. However, the limited functionality of current PHR systems has affected users' willingness to adopt them, leading to lower-than-expected usage rates. The HL7 (Health Level Seven) PHR System Functional Model (PHR-S FM) was proposed to address this issue, outlining all possible functionalities in PHR systems. Although the PHR-S FM provides a comprehensive theoretical framework, its practical effectiveness and applicability have not been fully explored. This study aimed to design and develop a tethered PHR prototype in accordance with the guidelines of the PHR-S FM. It sought to explore the feasibility of applying the PHR-S FM in PHR systems by comparing the prototype with the results of previous research. The PHR-S FM profile was defined to meet broad clinical data management requirements based on previous research. We designed and developed a PHR prototype as a web application using the Fast Healthcare Interoperability Resources R4 (FHIR) and Logical Observation Identifiers Names and Codes (LOINC) coding system for interoperability and data consistency. We validated the prototype using the Synthea dataset, which provided realistic synthetic medical records. In addition, we compared the results produced by the prototype with those of previous studies to evaluate the feasibility and implementation of the PHR-S FM framework. The PHR prototype was developed based on the PHR-S FM profile. We verified its functionality by demonstrating its ability to synchronize data with the FHIR server, effectively managing and displaying various health data types. Validation using the Synthea dataset confirmed the prototype's accuracy, achieving 100% coverage across 1157 data items. A comparison with the findings of previous studies indicated the feasibility of implementing the PHR-S FM and highlighted areas for future research and improvements. The results of this study offer valuable insights into the potential for practical application and broad adoption of the PHR-S FM in real-world health care settings.

Family history and cancer risk study (FOREST): A clinical trial assessing electronic patient-directed family history input for identifying patients at risk of hereditary cancer

BackgroundHereditary cancer syndromes cause a high lifetime risk of early, aggressive cancers. Early recognition of individuals at risk can allow risk-reducing interventions that improve morbidity and mortality. Family health history applications that gather data directly from patients could alleviate barriers to risk assessment in the clinical appointment, such as lack of provider knowledge of genetics guidelines and limited time in the clinical appointment. New approaches allow linking these applications to patient health portals and their electronic health records (EHRs), offering an end-to-end solution for patient-input family history information and risk result clinical decision support for their provider. MethodsWe describe the design of the first large-scale evaluation of an EHR-integrable, patient-facing family history software platform based on the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) standard. In our study, we leverage an established implementation science framework to evaluate the success of our model to facilitate scalable, systematic risk assessment for hereditary cancers in diverse clinical environments in a large pragmatic study at two sites. We will also evaluate the success of the approach to improve the efficiency of downstream genetic counseling resulting from pre-counseling pedigree generation. ConclusionsOur research study will provide evidence regarding a new care delivery model that is scalable and sustainable for a variety of medical centers and clinics. Trial registrationThis study was registered on ClinicalTrials.gov under NCT05079334 on 15 October 2021.

State-of-the-Art Fast Healthcare Interoperability Resources (FHIR)-Based Data Model and Structure Implementations: Systematic Scoping Review.

Data models are crucial for clinical research as they enable researchers to fully use the vast amount of clinical data stored in medical systems. Standardized data and well-defined relationships between data points are necessary to guarantee semantic interoperability. Using the Fast Healthcare Interoperability Resources (FHIR) standard for clinical data representation would be a practical methodology to enhance and accelerate interoperability and data availability for research. This research aims to provide a comprehensive overview of the state-of-the-art and current landscape in FHIR-based data models and structures. In addition, we intend to identify and discuss the tools, resources, limitations, and other critical aspects mentioned in the selected research papers. To ensure the extraction of reliable results, we followed the instructions of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. We analyzed the indexed articles in PubMed, Scopus, Web of Science, IEEE Xplore, the ACM Digital Library, and Google Scholar. After identifying, extracting, and assessing the quality and relevance of the articles, we synthesized the extracted data to identify common patterns, themes, and variations in the use of FHIR-based data models and structures across different studies. On the basis of the reviewed articles, we could identify 2 main themes: dynamic (pipeline-based) and static data models. The articles were also categorized into health care use cases, including chronic diseases, COVID-19 and infectious diseases, cancer research, acute or intensive care, random and general medical notes, and other conditions. Furthermore, we summarized the important or common tools and approaches of the selected papers. These items included FHIR-based tools and frameworks, machine learning approaches, and data storage and security. The most common resource was "Observation" followed by "Condition" and "Patient." The limitations and challenges of developing data models were categorized based on the issues of data integration, interoperability, standardization, performance, and scalability or generalizability. FHIR serves as a highly promising interoperability standard for developing real-world health care apps. The implementation of FHIR modeling for electronic health record data facilitates the integration, transmission, and analysis of data while also advancing translational research and phenotyping. Generally, FHIR-based exports of local data repositories improve data interoperability for systems and data warehouses across different settings. However, ongoing efforts to address existing limitations and challenges are essential for the successful implementation and integration of FHIR data models.

Building a Natural Language Interface for FHIR Clinical Terminology Server.

While Fast Healthcare Interoperability Resources (FHIR) clinical terminology server enables quick and easy search and retrieval of coded medical data, it still has some drawbacks. When searching, any typographical errors, variations in word forms, or deviations in word sequence might lead to incorrect search outcomes. For retrieval, queries to the server must strictly follow the FHIR application programming interface format, which requires users to know the syntax and remember the attribute codes they wish to retrieve. To improve its functionalities, a natural language interface was built, that harnesses the capabilities of two preeminent large language models, along with other cutting-edge technologies such as speech-to-text conversion, vector semantic searching, and conversational artificial intelligence. Preliminary evaluation shows promising results in building a natural language interface for the FHIR clinical terminology system.

Reusable Generic Clinical Decision Support System Module for Immunization Recommendations in Resource-Constraint Settings.

Clinical decision support systems (CDSS) are routinely employed in clinical settings to improve quality of care, ensure patient safety, and deliver consistent medical care. However, rule-based CDSS, currently available, do not feature reusable rules. In this study, we present CDSS with reusable rules. Our solution includes a common CDSS module, electronic medical record (EMR) specific adapters, CDSS rules written in the clinical quality language (CQL) (derived from CDC immunization recommendations), and patient records in fast healthcare interoperability resources (FHIR) format. The proposed CDSS is entirely browser-based and reachable within the user's EMR interface at the client-side. This helps to avoid the transmission of patient data and privacy breaches. Additionally, we propose to provide means of managing and maintaining CDSS rules to allow the end users to modify them independently. Successful implementation and deployment were achieved in OpenMRS and OpenEMR during initial testing.

PCEtoFHIR: Decomposition of Postcoordinated SNOMED CT Expressions for Storage as HL7 FHIR Resources.

To ensure interoperability, both structural and semantic standards must be followed. For exchanging medical data between information systems, the structural standard FHIR (Fast Healthcare Interoperability Resources) has recently gained popularity. Regarding semantic interoperability, the reference terminology SNOMED Clinical Terms (SNOMED CT), as a semantic standard, allows for postcoordination, offering advantages over many other vocabularies. These postcoordinated expressions (PCEs) make SNOMED CT an expressive and flexible interlingua, allowing for precise coding of medical facts. However, this comes at the cost of increased complexity, as well as challenges in storage and processing. Additionally, the boundary between semantic (terminology) and structural (information model) standards becomes blurred, leading to what is known as the TermInfo problem. Although often viewed critically, the TermInfo overlap can also be explored for its potential benefits, such as enabling flexible transformation of parts of PCEs. In this paper, an alternative solution for storing PCEs is presented, which involves combining them with the FHIR data model. Ultimately, all components of a PCE should be expressible solely through precoordinated concepts that are linked to the appropriate elements of the information model. The approach involves storing PCEs decomposed into their components in alignment with FHIR resources. By utilizing the Web Ontology Language (OWL) to generate an OWL ClassExpression, and combining it with an external reasoner and semantic similarity measures, a precoordinated SNOMED CT concept that most accurately describes the PCE is identified as a Superconcept. In addition, the nonmatching attribute relationships between the Superconcept and the PCE are identified as the "Delta." Once SNOMED CT attributes are manually mapped to FHIR elements, FHIRPath expressions can be defined for both the Superconcept and the Delta, allowing the identified precoordinated codes to be stored within FHIR resources. A web application called PCEtoFHIR was developed to implement this approach. In a validation process with 600 randomly selected precoordinated concepts, the formal correctness of the generated OWL ClassExpressions was verified. Additionally, 33 PCEs were used for two separate validation tests. Based on these validations, it was demonstrated that a previously proposed semantic similarity calculation is suitable for determining the Superconcept. Additionally, the 33 PCEs were used to confirm the correct functioning of the entire approach. Furthermore, the FHIR StructureMaps were reviewed and deemed meaningful by FHIR experts. PCEtoFHIR offers services to decompose PCEs for storage within FHIR resources. When creating structure mappings for specific subdomains of SNOMED CT concepts (eg, allergies) to desired FHIR profiles, the use of SNOMED CT Expression Templates has proven highly effective. Domain experts can create templates with appropriate mappings, which can then be easily reused in a constrained manner by end users.

EHR Interoperability Challenges Leveraging HL7 FHIR for Seamless Data Exchange in Healthcare

Electronic health records, often known as EHRs, have revolutionised the healthcare industry by making patient information more easily accessible and more efficient on the whole. There is still a huge obstacle to overcome in order to achieve seamless data transmission across different electronic health record systems. variances in data formats, terminologies, and standards often give rise to interoperability concerns. These variances impede the smooth flow of information across various systems and have the potential to cause problems. The Fast Healthcare Interoperability Resources (FHIR) standard, which is based on Health Level Seven (HL7), has emerged as a potentially useful option to overcome these difficulties. Through the provision of a uniform and standardized method for the sharing of healthcare data, FHIR is intended to facilitate the interchange of data in a manner that is both more efficient and trustworthy. The issues that are involved with electronic health record (EHR) interoperability are investigated in this study, as is the manner in which HL7 FHIR may ease the interchange of data in healthcare settings in a smooth manner. It starts out by providing an overview of the basic problems that exist in electronic health record (EHR) interoperability. These problems include data fragmentation, inconsistent data formats, and the absence of standardized protocols. HL7 FHIR is then presented in the article, along with a description of its fundamental principles. These concepts include the emphasis placed on interoperability, the simplicity of implementation, and the support for contemporary web technologies.

A systematic review of the use of FHIR to support clinical research, public health and medical education

PurposeThis systematic review aimed to identify and categorize applications using Fast Healthcare Interoperability Resources (FHIR) to support activities outside of direct healthcare provision.Design/methodology/approachA systematic electronic search was performed, and 53 studies were included after the selection process.FindingsThe results show that FHIR is being used to support (1) clinical research (i.e. clinical research based on interventional trials, data interoperability to support clinical research and advanced communication services to support clinical research), (2) public health and (3) medical education. Despite the FHIR potential to support activities outside of direct healthcare provision, some barriers were identified, namely difficulties translating the proposed applications to clinical environments or FHIR technical issues that require further developments.Originality/valueThis study provided a broad review of how FHIR is being applied in clinical activities outside of direct clinical care and identified three major domains, that is, clinical research, public health and medical education, being the first and most representative in terms of number of publications.

2024 HRS perspective on advancing workflows for CIED remote monitoring

Cardiac implantable electronic devices (CIEDs) generate substantial data, often stored in image or PDF formats. Remote monitoring, now an integral component of patient care, places considerable administrative burdens on clinicians and staff, in large part due to the challenge of integrating these data seamlessly into electronic health records (EHRs). Since 2006, the Heart Rhythm Society, in collaboration with the CIED industry, has led an initiative to establish a unified standard nomenclature. This effort has harmonized terminology, aligning diverse terms with single terms approved by the Institute of Electrical and Electronics Engineers. With this foundational work complete, attention now turns to developing technical standards for interoperability, which would enable the smooth communication of CIED data between information technology systems used in clinical practice. In this manuscript, by leveraging Health Level 7 Fast Healthcare Interoperability Resources, we present a roadmap for the technical committee to guide this endeavor. We identify critical data exchange points between remote transceivers, EHRs, and third-party platforms commonly used for CIED patient data management. Our objective is to establish bidirectional communication among these resources, ensuring the accuracy, timeliness, and accessibility of clinical data for clinicians. We also anticipate substantial benefits for both clinical research and administrative efficiency through the implementation of this interoperability framework.

Implementation of the World Health Organization Minimum Dataset for Emergency Medical Teams to Create Disaster Profiles for the Indonesian SATUSEHAT Platform Using Fast Healthcare Interoperability Resources: Development and Validation Study.

The National Disaster Management Agency (Badan Nasional Penanggulangan Bencana) handles disaster management in Indonesia as a health cluster by collecting, storing, and reporting information on the state of survivors and their health from various sources during disasters. Data were collected on paper and transferred to Microsoft Excel spreadsheets. These activities are challenging because there are no standards for data collection. The World Health Organization (WHO) introduced a standard for health data collection during disasters for emergency medical teams (EMTs) in the form of a minimum dataset (MDS). Meanwhile, the Ministry of Health of Indonesia launched the SATUSEHAT platform to integrate all electronic medical records in Indonesia based on Fast Healthcare Interoperability Resources (FHIR). This study aims to implement the WHO EMT MDS to create a disaster profile for the SATUSEHAT platform using FHIR. We extracted variables from 2 EMT MDS medical records-the WHO and Association of Southeast Asian Nations (ASEAN) versions-and the daily reporting form. We then performed a mapping process to match these variables with the FHIR resources and analyzed the gaps between the variables and base resources. Next, we conducted profiling to see if there were any changes in the selected resources and created extensions to fill the gap using the Forge application. Subsequently, the profile was implemented using an open-source FHIR server. The total numbers of variables extracted from the WHO EMT MDS, ASEAN EMT MDS, and daily reporting forms were 30, 32, and 46, with the percentage of variables matching FHIR resources being 100% (30/30), 97% (31/32), and 85% (39/46), respectively. From the 40 resources available in the FHIR ID core, we used 10, 14, and 9 for the WHO EMT MDS, ASEAN EMT MDS, and daily reporting form, respectively. Based on the gap analysis, we found 4 variables in the daily reporting form that were not covered by the resources. Thus, we created extensions to address this gap. We successfully created a disaster profile that can be used as a disaster case for the SATUSEHAT platform. This profile may standardize health data collection during disasters.

Feasibility of structuring electronic health record data to facilitate real-world data research: ICAREdata methods applied to multicenter cancer clinical trials.

The use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real-World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data. The ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave. By December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n=15), there was 87% agreement on cancer disease status. Documentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi-institutional cancer clinical trials. EDC as a reference data setallowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows. Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.

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.

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.

Comparing the Accuracy of Traditional vs. FHIR®-Based Extraction of Electronic Health Record Data for Two Clinical Trials.

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.

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.