Making Science Computable Using Evidence-Based Medicine on Fast Healthcare Interoperability Resources: Standards Development Project.

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.

Integrating Laboratory Testing Results at Point-of-Care in Hospital@Home Care Settings: A FHIR-Based Approach.

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.

Towards an Electronic Health Prevention Record Based on HL7 FHIR and the OMOP Common Data Model.

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.

recruIT: A cloud-native clinical trial recruitment support system based on Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM).

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.

Real world performance of the 21st Century Cures Act population-level application programming interface.

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.

Measuring the Coverage of the HL7® FHIR® Standard in Supporting Data Acquisition for 3 Public Health Registries.

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® ‒ and the infrastructure already in place for supporting exchange of clinical practice data ‒ 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.

Design of HL7 FHIR Profiles for Pathology Reports Integrated with Pathology Images.

This paper describes the development of Health Level Seven Fast Healthcare Interoperability Resource (FHIR) profiles for pathology reports integrated with whole slide images and clinical data to create a pathology research database. A report template was designed to collect structured reports, enabling pathologists to select structured terms based on a checklist, allowing for the standardization of terms used to describe tumor features. We gathered and analyzed 190 non-small-cell lung cancer pathology reports in free text format, which were then structured by mapping the itemized vocabulary to FHIR observation resources, using international standard terminologies, such as the International Classification of Diseases, LOINC, and SNOMED CT. The resulting FHIR profiles were published as an implementation guide, which includes 25 profiles for essential data elements, value sets, and structured definitions for integrating clinical data and pathology images associated with the pathology report. These profiles enable the exchange of structured data between systems and facilitate the integration of pathology data into electronic health records, which can improve the quality of care for patients with cancer.

Mapping Injection Order Messages to Health Level 7 Fast Healthcare Interoperability Resources to Collate Infusion Pump Data.

BACKGROUND: When administering an infusion to a patient, it is necessary to verify that the infusion pump settings are in accordance with the injection orders provided by the physician. However, the infusion rate entered into the infusion pump by the health care provider cannot be automatically reconciled with the injection order information entered into the electronic medical records (EMRs). This is because of the difficulty in linking the infusion rate entered into the infusion pump by the health care provider with the injection order information entered into the EMRs. OBJECTIVES: This study investigated a data linkage method for reconciling infusion pump settings with injection orders in the EMRs. METHODS: We devised and implemented a mechanism to convert injection order information into the Health Level 7 Fast Healthcare Interoperability Resources (FHIR), a new health information exchange standard, and match it with an infusion pump management system in a standard and simple manner using a REpresentational State Transfer (REST) application programming interface (API). The injection order information was extracted from Standardized Structured Medical Record Information Exchange version 2 International Organization for Standardization/technical specification 24289:2021 and was converted to the FHIR format using a commercially supplied FHIR conversion module and our own mapping definition. Data were also sent to the infusion pump management system using the REST Web API. RESULTS: Information necessary for injection implementation in hospital wards can be transferred to FHIR and linked. The infusion pump management system application screen allowed the confirmation that the two pieces of information matched, and it displayed an error message if they did not. CONCLUSION: Using FHIR, the data linkage between EMRs and infusion pump management systems can be smoothly implemented. We plan to develop a new mechanism that contributes to medical safety through the actual implementation and verification of this matching system.

Can OpenEHR, ISO 13606, and HL7 FHIR Work Together? An Agnostic Approach for the Selection and Application of Electronic Health Record Standards to the Next-Generation Health Data Spaces.

In order to maximize the value of electronic health records (EHRs) for both health care and secondary use, it is necessary for the data to be interoperable and reusable without loss of the original meaning and context, in accordance with the findable, accessible, interoperable, and reusable (FAIR) principles. To achieve this, it is essential for health data platforms to incorporate standards that facilitate addressing needs such as formal modeling of clinical knowledge (health domain concepts) as well as the harmonized persistence, query, and exchange of data across different information systems and organizations. However, the selection of these specifications has not been consistent across the different health data initiatives, often applying standards to address needs for which they were not originally designed. This issue is essential in the current scenario of implementing the European Health Data Space, which advocates harmonization, interoperability, and reuse of data without regulating the specific standards to be applied for this purpose. Therefore, this viewpoint aims to establish a coherent, agnostic, and homogeneous framework for the use of the most impactful EHR standards in the new-generation health data spaces: OpenEHR, International Organization for Standardization (ISO) 13606, and Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR). Thus, a panel of EHR standards experts has discussed several critical points to reach a consensus that will serve decision-making teams in health data platform projects who may not be experts in these EHR standards. It was concluded that these specifications possess different capabilities related to modeling, flexibility, and implementation resources. Because of this, in the design of future data platforms, these standards must be applied based on the specific needs they were designed for, being likewise fully compatible with their combined functional and technical implementation.

Design and Adoption of a FHIR IG to Support a Telemonitoring Environment in Gatekeeper Project.

Telemedicine can provide benefits in patient affected by chronic diseases or elderly citizens as part of standard routine care supported by digital health. The GATEKEEPER (GK) Project was financed to create a vendor independent platform to be adopted in medical practice and to demonstrate its effect, benefit value, and scalability in 8 connected medical use cases with some independent pilots. This paper, after a description of the GK platform architecture, is focused on the creation of a FHIR (Fast Healthcare Interoperability Resource) IG (Implementation Guide) and its adoption in specific use cases. The final aim is to combine conventional data, collected in the hospital, with unconventional data, coming from wearable devices, to exploit artificial intelligence (AI) models designed to evaluate the effectiveness of a new parsimonious risk prediction model for Type 2 diabetes (T2D).

Implementation of a Patient Summary Web Application According to the International Patient Summary and Validation in Common Use Cases in Japan.

BACKGROUND: The application of standardized patient summaries would reduce the risk of information overload and related problems for physicians and nurses. Although the International Patient Summary (IPS) standard has been developed, disseminating its applications has challenges, including data conversion of existing systems and development of application matching with common use cases in Japan. This study aimed to develop a patient summary application that summarizes and visualizes patient information accumulated by existing systems. METHODS: We converted clinical data from the Standardized Structured Medical Information eXchange version 2 (SS-MIX2) storage at Tohoku University Hospital into the Health Level 7 Fast Healthcare Interoperability Resource (FHIR) repository. Subsequently, we implemented a patient summary web application concerning the IPS and evaluated 12 common use cases of the discharge summary. RESULTS: The FHIR resources of seven of the necessary IPS sections were successfully converted from existing SS-MIX2 data. In the main view of the application we developed, all the minimum necessary patient information was summarized and visualized. All types of mandatory or required sections in the IPS and all structured information items of the discharge summary were displayed. Of the discharge summary, 75% of sections and 61.7% of information items were completely displayed, matching 12 common use cases in Japan. CONCLUSIONS: We implemented a patient summary application that summarizes and visualizes patient information accumulated by existing systems and is evaluated in common use cases in Japan. Efficient sharing of the minimum necessary patient information for physicians is expected to reduce information overload, workload, and burnout.

Evaluating Interoperability in German Critical Incident Reporting Systems.

INTRODUCTION: In industrialised countries, one in ten patients suffers harm during hospitalization. Critical Incident Reporting Systems (CIRS) aim to minimize this by learning from errors and identifying potential risks. However, a lack of interoperability among the 16 CIRS in Germany hampers their effectiveness. METHODS: This study investigates reports' syntactic and semantic interoperability across seven different reporting systems. Syntactic interoperability was examined using WHO's Minimal Information Models (MIM), while semantic interoperability was evaluated with SNOMED concepts. RESULTS: The findings reveal a low structural overlap, with only two terms correctly represented in the SNOMED CT terminology. In addition, most systems showed no syntactic interoperability. CONCLUSION: Improving interoperability is essential for increasing the effectiveness and usability of CIRS. The study suggests a unified data model such as MIM or using Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) resources and expanding SNOMED CT with patient safety-relevant terms for semantic interoperability. Given the current lack of both syntactic and semantic interoperability in CIRS, developing a patient safety ontology is recommended for efficient critical incident analysis too.

FHIR-up! Advancing knowledge from clinical data through application of standardized nursing terminologies within HL7® FHIR®.

Health Level 7®'s (HL7) Fast Healthcare Interoperability Resources® (FHIR®) is leading new efforts to make data available to healthcare clinicians, administrators, and leaders. Standardized nursing terminologies were developed to enable nursing's voice and perspective to be visible within the healthcare data ecosystem. The use of these SNTs has been shown to improve care quality and outcomes, and to provide data for knowledge discovery. The role of SNTs in describing assessments and interventions and measuring outcomes is unique in health care, and synergistic with the purpose and goals of FHIR. FHIR acknowledges nursing as a discipline of interest and yet the use of SNTs within the FHIR ecosystem is rare. The purpose of this article is to describe FHIR, SNTs, and the potential for synergy in the use of SNTs with FHIR. Toward improving understanding how FHIR works to transport and store knowledge and how SNTs work to convey meaning, we provide a framework and examples of SNTs and their coding for use within FHIR solutions. Finally, we offer recommendations for the next steps to advance FHIR-SNT collaboration. Such collaboration will advance both nursing specifically and health care in general, and most importantly, improve population health.

FHIR-PYrate: a data science friendly Python package to query FHIR servers.

BACKGROUND: We present FHIR-PYrate, a Python package to handle the full clinical data collection and extraction process. The software is to be plugged into a modern hospital domain, where electronic patient records are used to handle the entire patient's history. Most research institutes follow the same procedures to build study cohorts, but mainly in a non-standardized and repetitive way. As a result, researchers spend time writing boilerplate code, which could be used for more challenging tasks. METHODS: The package can improve and simplify existing processes in the clinical research environment. It collects all needed functionalities into a straightforward interface that can be used to query a FHIR server, download imaging studies and filter clinical documents. The full capacity of the search mechanism of the FHIR REST API is available to the user, leading to a uniform querying process for all resources, thus simplifying the customization of each use case. Additionally, valuable features like parallelization and filtering are included to make it more performant. RESULTS: As an exemplary practical application, the package can be used to analyze the prognostic significance of routine CT imaging and clinical data in breast cancer with tumor metastases in the lungs. In this example, the initial patient cohort is first collected using ICD-10 codes. For these patients, the survival information is also gathered. Some additional clinical data is retrieved, and CT scans of the thorax are downloaded. Finally, the survival analysis can be computed using a deep learning model with the CT scans, the TNM staging and positivity of relevant markers as input. This process may vary depending on the FHIR server and available clinical data, and can be customized to cover even more use cases. CONCLUSIONS: FHIR-PYrate opens up the possibility to quickly and easily retrieve FHIR data, download image data, and search medical documents for keywords within a Python package. With the demonstrated functionality, FHIR-PYrate opens an easy way to assemble research collectives automatically.

Arden Syntax on FHIR.

Arden Syntax, a medical knowledge representation and processing language for clinical decision support tasks supervised by Health Level Seven International (HL7), was extended with HL7's Fast Healthcare Interoperability Resources (FHIR) constructs to allow standardized data access. The new version, Arden Syntax version 3.0, was successfully balloted as part of the audited, consensus-based, iterative HL7 standards development process.

The Case Manager: An Agent Controlling the Activation of Knowledge Sources in a FHIR-Based Distributed Reasoning Environment.

BACKGROUND: Within the CAPABLE project the authors developed a multi-agent system that relies on a distributed architecture. The system provides cancer patients with coaching advice and supports their clinicians with suitable decisions based on clinical guidelines. OBJECTIVES: As in many multi-agent systems we needed to coordinate the activities of all agents involved. Moreover, since the agents share a common blackboard where all patients' data are stored, we also needed to implement a mechanism for the prompt notification of each agent upon addition of new information potentially triggering its activation. METHODS: The communication needs have been investigated and modeled using the HL7-FHIR (Health Level 7-Fast Healthcare Interoperability Resources) standard to ensure proper semantic interoperability among agents. Then a syntax rooted in the FHIR search framework has been defined for representing the conditions to be monitored on the system blackboard for activating each agent. RESULTS: The Case Manager (CM) has been implemented as a dedicated component playing the role of an orchestrator directing the behavior of all agents involved. Agents dynamically inform the CM about the conditions to be monitored on the blackboard, using the syntax we developed. The CM then notifies each agent whenever any condition of interest occurs. The functionalities of the CM and other actors have been validated using simulated scenarios mimicking the ones that will be faced during pilot studies and in production. CONCLUSION: The CM proved to be a key facilitator for properly achieving the required behavior of our multi-agent system. The proposed architecture may also be leveraged in many clinical contexts for integrating separate legacy services, turning them into a consistent telemedicine framework and enabling application reusability.

Performance Benchmarking of FHIR Terminology Operations in ETL Jobs.

Interoperability in healthcare cannot be achieved without mapping local data to standardized terminology. In this paper, we investigate the performance of different approaches for implementing HL7 FHIR Terminology Module operations using a benchmarking methodology, to gather evidence on the benefits and pitfalls of these methods in terms of performance from the point-of-view of a terminology client. The approaches perform very differently, while having a local client-side cache for all operations is of supreme importance. The results of our investigation show that careful consideration of the integration environment, potential bottlenecks, and implementation strategies is required.

Exploring New Possibilities for Research Data Exploration Using the Example of the German Core Data Set.

The German Medical Informatics Initiative (MII) aims to increase the interoperability and reuse of clinical routine data for research purposes. One important result of the MII work is a German-wide common core data set (CDS), which is to be provided by over 31 data integration centers (DIZ) following a strict specification. One standard format for data sharing is HL7/FHIR. Locally, classical data warehouses are often in use for data storage and retrieval. We are interested to investigate the advantages of a graph database in this setting. After having transferred the MII CDS into a graph, storing it in a graph database and subsequently enriching it with accompanying meta-information, we see a great potential for more sophisticated data exploration and analysis. Here we describe the extract-transform-load process which we set up as a proof of concept to achieve the transformation and to make the common set of core data accessible as a graph.

Breaking Barriers for Interoperability: A Reference Implementation of CSV-FHIR Transformation Using Open-Source Tools.

FHIR is a widely accepted interoperability standard for exchanging medical data, but data transformation from the primary health information systems into FHIR is usually challenging and requires advanced technical skills and infrastructure. There is a critical need for low-cost solutions, and using Mirth Connect as an open-source tool provides this opportunity. We developed a reference implementation to transform data from CSV (the most common data format) into FHIR resources using Mirth Connect without any advanced technical resources or programming skills. This reference implementation is tested successfully for both quality and performance, and it enables reproducing and improving the implemented approach by healthcare providers to transform raw data into FHIR resources. For ensuring replicability, the used channel, mapping, and templates are available publicly on GitHub (https://github.com/alkarkoukly/CSV-FHIR-Transformer).

Implementation of HL7 FHIR-Based Interoperability Profiles to Manage Care Plans for Multimorbid Patients with Mild Dementia.

Management of multimorbidity in patients with mild dementia and mild cognitive impairment introduces additional challenges. The CAREPATH project provides an integrated care platform to assist both healthcare professionals and patients and their informal caregivers in the day-to-day management of care plans for this patient population. This paper introduces an HL7 FHIR-based interoperability approach for exchanging care plan action and goals with the patients and collecting feedback and adherence information from patients. In this way, seamless information exchange between healthcare professionals, patients and their informal care givers is achieved to support patients in their self-care management journey and increase their adherence to their care plans despite the burdens of mild dementia.