UNASSIGNED: Transparency and traceability are essential for establishing trustworthy artificial intelligence (AI). The lack of transparency in the data preparation process is a significant obstacle in developing reliable AI systems which can lead to issues related to reproducibility, debugging AI models, bias and fairness, and compliance and regulation. We introduce a formal data preparation pipeline specification to improve upon the manual and error-prone data extraction processes used in AI and data analytics applications, with a focus on traceability.
UNASSIGNED: We propose a declarative language to define the extraction of AI-ready datasets from health data adhering to a common data model, particularly those conforming to HL7 Fast Healthcare Interoperability Resources (FHIR). We utilize the FHIR profiling to develop a common data model tailored to an AI use case to enable the explicit declaration of the needed information such as phenotype and AI feature definitions. In our pipeline model, we convert complex, high-dimensional electronic health records data represented with irregular time series sampling to a flat structure by defining a target population, feature groups and final datasets. Our design considers the requirements of various AI use cases from different projects which lead to implementation of many feature types exhibiting intricate temporal relations.
UNASSIGNED: We implement a scalable and high-performant feature repository to execute the data preparation pipeline definitions. This software not only ensures reliable, fault-tolerant distributed processing to produce AI-ready datasets and their metadata including many statistics alongside, but also serve as a pluggable component of a decision support application based on a trained AI model during online prediction to automatically prepare feature values of individual entities. We deployed and tested the proposed methodology and the implementation in three different research projects. We present the developed FHIR profiles as a common data model, feature group definitions and feature definitions within a data preparation pipeline while training an AI model for \"predicting complications after cardiac surgeries\".
UNASSIGNED: Through the implementation across various pilot use cases, it has been demonstrated that our framework possesses the necessary breadth and flexibility to define a diverse array of features, each tailored to specific temporal and contextual criteria.

UNASSIGNED: Unlocking the potential of routine medical data for clinical research requires the analysis of data from multiple healthcare institutions. However, according to German data protection regulations, data can often not leave the individual institutions and decentralized approaches are needed. Decentralized studies face challenges regarding coordination, technical infrastructure, interoperability and regulatory compliance. Rare diseases are an important prototype research focus for decentralized data analyses, as patients are rare by definition and adequate cohort sizes can only be reached if data from multiple sites is combined.
UNASSIGNED: Within the project \"Collaboration on Rare Diseases\", decentralized studies focusing on four rare diseases (cystic fibrosis, phenylketonuria, Kawasaki disease, multisystem inflammatory syndrome in children) were conducted at 17 German university hospitals. Therefore, a data management process for decentralized studies was developed by an interdisciplinary team of experts from medicine, public health and data science. Along the process, lessons learned were formulated and discussed.
UNASSIGNED: The process consists of eight steps and includes sub-processes for the definition of medical use cases, script development and data management. The lessons learned include on the one hand the organization and administration of the studies (collaboration of experts, use of standardized forms and publication of project information), and on the other hand the development of scripts and analysis (dependency on the database, use of standards and open source tools, feedback loops, anonymization).
UNASSIGNED: This work captures central challenges and describes possible solutions and can hence serve as a solid basis for the implementation and conduction of similar decentralized studies.

UNASSIGNED: The increasing prevalence of electronic health records (EHRs) in healthcare systems globally has underscored the importance of data quality for clinical decision-making and research, particularly in obstetrics. High-quality data is vital for an accurate representation of patient populations and to avoid erroneous healthcare decisions. However, existing studies have highlighted significant challenges in EHR data quality, necessitating innovative tools and methodologies for effective data quality assessment and improvement.
UNASSIGNED: This article addresses the critical need for data quality evaluation in obstetrics by developing a novel tool. The tool utilizes Health Level 7 (HL7) Fast Healthcare Interoperable Resources (FHIR) standards in conjunction with Bayesian Networks and expert rules, offering a novel approach to assessing data quality in real-world obstetrics data.
UNASSIGNED: A harmonized framework focusing on completeness, plausibility, and conformance underpins our methodology. We employed Bayesian networks for advanced probabilistic modeling, integrated outlier detection methods, and a rule-based system grounded in domain-specific knowledge. The development and validation of the tool were based on obstetrics data from 9 Portuguese hospitals, spanning the years 2019-2020.
UNASSIGNED: The developed tool demonstrated strong potential for identifying data quality issues in obstetrics EHRs. Bayesian networks used in the tool showed high performance for various features with area under the receiver operating characteristic curve (AUROC) between 75% and 97%. The tool\'s infrastructure and interoperable format as a FHIR Application Programming Interface (API) enables a possible deployment of a real-time data quality assessment in obstetrics settings. Our initial assessments show promised, even when compared with physicians\' assessment of real records, the tool can reach AUROC of 88%, depending on the threshold defined.
UNASSIGNED: Our results also show that obstetrics clinical records are difficult to assess in terms of quality and assessments like ours could benefit from more categorical approaches of ranking between bad and good quality.
UNASSIGNED: This study contributes significantly to the field of EHR data quality assessment, with a specific focus on obstetrics. The combination of HL7-FHIR interoperability, machine learning techniques, and expert knowledge presents a robust, adaptable solution to the challenges of healthcare data quality. Future research should explore tailored data quality evaluations for different healthcare contexts, as well as further validation of the tool capabilities, enhancing the tool\'s utility across diverse medical domains.

OBJECTIVE: Real-time data (RTD) are data that are delivered immediately after creation. The key feature of RTD is low delivery latency. Information systems in health care are extremely time-sensitive and their building block is the electronic health record (EHR). Real-time data from EHRs play an important role to support decision-making, analytics and coordination of care. This is well mentioned in the literature, but the process has not yet been described, providing reference implementations and testing. Real-time data delivery can technically be achieved using several methods. The objective of this work is to evaluate the performance of different transfer methods of RTD from EHRs by measuring delivery latency.
METHODS: In our work we used four approaches to transfer RTD from EHRs: REST hooks, WebSocket notifications, reverse proxy and database triggers. We deployed a Fast Health Interoperability Resources (FHIR) server as it is one of the most widely used EHR standard. For the reference implementations we used Python and Golang. Delivery latency was selected as performance metric, derived by subtracting the timestamp of the EHR resource creation from the timestamp of the EHR resource receipt in millisecond. The data was analyzed using descriptive statistics, cumulative distribution function (CDF), Kruskal-Wallis and post-hoc tests.
RESULTS: The database trigger approach had the best mean delivery latency 13.52±5.56 ms, followed by the reverse proxy 14.43±4.58 ms, REST hooks 19.26±5.76 ms and WebSocket 27.32±9.44 ms. The reverse proxy showed a tighter range of the values and lower variability. There were significant differences in the latencies between all pairs of approaches, except for reverse proxy and database trigger.
CONCLUSIONS: Real-time data transfer is vital for the development of robust and innovative healthcare applications. Properties of current EHR systems as a data source predefine the approaches for transfer. In our work for the first time the performance of RTD transfer from the EHRs with reference implementations is measured and evaluated. We found that database triggers achieve lowest delivery latency. Reverse proxy performed slightly slower, but offered more stability, followed by REST hooks and WebSocket notifications.

BACKGROUND: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries.
METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability.
RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented.
CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.

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.

BACKGROUND: Precision public health (PPH) can maximize impact by targeting surveillance and interventions by temporal, spatial, and epidemiological characteristics. Although rapid diagnostic tests (RDTs) have enabled ubiquitous point-of-care testing in low-resource settings, their impact has been less than anticipated, owing in part to lack of features to streamline data capture and analysis.
OBJECTIVE: We aimed to transform the RDT into a tool for PPH by defining information and data axioms and an information utilization index (IUI); identifying design features to maximize the IUI; and producing open guidelines (OGs) for modular RDT features that enable links with digital health tools to create an RDT-OG system.
METHODS: We reviewed published papers and conducted a survey with experts or users of RDTs in the sectors of technology, manufacturing, and deployment to define features and axioms for information utilization. We developed an IUI, ranging from 0% to 100%, and calculated this index for 33 World Health Organization-prequalified RDTs. RDT-OG specifications were developed to maximize the IUI; the feasibility and specifications were assessed through developing malaria and COVID-19 RDTs based on OGs for use in Kenya and Indonesia.
RESULTS: The survey respondents (n=33) included 16 researchers, 7 technologists, 3 manufacturers, 2 doctors or nurses, and 5 other users. They were most concerned about the proper use of RDTs (30/33, 91%), their interpretation (28/33, 85%), and reliability (26/33, 79%), and were confident that smartphone-based RDT readers could address some reliability concerns (28/33, 85%), and that readers were more important for complex or multiplex RDTs (33/33, 100%). The IUI of prequalified RDTs ranged from 13% to 75% (median 33%). In contrast, the IUI for an RDT-OG prototype was 91%. The RDT open guideline system that was developed was shown to be feasible by (1) creating a reference RDT-OG prototype; (2) implementing its features and capabilities on a smartphone RDT reader, cloud information system, and Fast Healthcare Interoperability Resources; and (3) analyzing the potential public health impact of RDT-OG integration with laboratory, surveillance, and vital statistics systems.
CONCLUSIONS: Policy makers and manufacturers can define, adopt, and synergize with RDT-OGs and digital health initiatives. The RDT-OG approach could enable real-time diagnostic and epidemiological monitoring with adaptive interventions to facilitate control or elimination of current and emerging diseases through PPH.

It is necessary to harmonize and standardize data variables used in case report forms (CRFs) of clinical studies to facilitate the merging and sharing of the collected patient data across several clinical studies. This is particularly true for clinical studies that focus on infectious diseases. Public health may be highly dependent on the findings of such studies. Hence, there is an elevated urgency to generate meaningful, reliable insights, ideally based on a high sample number and quality data. The implementation of core data elements and the incorporation of interoperability standards can facilitate the creation of harmonized clinical data sets.
This study\'s objective was to compare, harmonize, and standardize variables focused on diagnostic tests used as part of CRFs in 6 international clinical studies of infectious diseases in order to, ultimately, then make available the panstudy common data elements (CDEs) for ongoing and future studies to foster interoperability and comparability of collected data across trials.
We reviewed and compared the metadata that comprised the CRFs used for data collection in and across all 6 infectious disease studies under consideration in order to identify CDEs. We examined the availability of international semantic standard codes within the Systemized Nomenclature of Medicine - Clinical Terms, the National Cancer Institute Thesaurus, and the Logical Observation Identifiers Names and Codes system for the unambiguous representation of diagnostic testing information that makes up the CDEs. We then proposed 2 data models that incorporate semantic and syntactic standards for the identified CDEs.
Of 216 variables that were considered in the scope of the analysis, we identified 11 CDEs to describe diagnostic tests (in particular, serology and sequencing) for infectious diseases: viral lineage/clade; test date, type, performer, and manufacturer; target gene; quantitative and qualitative results; and specimen identifier, type, and collection date.
The identification of CDEs for infectious diseases is the first step in facilitating the exchange and possible merging of a subset of data across clinical studies (and with that, large research projects) for possible shared analysis to increase the power of findings. The path to harmonization and standardization of clinical study data in the interest of interoperability can be paved in 2 ways. First, a map to standard terminologies ensures that each data element\'s (variable\'s) definition is unambiguous and that it has a single, unique interpretation across studies. Second, the exchange of these data is assisted by \"wrapping\" them in a standard exchange format, such as Fast Health care Interoperability Resources or the Clinical Data Interchange Standards Consortium\'s Clinical Data Acquisition Standards Harmonization Model.

HL7 FHIR was created almost a decade ago and is seeing increasingly wide use in high income settings. Although some initial work was carried out in low and middle income (LMIC) settings there has been little impact until recently. The need for reliable and easy to implement interoperability between health information systems in LMICs is growing with large scale deployments of EHRs, national reporting systems and mHealth applications. The OpenMRS open source EHR has been deployed in more than 44 LMIC with increasing needs for interoperability with other HIS. We describe here the development and deployment of a new FHIR module supporting the latest standards and its use in interoperability with laboratory systems, mHealth applications, pharmacy dispensing system and as a tool for supporting advanced user interface designs. We also show how it facilitates date science projects and deployment of machine leaning based CDSS and precision medicine in LMICs.

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.