[Interoperability in healthcare: also prescribed for digital health applications (DiGA)]. / Interoperabilität im Gesundheitswesen: auch für digitale Gesundheitsanwendungen (DiGA) verordnet.

Digital health applications (DiGA) are a cog in the machine of a digital health system that must be interoperable like all other communicating applications in order to function smoothly. Interoperability takes place at four levels: functional subject definition of content, semantic and syntactic standardization, security and transport requirements, and organizational aspects.In Germany, a major leap towards a more digital healthcare system has been initiated in recent years, reinforced by the experience gained from the COVID-19 pandemic. Current legislation aims at a uniform definition of standards and processes and thus establishes the required binding framework for an overall concept in digitization. DiGA can communicate with other healthcare systems using the same semantic and syntactic standardizations if the patient so desires. With the possible connection to electronic patient records and the accompanying data donation option, patients can benefit more than once through interoperable DiGA - not only through the direct positive care effect of the digital health application, but also indirectly through data donation, which can contribute to improving the entire healthcare system through appropriate research.

The German Corona Consensus Dataset (GECCO): a standardized dataset for COVID-19 research in university medicine and beyond.

BACKGROUND: The current COVID-19 pandemic has led to a surge of research activity. While this research provides important insights, the multitude of studies results in an increasing fragmentation of information. To ensure comparability across projects and institutions, standard datasets are needed. Here, we introduce the "German Corona Consensus Dataset" (GECCO), a uniform dataset that uses international terminologies and health IT standards to improve interoperability of COVID-19 data, in particular for university medicine. METHODS: Based on previous work (e.g., the ISARIC-WHO COVID-19 case report form) and in coordination with experts from university hospitals, professional associations and research initiatives, data elements relevant for COVID-19 research were collected, prioritized and consolidated into a compact core dataset. The dataset was mapped to international terminologies, and the Fast Healthcare Interoperability Resources (FHIR) standard was used to define interoperable, machine-readable data formats. RESULTS: A core dataset consisting of 81 data elements with 281 response options was defined, including information about, for example, demography, medical history, symptoms, therapy, medications or laboratory values of COVID-19 patients. Data elements and response options were mapped to SNOMED CT, LOINC, UCUM, ICD-10-GM and ATC, and FHIR profiles for interoperable data exchange were defined. CONCLUSION: GECCO provides a compact, interoperable dataset that can help to make COVID-19 research data more comparable across studies and institutions. The dataset will be further refined in the future by adding domain-specific extension modules for more specialized use cases.

Clinical Text Mining on FHIR.

Semantic standards and human language technologies are key enablers for semantic interoperability across heterogeneous document and data collections in clinical information systems. Data provenance is awarded increasing attention, and it is especially critical where clinical data are automatically extracted from original documents, e.g. by text mining. This paper demonstrates how the output of a commercial clinical text-mining tool can be harmonised with FHIR, the leading clinical information model standard. Character ranges that indicate the origin of an annotation and machine generates confidence values were identified as crucial elements of data provenance in order to enrich text-mining results. We have specified and requested necessary extensions to the FHIR standard and demonstrated how, as a result, important metadata describing processes generating FHIR instances from clinical narratives can be embedded.

Team Competencies and Educational Threshold Concepts for Clinical Information Modelling.

Healthcare interoperability depends upon sound semantic models to support safe and reliable exchange of information. We argue that clinical information modelling requires a collaborative team of healthcare professionals, process and content analysts and terminologists and that 'separation of concerns' is unhelpful. We present six fundamental concepts that participants must understand to collaborate meaningfully in technology-agnostic information modelling.

Interoperability Assets for Patient Summary Components: A Gap Analysis.

The International Patient Summary (IPS) standards aim to define the specifications for a minimal and non-exhaustive Patient Summary, which is specialty-agnostic and condition-independent, but still clinically relevant. Meanwhile, health systems are developing and implementing their own variation of a patient summary while, the eHealth Digital Services Infrastructure (eHDSI) initiative is deploying patient summary services across countries in the Europe. In the spirit of co-creation, flexible governance, and continuous alignment advocated by eStandards, the Trillum-II initiative promotes adoption of the patient summary by engaging standards organizations, and interoperability practitioners in a community of practice for digital health to share best practices, tools, data, specifications, and experiences. This paper compares operational aspects of patient summaries in 14 case studies in Europe, the United States, and across the world, focusing on how patient summary components are used in practice, to promote alignment and joint understanding that will improve quality of standards and lower costs of interoperability.

Disseminating a Standard for Medical Records in Emergency Departments Among Different Software Vendors Using HL7 CDA.

A standardized medical record for the emergency department (GEDMR) was released in Germany, but only sparsely and randomly implemented by emergency department (ED) electronic health record (EHR) vendors. A reason for this may be a lacking common language between the medical and the Health Information Technology (HIT) domain. HL7 clinical document architecture (CDA) may leverage this communication gap. This paper reports on the effects of a professional medical association record standard on EHR vendors and the German ED-EHR market. Standard records and data standards are developed and published by different institutions either on governmental, healthcare agency or medical association level. There are some standard records, especially by US cardiology associations, transformed into HL7 C-CDA. GEDMR was modeled as HL7 CDA with the use of interoperable terminologies like LOINC and SNOMED CT. Being part of an emergency department data registry development project, local deployment at 15 project hospitals receiving sufficient funding was performed. Two major ED-EHR vendors adapted GEDMR within their product including CDA export. 106,868 CDAs were produced in six hospitals until now. Four local implementations with four different ED-EHRs were developed, producing 42,256 CDAs. Five additional vendors are adapting or developing an ED-EHR. The GEDMR-CDA implementation guide with funding for implementation in project hospitals had a significant impact on the German ED-EHR market. Within two years after release, a broadening and increasingly self-enforcing support by German ED-EHR vendors is notable.

Mapping Equivalence of German Emergency Department Medical Record Concepts with SNOMED CT After Implementation with HL7 CDA.

INTRODUCTION: The German Emergency Department Medical Record (GEDMR) was created by medical domain experts and healthcare providers providing a dataset as well as a form. The trauma module of GEDMR was syntactically standardized using HL7 CDA and semantically standardized using different terminologies including SNOMED CT, LOINC and proprietary coding systems. This study depicts the mapping accuracy with aforementioned syntactical and semantical standards in general and especially the content coverage of SNOMED CT. METHODS: The specification of GEDMR (V2015.1) concepts with eHealth-standards HL7-CDA, LOINC, SNOMED CT was analyzed. A content coverage assessment was made using the ISO TR 12300 rating scheme, following descriptive analysis. RESULTS: The trauma module of GEDMR contains 489 concepts, with 202 concepts expressed via HL7 CDA structure. It is possible to code 89 % of the remaining concepts via SNOMED CT. 79 % provide an advanced level of semantic interoperability, as they represent the source information either lexically or as an approved synonym. DISCUSSION: The terminology binding problem is relevant when combining different standards for syntactic and semantic interoperability with best practice documents and reference specifications providing guidance. A national license and extension for SNOMED CT in Germany as well as an ongoing effort in contributing to the International Version of SNOMED CT would be necessary to gain full coverage for concepts in German Emergency Medicine and to leverage the associated standardization process.

Effective ways for the transmission of infection prevention data according to German legal specifications via the medical terminology SNOMED CT used with HL7 CDA templates.

According to German legal specifications each national federal state is obliged to transmit infection prevention data to the relevant health authority. In case of reasonable suspicion, affection or death by infectious diseases specific information is differently communicated by laboratories and physicians. Proprietary ways of transmission inherit threats like deficient or incomplete availability of data. At least these circumstances imply non-predictable health-related hazards for the population. The international established medical terminology SNOMED CT can contribute semantic interoperability and a highly specific description of diagnoses and procedures. The applicability of SNOMED CT shall be tested in the domain of diagnostic findings respective notifiable infectious agents. In addition, specific hierarchical links from the agents to the associated infectious diseases inside the terminology are expected and verified. As the carrier of the information, HL7's Clinical Document Architecture (CDA) is used by designing appropriate CDA templates to define the contents of the notifiable disease documentation. The results demonstrate that the entirety of the notifiable infectious agents is displayed in the terminology SNOMED CT by relating codes at 100 percent. Furthermore, each single term is hierarchically connected to the relating infectious diseases. The use of SNOMED CT for the purpose of infection prevention in Germany is tied to licensing and license costs. Irrespective of these facts, the use of SNOMED CT shows obvious advantages in this field and an implementation of the terminology can be recommended.

The need for standardised documents in continuity of care: results of standardising the eNursing summary.

Continuity of care is a concept that is defined as the uninterrupted and coordinated care provided to a patient and that includes an informational dimension which describes the information exchange between the parties involved. In nursing, the nursing summary is the main instrument to ensure informational continuity of care. The aim of this paper is to present an HL7 Clinical Document Architecture based document standard for the eNursing Summary and to discuss the need for harmonizing these results at international level. The eNursing Summary proposed in this paper was developed on the basis of several internationally accepted concepts, primarily the nursing process, the ISO 18104 Reference Terminology Model for Nursing and various data sets. The standardisation process embraced several phases of involving nursing experts for validating its structure and content. It was finally evaluated by a network of 100 healthcare organizations. We argue that the eNursing Summary is a good starting point for standardising nursing discharge and transfer documents on a global level. However, further work is needed to bring together the different national and international strands in standardisation. .

LOINC codes for hospital information systems documents: a case study.

Hospital Information Systems (HIS) handle a large number of different types of documents. Exchange and analysis of data from different HIS is facilitated by the use of standardized codes to identify document types. HL7's Clinical Document Architecture (CDA) uses LOINC (logical observation identifiers names and Codes) codes for clinical documents. The authors assessed the coverage of LOINC codes for document types in a German HIS. The authors analyzed document types that occurred more than 10 times in approximately 1.3 million documents in a commercial HIS at a major German University Hospital. Document types were mapped manually to LOINC using the Regenstrief LOINC Mapping Assistant (RELMA). Each document type was coded by two physicians. In case of discrepancies a third expert was consulted to reach consensus. For 76 of 86 document categories a LOINC code was identified, but for 38 of these categories, the LOINC code was not specific as deemed necessary. More than 93% of our local HIS documents had local document types that could be assigned a LOINC code.

Discharge and referral data exchange using global standards--the SCIPHOX project in Germany.

The goal of the German project "Standardization of Communication between Information Systems in Physician Offices and Hospitals using XML" (aka SCIPHOX) in its first phase is to provide information exchange based on the Extended Markup Language XML between Hospital Information Systems (HIS) and Physician Office Systems (POS). The Clinical Document Architecture (CDA), a standard developed by the Health Level Seven organization (HL7), was chosen to serve as the "backbone" specification. The CDA is an ANSI approved document architecture for exchange of clinical information using XML. In phase I of the SCIPHOX project the proposal specifies the use of the CDA as a generalized international standard in the national context of discharge and referral letters in Germany. The specification defines how to use the CDA header and associated vocabularies by providing a translation and interpretation of the CDA header tags and provides a solution for taking local needs (insurance information etc.) into account.

Electronic patient records: domain message information model perinatology.

PURPOSE: The Netherlands is developing a set of national domain information models to support electronic information exchange and electronic patient records (EPR). These domain information models aim to support the development, adoption, implementation and maintenance of the EPR in Dutch healthcare practice. This article describes the modelling for a pilot for mother- and childcare (perinatology). METHODOLOGY: Cases' from perinatology are modelled using the Health Level 7 version 3 Reference Information Model (HL7 RIM) as the methodology and tools. RESULTS: Results include descriptions of care processes, communication and information that are broken down into interaction tables and tables with information. Next several domain information models for perinatology are drawn up. These models allow healthcare professionals to recognise their communication, content and work. Currently, the models facilitate discussion and critique by clinician and informaticians. CONCLUSION: The perinatology domain information models facilitate in building implementations because they contain sufficient details for EPR developers and for developers of messages for information exchange. The first results of the project are useful, despite the fact that HL7 RIM modelling methodology is still not finalized. The approach bridges professional content, technical implementation of messages, and future EPR development.

Discharge and referral data exchange using global standards--the SCIPHOX project in Germany.

The goal of the German project "Standardization of Communication between Information Systems in Physician Offices and Hospitals using XML" (aka SCIPHOX) is to provide an XML based information exchange between Hospital Information Systems (HIS) and Physician Office Systems (POS). HL7's Clinical Document Architecture (CDA) was chosen to serve as the "backbone" specification. The CDA is an ANSI approved document architecture for exchange of clinical information using XML. The SCIPHOX proposal specifies the use of the CDA in the context of discharge and referral letters in Germany, taking local needs (insurance information etc.) into account.