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Objectives The TMF (Technology, Methods, and Infrastructure for Networked Medical Research) Data Protection Guide (TMF-DP) makes path-breaking recommendations on the subject of data protection in research projects. It includes comprehensive requirements for applications such as patient lists, pseudonymization services, and consent management services. Nevertheless, it lacks a structured, categorized list of requirements for simplified application in research projects and systematic evaluation. The 3LGM2IHE (“Three-layer Graphbased meta model – Integrating the Healthcare Enterprise [IHE] ” ) project is funded by the German Research Foundation (DFG). 3LGM2IHE aims to define modeling paradigms and implement modeling tools for planning health care information systems. In addition, one of the goals is to create and publish 3LGM2 information system architecture design patterns (short “design patterns”) for the community as design models in terms of a framework. A structured list of data protection-related requirements based on the TMF-DP is a precondition to integrate functions (3LGM2 Domain Layer) and building blocks (3LGM2 Logical Tool Layer) in 3LGM2 design patterns. Methods In order to structure the continuous text of the TMF-DP, requirement types were defined in a first step. In a second step, dependencies and delineations of the definitions were identified. In a third step, the requirements from the TMF-DP were systematically extracted. Based on the identified lists of requirements, a fourth step included the comparison of the identified requirements with exemplary open source tools as provided by the “Independent Trusted Third Party of the University Medicine Greifswald” (TTP tools). Results As a result, four lists of requirements were created, which contain requirements for the “patient list”, the “pseudonymization service”, and the “consent management”, as well as cross-component requirements from the TMF-DP chapter 6 in a structured form. Further to requirements (1), possible variants (2) of implementations (to fulfill a single requirement) and recommendations (3) were identified. A comparison of the requirements lists with the functional scopes of the open source tools E-PIX (record linkage), gPAS (pseudonym management), and gICS (consent management) has shown that these fulfill more than 80% of the requirements. Conclusions A structured set of data protection-related requirements facilitates a systematic evaluation of implementations with respect to the fulfillment of the TMF-DP guidelines. These re-usable lists provide a decision aid for the selection of suitable tools for new research projects. As a result, these lists form the basis for the development of data protection-related 3LGM2 design patterns as part of the 3LGM2IHE project.

IHE has defined more than 200 integration profiles in order to improve the interoperability of application systems in healthcare. These profiles describe how standards should be used in particular use cases. These profiles are very helpful but their correct use is challenging, if the user is not familiar to the specifications. Therefore, inexperienced modelers of information systems quickly lose track of existing IHE profiles. In addition, the users of these profiles are often not aware of rules that are defined within these profiles and of dependencies that exist between the profiles. There are also modelers that do not notice the differences between the implemented actors, because they do not know the optional capabilities of some actors. The aim of this paper is therefore to describe a concept how modelers of information systems can be supported in the selection and use of IHE profiles and how this concept was prototypically implemented in the "Three-layer Graph-based meta model" modeling tool (3LGM2 Tool). The described modeling process consists of the following steps that can be looped: defining the use case, choosing suitable integration profiles, choosing actors and their options and assigning them to application systems, checking for required actor groupings and modeling transactions. Most of these steps were implemented in the 3LGM2 Tool. Further implementation effort and evaluation of our approach by inexperienced users is needed. But after that our tool should be a valuable tool for modelers planning healthcare information system architectures, in particular those based on IHE.

IHE has defined more than 200 integration profiles in order to improve the interoperability of application systems in healthcare. These profiles describe how standards should be used in particular use cases. These profiles are very helpful but their correct use is challenging, if the user is not familiar to the specifications. Therefore, inexperienced modelers of information systems quickly lose track of existing IHE profiles. In addition, the users of these profiles are often not aware of rules that are defined within these profiles and of dependencies that exist between the profiles. There are also modelers that do not notice the differences between the implemented actors, because they do not know the optional capabilities of some actors. The aim of this paper is therefore to describe a concept how modelers of information systems can be supported in the selection and use of IHE profiles and how this concept was prototypically implemented in the “Three-layer Graph-based meta model” modeling tool (3LGM2 Tool). The described modeling process consists of the following steps that can be looped: defining the use case, choosing suitable integration profiles, choosing actors and their options and assigning them to application systems, checking for required actor groupings and modeling transactions. Most of these steps were implemented in the 3LGM2 Tool. Further implementation effort and evaluation of our approach by inexperienced users is needed. But after that our tool should be a valuable tool for modelers planning healthcare information system architectures, in particular those based on IHE.

The HiGHmed research project as part of Germany's Medical Informatics Initiative aims to establish Medical Data Integration Centers (MeDIC) at each participating institution to integrate data of multiple primary information systems in a single place. The MeDICs are based on an IHE XDS.b Affinity Domain in conjunction with an openEHR clinical data repository. This paper presents two ways of storing and retrieving structured and semantically annotated data from an openEHR repository whilst keeping data integrated in an existing IHE XDS.b infrastructure. Furthermore, the paper discusses multiple benefits of the presented approach as well as challenges and corresponding solutions.

Background Digital operating rooms (ORs), when optimally designed and integrated, can reduce the complexity of the surgery suite. However, many integrated ORs are effectively isolated from other IT systems in the hospital because there is little or no connectivity with them. Within the German flagship project OR.NET, concepts and components were developed for a standard-based connection of the OR with hospital IT systems. Objectives The aim of this work was to implement and evaluate OR.NET concepts and components within the existing IT landscape of a German university hospital. This article describes and evaluates the implemented architecture and processes for connecting a demo OR to existing hospital IT systems at Heidelberg University Hospital. Methods For the design, establishment, and evaluation of standard-based connections of the demo OR with hospital IT systems, the iterative method “Design and Creation” with four iterations was applied. Results A generic and a concrete architecture for several standard-based connection concepts of the demo OR were developed. Furthermore, the concrete architecture was implemented and evaluated for its technical and clinical relevance. The main benefits of the project were the establishment of basic requisites for improving the efficiency within the OR, easier operation of medical devices as a result of harmonized human–machine interfaces, and providing additional data for improving healthcare. Conclusion OR.NET concepts for a standard-based connection of the OR with hospital IT systems have proven to be promising. They can serve as a reference for further integration scenarios in other hospitals.

As hospital information systems are complex and the requirements for interoperability grow with the increasing networking in healthcare, careful planning becomes more and more necessary. The use of standards as described in IHE profiles, for example, are an important prerequisite for enabling interoperability. Enterprise Architecture Planning (EAP) methods should support this, but none of the currently available EAP methods offers the option of using IHE profiles. The 3LGM2IHE project wants to close this gap and implement the support of IHE profiles in the 3LGMsup2/suptool. This paper describes how requirements for this tool were determined and presents the results.

The re-use of healthcare information for biomedical research is increasing and with it the importance of a consent management framework implementing computable consents. Based on requirements concerning a consent representation the Advanced Patient Privacy Consents (APPC) Profile of Integrating the Healthcare Enterprise (IHE) is evaluated and mapped to these requirements. As IHE APPC was developed for computable patient consents, the mapping of consents for research projects is possible by re-using the elements defined. Compared to other approaches like gICS, approaches using APPC can be based on commercial software products and integrated into IHE environments. IHE APPC was already successfully used in EHR projects like INFOPAT. For interoperability reasons IT platforms intending to support biomedical research including clinical data, research data, biomaterial and imaging data, IHE APPC seems to be an appropriate standard to choose.

Telemedizinische Systeme werden bereits heute in vielen Bereichen zur verbesserten Patientenversorgung eingesetzt. Aufgrund fehlender Standardisierung sind diese Losungen aber selten interoperabel. International anerkannte Standards konnen hier Abhilfe schaffen. Mit Integrating the Healthcare Enterprise (IHE) befasst sich eine weltweite Initiative aus Anwendern und Herstellern im Gesundheitswesen mit der Nutzung von definierten Standards fur konkrete Anwendungsfalle durch Beschreibung in sogenannten Profilen. Ziel des vorliegenden Beitrags ist es aufzuzeigen, inwieweit sich telemedizinische Anwendungsfalle mit IHE-Profilen umsetzen lassen. Auf Basis einer Literaturrecherche werden beispielhafte Telemedizinanwendungen beschrieben und die technischen Moglichkeiten der IHE-Profile dargestellt. Diese werden dann auf ihre Nutzbarkeit hin untersucht und anhand beispielhafter telemedizinischer Architekturen gepruft. Sowohl fur einrichtungsubergreifende Akten (z. B. Heidelberger PEPA) als auch fur die aktenlose Punkt-zu-Punkt-Kommunikation lassen sich IHE-Profile identifizieren. In der Aktenwelt ist schon heute das Cross-Enterprise Document Sharing (XDS-) Profil verbreitet. Die Punkt-zu-Punkt-Kommunikation lasst sich mittels IHE Cross-Enterprise Document Media Interchange (XDM) unterstutzen. IHE-basierte Telemedizinanwendungen bieten die Moglichkeit, Behandler durch einrichtungsubergreifende Akten mit Informationen uber den Patienten zu versorgen und gleichzeitig Einsparpotenziale durch Wiederverwendbarkeit der Schnittstellen in anderen Szenarien zu nutzen. Aktuelle telemedizinische Anwendungen stosen bei der Interoperabilitat noch an ihre Grenzen. Mit IHE-Profilen konnen, bis auf die synchrone Kommunikation, alle relevanten Telemedizinszenarien umgesetzt werden.

The effective development and dissemination of the open integration for the next generation of operating rooms require a comprehensive testing environment. In this paper, we present the various challenges to be addressed in demonstration applications, and we discuss the implementation approach, the foci of the demonstration sites and the evaluation efforts. Overall, the demonstrator setups have proven the feasibility of the service-oriented medical device architecture (SOMDA) and real-time approaches with a large variety of example applications. The applications demonstrate the potentials of open device interoperability. The demonstrator implementations were technically evaluated as well as discussed with many clinicians from various disciplines. However, the evaluation is still an ongoing research at the demonstration sites. Technical evaluation focused on the properties of a network of medical devices, latencies in data transmission and stability. A careful evaluation of the SOMDA design decisions and implementations are essential to a safe and reliable interoperability of integrated medical devices and information technology (IT) system in the especially critical working environment. The clinical evaluation addressed the demands of future users and stakeholders, especially surgeons, anesthesiologists, scrub nurses and hospital operators. The opinions were carefully collected to gain further insights into the potential benefits of the technology and pitfalls in future work.

Das Gesundheitssystem steht vor grosen Herausforderungen, wie zum Beispiel die Bewaltigung zunehmender multimorbider Patienten mit chronischen Erkrankungen im Rahmen des demografischen Wandels. Es gilt neue Versorgungsmodelle zu finden, die jedoch ohne adaquate Unterstutzung durch telemedizinische Verfahren und Einfuhrung von Interoperabilitatsstandards nicht effizient durchfuhrbar sind. Die Digitalisierung im Gesundheitswesen kann zugleich als Basis und Motor fur die Vernetzung aller Akteure dienen. In diesem Beitrag beleuchten wir die Moglichkeiten, die Integrating the Healthcare Enterprise (IHE) und die personliche elektronische Patientenakte (PEPA) fur die Vernetzung von Gesundheitsregionen bieten. Wir beschreiben, welche Komponenten von IHE relevant sind und welche in der Gesundheitsregion Rhein Neckar Anwendung finden. Abschliesend betrachten wir Mehrwerte der Umsetzungsperspektive fur eine Gesundheitsregion und daruber hinaus.

Integrating healthcare IT with medical devices in the operating room means to bridge a gap between two different worlds, which often speak diverse languages. This paper presents an IHE based gateway architecture to overcome this interoperability gap, which is currently accompanied by proprietary gateways significantly increasing costs as requiring specific skills, resources and services.

Collecting, saving, and providing patient data are essential processes of documentation in a hospital. Many IT systems have evolved to provide solutions in this area. The automatic transfer of medical device data to these information systems is a new challenge for hospital IT systems. Some vendors are focused on the integration of medical IT systems and medical devices. They provide great solutions with magnificent features. Nevertheless, those integration solutions are proprietary and isolated, limiting the operator's selection of his medical devices and medical IT systems. Standardizing communication processes within the operating room and between medical devices and medical IT systems brings benefits for both patient and hospital staff. This work identifies and proposes micro- and macrointegration profiles as a basis for new IHE Integration Profiles for both medical IT systems and medical devices of the operating room.

Background In the context of more than 20 therapy optimizing clinical trials in pediatric oncology an extensive documentation with a big number of case report forms was developed in the last 20 to 25 years. Across these trials same information is partially captured in different terminological ways, by which documentation about patients in the clinics is made more difficult. Method Terminology of therapy optimizing clinical trials of German Society for Pediatric Oncology and Hematology (GPOH) is standardized by a central "standards committee". Result As a first result the basic data set of GPOH could be revised and made available in internet via http://www.dospo.uni-hd.de. Conclusion A basis of a unique documentation language in pediatric oncology is available for German speaking regions.

Summary Ubiquitous information is currently one of the most challenging slogans in medical informatics research. An adequate architecture for shared electronic patient records is needed which can use data for multiple purposes and which is extensible for new research questions. We introduce eardap as architecture for using routine data for nationwide clinical research in a multihospital environment. eardap can be characterized as terminology-based. Main advantage of our approach is the extensibility by new items and new research questions. Once the definition of items for a research question is finished, a consistent, corresponding database can be created without any informatics skills. Our experiences in pediatric oncology in Germany have shown the applicability of eardap . The functions of our core system were in routine clinical use in several hospitals. We validated the terminology management system (TMS) and the module generation tool with the basic data set of pediatric oncology. The multiple usability depends mainly on the quality of item planning in the TMS. High quality harmonization will lead to a higher amount of multiply used data. When using eardap , special emphasis is to be placed on interfaces to local hospital information systems and data security issues.

Within cooperative groups of multi-center clinical trials a standardized documentation is a prerequisite for communication and sharing of data. Standardizing documentation systems means standardizing the underlying terminology. The management and consistent application of terminology systems is a difficult and fault-prone task, which should be supported by appropriate software tools. Today, documentation systems for clinical trials are often implemented as so-called Remote-Data-Entry-Systems (RDE-systems). Although there are many commercial systems, which support the development of RDE-systems there is none offering a comprehensive terminological support. Therefore, we developed the software system TERMTrial which consists of a component for the definition and management of terminology systems for cooperative groups of clinical trials and two components for the terminology-based automatic generation of trial databases and terminology-based interactive design of electronic case report forms (eCRFs). TERMTrial combines the advantages of remote data entry with a comprehensive terminological control.