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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.

Data integration and exchange are becoming more crucial with the increasing amount of distributed systems and ever-growing amounts of data. This need is also widely known in medical research and not yet comprehensively solved. Practical implementation steps will demonstrate the different challenges in the context of the National Medical Informatics Initiative in Germany. Top-down versus bottom-up approaches as general methods of standard-based data integration in healthcare will be discussed and illustrated in the process of building up Medical Data Integration Centers. As practical examples, the use cases Infection Control, Cardiology, and Molecular Tumor Board, will be presented. Finally, limitations that prevent the use of theoretically recommended data integration methods in the particular field of medical informatics are illustrated.

Sharing of medical data is crucial for the proper treatment of patients as it could reduce the risk of duplicated medical tests and speed up the care process if all documents are readily available. Despite great technical progress, sharing patient data while maintaining full control over the process in an intersectoral (in Germany, this describes the different actors in the healthcare system consisting of clinic, ambulatory care, etc.) setting remains a particular challenge. This paper focuses on the successful implementation of a privacy compliant, standards-based image-management component of a personal electronic health record. Over a 5-year period, a sharing system based on readily available IHE profiles constructed around XDS has been built. It was necessary to create interfaces for the existing hospital sub-systems to become part of the network. Specifically, the imaging workflow had to be adapted to allow for fast and easy access to DICOM images utilizing a flexible web-based image viewer. In addition to the standard XDS workflow, an Imaging Cache was established which combines the Imaging Document Source and Consumer to guarantee fast and streaming-based access to all images in the network observing the high security standards of the hospital network. The authors of this paper have proven that it is possible to build a fast and reliable sharing system based on IHE profiles using most of the transactions of XDS-I with some adaptions to the clinical workflow. Primary hospital systems were enabled by building adapters to overcome lack of IHE compatibility. The established system embraces the existing security mechanisms in hospital networks while connecting patients and referring physicians from outside in a secure and convenient manner. A state-of-the-art sharing system that is used in a productive clinical environment has been established and is ready to grow with more partners. The system is the basis for an elaborated interdisciplinary collaboration where data, and in particular images, can now be shared between medical professionals.

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.

Background The use of medical data for research purposes requires an informed consent of the patient that is compliant with the EU General Data Protection Regulation. In the context of multi-centre research initiatives and a multitude of clinical and epidemiological studies scalable and automatable measures for digital consent management are required. Modular form, structure, and contents render a patient’s consent reusable for varying project settings in order to effectively manage and minimise organisational and technical efforts. Results Within the DFG-funded project “MAGIC” (Grant Number HO 1937/5-1) the digital consent management service tool gICS was enhanced to comply with the recommendations published in the TMF data protection guideline for medical research. In addition, a structured exchange format for modular consent templates considering established standards and formats in the area of digital informed consent management was designed. Using the new FHIR standard and the HAPI FHIR library, the first version for an exchange format and necessary import-/export-functionalities were successfully implemented. Conclusions The proposed exchange format is a “work in progress”. It represents a starting point for current discussions concerning digital consent management. It also attempts to improve interoperability between different approaches within the wider IHE-/HL7-/FHIR community. Independent of the exchange format, providing the possibility to export, modify and import templates for consents and withdrawals to be reused in similar clinical and epidemiological studies is an essential precondition for the sustainable operation of digital consent management.

Summary Introduction: This article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. HiGHmed brings together 24 partners from academia and industry, aiming at improvements in care provision, biomedical research and epidemiology. By establishing a shared information governance framework, data integration centers and an open platform architecture in cooperation with independent healthcare providers, the meaningful reuse of data will be facilitated. Complementary, HiGHmed integrates a total of seven Medical Informatics curricula to develop collaborative structures and processes to train medical informatics professionals, physicians and researchers in new forms of data analytics. Governance and Policies: We describe governance structures and policies that have proven effective during the conceptual phase. These were further adapted to take into account the specific needs of the development and networking phase, such as roll-out, carerelated aspects and our focus on curricula development in Medical Inform atics. Architectural Framework and Methodology: To address the challenges of organizational, technical and semantic interoperability, a concept for a scalable platform architecture, the HiGHmed Platform, was developed. We outline the basic principles and design goals of the open platform approach as well as the roles of standards and specifications such as IHE XDS, openEHR, SNOMED CT and HL7 FHIR. A shared governance framework provides the semantic artifacts which are needed to establish semantic interoperability. Use Cases: Three use cases in the fields of oncology, cardiology and infection control will demonstrate the capabilities of the HiGHmed approach. Each of the use cases entails diverse challenges in terms of data protection, privacy and security, including clinical use of genome sequencing data (oncology), continuous longitudinal monitoring of physical activity (cardiology) and cross-site analysis of patient movement data (infection control). Discussion: Besides the need for a shared governance framework and a technical infrastructure, backing from clinical leaders is a crucial factor. Moreover, firm and sustainable commitment by participating organizations to collaborate in further development of their information system architectures is needed. Other challenges including topics such as data quality, privacy regulations, and patient consent will be addressed throughout the project.

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.

The aim of this study was to develop and verify different methods of measuring time-to-display (TTD) for radiological images with image web systems (IWS). The process should be automatable in order to repeatedly perform a large number of measurements without human interaction. Three methods were defined and compared with respect to usability, stability, and quality of results. Method 1 was based on Windows 2000 Performance Monitor, whereas method 2 employed phototransistors taped to the screen and connected to a separate PC. A software tool developed for method 3, which used Windows application programming interface (API) function, calls to read the color code assigned to specific pixels on the screen. Method 3 proved to be the most reliable and easy to automate. The accuracy is practically equivalent to method 2, but it proved to be far more automatable. Method 1 produced the largest mean error, was easily disturbed, but was also easy to set up and provided additional insights into the system’s architecture especially if combined with method 3. To measure the performance of image distribution systems, any of these methods can be used, but method 3 proved to be superior.

PURPOSE To assess different network and security technologies for remote access to a web-based image distribution system of a hospital intranet. MATERIALS AND METHODS Following preparatory testing, the time-to-display (TTD) was measured for three image types (CR, CT, MR). The evaluation included two remote access technologies consisting of direct ISDN-Dial-Up or VPN connection (Virtual Private Network), with three different connection speeds of 64, 128 (ISDN) and 768 Kbit/s (ADSL-Asymmetric Digital Subscriber Line), as well as with lossless and lossy compression. RESULTS Depending on the image type, the TTD with lossless compression for 64 Kbit/s varied from 1 : 00 to 2 : 40 minutes, for 128 Kbit/s from 0 : 35 to 1 : 15 minutes and for ADSL from 0 : 15 to 0 : 45 minutes. The ISDN-Dial-Up connection was superior to VPN technology at 64 Kbit/s but did not allow higher connection speeds. Lossy compression reduced the TTD by half for all measurements. CONCLUSIONS VPN technology is preferable to direct Dial-Up connections since it offers higher connection speeds and advantages in usage and security. For occasional usage, 128 Kbit/s (ISDN) can be considered sufficient, especially in conjunction with lossy compression. ADSL should be chosen when a more frequent usage is anticipated, whereby lossy compression may be omitted. Due to higher bandwidths and improved usability, the web-based approach appears superior to conventional teleradiology systems.

INTRODUCTION: An ROC analysis was carried out in order to determine the reliability of digital luminescence radiography review at a PC and this was compared with a radiological work station and with X-ray film on a viewing box. MATERIAL AND METHOD: 54 chest images obtained by digital luminescence radiography were selected, 31 of these contained small pulmonary nodules. In order to evaluate critical detail, five images of a phantom showing round foci were used. Five radiologists examined these, using a Siemens Magic View work station, a PC with proprietary software (ViewMed) and X-ray films on a viewing box. Image processing of the work station used the standard clinical application. ViewMed performs linear scaling of grey levels to 8 Bit. The results were examined statistically by means of a t-test. RESULTS: As far as the chest images were concerned there was no significant difference in the diagnostic value of these methods. There was, however, a highly significant loss of diagnostic information with respect to the round focus phantom when using the PC compared with the other methods. CONCLUSION: In the configuration in which it was used, the PC should not be relied on as a primary means of examination since critical details cannot always be seen. In routine use these play a subordinate role and there was no significant diagnostic loss where the chest images were concerned. We expect that by improvements in the frequency and contrast processing the PC accuracy will be considerably increased.

Summary Objective: (1) To define features and data items of a Patient Recruitment System (PRS); (2) to design a generic software architecture of such a system covering the requirements; (3) to identify implementation options available within different Hospital Information System (HIS) environments; (4) to implement five PRS following the architecture and utilizing the implementation options as proof of concept. Methods: Existing PRS were reviewed and interviews with users and developers conducted. All reported PRS features were collected and prioritized according to their published success and user’s request. Common feature sets were combined into software modules of a generic software architecture. Data items to process and transfer were identified for each of the modules. Each site collected implementation options available within their respective HIS environment for each module, provided a prototypical implementation based on available implementation possibilities and supported the patient recruitment of a clinical trial as a proof of concept. Results: 24 commonly reported and requested features of a PRS were identified, 13 of them prioritized as being mandatory. A UML version 2 based software architecture containing 5 software modules covering these features was developed. 13 data item groups processed by the modules, thus required to be available electronically, have been identified. Several implementation options could be identified for each module, most of them being available at multiple sites. Utilizing available tools, a PRS could be implemented in each of the five participating German university hospitals. Conclusion: A set of required features and data items of a PRS has been described for the first time. The software architecture covers all features in a clear, well-defined way. The variety of implementation options and the prototypes show that it is possible to implement the given architecture in different HIS environments, thus enabling more sites to successfully support patient recruitment in clinical trials. Citation: Trinczek B, Köpcke F, Leusch T, Majeed RW, Schreiweis B, Wenk J, Bergh B, Ohmann C, Röhrig R, Prokosch HU, Dugas M. Design and multicentric implementation of a generic software architecture for patient recruitment systems re-using existing HIS tools and routine patient data. Appl Clin Inf 2014; 5: 264–283 http://dx.doi.org/10.4338/ACI-2013-07-RA-0047