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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.

BACKGROUND In patient care, data are historically generated and stored in heterogeneous databases that are domain specific and are often non-interoperable or isolated. As the amount of health data increases, the number of isolated data silos is also expected to grow, limiting the accessibility of collected data. Medical Informatics is developing ways to move from siloed data to a more harmonized arrangement in information architectures. This paradigm shift will allow future research to integrate medical data at many levels and from various sources. Currently comprehensive requirements engineering is working on data integration projects both in a patient care- and research-oriented context and they are significantly contributing to the success of such data integration projects. In addition to various stakeholder-based methods, document-based requirements elicitation is a valid method to improve the scope and quality of requirements. OBJECTIVE Our main objective is to provide a general set of functional requirements for medical data integration into knowledge management environments. We aim to identify where integration projects intersect to derive consistent and representative functional requirements from literature. Based on these findings, we identify which functional requirements for data integration exist in the literature and thus provide a generic blueprint of requirements. METHODS This work begins by conducting a literature-based requirement elicitation based on a holistic requirement engineering approach. We thus first perform a web based systematic literature review to identify published articles that deal with requirements for medical data integration. We identify and analyze the available literature by applying the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines and screen the results for functional requirements using the requirements engineering method of document analysis and derive requirements into a uniform requirement syntax. Finally, we classify the elicited requirements into a category scheme that represents the data life cycle. RESULTS Our systematic literature search yielded 821 articles of which we include 61 articles in the requirements elicitation process. There we identify a total of 217 requirements, which are covered by a total of 314 references. We assign the requirements to the different data life cycle categories as follows: 56 to the Data Acquisition, 77 to Data Processing, 26 to Data Storage, 20 to Data Analysis, 14 to Metadata Management, 5 to Data Lineage, 7 to Data Traceability, and 12 to the category Data Security. CONCLUSIONS The aim of this work is to present a cross-section of functional data integration related requirements defined in literature by other researchers. The aim is achieved with 217 distinct requirements from a total of 61 publications. We conclude that scientific publications are in principle a reliable source of information for functional requirements with respect to medical data integration. Finally, we provide a generic blueprint to support other scientists in the requirements elicitation phase.

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.

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 field of eHealth has a history of more than 20 years. During that time, many different eHealth services were developed. However, factors influencing the adoption of such services were seldom the main focus of analyses. For this reason, organizations adopting and implementing eHealth services seem not to be fully aware of the barriers and facilitators influencing the integration of eHealth services into routine care. Objective The objective of this work is to provide (1) a comprehensive list of relevant barriers to be considered and (2) a list of facilitators or success factors to help in planning and implementing successful eHealth services. Methods For this study, a twofold approach was applied. First, we gathered experts’ current opinions on facilitators and barriers in implementing eHealth services via expert discussions at two health informatics conferences held in Europe. Second, we conducted a systematic literature analysis concerning the barriers and facilitators for the implementation of eHealth services. Finally, we merged the results of the expert discussions with those of the systematic literature analysis. Results Both expert discussions (23 and 10 experts, respectively) identified 15 barriers and 31 facilitators, whereas 76 barriers and 268 facilitators were found in 38 of the initial 56 articles published from 12 different countries. For the analyzed publications, the count of distinct barriers reported ranged from 0 to 40 (mean 10.24, SD 8.87, median 8). Likewise, between 0 and 48 facilitators were mentioned in the literature (mean 9.18, SD 9.33, median 6). The combination of both sources resulted in 77 barriers and 292 facilitators for the adoption and implementation of eHealth services. Conclusions This work contributes a comprehensive list of barriers and facilitators for the implementation and adoption of eHealth services. Addressing barriers early, and leveraging facilitators during the implementation, can help create eHealth services that better meet the needs of users and provide higher benefits for patients and caregivers.

Integrating data from various source systems to gain knowledge and meaningful data about patients for care and research is challenging. This work demonstrates how medication knowledge data from the database of the Federal Union of German Associations of Pharmacists (ABDA) can be used for storing and annotating medicinal products in an openEHR medication archetype.

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.

BACKGROUND The field of eHealth has a history of more than 20 years. During that time, many different eHealth services were developed. However, factors influencing the adoption of such services were seldom the main focus of analyses. For this reason, organizations adopting and implementing eHealth services seem not to be fully aware of the barriers and facilitators influencing the integration of eHealth services into routine care. OBJECTIVE The objective of this work is to provide (1) a comprehensive list of relevant barriers to be considered and (2) a list of facilitators or success factors to help in planning and implementing successful eHealth services. METHODS For this study, a twofold approach was applied. First, we gathered experts’ current opinions on facilitators and barriers in implementing eHealth services via expert discussions at two health informatics conferences held in Europe. Second, we conducted a systematic literature analysis concerning the barriers and facilitators for the implementation of eHealth services. Finally, we merged the results of the expert discussions with those of the systematic literature analysis. RESULTS Both expert discussions (23 and 10 experts, respectively) identified 15 barriers and 31 facilitators, whereas 76 barriers and 268 facilitators were found in 38 of the initial 56 articles published from 12 different countries. For the analyzed publications, the count of distinct barriers reported ranged from 0 to 40 (mean 10.24, SD 8.87, median 8). Likewise, between 0 and 48 facilitators were mentioned in the literature (mean 9.18, SD 9.33, median 6). The combination of both sources resulted in 77 barriers and 292 facilitators for the adoption and implementation of eHealth services. CONCLUSIONS This work contributes a comprehensive list of barriers and facilitators for the implementation and adoption of eHealth services. Addressing barriers early, and leveraging facilitators during the implementation, can help create eHealth services that better meet the needs of users and provide higher benefits for patients and caregivers.

BACKGROUND Clinical trials constitute an important pillar in medical research. It is beneficial to support recruitment for clinical trials using software tools, so-called patient recruitment support systems; however, such information technology systems have not been frequently used to date. Because medical information systems' underlying data collection methods strongly influence the benefits of implementing patient recruitment support systems, we investigated patient recruitment support system requirements and corresponding electronic record types such as electronic medical record, electronic health record, electronic medical case record, personal health record, and personal cross-enterprise health record. OBJECTIVE The aim of this study was to (1) define requirements for successful patient recruitment support system deployment and (2) differentiate and compare patient recruitment support system–relevant properties of different electronic record types. METHODS In a previous study, we gathered requirements for patient recruitment support systems from literature and unstructured interviews with stakeholders (15 patients, 3 physicians, 5 data privacy experts, 4 researchers, and 5 staff members of hospital administration). For this investigation, the requirements were amended and categorized based on input from scientific sessions. Based on literature with a focus on patient recruitment support system–relevant properties, different electronic record types (electronic medical record, electronic health record, electronic medical case record, personal health record and personal cross-enterprise health record) were described in detail. We also evaluated which patient recruitment support system requirements can be achieved for each electronic record type. RESULTS Patient recruitment support system requirements (n=16) were grouped into 4 categories (consent management, patient recruitment management, trial management, and general requirements). All 16 requirements could be partially met by at least 1 type of electronic record. Only 1 requirement was fully met by all 5 types. According to our analysis, personal cross-enterprise health records fulfill most requirements for patient recruitment support systems. They demonstrate advantages especially in 2 domains (1) supporting patient empowerment and (2) granting access to the complete medical history of patients. CONCLUSIONS In combination with patient recruitment support systems, personal cross-enterprise health records prove superior to other electronic record types, and therefore, this integration approach should be further investigated.

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.