Pitfalls in Analyzing FHIR Data from Different University Hospitals.

The German Medical Informatics Initiative has agreed on a HL7 FHIR-based core data set as the common data model that all 37 university hospitals use for their patient's data. These data are stored locally at the site but are centrally queryable for researchers and accessible upon request. This infrastructure is currently under construction, and its functionality is being tested by so-called Projectathons. In the 6th Projectathon, a clinical hypothesis was formulated, executed in a multicenter scenario, and its results were analyzed. A number of oddities emerged in the analysis of data from different sites. Biometricians, who had previously performed analyses in prospective data collection settings such as clinical trials or cohorts, were not consistently aware of these idiosyncrasies. This field report describes data quality problems that have occurred, although not all are genuine errors. The aim is to point out such circumstances of data generation that may affect statistical analysis.

3LGM2IHE: Requirements for Data-Protection-Compliant Research Infrastructures-A Systematic Comparison of Theory and Practice-Oriented Implementation.

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.

The Process of Modeling Information System Architectures with 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.

Towards a Software Tool for Planning IHE-Compliant Information Systems.

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 3LGM2 tool. This paper describes how requirements for this tool were determined and presents the results.

On Teaching International Courses on Health Information Systems. Lessons Learned during 16 Years of Frank - van Swieten Lectures on Strategic Information Management in Health Information Systems.

BACKGROUND: Health information systems (HIS) are one of the most important areas for biomedical and health informatics. In order to professionally deal with HIS well-educated informaticians are needed. Because of these reasons, in 2001 an international course has been established: The Frank - van Swieten Lectures on Strategic Information Management of Health Information Systems. OBJECTIVES: Reporting about the Frank - van Swieten Lectures and about our students' feedback on this course during the last 16 years. Summarizing our lessons learned and making recommendations for such international courses on HIS. METHODS: The basic concept of the Frank - van Swieten lectures is to teach the theoretical background in local lectures, to organize practical exercises on modelling sub-information systems of the respective local HIS and finally to conduct Joint Three Days as an international meeting were the resulting models are introduced and compared. RESULTS: During the last 16 years, the Universities of Amsterdam, Braunschweig, Heidelberg/Heilbronn, Leipzig as well as UMIT were involved in running this course. Overall, 517 students from these universities participated. Our students' feedback was clearly positive. The Joint Three Days of the Frank - van Swieten Lectures, where at the end of the course all students can meet, turned out to be an important component of this course. Based on the last 16 years, we recommend common teaching materials, agreement on equivalent clinical areas for the exercises, support of group building of international student groups, motivation of using a collaboration platform, ensuring quality management of the course, addressing different levels of knowledge of the students, and ensuring sufficient funding for joint activities. CONCLUSIONS: Although associated with considerable additional efforts, we can clearly recommend establishing such international courses on HIS, such as the Frank - van Swieten Lectures.