Designing a Concept for an IT-Infrastructure for an Integrated Research and Treatment Center Sebastian Stäuberta, Alfred Wintera, Ronald Speerb, Markus Löfflerab a
Institute for Medical Informatics (IMISE), University of Leipzig, Leipzig, Germany b Clinical Trials Centre Leipzig (ZKS), Leipzig, Germany
Abstract Healthcare and medical research in Germany are heading to more interconnected systems. New initiatives are funded by the German government to encourage the development of Integrated Research and Treatment Centers (IFB). Within an IFB new organizational structures and infrastructures for interdisciplinary, translational and trans-sectoral working relationship between existing rigid separated sectors are intended and needed. This paper describes how an IT-infrastructure of an IFB could look like, what major challenges have to be solved and what methods can be used to plan such a complex ITinfrastructure in the field of healthcare. By means of project management, system analyses, process models, 3LGM²models and resource plans an appropriate concept with different views is created. This concept supports the information management in its enterprise architecture planning activities and implies a first step of implementing a connected healthcare and medical research platform. Keywords: Medical Informatics, Hospital Information Systems, Integrated Advanced Information Management Systems, Biomedical Research, Clinical Trials, Information Management, Systems Analysis, Information System Models, Translational Medicine.
Introduction Integration of inpatient and outpatient Care in Germany From an information management point of view, healthcare in Germany is strictly separated in two sectors: outpatient (practitioners and specialists) and inpatient (hospitals) treatment. Both sectors have had different information systems, no common communication standards, no harmonized electronic health records and no common IT-infrastructure which they can share. Because of demographical change, improvements in medicine and following increase of costs, the German government started at least two major strategies to reform this situation. One example is “Integrated Care” which allows process-oriented, interdisciplinary and trans-sectoral networks
between practitioners and hospitals [1]. The second example is the German electronic health insurance card and the underlying IT-infrastructure which will provide a shared platform for administrational and medical data [2]. Integration of Healthcare and Medical Research in Germany Likewise there is a strict separation between care and research. Medical research is commonly organized in clinical trials and studies. To coordinate studies competence networks with focus on selected diseases were built [3, 4]. A competence network consist of a coordination center which controls the trials and collect the medical data from the study centers (about 20-100) which are performing the trials [5-7]. To avoid reinventing the wheel in every competence network the German Telematikplattform für Medizinische Forschungsnetze (TMF) e. V. 1 gives support in common issues like legal, ethical and questions of quality management furthermore in ITprojects, biobanking and privacy concepts [8]. The next and current integrative step is to improve medical research by considering cause and effect of a disease and encouraging translational medicine as a two-way road between research and treatment [9]. Since 2008 this has been done in Germany by funding “Integrated Research and Treatment Centers” (IFB) by the German Ministry of Education and Research (BMBF) [10]. Translation here means accelerating knowledge transfer between basic research, patient-oriented research and clinical application. An IFB is focused on a selected disease like a competence network but in a wide (cause and effect) and interdisciplinary way flanked by offers for young researchers and professional education. To obtain these goals new structures in organization and infrastructures especially IT-infrastructures are needed. Major Challenges Establishing an IT-infrastructure for better integration of patient care and medical research, i.e. for efficient support of translational medicine leads to considerable challenges. These challenges range from technical to financial issues [11]. In this paper we will focus on the Integrated Research and Treatment Center at Leipzig University Medical School and 1
http://www.tmf-ev.de
Leipzig University Hospital (LUH). This center integrates research and treatment for adiposity diseases. We will deal with the challenges by answering the following questions: • Screening and Tagging: How to identify patients as being at risk of adiposity? How to recruit the identified patients as attendees for clinical trials and refer them to the IFB for treatment? • Integration of information systems: How can medical data of patients being treated within the IFB be collected in the respective information system of the hospital and afterwards made available in the information system of clinical trial management organization? • Pseudonymization: How medical data originating from patients’ treatment can be reused for research and clinical trials without violating patients’ privacy?
Methods Based on an analysis of the business processes the architecture of the IT-infrastructure can be designed. Doing so we applied the following methods: Process Modeling Flow charts [12] have been used for modeling the business processes. Note that ‘business’ does not imply a focus on administrative aspects but implies a holistic view on the patient related processes constituting the business of an IFB. The simplicity of flow charts is their advantage. So even persons involved in IFB who are not familiar with business process modeling can understand it and are able to collaborate specifying the processes. After having modeled the processes we enhanced the resulting flow chart with assignments of information system components to be used. The enhanced FC (eFC) served as a specification for the architecture of the IT-infrastructure.
Systems Analyses Existing 3LGM²-models of the Leipzig University Hospital (LUH) and reference models for information system architectures [16] were used for system analyses. Furthermore models and experiences from previous projects in competence networks in the Center of Clinical Trials Leipzig 2 and from activities in the TMF [17] were included.
Results Process model There are several processes in the IFB needed to subscribe patients and to analyze their data with respect to the referral to IFB. The process model in Figure 1 shows some of these processes, their requirements and the data used. The processes at IFB can be divided into two steps. At first step, there is a need to identify, tag and follow-up patients during the conventional treatment at LUH (light gray boxes). The second step is to enclose these patients in trials at the IFB (dark grey boxes). Both processes need a seamless integration of application systems in LUH and application systems in clinical research. It is indicated where single processes are located by assigning annotations of information system components to processes (links with dotted lines).
Modeling Enterprise Architectures There are several modeling approaches to support information managers in healthcare in enterprise architecture planning. Based on our experiences in modeling information systems of institutions in healthcare [13] we decided to use the three layer graph-based meta model (3LGM²) [14] for this integrated IT-infrastructure as well. Based on 3LGM² the 3LGM²tool [15] was developed to support modeling of information systems in health care. 3LGM² distinguishes an information system in a domain layer to describe enterprise functions and processed information, a logical tool layer to describe application components and the communication between them and a physical tool layer to describe hardware components. Interdependencies between concepts of different layers are described as so called inter-layer-relationships. 3LGM²-tool has important features to work with sub-models and doing analyses on the modeled information system. In order to link the process model to the architecture model we extracted the ‘activities’ of the eFC and mapped them onto functions at the domain layer of the 3LGM² based architecture model.
Figure 1 – Model of workflow The processes consist of sub-processes, which give detailed information about single steps. The process “Screening” for example describes how patients could be identified from a hospital information system [18]. To achieve this, patient records have to be scanned for relevant items. Based on this item data, scores (e.g. body mass index) and ratings were calculated. These scores and ratings are required to support a doctor’s decision of the following processes. So she/he can decide whether the patient continues the conventional care process or is suitable for treatment within IFB.
2
http://www.zks.uni-leipzig.de
All processes have to comply to legal aspects of data privacy and data security. Domain layer The process model is a good preparation for 3LGM²s domain layer. In this layer a more detailed view on the processes is possible. In Figure 2 relations between functions (rectangles) and object types (ellipses) are modeled. Activities of the eFC have been mapped onto respective functions. This approach leads to a clear understanding of the information objects and how they are linked with functions and therefore activities from the process model. In the part of the domain layer shown in Figure 2 there is a function called “test person administration”. This function is a sub-process of “IFB-Outpatient Admission” from eFC. It is linked with several object types like “master data”, “covering letter” and “target date” which are needed for this task or which are interpreted.
teed by using Study Identification Codes (SIC) in the context of trials instead of Patient IDs, which are used in the treatment context. A Pseudonymization Service [20, 21] will provide an appropriate SIC for a PID on request. The Pseudonymization Service will store a list of PIDs and corresponding SICs, but no more identification data. MDAT delivered to TDMS may be passed to the Biobank Management System where applicable. Because of the high amount of data of high throughput sequencers their data is stored in a separate application system which is designed to handle genetic data (GeWare).
Figure 3 – 3LGM² logical tool layer
Figure 2 – 3LGM² domain layer Logical tool layer The concept for the information systems architecture at its application systems’ layer is outlined in Figure 3. This concept includes not only Leipzig University Hospital (LUH) but third parties contributing to this project as well. Patient care in LUH and at third parties is supported by their application systems for patient management (PMS), intensive care unit management (PDMS), laboratory (LIS) and so on. Trial data is stored and trial management is supported by the trial data management system (TDMS). There are two ways for data capturing. First data collected in PDMS and LIS can be sent to the TDMS. The second way is to capture data using electronic case report forms (eCRF) provided by the software used for the TDMS. The eCRF modules will be used in the context of clinical documentation and therefore in parallel to using the PMS. Integration can be provided by “context integration” techniques; but it still has to be decided whether the HL7 related CCOW standard or service oriented portals shall be used [19]. According to data privacy and security constraints the separation of data in treatment and research contexts will be guaran-
The sub-model of application systems in Figure 3 is related to the activities in the workflow as described in Figure 1 and linked with the domain layer in Figure 2 as part of the whole 3LGM²-model. These links associate functions with application systems and object types with data bases, interfaces and communication links. In summary the logical tool layer explains how the activities will be supported by application systems. Physical tool layer 3LGM² also supports modeling hardware components of an information system. A part of the physical tool layer of IFB is shown in Figure 4. Hence an overview of the planned network components, servers, laboratory hardware and workstations is modeled (boxes in Figure 4). Locations, information about network links (e.g. network type, link speed), operating systems and a lot of additional metadata is included, too. Inter-layer-relations to the logical tool layer describe for example links between application systems and physical hardware. In this way it is modeled that e.g. TDMS and LIS is planned for installation on a dedicated server with defined parameters on a specified location and environment.
and furthermore network and server hardware which are hosting all components from the logical tool layer.
Conclusion
Figure 4 – 3LGM² physical tool layer
Discussion All models presented here are based on information available at the beginning of this ambitious project. Thus we could not report on an implemented IT-infrastructure but on the models serving as the blueprint for the implementation and on the methods used to achieve the models. Hence this approach is not validated until now. We are sure that during the implementation of single working packages the models will have to be refined to synchronize them with reality. This is needed to keep track of the work in progress. Some changes are predictable. The role of the communication server (CS) in the hospital information system (HIS) is an example. At the logical tool layer of the current 3LGM²model, the CS supports the screening process by processing HL7 messages. This is a possible way but there are other suggestions and ideas to support the screening process like mentioned in this overview [18] or perhaps in a single source approach [22]. So new information system components in logical tool layer could appear, like a data-warehouse which collects medical data of the HIS. Another example is the rollout of the German health insurance card and their underlying ITinfrastructure. This infrastructure could help to connect third party health organizations much easier. But today there is no final date known, when all needed features will be available. We found, that the model based approach presented here provides effective support in designing a complex IT-infrastructure for translational medicine. Process analyses help to understand the processes which are needed for IFB. A 3LGM²model proceeds clear functions and object types from the process model and is able to describe the connected application systems, data bases and their communication relations
As shown in this paper, major challenges have to be solved to plan an IT-infrastructure for an Integrated Research and Treatment Center. Especially screening and tagging, integration of information systems and pseudonymization have to be realized. Screening and tagging are necessary functions to make sure that patient being at risk of adiposity can be identified and both be recruited as attendees for clinical trials and referred to the IFB for treatment. The outlined modifications of the information systems illustrate in multiple views how this could be achieved. The integration of both the information systems in context of care and the information systems in research context leads to an IT-infrastructure we searched for. This integrated ITinfrastructure is able to support the specified processes. Especially in healthcare data privacy is one of the most important constraints. So an integrated IT-infrastructure has to implement facilities to ensure this. Besides implementing features of application and network security the use of a pseudonymization service guaranties a reuse of medical data originating from patients’ treatment or research and clinical trials without violating patients’ privacy.
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