Migration path for structured documentation systems including standardized medical device data.

A standardized end-to-end solution has been implemented with the aim of supporting the semantic integration of clinical content in institution spanning applications. The approach outlined is a proof-of-concept design. It has shown that the standards chosen are suitable to integrate device data into forms, to document the results consistently and finally enable semantic interoperability. In detail the implementation includes a standardized device interface, a standardized representation of data entry forms and enables the communication of structured data via HL7 CDA. Because the proposed method applies a combination of standards semantic interoperability and the possibility of a contextual interpretation at each stage can be ensured.

Standardizing intensive care device data to enable secondary usages.

To represent medical device observations in a format that is consumable by clinical software, standards like HL7v3 and ISO/IEEE 11073 should be used jointly. This is demonstrated in a project with Dräger Medical GmbH focusing on their Patient Data Management System (PDMS) in intensive care, called Integrated Care Manager (ICM). Patient and device data of interest should be mapped to suitable formats to enable data exchange and decision support. Instead of mapping device data to target formats bilaterally we use a generic HL7v3 Refined Message Information Model (RMIM) with device specific parts adapted to ISO/IEEE 11073 DIM. The generality of the underlying model (based on Yuksel et al. [1]) allows the flexible inclusion of IEEE 11073 conformant device models of interest on the one hand and the generation of needed artifacts for secondary usages on the other hand, e.g. HL7 V2 messages, HL7 CDA documents like the Personal Health Monitoring Report (PHMR) or web services. Hence, once the medical device data are obtained in the RMIM format, it can quite easily be transformed into HL7-based standard interfaces through XSL transformations because these interfaces all have their building blocks from the same RIM. From there data can be accessed uniformly, e.g. as needed by Dräger´s decision support system SmartCare [2] for automated control and optimization of weaning from mechanical ventilation.

Metadata Repository for Improved Data Sharing and Reuse Based on HL7 FHIR.

Unreconciled data structures and formats are a common obstacle to the urgently required sharing and reuse of data within healthcare and medical research. Within the North German Tumor Bank of Colorectal Cancer, clinical and sample data, based on a harmonized data set, is collected and can be pooled by using a hospital-integrated Research Data Management System supporting biobank and study management. Adding further partners who are not using the core data set requires manual adaptations and mapping of data elements. Facing this manual intervention and focusing the reuse of heterogeneous healthcare instance data (value level) and data elements (metadata level), a metadata repository has been developed. The metadata repository is an ISO 11179-3 conformant server application built for annotating and mediating data elements. The implemented architecture includes the translation of metadata information about data elements into the FHIR standard using the FHIR Data Element resource with the ISO 11179 Data Element Extensions. The FHIR-based processing allows exchange of data elements with clinical and research IT systems as well as with other metadata systems. With increasingly annotated and harmonized data elements, data quality and integration can be improved for successfully enabling data analytics and decision support.

Reporting Device Observations for semantic interoperability of surgical devices and clinical information systems.

Service-oriented medical device architectures make the progress from interdisciplinary research projects to international standardisation: A new set of IEEE 11073 proposals shall pave the way to industry acceptance. This expected availability of device observations in a standardised representation enables secondary usage if interoperability with clinical information systems can be achieved. The Device Observation Reporter (DOR) described in this work is a gateway that connects these realms. After a user chooses a selection of signals from different devices in the digital operating room, the DOR records these semantically described values for a specified duration. Upon completion, the signals descriptions and values are transformed to Health Level Seven version 2 messages and sent to a hospital information system/electronic health record system within the clinical IT network. The successful integration of device data for documentation and usage in clinical information systems can further leverage the novel device communication standard proposals. Complementing these, an Integrating the Healthcare Enterprise profile will aid commercial implementers in achieving interoperability. Their solutions could incorporate clinical knowledge to autonomously select signal combinations and generate reports of diagnostic and interventional procedures, thus saving time and effort for surgical documentation.

A mobile application to manage and minimise the risk of late effects caused by childhood cancer.

In their first 15 years of life, about 1 800 children are diagnosed with cancer each year in Germany. Their chances of survival, however, have improved significantly over the last 40 years. In Germany alone, over 30 000 survivors of childhood cancer are presently living. Therefore, the late effects caused by the therapy occur ever more frequently as chemotherapy and radiotherapy may leave traces even years later. In order to recognize and treat these late effects in survivors, structured and regular follow-up examinations are necessary from an early stage on. However, the compliance of former patients to participate in the recommended check-ups is not satisfying for multiple reasons. To enhance this compliance, an application for smartphones and tablets has been developed. The Aftercare App supplies a wide range of information regarding the aftercare and supports a reminder functionality to attend medical visits.

Rule-based interface generation on mobile devices for structured documentation.

In many software systems to date, interactive graphical user interfaces (GUIs) are represented implicitly in the source code, together with the application logic. Hence, the re-use, development, and modification of these interfaces is often very laborious. Flexible adjustments of GUIs for various platforms and devices as well as individual user preferences are furthermore difficult to realize. These problems motivate a software-based separation of content and GUI models on the one hand, and application logic on the other. In this project, a software solution for structured reporting on mobile devices is developed. Clinical content archetypes developed in a previous project serve as the content model while the Android SDK provides the GUI model. The necessary bindings between the models are specified using the Jess Rule Language.