Björn Andersen

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.

Semantic interoperability in the OR.NET project on networking of medical devices and information systems — A requirements analysis

OR.NET is the German national flagship project on networking of medical devices and information systems. Its objective is to define, implement and validate a standard-based integration solution for safe and dynamic networking of devices and systems in the operating room and its clinical surroundings. An important part of this project is to ensure semantic interoperability. Besides standardized inter-device communication, this task needs an engine for semantic mediation between heterogeneous communication partners. This work analyses the requirements that need to be satisfied by such an engine. It will have to transform messages between different forms of standardized representation in the operational environment of an open communication framework. Especially the information exchange between devices and information systems will be dependent on the engines reliable and verifiable semantic mediation. Being deployed on an embedded device in a service-oriented architecture based on web services, the component will have to comply not only with international healthcare standards and medical device directives but also with W3C specifications to provide and describe its capabilities. In the future, the semantic interoperability engine could be extended to a general ontology-based framework, further promoting and supporting device integration based on standards in the surgery domain.

OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC

PurposeClinical working environments have become very complex imposing many different tasks in diagnosis, medical treatment, and care procedures. During the German flagship project OR.NET, more than 50 partners developed technologies for an open integration of medical devices and IT systems in the operating room. The aim of the present work was to evaluate a large set of the proposed concepts from the perspectives of various stakeholders.MethodThe demonstration OR is focused on interventions from the head and neck surgery and was developed in close cooperation with surgeons and numerous colleagues of the project partners. The demonstration OR was qualitatively evaluated including technical as well as clinical aspects. In the evaluation, a questionnaire was used to obtain feedback from hospital operators. The clinical implications were covered by structured interviews with surgeons, anesthesiologists and OR staff.ResultsIn the present work, we qualitatively evaluate a subset of the proposed concepts from the perspectives of various stakeholders. The feedback of the clinicians indicates that there is a need for a flexible data and control integration. The hospital operators stress the need for tools to simplify risk management in openly integrated operating rooms.ConclusionThe implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices

Abstract The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

Design, implementation, and evaluation of a mobile application for patient empowerment and management of long-term follow-up after childhood cancer.

In Germany, about 1,800 new cases of childhood cancer are diagnosed every year. The chances of survival have increased significantly over the last 40 years due to the continuous improvement of treatment strategies. The number of childhood cancer survivors in Germany thus ranges around 30,000 nowadays. But their treatment with surgery, chemotherapy, and radiation has certain side-effects. In addition to the acute effects during the treatment phase, the disease- and treatment-related late effects can occur even decades after the end of therapy. These late effects draw attention as the survival rate constantly increases. Two-thirds of the former patients retain long-term consequences, nearly a fifth with a resulting diminished quality of life. Early detection of these late effects can help to reduce or even to prevent serious health damage. Therefore, the study group LESS supplies long-term follow-up recommendations for former patients. The project described in this paper was to design and implement a mobile application to increase the compliance for this aftercare program. This application provides information about the patients individual aftercare plan and supports appointment management as well as a reminding functionality. A prototype for former osteosarcoma patients was tested and evaluated in two university hospitals. First results show the applications very high potential for patient empowerment.

From SOMDA to application – integration strategies in the OR.NET demonstration sites

Abstract The effective development and dissemination of the open integration for the next generation of operating rooms require a comprehensive testing environment. In this paper, we present the various challenges to be addressed in demonstration applications, and we discuss the implementation approach, the foci of the demonstration sites and the evaluation efforts. Overall, the demonstrator setups have proven the feasibility of the service-oriented medical device architecture (SOMDA) and real-time approaches with a large variety of example applications. The applications demonstrate the potentials of open device interoperability. The demonstrator implementations were technically evaluated as well as discussed with many clinicians from various disciplines. However, the evaluation is still an ongoing research at the demonstration sites. Technical evaluation focused on the properties of a network of medical devices, latencies in data transmission and stability. A careful evaluation of the SOMDA design decisions and implementations are essential to a safe and reliable interoperability of integrated medical devices and information technology (IT) system in the especially critical working environment. The clinical evaluation addressed the demands of future users and stakeholders, especially surgeons, anesthesiologists, scrub nurses and hospital operators. The opinions were carefully collected to gain further insights into the potential benefits of the technology and pitfalls in future work.

Extending the IEEE 11073-1010X nomenclature for the modelling of surgical devices

The current lack of medical device interoperability can only be overcome by the usage of structural and semantic standards. Therefore, a modern service-oriented architecture for systems of networked medical devices has been developed within the IEEE 11073 series. Its application to new domains such as surgery also demands an extension of the IEEE 11073-1010X Nomenclature, which was initially designed for only a limited set of device types. We thus propose new terms for surgical devices and component interactions, options for the (limited) post-coordination of terms, and term mapping to SNOMED CT and LOINC. In addition, we discuss the development of device specialisation standards.

Point-of-care medical devices and systems interoperability: A mapping of ICE and FHIR

Medical devices at the point-of-care can be interconnected through standardised communication protocols to build an Integrated Clinical Environment (ICE), but in order to interoperate with clinical information systems, different data exchange standards need to be conformed to. The emerging HL7 Fast Healthcare Interoperability Resources (FHIR) framework appeals to developers and clinicians alike and is a promising candidate to modernise this domain. Novel IEEE 11073 standard proposals that specify a service-oriented architecture of networked medical devices are one example for an ICE architecture. They are based on expressing a devices capabilities and state in a machine-readable way in order to be safely accessed and manipulated by other participants in the networked device system. In this work, the domain information and service model of this ICE architecture was mapped to FHIR resources that were constrained and extended to support the modelling of this device architecture. Through the definition of a FHIR profile, the data structures were aligned, effectively allowing for the transformation of medical device observation data from ICE to FHIR representation without the need for any proprietary interface. The implementation of this transformation, e. g. as a gateway, bridges the structural interoperability gap between two contemporary communication architectures for medical devices and clinical information systems and thus lays the foundation for semantic interoperability that can be achieved through the combined use with controlled vocabularies. The consequent availability of device data enables secondary usage such as large-scale data analytics. Future sub-profiles for specific device types further simplify the transformation.