Unique Device Identification-Based Linkage of Hierarchically Accessible Data Domains in Prospective Surgical Hospital Data Ecosystems: User-Centered Design Approach

Abstract

Background: The electronic health record (EHR) targets systematized collection of patient-specific, electronically stored health data. The EHR is an evolving concept driven by ongoing developments and open or unclear legal issues concerning medical technologies, cross-domain data integration, and unclear access roles. Consequently, an interdisciplinary discourse based on representative pilot scenarios is required to connect previously unconnected domains.

Objective: We address cross-domain data integration including access control using the specific example of a unique device identification (UDI)-expanded hip implant. In fact, the integration of technical focus data into the hospital information system (HIS) is considered based on surgically relevant information. Moreover, the acquisition of social focus data based on mobile health (mHealth) is addressed, covering data integration and networking with therapeutic intervention and acute diagnostics data.

Methods: In addition to the additive manufacturing of a hip implant with the integration of a UDI, we built a database that combines database technology and a wrapper layer known from extract, transform, load systems and brings it into a SQL database, WEB application programming interface (API) layer (back end), interface layer (rest API), and front end. It also provides semantic integration through connection mechanisms between data elements.

Results: A hip implant is approached by design, production, and verification while linking operation-relevant specifics like implant-bone fit by merging patient-specific image material (computed tomography, magnetic resonance imaging, or a biomodel) and the digital implant twin for well-founded selection pairing. This decision-facilitating linkage, which improves surgical planning, relates to patient-specific postoperative influencing factors during the healing phase. A unique product identification approach is presented, allowing a postoperative read-out with state-of-the-art hospital technology while enabling future access scenarios for patient and implant data. The latter was considered from the manufacturing perspective using the process manufacturing chain for a (patient-specific) implant to identify quality-relevant data for later access. In addition, sensor concepts were identified to use to monitor the patient-implant interaction during the healing phase using wearables, for example. A data aggregation and integration concept for heterogeneous data sources from the considered focus domains is also presented. Finally, a hierarchical data access concept is shown, protecting sensitive patient data from misuse using existing scenarios.

Conclusions: Personalized medicine requires cross-domain linkage of data, which, in turn, require an appropriate data infrastructure and adequate hierarchical data access solutions in a shared and federated data space. The hip implant is used as an example for the usefulness of cross-domain data linkage since it bundles social, medical, and technical aspects of the implantation. It is necessary to open existing databases using interfaces for secure integration of data from end devices and to assure availability through suitable access models while guaranteeing long-term, independent data persistence. A suitable strategy requires the combination of technical solutions from the areas of identity and trust, federated data storage, cryptographic procedures, and software engineering as well as organizational changes.

Keywords: cyber-physical production systems; data integration ecosystem; electronic health record; hierarchical data access; mHealth; shell embedded role model; unique device identification.