gms | German Medical Science

Introduction: Modern mobile technology used for medical purposes allows assessing daily life behavior and quality of life in a new dimension of precision. It is accepted that parameters derived from such technique can increase treatment quality [1], [2], [3]. Studies in IBD patients show that co-morbidities (fatigue, depression) [4], [5] are associated with the course of the disease, which reflects in changes in activity, movement and sleep patterns. Immediate reaction to these changes, measured by sensors and patient reported outcomes (PRO), is crucial for the treatment outcome and can pave the way to precision medicine. We developed an architecture to receive data from a Fitness-Tracker (Garmin vívosmart 4), validated movement trackers (McRoberts MoveMonitor) and an App for PROs collection. Which will be the foundation for a disease monitoring and treatment management tool.

Methods: Inside the project GUIDE-IBD [6] the UI design, architecture and concept for the system was developed and implemented. Design experts adapted a concept for treatment management [7] for this project. Different security, encryption, authentication, authorization technologies were reviewed to create an architecture for the sensitive medical data that is processed and to be compliant with the General Data Protection Regulation (GDPR). The implementation of the Fitness-Tracker was conducted in another project [8].

Results: The developed architecture can be divided into three layers (Public (Internet), DMZ and Research Network (RN)) and four main components (Data collection, data receiving backend (DRB), data management system (DMS), study portal (SP)). Components in DMZ are accessible from public layer. Services deployed in the secured RN layer only accessible internally. The data collection component in the public layer consists of Fitness-Trackers and our GUIDE-IBD App to collect the PROs. Data from the App is end-to-end encrypted by hybrid encryption and received by the DRB that is located inside the DMZ. The DRB provides services to receive data, encryption key management and an API to provide the received encrypted data to the DMS that is located inside the secure RN. The DMS decrypts the data and sends the data to a FHIR Server [9]. The FHIR Server provides data directly for analysis and the SP inside the secure RN. The SP enables the compliance monitoring and visualizations of the data. All these services are protected by oAuth2 authorization framework. All communicate is secured with TLS. This project is realized using open-source tools and can be scaled easily for different research studies. The architecture is generic, only the FHIR profiles and resources need to be adapted for new projects.

Discussion: Until today, 30 Participants are using the system, and it is running without problems for over one year. The feedback from participants and researchers was positive. Participants praised the usability. The loosely coupled architecture fosters easy updated and improvements. The underlying FHIR data structure enables easy integration into other systems.

Conclusion: The developed system together with new biomarkers, derived from the collected data during this observation study, provides a good foundation for further developments in the direction of treatment management tools for precision medicine.

The authors declare that they have no competing interests.

The authors declare that a positive ethics committee vote has been obtained.