TrustSphere - Enabling patient-directed access to clinical and patient-generated health data: a novel multi-source architecture (Preprint)
Authors: van Rooij Tibor , Ali Taqdir , Toledo-Marín J. Quetzalcóatl , Laws Alec , Barrett Bonnie , Payne Beth A , Amed Shazhan , Portales-Casamar Elodie , Wasserman Wyeth W , Görges Matthias 
Published: January 2025

BACKGROUND

Recent advances in digital health, the growth of wearable device use, and ubiquitous internet access are generating growing amounts of health and well-being data. Yet, people need tools to manage their health and wellness journeys, including trustworthy health access platforms to easily view, share, and manage their data as part of health systems.

OBJECTIVE

To describe the initial concept and architecture development of a patient-centric platform, TrustSphere, that empowers patients by enabling them to manage and securely share health data with caregivers, healthcare providers and, if desired, researchers.

METHODS

The TrustSphere digital health platform integrates data through a digital trust layer (using strong digital identity combined with fine-grained consenting capacities) and secure access to digital health applications and patient-generated health data to support patient and healthcare-team coordination for chronic diseases. TrustSphere was designed and developed by a novel collaboration between clinicians, researchers, and digital health innovators (com-panies) using a novel architecture that allows patients and families to securely, ethically, and scalably share patient-generated, clinical, and administrative health data with clinicians and researchers via federated authentication, authorization, and consent management tools. Healthcare providers and researchers can securely access consented data using an array of visualization, cohort, and data export tools. The design allows for the integration of clinical re-search registries using REDCap and other electronic health records systems. The TrustSphere architecture was implemented for an initial use case in pediatric type 1 diabetes while being readily generalizable to patients with other data-intense chronic diseases.

RESULTS

To address the needs of our initial users (children living with type 1 diabetes, their families, and care providers), TrustSphere allows the acquisition of data from multiple patient sources (e.g., continuous glucose monitoring systems, glucometers, and insulin pumps) and can also extract data from clinical databases to store within a secure clinical repository. With patient consent, research data are exported to TrustSphere’s Research Registry. Interoperable reposi-tories combine diverse data sources using the Fast Healthcare Interoperability Resources (FHIR) clinical data exchange standard. The software applications “BC Children's Hospital Care Hub” and “Researcher Dashboard” are available in the current implementation. Leverag-ing a custom data model, we implemented standalone software components for data import and export from the TrustSphere Research Registry.

CONCLUSIONS

TrustSphere’s novel architecture provides a single point of access and integrates clinical infor-mation with patient-generated healthcare data. This enables patients to share their data with clinicians and researchers for clinical care delivery and enhances clinical research as part of a learning health system.