A standards-based approach to digital health research: implementing the people heart study

To assess whether HL7 Fast Healthcare Interoperability Resources (FHIR) can underpin a fully standards-based, end-to-end digital research architecture, demonstrate it in a live study, and quantify its benefits for interoperability and development efficiency.

We designed a generalizable standards-based architecture to accelerate digital health research relying on FHIR as the sole transactional model throughout a participant research lifecycle starting from API-based study discovery to results. It was instantiated for People Heart Study, a real-world digital health cardiovascular-risk assessment study with its protocol transformed into FHIR resources (eligibility, consent, tasks, and results). Evaluation examined workflow coverage, validator conformance across independent servers, and points requiring custom extensions or app logic.

The architecture was implemented using cloud managed FHIR stores including an illustrative public research discovery API for first-/third-party apps. A participant-facing iOS app was published on the App Store. Our evaluation reveals that 6 of 10 research app workflows could be executed entirely from FHIR artifacts; 2 were partially standards-driven and 2 remained limited requiring custom development. All FHIR resources passed structural, semantic validation with minimal custom extension usage and terminology integrity issues.

Our approach addresses persistent challenges in digital health research by enhancing data interoperability, minimizing redundant development, and supporting the full research lifecycle. The architecture aligns with national priorities and complements healthcare standardization efforts.

By leveraging FHIR, our architecture enables generalizability, interoperability, and reuse across diverse digital health research contexts, transforming study design into data modeling rather than software development, and fostering a more inclusive and agile digital health ecosystem.