Digital Health Governance and Longitudinal Care Coordination in Outpatient Trajectories: Study Protocol for the Health Strategy Office (HSO) Operational Model

Background: Outpatient healthcare remains profoundly decentralized across independent provider networks, commercial electronic health records (EHRs), and diagnostic facilities. In multi-payer and decentralized environments like the United States, where a unified national patient identifier does not exist, the administrative task of assembling fragmented records and tracking treatment plans falls almost entirely on patients. While clinical trials and regulatory frameworks increasingly rely on Real-World Data (RWD) and Electronic Patient-Reported Outcomes (ePRO), primary medical practices rarely possess the operational infrastructure required to synthesize cross-institutional data or monitor adherence between scheduled visits. Objective: To present the operational framework and study protocol evaluating the Health Strategy Office (HSO) model—an independent, non-clinical governance architecture designed to synthesize longitudinal records, support patient navigation, and evaluate routine preventive adherence. Methods: A 12-week prospective, observational feasibility study will enroll adult participants (n=45) managing multi-specialty outpatient regimens. The HSO framework operates through three core layers: record ingestion and clinical synthesis, continuous mobile engagement via the proprietary HSO platform (hsogovernance.app), and cross-specialist coordination briefs. The platform integrates evidence-based screening algorithms (derived from USPSTF and WHO guidelines) that prompt patients regarding routine screenings to discuss with their personal clinicians. Key outcomes include the System Usability Scale (SUS), 12-week retention, ePRO completion fidelity, and prompt engagement rates. Significance: This study establishes how dedicated non-clinical governance can mitigate data fragmentation outside hospital networks, providing clinicians with auditable longitudinal context while maintaining regulatory privacy safeguards (LGPD/HIPAA).