MedTech Wearable Data Analytics Platform — UK NHS Trust Research

MHRA Research Use Medical Device Assessment: Research use of wearable analytics: MHRA assessment — if the platform makes clinical conclusions from wearable data that influence patient management, it is a medical device. Scope definition: platform classified as research data management software (not medical device) by limiting outputs to research data aggregation without clinical decision support. Clinical conclusions drawn by the research clinician, not the software. Wearable Device Integration: Fitbit Web API: heart rate, steps, active minutes, sleep stages, SpO2 (blood oxygen). Apple HealthKit: identical metrics via Apple Health Research app. Harmonisation layer: both platforms return different data formats and sampling rates — normalisation to common 1-minute resolution time-series. Missing data handling: wear compliance tracking (percentage of time device worn) — flagged in research dashboard. UK GDPR Article 9 Research Exemption: UK GDPR Article 9(2)(j): processing for scientific research is an exemption to the special category prohibition, subject to safeguards. HRA ethics approval as the safeguard. NHS Research Governance Framework: data sharing agreement between the NHS Trust and any research partners. Anonymisation schedule: all data anonymised (k-anonymity ≥5) for publication — identifiable data used only for direct patient care linkage. DTAC Research Application Evidence: DTAC Domain 1: DCB0129 clinical safety case (CSO: Consultant Cardiologist PI). Domain 2: HRA ethics approval as GDPR Article 9(2)(j) safeguard, DPIA. Domain 3: Cyber Essentials Plus, CREST pen test. Domain 4: HL7 FHIR R4 for patient demographic data from EPR. Domain 5: accessibility testing (WCAG 2.1 AA) — research staff portal and patient-facing data consent portal.