Project Overview
An NHS Foundation Trust conducting clinical research in cardiac rehabilitation wanted to build a wearable data...
Technology Stack
Compliance & Standards
The Challenge
An NHS Foundation Trust conducting clinical research in cardiac rehabilitation wanted to build a wearable data analytics platform — processing continuous heart rate, activity, and sleep data from Fitbit and Apple Watch devices worn by 340 cardiac rehabilitation patients over 12 weeks. MHRA Class IIa medical device classification review, DTAC all 5 domains (research application), UK GDPR Article 9, NHS Research Governance Framework, and HRA (Health Research Authority) ethics approval integration were mandatory. Budget: £85,000.
Our Approach
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.
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 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.
The Results
Platform live at 14 weeks, £78,000 — under budget.
DTAC approved all 5 domains.
HRA ethics compliance maintained. 340 patients enrolled in 12-week programme.
Wearable compliance: 84% of patients achieving ≥80% wear time (target: 70%).
Research dataset: 4.2 million heart rate data points, 98.2% completeness.
Publication submitted to European Heart Journal: wearable-monitored cardiac rehab showing statistically significant improvement in exercise capacity vs standard care.
“The HRA ethics compliance architecture was what made the research possible — without it, the ethics board would not have approved the data collection. The TimescaleDB time-series architecture handled 4.2 million data points without performance issues. The paper has been submitted — the data quality was sufficient for peer review." — Consultant Cardiologist PI, NHS Foundation Trust (name withheld)”
Project Details
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