Regulatory position
Where ēpi stands, and how to check it
Compliance is how we build, not a page we publish. Each row states our position and names the document or control that supports it. The documents themselves are shared with investors, partners and regulators on request.
| Area | Position | Evidence |
|---|---|---|
| Medical device status (UK MDR 2002, MHRA guidance) | ēpi is a wellness and care-coordination companion. It records what a person reports, organises it into the Functional Health Matrix, and connects them with regulated practitioners. It does not diagnose, treat, prescribe or recommend dose changes, and a red-flag detector routes emergencies to 999 and NHS 111 before any model responds. On that intended purpose it is not a medical device; the boundary note records the reasoning and the features that would change the answer. | MHRA software-as-a-medical-device boundary note; red-flag detector and its tests. |
| Data protection (UK GDPR, Data Protection Act 2018) | Codenutri Limited (company no. 17062603) is the controller. Health data is special category data processed on the basis of explicit consent, with contract and, where a practitioner directs care, health-care purposes. Patient data is processed and stored in the United Kingdom: London serverless functions, a London database, inference on Google Cloud in London. Erasure cascades across every table that holds patient data. | Data map and processor register (v0.2); Data Protection Impact Assessment for the Concierge; the Article 17 erasure cascade in code. |
| Confidential patient information and model inference | Inference runs on Google Vertex AI in an EU region under the Google Cloud Business Associate Agreement and Data Processing Addendum, authenticated without any key file. Production refuses any model path outside that agreement. | Architecture decisions ADR-001 and ADR-002; the inference policy in both applications; the Cloud Logging exhibit in the evidence pack once collected. |
| Clinical safety (DCB0129) | A hazard log is maintained in the DCB0129 format for the Concierge and chat surfaces. A named Clinical Safety Officer signs it before any pilot recruitment. | DCB0129 hazard log; the crisis surface and safety event audit trail. |
| NHS digital technology (DTAC) | A DTAC self-assessment is drafted across clinical safety, data protection, technical security, interoperability and usability, and is updated as the evidence pack fills. | DTAC self-assessment; security headers, dependency audit gate and secret scanning in continuous integration. |
| Interoperability | Health data exports and imports use HL7 FHIR R4 resources: Patient, Observation, Condition, MedicationStatement. | FHIR compliance harness in the patient app test suite. |
Questions about any of this: privacy@epinutri.com. Back to the home page.