Governance & interoperability
Compliance, safety case, and FHIR staging
Design alignment for NHS clinical safety, DCB0129 hazard log status, DTAC evidence, and EHR integration pathways.
Compliance
Aligned design pathways, not certification claims
Aksh Health aligns with NHS clinical safety and digital technology assessment pathways. We do not claim certification. Internal clinical safety evidence remains confidential; public resources describe design alignment only.
- 1DCB0129 clinical safety case pathway in active development
- 2DTAC-aligned evidence scaffolding for NHS procurement
- 3GDPR Art. 9 special category health data handling
- 4MHRA-aware positioning: decision support, not autonomous diagnosis
- 5Human-in-the-loop review on every clinical output
DCB0129 hazard log
Safety case in progress: hazard log structure
The clinical safety case for Aksh Health follows the DCB0129 hazard log structure. This build has not completed a signed-off safety case; the outline below describes the working structure our clinical safety officer maintains internally.
- 1Hazard identification: catalogue where an agent output could cause patient harm if acted on unreviewed
- 2Risk evaluation: likelihood and severity scoring per hazard, aligned to NHS clinical risk grading
- 3Mitigation: control measures, including the human-in-the-loop review gate on every clinical output
- 4Residual risk sign-off: named clinical safety officer approval before any production deployment
- 5Status: safety case in progress. No production EHR write-back is enabled until sign-off completes
DTAC checklist
DTAC alignment checklist status
The NHS Digital Technology Assessment Criteria covers five domains. Status below reflects design alignment work completed in this build, not a submitted or approved DTAC assessment.
- 1Clinical safety: DCB0129 hazard log in progress (see above)
- 2Data protection: GDPR Art. 9 handling and RBAC design in place
- 3Technical assurance: FHIR R4 staging and audit trail architecture documented
- 4Interoperability: EMIS Web and SystmOne integration paths designed, not yet live
- 5Usability and accessibility: WCAG 2.1 AA target across dashboards, ongoing review
FHIR & interoperability
FHIR R4 staging above existing EHR systems
Clinical outputs are staged as FHIR R4 draft resources for reviewer inspection. Integration architecture is designed for EMIS Web and SystmOne, the dominant UK primary care EHR systems. Production EHR connections are not live in this build.
- 1Encounter, Condition, MedicationRequest, Observation in collection bundles
- 2DocumentReference for SYNTHESIS SOAP output in the review queue
- 3RiskAssessment for ORACLE score updates
- 4AuditEvent for SHIELD compliance trail on Accept, Edit, Reject
- 5Designed for EMIS Web and SystmOne FHIR exchange patterns