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Architecture, compliance, and integration documentation

Technical reference for NHS procurement, clinical safety review, and integration planning. FHIR R4 staging, human-in-the-loop review, and compliance design pathways for primary and secondary care.

NHS-readyFHIR R4GDPR Art. 9MHRA-awareHuman-in-the-loop

Architecture and review specification

Compliance badges describe aligned design pathways and control mapping. They do not represent certification, accreditation, or regulatory approval. Resources below describe design alignment, not certification or regulatory approval.

Five layers from intake to export

Aksh Health organises clinical AI into five layers: intake, agent orchestration, synthesis, review queue, and export. Consultation data flows through named clinical agents. Outputs land in a draft review queue. No autonomous write-back to active clinical records.

  • 1Five layers: intake, agents, synthesis, review, export
  • 2Seven agents: VOICE, SYNTHESIS, Dr.Assist, GUARDIAN, ORACLE, EQUITY, SHIELD
  • 3FHIR R4 resources staged as DRAFT until named reviewer approval
  • 4Human-in-the-loop on every clinical output before record impact

Named reviewer approval on every output

Every AI-generated clinical output requires named clinician review before it reaches a care record or pathway. Queue items carry agent badges and DRAFT status until a reviewer records a decision.

  • 1Accept: freeze evidence artifacts and append FHIR AuditEvent to export bundle
  • 2Edit: reviewer modifies draft content before acceptance
  • 3Reject: discard output with audit trail; no write to clinical record
  • 4Draft-only writes: no production record impact without explicit approval

Compliance, safety case, and FHIR staging

Design alignment for NHS clinical safety, DCB0129 hazard log status, DTAC evidence, and EHR integration pathways.

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

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 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 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

Integration and database boundaries

Explicit contracts for adapter implementations and external system integration.

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