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Command: /arckit:uk-nhs-dcb0160 | Overlay: UK NHS Clinical Safety Overlay | Origin: Community-contributed

Purpose

Generates the deployer-side clinical safety documentation required under NHS DCB0160 for an NHS organisation (Trust, ICS, GP federation, mental health Trust, ambulance service) deploying or significantly configuring a health IT product into a specific clinical setting.

DCB0160 sits alongside DCB0129 — neither replaces the other. The manufacturer's DCB0129 case argues the product is acceptably safe when used as intended; the deployer's DCB0160 case argues that this specific deployment, with this organisation's clinicians, workflows, integrations, training, and business continuity, is acceptably safe in this clinical context.

What it produces

Three files in projects/{NNN}-<slug>/clinical-safety/deployment/, following the same Marcus Baw SAFETY.md spec adapted for deployer use:

File Purpose
SAFETY.md Deployer anchor: product, version-being-deployed, deploying organisation, deploying-organisation CSO, link to manufacturer case
DEPLOYMENT-SAFETY-CASE.md 7 sections: Deployment Context, Scope + Phasing, Manufacturer Case Acceptance, Deployment Safety Argument (G1.1–G1.6 with deployment-specific claims), Local Evidence, Residual Deployment Risk, Deploying-organisation CSO Sign-off
DEPLOYMENT-HAZARD-LOG.md YAML-frontmatter hazard array + controls + rendered Markdown table. 10 starter deployment hazards: inadequate training, workflow integration gap, integration failure, BC failure, parallel-running confusion, data migration error, local configuration error, terminology mismatch, RBAC misalignment, incident-reporting failure

When to use

  • An NHS organisation is deploying any third-party or in-house health IT product into a clinical setting
  • A deployment involves material local configuration (drug formularies, alert thresholds, role mappings, terminology subsets)
  • A deployment involves significant change to existing clinical workflows
  • Multi-site deployments with material differences in clinical context — run once per site with separate clinical-safety/deployment/{site-slug}/ subdirectories

Prerequisites

Requires the project's REQ, DATA, STKE artefacts. If the project also has the manufacturer DCB0129 case (clinical-safety/SAFETY-CASE.md and clinical-safety/HAZARD-LOG.md), the deployer case directly references those as inputs. If the product is third-party (no in-repo manufacturer case), the manufacturer's externally-supplied case should be linked or attached as a reference.

A named, qualified Clinical Safety Officer at the deploying organisation (NOT the product manufacturer's CSO) MUST be appointed to sign off the deployment case.

Deploying-organisation roles

The template prompts for several NHS-specific governance roles:

  • CSO at the deploying organisation (GMC / NMC / HCPC / GPhC registered)
  • Caldicott Guardian sign-off (information governance)
  • Senior Information Risk Owner (SIRO) sign-off
  • Local Implementation Lead and Executive Sponsor at the deploying organisation

Deployment-specific hazard themes

Beyond the starter set, common deployment-specific hazards to consider in real projects:

  • Paediatric vs adult dosing if the local service treats paediatrics — the manufacturer's adult-defaults are a deployment hazard
  • Mental Health Act considerations if the local service is MH
  • Out-of-hours coverage and on-call workflows
  • Interface engine + integration with local PAS / EPR / order-comms / results
  • Local Caldicott / IG positions on data flows the manufacturer assumed were acceptable

Important

The deployment safety case is a legal obligation of the deploying NHS organisation under DCB0160. A complete DCB0129 manufacturer case does not discharge this obligation.

  • /arckit:uk-nhs-dcb0129 — manufacturer-side companion (run first or attach external)
  • /arckit:uk-nhs-dtac — DTAC Section 1 may need the deployer case if the deploying NHS organisation is responsible for procurement assurance
  • /arckit:risk — deployment-specific risks cross-reference the project risk register
  • /arckit:operationalize — builds the runbooks, on-call and incident-response procedures that carry out the deployment hazard controls (manual fallback, interface monitoring, local incident reporting)