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Command: /arckit:uk-nhs-dcb0129 | Overlay: UK NHS Clinical Safety Overlay | Origin: Community-contributed

Purpose

Generates the manufacturer-side clinical safety documentation required under NHS DCB0129 for any health IT product being placed on the NHS market. NHS DCB0129 is mandated under the Health and Social Care Act 2012 s250 and applies to any health IT system deployed in the NHS, regardless of whether the product is also a medical device.

The output is a 3-file set that follows Dr Marcus Baw's SAFETY.md spec v2.0.0-draft verbatim — chosen so the documents remain readable by clinicians, NHS England assessors, MHRA inspectors, and Notified Body reviewers without ArcKit-specific tooling.

What it produces

Three files in projects/{NNN}-<slug>/clinical-safety/:

File Purpose
SAFETY.md Front-door anchor: required Marcus-spec fields (product-name, version, standard, CSO, organisation, status, hazard-log-url, last-reviewed) + ArcKit Document Control + Summary
SAFETY-CASE.md Clinical Safety Case Report with 6 GSN-inspired sections: Intended Use, Scope, Safety Argument (G1.1–G1.6 cross-referencing hazards), Evidence, Residual Risk, CSO Sign-off
HAZARD-LOG.md YAML-frontmatter hazard array + controls + rendered Markdown table. 6 starter hazards: wrong-patient identity, stale clinical data, audit-trail gap, authorisation bypass, alert delivery failure, write-integrity loss

The 3 files together implement the four DCB0129 deliverables — Clinical Risk Management Plan (summarised in SAFETY.md), Hazard Log, Clinical Safety Case Report, and Clinical Risk Management File (the repository itself; Git history is the audit trail).

Risk scoring scales (DCB0129 convention)

  • Severity: 1 Catastrophic | 2 Major | 3 Considerable | 4 Significant | 5 Minor
  • Likelihood: 1 Very High | 2 High | 3 Medium | 4 Low | 5 Very Low
  • Risk level: unacceptable | high | medium | low
  • Status: open | mitigated | accepted | closed

⚠️ Numbering note (ArcKit encoding, not DCB0129). ArcKit numbers the DCB0129 labels 1 (worst) to 5 (least) purely to store them. DCB0129 itself puts no numbers on the severity/likelihood axes - they are word-labelled; the only numbers in the standard are the Risk Class cells (1-5, where 5 = unacceptable/highest, the conventional direction). So these ordinals run opposite to both the usual risk-register convention and DCB0129's own risk classes. The templates carry this legend prominently.

When to use

  • The system will be deployed in NHS England, Scotland, Wales, or NI as a manufacturer-supplied product
  • The system is software intended to support, inform, or perform clinical functions (decision support, observation capture, prescribing, results display, scheduling for clinical purposes, identity / demographics, etc.)
  • Compare with DCB0160 for deployer-side obligations at the deploying NHS organisation

Prerequisites

Requires the project's REQ, DATA and STKE artefacts. Will read the project's RISK register if present (to cross-reference project risks and clinical hazards) and its DPIA if present (privacy hazards may overlap with clinical hazards).

A named, qualified Clinical Safety Officer (CSO) with current GMC / NMC / HCPC / GPhC registration MUST be appointed to sign off the case. The command generates the documents in DRAFT status with the CSO field left as [PENDING].

Tiering (Marcus's SAFETY.md spec)

  • Tier 1 (low-risk reference / informational): the CSO may consolidate to a single SAFETY.md with embedded hazard table and delete the case + log files
  • Tier 2 (moderate-risk; the command's default output)
  • Tier 3 (SaMD; high-risk regulated medical devices): additionally author a SAFETY-PLAN.md

Filename convention

The three filenames deliberately do not carry the ArcKit ARC- prefix. They pass through the validate-arc-filename hook untouched and do not appear in the ArcKit manifest as discrete ARC artefacts. Other documents (DTAC, MDR, project risk register) cross-reference them by relative path.

Important

This guide and the command's output are not clinical, legal, or regulatory advice. The Clinical Safety Case Report MUST be reviewed, materially supplemented, and signed off by a qualified CSO before the product is placed into clinical use.

  • /arckit:uk-nhs-dcb0160 — deployer-side companion (DCB0160)
  • /arckit:uk-nhs-dtac — NHS DTAC v3 (consumes the SAFETY-CASE.md content in Section 1)
  • /arckit:uk-mdr-classification — if the product is also a medical device, DCB0129 hazards feed the ISO 14971 risk file
  • /arckit:risk — project-level risk register cross-references clinical hazards
  • /arckit:dpia — privacy hazards may overlap with clinical hazards