Boundary Risk Assessment for Clinical Safety Officers
Extending DCB 0129 & DCB 0160 clinical safety assurance to the boundaries between organisations.
The Compliance Gap in DCB 0129 & DCB 0160 Clinical Safety Cases
A boundary-specific clinical risk is a risk that arises when clinical data, intent, or responsibility degrades during transmission between two distinct healthcare organisations' IT systems or governance frameworks. These risks are not captured by DCB 0129 or DCB 0160 because neither standard addresses inter-organisational boundaries.
DCB 0129 requires manufacturers to maintain clinical safety cases. DCB 0160 requires deploying organisations to maintain their own. Both standards are robust within their scope — a single organisation's deployment context.
But your health IT doesn't operate within a single organisation. It sends data to GP practices. It receives referrals from NHS Trusts. It routes patients across provider boundaries. It shares results with diagnostics partners. At every one of these boundaries, clinical risks arise that neither your safety case nor the other organisation's safety case addresses.
These are boundary-specific risks: translation failures between systems, identity verification that doesn't propagate, clinical intent that degrades in transmission, alerts that are high-priority in your system but enter a general workflow queue in the receiving system, responsibility that is relinquished before it is accepted.
You carry personal liability for clinical safety assurance. The risks at your boundaries are real, they affect patients, and they fall within your professional accountability. But no existing methodology gives you a structured way to identify, assess, evidence, and log them.
That's what the Boundary Risk Assessment provides.
Clinical Governance Deliverables for Your Hazard Log
Boundary-specific risk identification
For each of your organisational boundaries, we identify the clinical risks that arise specifically from the crossing. These aren't the same as risks within your system. They're the risks of transmission, translation, and transfer that manifest only at the boundary.
Evidence from both sides
We interview stakeholders on both sides of every boundary. If your team claims a process exists but the receiving organisation is unaware of it, we flag it. The lower assessment prevails. This cross-organisation reconciliation provides evidence you cannot generate unilaterally.
Statutory traceability
Every finding maps to a specific obligation: DCB 0160, CQC Regulation 12, CQC Regulation 17, UK GDPR Article 6, PSIRF principles. Findings are formatted for direct adoption into your hazard log.
Cascade-adjusted scoring
The scorecard shows both raw and cascade-adjusted scores. You see which flow failures structurally undermine other flows — information that no internal review produces.
MVRT compliance assessment
Every boundary is assessed for Minimum Viable Responsibility Transfer. Can your system demonstrate explicit, bilateral handover? If not, that's a hazard log entry with a specific mitigation path.
Assessment Scope and CSO Liability
The assessment evaluates governance control maturity at your boundaries. It does not certify clinical safety outcomes. It does not transfer your statutory responsibility. It does not replace your clinical safety case — it extends it to boundaries that your current case does not cover.
Your liability as CSO remains unchanged. What changes is your ability to evidence that boundary-specific risks have been identified, assessed, and managed — which is precisely what a regulator or coroner would expect to see.
Frequently Asked Questions for CSOs
No. The assessment does not replace your clinical safety case — it extends it to boundaries that your current case does not cover. Your CSO liability remains unchanged. What changes is your ability to evidence that boundary-specific risks have been identified, assessed, and managed — which is precisely what a regulator or coroner would expect to see.
Every finding maps to a specific statutory obligation: DCB 0160, CQC Regulation 12, CQC Regulation 17, UK GDPR Article 6, and PSIRF principles. Findings are formatted for direct adoption into your hazard log with statutory traceability, so you can demonstrate to regulators that boundary-specific risks have been formally assessed.
No. The assessment is based on structured interviews, document review, and observed processes. We assess governance control maturity at boundaries — the processes, documentation, and organisational arrangements that govern how data and responsibility cross between organisations. We do not require access to clinical systems, patient records, or live data.
