Governance England
DCB0129 and DCB0160: what pharmacy operators need to know
Clinical safety depends on both the software and the way it is used. These related standards help separate the manufacturer's work from the deploying organisation's responsibilities.
Start with scope and responsibility
DCB0129 addresses clinical risk management by health IT manufacturers. DCB0160 addresses the organisations deploying and using those systems. NHS England publishes applicability guidance, which should inform the assessment of the particular system and service.
Avoid reducing this to a claim that a supplier 'holds DCB0129' and the pharmacy 'holds DCB0160'. The standards describe processes and evidence across a system's life. The useful procurement question is what work has been completed, for which release and intended use, and what the deploying organisation still needs to do.
Ask for the manufacturer's evidence
The DCB0129 specification describes clinical-risk management arrangements, a Clinical Safety Officer, hazard documentation and a clinical safety case report. Ask how those documents relate to the version offered to your pharmacy and which residual risks or operating constraints need local action.
A useful supplier discussion might take one risk, such as selecting the wrong patient record, and follow it through the evidence. What contributes to it? Which controls are built into the product? What must the pharmacy do? What testing or other evidence supports the conclusion? You are asking for an understandable chain of reasoning, not a claim that risk has disappeared.
Assess the system in your own pharmacy
Local assessment should consider the people, room, devices, records and service arrangements around the software. A control that works in the supplier's example may not work in a busy shared consultation room. Identify differences and agree who will address them before accepting the remaining risk.
For a remote service, use realistic scenarios: an interrupted consultation, an unavailable clinical record, a staff member leaving mid-session or an escalation needing immediate local action. These examples are prompts for your assessment, not a complete hazard list. Include the clinical and operational staff who will manage those situations.
Keep supplier and local work connected
The manufacturer's material is an input to deployment assurance, not a substitute for it. Ask for the current evidence early enough that unanswered questions can change the procurement or implementation plan. If evidence is incomplete, record the gap explicitly and have the accountable clinical-safety lead decide its consequence.
The pharmacy should know which assumptions its local arrangements depend on. If a supplier says a risk is controlled through training, confirm that the relevant training exists, reaches the right people and is usable during the work. If the control depends on another system, check the handover and failure path rather than assessing each screen separately.
Review changes and the end of the service
Agree triggers for review: a new pathway, different staffing arrangement, software release, integration change or significant incident. Name who receives change notices and who decides whether existing procedures or training need updating. Keep versions and approval dates visible so people can tell which evidence remains applicable.
Also plan what happens when the service is withdrawn or replaced. Decide how ongoing patient actions are handed over, how records remain accessible and how accounts and devices are retired. Deployment safety includes these transitions; it should not finish with the first successful consultation.
Read current status precisely
NHS England's standards pages state that DCB0129 and DCB0160 are under review. That notice is not a replacement standard or permission to ignore the currently published requirements. Check the official pages when assessing a new deployment or a material change.
Remote Pharmacist's published assurance page describes its DCB0129 work as in progress. Ask for the current evidence and outstanding actions when evaluating the product. This article explains the framework; it is not a claim of completed assurance, clinical approval or a completed DCB0160 assessment for your pharmacy.
Frequently asked questions
Does the supplier's safety case complete our assessment?
No. It provides essential input, but the deploying organisation must assess its intended use and local arrangements where the standard applies.
Are these one-off certificates?
No. They concern clinical risk management and supporting evidence through the relevant stages of the system's life, including change.
Sources & further reading
Checked against the following sources on 1 October 2026. Service rules and payments can change; use the current specification and Drug Tariff when making decisions.
- NHS England: DCB0129 manufacturer clinical risk standard
- NHS England: DCB0160 deployment and use clinical risk standard
- NHS England: DCB0129 specification (PDF)
- NHS England: determining the applicability of DCB0129 and DCB0160
This is business and service-planning information. It does not assess an individual patient, authorise a delivery model or replace local clinical and contractual decisions. Source checking is not a claim of independent clinical review.
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