SafeDeploy
DCB0129 and DCB0160, without the spreadsheet archaeology
DCB0129 requires any manufacturer of health IT to appoint a Clinical Safety Officer and maintain a Clinical Risk Management Plan, a Hazard Log and a Clinical Safety Case Report — reissued for every significant release. DCB0160 places matching duties on the organisation deploying that software.
Both are mandatory under section 250 of the Health and Social Care Act 2012, and both apply whether or not your product is a medical device. SafeDeploy generates and maintains those artefacts, and keeps them current as your product changes.
Who this is for
Three groups carry clinical risk management duties in NHS primary care: the practices deploying software, and the suppliers building it. SafeDeploy serves all three from the same hazard log.
GP practices and PCNs
GP practices and Primary Care Networks deploying clinical systems, AI scribes and patient-facing tools carry DCB0160 duties that arrived with the software. SafeDeploy builds the deployment-side hazard log, clinical risk management plan and safety case your organisation needs to hold those duties properly.
Link straight here: simplify-hcs.com/safedeploy#gp-practices
Dental practices and groups
Dental practices are in exactly the same position as GP practices, with no supplier currently offering them clinical safety at all. The DCB0160 duty applies to a dental practice deploying clinical software in NHS care the same way it applies to a GP practice.
Link straight here: simplify-hcs.com/safedeploy#dental-practices
Primary care software suppliers
Suppliers need a DCB0129 safety case to sell into the NHS, and their customers then need a DCB0160 pack to deploy it. SafeDeploy produces both from one hazard log, so the evidence you give a customer is generated from the evidence you already maintain.
Link straight here: simplify-hcs.com/safedeploy#suppliers
What it does
SafeDeploy holds one hazard log per product and generates every downstream artefact from it. The plan, the safety case and the deployment pack are outputs of the log, not separate documents to keep in step by hand.
Structured hazard log
Organised by product feature, with causes, controls and residual risk recorded against each hazard.
Plan and safety case, generated
Clinical Risk Management Plan and Clinical Safety Case Report generated from that log and versioned per release.
Change tracking
Flags which hazards a release affects, so a reissue is a review of what changed rather than a rewrite.
Deployment packs
Turns your DCB0129 evidence into the DCB0160 documentation your customer needs to deploy.
Clinical Safety Officer review
Review by a registered clinician. Every entry is approved by a named Clinical Safety Officer before it is filed.
Where AI does the work
Hazard identification is the slowest part of clinical risk management and the part most often done badly. SafeDeploy proposes candidate hazards, causes and controls for a Clinical Safety Officer to review, edit and approve.
SafeDeploy reads your product’s functional description and release notes — or, for a practice, your supplier’s safety case and your own deployment context — and proposes candidate hazards, causes and controls, mapped to the relevant standard.
What we’re not
Talk to our Clinical Safety Officer
A registered clinician will walk through your deployment or your product and tell you what DCB0129 or DCB0160 actually requires of you.