Options appraisal, business case and both NHS clinical safety standards in one continuous record. For the teams who build digital health software, and the organisations that deploy it.
Write the criteria before you see the options, score the candidates against the same ones, and model the do-nothing baseline properly so the cost of inaction is on the record rather than assumed. Options you reject keep their reasoning, which is exactly what a commissioner or an auditor asks for eighteen months later.
Work out what the change does to workforce and finances at steady state, including the work it moves rather than removes - a tool that clears the front door faster usually pushes the queue further down the pathway. The benefits claimed here are the ones your intended use and your clinical risk benefit analysis will rest on later, so they are stated once and inherited.
A 208-question guided scope driven by your intended use, AI-seeded hazard workshops, 5×5 scoring with pre- and post-control positions, controls linked to the evidence that they were actually implemented, ALARP and CRBA where they trigger, and a named Clinical Safety Officer signing every judgement. Both standards run on the same record, so neither side rebuilds the other's work.
The safety case is frozen, versioned and timestamped at hand-over and gated on a compliance check, so an incomplete file cannot cross and both sides hold the same artefact rather than two that quietly diverge. After go-live, a new release or a changed pathway re-opens the assessment instead of escaping it.
A short daily email - 5 minutes a day for 14 days - covering everything a manufacturer or NHS deployer needs to know to navigate DCB0129 and DCB0160 with confidence.
Most organisations appraise digital options in a spreadsheet somebody built once and a business case template somebody else wrote, then open a hazard log weeks later. By that point the choice has already been made, somewhere nobody can trace.
Nobody can reconstruct why this product was chosen over the two that were rejected, or what those rejected options would have cost.
A product that clears the front door faster moves the queue further down the pathway, unless somebody modelled that before go-live. Hazards, meanwhile, sit in a spreadsheet drifting from the real product.
The safety case cites an intended use that lives in a business case the platform has never seen, and the DCB0129 work never translates into the deployer's DCB0160 case. Two versions of the truth, one of them stale.
Each stage inherits everything the stage before it decided. Nothing is re-typed, and nothing is asserted twice.
Frame the operational or clinical problem, compare the candidate solutions including doing nothing, model the workforce and financial position once the change has stabilised, and produce a business case an executive team can act on.
Turn the chosen solution into a defensible clinical safety case under DCB0129 and DCB0160, with a 208-question guided scope, AI-seeded hazard workshops, 5×5 risk scoring, controls, CRBA and ALARP - and a named Clinical Safety Officer signing every judgement.
Freeze the evidence, hand it across on a gated and versioned handshake, map the clinical pathway and interfaces it lands in, and keep the safety case live so a new release or a changed pathway re-opens the assessment rather than escaping it.
Trygg.Health turns options appraisal, business case development and the two NHS clinical safety standards into a single guided workflow your whole team can run. Problem, options, benefits, hazards, controls, ALARP, CRBA, documents - all in one place, all linked, all auditable.
Trygg.Health understands the full lifecycle - from the manufacturer building software, to the organisation appraising it and putting it into a live clinical pathway. We have done it, from both sides.
For health tech founders, regulatory leads and clinical safety officers building digital health products that need to land in the NHS.
For NHS Trusts, ICBs and independent providers appraising digital options and responsible for deploying third-party products into a live clinical pathway.
Each step builds on the last. No retyping, no re-versioning Word documents, and no "where's the latest hazard log?" messages.
Start from the operational or clinical problem, not from the product a supplier is selling.
Compare the candidates, including doing nothing, and model the workforce and financial impact.
A structured case generated from the appraisal, ready for an executive team to act on.
208 questions with conditional logic, then a hazard workshop with AI suggestions and 5×5 scoring.
Generate the documents, gate the safety statement at 100%, then a versioned handshake into deployment.
Eleven modules built for the realities of running clinical safety inside a fast-moving health tech team.
Manufacturer, CSO, Deployment CSO and Superuser - each with the right level of access.
Two parallel paths for DCB0129 (dev) and DCB0160 (deployment) with shared lifecycle phases.
208 questions with auto-save, conditional logic and per-component sub-questions.
Workshop prep, AI suggestions, identification, scoring, controls and residual risk - all in one place.
Colour-coded clinical risk visualisation - green, amber, red - for severity × likelihood.
Clinical Risk Benefit Analysis and "As Low As Reasonably Practicable" assessments - only when needed.
CRMP, Hazard Log, Workshop Reports and Safety Case as PDF, Word and Excel - versioned.
10-item checklist gates the safety statement until 100% - no surprises at sign-off.
5-point eligibility check, then a versioned, frozen artefact handed to the deployer.
Assign team members to products with roles. UI alerts when no one is set for a workshop.
Clinical pathways, system interfaces and IT infrastructure - granular CRUD for the real world.
Built-in feedback and contact loops so issues never disappear into a support inbox.
Trygg.Health uses AI to pattern-match against a curated hazard library, draft your intended-use statement, and flag safety-critical features in your questionnaire answers - so your workshop starts at "review and refine," not "blank page."
Clinical judgement stays with your CSO. AI just stops you missing the obvious.
Try the AI workflowGenerate the documents directly from your live data. No re-typing. No version drift. Re-export any time the product changes.
Your CRMP - the spine of your safety case. Personnel, scope and methodology, exported on demand.
Every hazard, control, residual risk and ALARP statement - straight to Excel for review.
Workshop attendees, decisions, scoring rationale and outputs - ready to circulate.
The headline DCB0129 / DCB0160 deliverable - current with the latest product version.
Executive-friendly summary, gated by a 100% compliance check before it becomes available.
Conditional outputs - only generated when residual risk requires them.
Clinical pathways, interfaces and IT infrastructure mapped for DCB0160 deployers.
Versioned, frozen package handed from manufacturer to NHS deployer - auditable end-to-end.
Clinical safety data is sensitive. Trygg.Health is built with the assumption that the wrong person should never see, edit or delete it.
Every login requires a fresh email-verified 6-digit code. No exceptions, no opt-out.
Every database query is scoped to the owning user. Superuser access is logged and limited.
Account deletion cascades cleanly across 31 tables in a single transaction - no orphan data.
Every deployment package is frozen and timestamped - re-issue cleanly when the product evolves.
A free tier to test the workflow on a single product, one paid tier that includes everything, and a named Clinical Safety Officer on tap if you would rather not appoint one internally.
Test-drive the scoping questionnaire and hazard workflow on a single product.
Every stage and both standards, for one price. £8,100 paid annually, a 10% discount.
Everything in Access, plus a Named Clinical Safety Officer to facilitate workshops and sign off your safety case.
Trygg Health was founded by clinicians who have built and deployed digital health software inside the NHS. We made the platform we wished we'd had.
Driven by a passion for digital innovation and clinical safety, Luke co-founded Trygg Health with Simon. Over 15 years in healthcare and HealthTech, with strategic leadership at C-suite and board level steering Trygg from a strategy perspective.
Luke excels at transforming healthcare ideas into market-ready solutions and scaling them for broad impact, forging partnerships with NHS commissioners, patients, elite sports, and corporate stakeholders.
Over the past five years, Simon has designed and deployed software for the NHS, meeting clinical safety standards and streamlining care pathways. He balances pragmatic development with complex regulatory demands across the full software lifecycle.
His expertise covers Clinical Safety Officer duties, DCB0129, DCB0160, Software as a Medical Device, and quality/risk management systems (ISO 13485, ISO 14971). Nearly 30 years in clinical practice and 13 years in leadership across radiology, medicines management and surgical pathways.
Yes, and that is the part most tools skip. Before any hazard log is opened you can frame the problem you are actually solving, appraise the candidate solutions against it including the option of doing nothing, model the workforce and financial position once the change has stabilised, and generate a business case from that appraisal. Because it lives in the same record that later carries the safety case, the intended use and the benefits claimed are stated once rather than asserted twice in two documents that drift apart.
A product that clears the front door faster often just moves the queue further down the pathway, and infrastructure cost that falls out of one budget has to be reinvested somewhere. If those consequences are modelled before go-live, finance and operations are given a decision rather than a request to fund an experiment, which is usually the difference between a business case that moves and one that stalls for a quarter.
DCB0129 is the NHS clinical safety standard for manufacturers of health IT software. If you build digital health software intended to be deployed in the NHS, you need a clinical risk management process - including a Clinical Safety Officer, a hazard log, and a Clinical Safety Case Report - that conforms to it. Trygg.Health implements that process end-to-end.
DCB0160 is the matching standard for the deploying organisation - typically an NHS Trust or ICB. It governs how the deploying CSO assures safe deployment of a third-party product into a specific clinical pathway and IT environment. Our deployment handshake makes the manufacturer-to-deployer transition seamless.
Yes - both DCB0129 and DCB0160 require a named CSO, and they must be a registered healthcare professional. If you don't have one in-house, our CSO-as-a-Service tier provides a Named CSO from Trygg.Health to facilitate workshops and sign off your safety case.
Most teams move from sign-up to a draft Clinical Safety Case Report in 1-3 weeks, depending on product complexity. The 208-question scope, AI hazard suggestions and auto-generated documents collapse the work that traditionally takes 2-6 months.
Yes. You can paste your intended-use statement, upload your existing hazard log, and use Trygg.Health to keep it living from that point forward. Existing artefacts can be referenced in the document repository.
Data is stored in PostgreSQL (Neon) with per-user isolation enforced at the query layer. Every login requires email-verified 2FA. We do not share your data with any third party except where you explicitly trigger it (e.g. AI hazard suggestions through OpenAI).
No. The AI suggests hazards and drafts language. Your Clinical Safety Officer always reviews, scores and signs off. AI proposes, the clinical team reviews, the CSO decides, and your organisation signs off.
No, and any supplier telling you otherwise is worth a second look. The platform structures the work, seeds hazard suggestions, scores and versions every record, generates the documents, and stops a safety statement being issued before the mandatory items are complete. Clinical judgement, the named Clinical Safety Officer's sign-off, the decision on whether residual risk is acceptable, and organisational accountability for what gets deployed all remain with you.
Start free on a single product, or talk to us about Access for your organisation.
