DCB0129 clinical safety for health IT manufacturers

If you build software that will be used in NHS or social care settings, DCB0129 applies to you. We help manufacturers put a proportionate clinical risk management system in place, produce the evidence NHS buyers ask for, and keep it current as the product changes.

What is DCB0129?

DCB0129 (Clinical Risk Management: its Application in the Manufacture of Health IT Systems) is an information standard published under section 250 of the Health and Social Care Act 2012. It requires manufacturers of health IT systems to identify, assess and control the clinical hazards their product could introduce, and to evidence that work in a structured way. Its partner standard, DCB0160, applies to the organisations that deploy and use your product.

Most NHS buyers will not progress a procurement, a DTAC assessment or a go-live without DCB0129 evidence. It is usually the first thing a deploying organisation's Clinical Safety Officer asks for.

Who needs it?

  • Start-ups and scale-ups selling software into the NHS, GP practices, pharmacies or social care

  • AI and ambient voice tools, triage and booking platforms, EPR add-ons, remote monitoring and patient-facing apps

  • Established suppliers whose safety case is out of date or no longer reflects the product

What DCB0129 requires

  • A named Clinical Safety Officer (CSO): a suitably qualified and experienced registered clinician who takes responsibility for clinical safety

  • A Clinical Risk Management System and Clinical Risk Management Plan (CRMP)

  • A Hazard Log recording hazards, causes, controls and residual risk

  • A Clinical Safety Case Report (CSCR) setting out the argument and evidence that the product is acceptably safe for release

  • Ongoing management of change, incidents and new releases

How we help

  • Gap analysis of your existing documentation against DCB0129

  • A Clinical Risk Management Plan tailored to your product and team size

  • Facilitated hazard workshops with your product and engineering teams

  • Hazard Log creation and review, including AI-specific hazards

  • Clinical Safety Case Report and release sign-off by our CSO

  • Change and release reviews built into agile delivery, so safety keeps pace with your sprints

  • Support answering DCB0129 and DCB0160 questions from NHS buyers

Why work with us

Our lead CSO, Dr Yasmin Karsan PhD FRPharmS, is a pharmacist and independent prescriber who has supported more than 40 health tech organisations with clinical safety. We work as part of your team, write documentation that reflects how your product actually works, and keep it proportionate to your risk.

A note on the national review

NHS England is reviewing DCB0129 and DCB0160 to reflect agile development, AI and cross-organisation data sharing. Until revised versions are published, the current standards are the ones to comply with. We are following the review closely and will help you adapt when changes land.

Book a free 15-minute call to talk through where you are with DCB0129.