What is the difference between DCB0129 and DCB0160?

DCB0129 is for the manufacturer of a health IT system and covers how it manages clinical risk while building and maintaining the product. DCB0160 is for the organisation that deploys and uses it, and covers the clinical risk of using that product in its own setting.

Does my private clinic legally need DCB0160?

The standards are mandated for NHS and publicly funded care in England, so a purely private clinic is not formally bound. CQC and NHS England guidance both expect DCB0160-style clinical risk management for AI tools, so most clinics benefit from doing a proportionate version. If you deliver NHS-funded care, take advice on whether it applies directly.

Who can be our clinical safety officer?

A senior clinician with current professional registration who has completed training in digital clinical safety. CQC's mythbuster 109 describes practitioner-level training. In a small clinic this is usually the clinical lead or owner.

What goes in a hazard log for an AI scribe?

Each way the tool could cause harm in your clinic, such as a mis-transcribed dose, fabricated content, an omitted safety-netting statement or a note attached to the wrong patient. For each hazard, record its likelihood and severity, the controls you rely on, and the residual risk.

What should we ask the AI vendor for?

Its DCB0129 clinical safety case report and hazard log, the name of its clinical safety officer, its medical device classification and MHRA registration where applicable, and how it tells customers about changes that could affect clinical safety.

Do we need to update our safety case when the product changes?

Yes. Review the hazard log whenever the vendor adds features or you change how you use the tool. NHS England's guidance notes that generative AI products may add functions over time, sometimes unintentionally.

DCB0129 and DCB0160 for Clinic AI: Clinical Safety Explained

Short answer

They are NHS clinical risk management standards for health IT, published under section 250 of the Health and Social Care Act 2012. DCB0129 applies to manufacturers, who must run clinical risk management and keep a safety case. DCB0160 applies to organisations deploying the system, who need a clinical safety officer, a hazard log and a safety case for local use.

Two halves of one chain

The standards are designed to work together. DCB0129 requires the manufacturer of a health IT system to run a clinical risk management process, appoint a clinical safety officer and keep a clinical safety case and hazard log for the product. DCB0160 requires the organisation deploying that system to do the same for its own use of it: assess the hazards in its setting, check the manufacturer complies with DCB0129, and document a safety case before go-live and as things change.

Do they apply to a private clinic?

The standards are mandated for health IT used in NHS and publicly funded care in England. A purely private clinic is not formally bound by them. In practice they are still the expected approach. CQC's GP mythbuster 109 tells GP services to procure AI against DCB0160 and keep a hazard log, and NHS England's ambient scribing guidance tells adopters to complete DCB0160 documentation. If an inspector, insurer or NHS partner asks how you assessed the clinical risk of an AI tool, a short DCB0160-style safety case is the clearest answer.

What DCB0160 looks like in a small clinic

A clinical safety officer: CQC describes a senior clinician with current professional registration and practitioner-level digital clinical safety training. In most small clinics this is the clinical lead.
The vendor's DCB0129 evidence: its clinical safety case report and hazard log, reviewed by your clinical safety officer.
Your hazard log: the ways the tool could harm a patient in your setting, how likely and severe each is, and what controls you rely on.
A clinical safety case report: a short document concluding whether the residual risk is acceptable, signed off before go-live.
Monitoring: incident reporting, periodic documentation audit, and a review when the product or your use of it changes.

Starter hazards for an AI scribe

Mis-transcribed drug name, dose or laterality reaches the record.
Content that was not said (a fabricated finding) appears in the draft.
A relevant negative or safety-netting advice is omitted.
A note is attached to the wrong patient.
The clinician approves the draft without reading it.
Performance is worse for some accents, dialects or interpreters.
The service is unavailable mid-clinic.

The main control for most of these is the same: a clinician reviews and edits every draft before it is filed. Others need specific mitigations, such as a fallback to typing or dictation during outages and audit of a sample of notes against the audio. NHS England's guidance also warns that generative AI products may add functions over time, so review the hazard log when the vendor ships new features.

Medical device status

Whether an AI tool is a medical device depends on the manufacturer's stated intended purpose. NHS England's guidance asks adopters to confirm the product has been correctly assessed and, where applicable, registered with the MHRA. Ask the vendor for its classification and registration evidence.

What Motics does

Motics Scribe Agent is a Class I medical device under UK MDR.
Our clinical safety documentation, including our DCB 0129 clinical safety case, is available on request for your clinical safety officer to review.
Motics has been assessed against DTAC, which includes clinical safety. Evidence is on our Trust Centre.
Scribe Agent produces draft outputs for clinician review. It does not autonomously diagnose, recommend treatment or make clinical decisions, and every output needs clinician approval before use.

Full detail on our security and compliance page and the Trust Centre. Ask any vendor, including us, to put these answers in writing.

Primary sources

Practical orientation for UK clinics, not legal advice. For your own circumstances, take advice from your data protection officer, indemnity provider or a solicitor.

What are DCB0129 and DCB0160, and do they apply to my clinic?