DCB0129 and DCB0160 are NHS England standards for managing clinical risks associated with health IT systems.
- DCB0129 applies to organisations that develop or modify health IT systems. It requires the manufacturer to identify potential clinical hazards, introduce appropriate controls, maintain safety documentation and monitor the system throughout its lifecycle.
- DCB0160 applies to healthcare organisations deploying and using those systems. It requires the organisation to consider how the technology interacts with its staff, patients, procedures and local working environment.
These standards apply when software is used to support NHS patient care in England, including NHS dental treatment.
They do not normally apply where software is developed and used solely for private dental care, although NHS England recommends following them as good practice.
Deltaly’s current position
Deltaly is not currently claiming formal conformance with DCB0129.
Formal conformance requires an appropriately competent Clinical Safety Officer, a controlled clinical-risk management process and a substantial body of maintained documentation and evidence. Completing and maintaining this work carries significant specialist, administrative and financial costs for a small, early-stage service.
We nevertheless recognise the value of the standard and are working towards formal DCB0129 conformance as Deltaly develops.
How we currently manage clinical safety
Although our formal DCB0129 assurance work is not yet complete, clinical safety is already considered throughout Deltaly’s design and development.
Our existing measures include:
- maintaining a clinical hazard log;
- identifying how Deltaly could contribute to patient harm in normal use or if a feature fails;
- assessing the potential severity and likelihood of identified hazards;
- designing controls to reduce those risks;
- requiring clinicians to review information before it is added to a patient record;
- avoiding automatic clinical decisions or changes to clinical records;
- testing safety-relevant functionality and retaining supporting evidence;
- using referenced professional sources for prescribing information;
- reviewing the safety implications of new and modified features;
- providing visible failure states where Deltaly cannot complete an action reliably; and
- maintaining routes for users to report defects and safety concerns.
Deltaly supplements rather than replaces Dentally, professional judgement or a practice’s established clinical procedures. Users remain responsible for checking patient identity, reviewing information and deciding whether any content is clinically appropriate before relying on or recording it.
What this means for dental practices
Organisations providing NHS care in England are expected to consider the clinical safety of health IT systems under DCB0160. In practice, the formality and extent of this assessment vary considerably between organisations.
Practices should consider whether Deltaly is suitable for their intended use, ensure users understand its limitations and maintain appropriate training, procedures and clinical oversight. Deltaly supports rather than replaces Dentally, professional judgement or the practice’s established clinical processes.
Organisations operating a formal DCB0160 assurance process should include Deltaly within that assessment. We can provide our available clinical-safety information to support this, although Deltaly is not yet able to provide a formally approved DCB0129 Clinical Safety Case Report.
We will update this statement as our formal clinical-safety assurance work progresses. Practices requiring further safety information or wishing to report a clinical-safety concern can contact us by making a support ticket in Deltaly, or via our contact form.
Local clinical safety and deployment record
We provide an optional record to help dental practices consider and document the safe local use of Deltaly.
The record guides the practice through:
- the Deltaly functions it plans to use;
- who will use them and any role restrictions;
- the main clinical risks and existing safeguards;
- training, fallback and incident-reporting arrangements;
- any additional local controls; and
- the decision to approve, restrict or decline deployment.
It is written for dental teams and is intended to provide a practical, proportionate record rather than an extensive compliance exercise.
Where Deltaly is used to support NHS care in England, the record may contribute to the practice’s wider DCB0160 clinical-safety arrangements. It is not a complete DCB0160 assessment and does not replace DCB0129 manufacturer assurance or Clinical Safety Officer review where these are required.