Practical DCB0129 Support from Experienced Consultants

Yes. NHS suppliers of all sizes may be required to demonstrate DCB0129 compliance, though the approach should be proportionate.

DCB0129 is a mandated NHS information standard and is commonly required as part of NHS procurement and assurance processes.

Yes. DCB0129 requires a named CSO with appropriate competence and authority. We can provide that as part of any DCB0129 package.

DCB0129 compliance is not a one-off exercise. It must be maintained for as long as the system is deployed, with reviews triggered by functionality changes, updates, incidents and new deployments. To confirm whether your product needs to comply in the first place, NHS England provides a flowchart here, and we can give expert advice on navigating it where the answer is still unclear.

We pride ourselves in working with SMEs and startups through to some of the largest companies in the world for this standard. We can support any company size with any product at any stage of development.

Yes - in fact, outsourcing DCB0129 and the Clinical Safety Officer role is the most common way of working for health IT suppliers, and frequently the most efficient way to fulfil the standard.

If you are still potentially impacting on patient care, then the answer is yes. Frequently, deploying organisations will ask for evidence of DCB0129 before even starting a pilot or proof-of-concept study now.

Broadly speaking, yes. If you are connecting to central NHS systems (IM1, PDS, EPS), then not only will you need to complete DCB0129 for your product, but you may also need to complete a specific hazard log provided by the NHS for that integration and return it in a specific format. Very few people understand this requirement but it can delay connectivity significantly.

We always aim to include DCB0129 as early in the software development life cycle process as possible. This ensures maximal stakeholder engagement and sets up the process of ongoing compliance in the organisation.

Deploying organisations or regulators will generally look at whether the documentation provided has fulfilled all of the requirements of the standards. Having done this for over 100 products and taken clients through every local or national onboarding scheme, we know how best to structure and present documents for easier procurements.

This depends on the complexity and number of products but generally for a simple one-product company, the initial paperwork can be created within a 3-month period. However, if there is a pressing procurement requirement, we may be able to expedite that timeline.

Broadly speaking, yes. We always say that at the least all major and minor releases and associated testing reports should be reviewed by the CSO prior to go-live. Any incident that may impact on patient care should also be escalated for review too.

Yes, and this is frequently the most common way for health IT companies to fulfil the standard.

The honest answer is: very variably. We have seen hugely disparate ways of assessing DCB0129 documentation, and it really operates on a case-by-case basis. That said, having managed over 100 products to date in this area, we have seen almost every type of organisation response and are well equipped to respond accordingly.