We build our own clinical software, so we apply DCB0129, the NHS clinical risk management standard for health IT manufacturers. Our Clinical Safety Officer leads this work, including product hazard logs and clinical safety case documentation. We share this documentation with practices to support their own DCB0160 responsibilities.
For us, DCB0129 is part of how we design, maintain and review software used in clinical pharmacy work, every time that software changes.
What DCB0129 is, and who it applies to
DCB0129 is the NHS clinical safety standard that applies to manufacturers of health IT systems. NHS England describes it as setting clinical risk management requirements for those manufacturers, while the related DCB0160 standard applies to the health organisation deploying and using the system locally.
That distinction matters. A supplier cannot leave clinical safety entirely to the GP practice, PCN or NHS organisation using the product. If a system is built to support clinical work, the manufacturer has a responsibility to identify hazards, assess clinical risk, put controls in place and keep that evidence up to date.
How we manage clinical risk
At Virtual Pharmacist, our DCB0129 process covers the software we develop and maintain for clinical pharmacy services, including the systems used to support workflow, audit, medicines-related activity and clinical review.
Our approach includes a named Clinical Safety Officer, documented clinical risk management processes, product hazard logs, safety case reporting and review of clinical risk when changes are made. These documents are maintained as live records rather than filed away after release.
The aim is straightforward: when our systems are used in care settings, the clinical risks linked to the software have been considered, documented and controlled as far as reasonably practicable.
DCB0129 and DCB0160: a shared responsibility
DCB0129 does not remove the need for local clinical safety work by the organisation deploying the system. NHS organisations still need to consider their own use case, local processes, staff training, configuration and responsibilities under DCB0160. NHS England describes DCB0160 as requiring a health organisation to establish a framework for managing clinical risks associated with deploying and using a new or modified health IT system.
For that reason, we make our clinical safety documentation available to NHS customers and assurance teams where required. This supports procurement, deployment, DTAC review and local governance.
Where DCB0129 fits in NHS digital assurance
DCB0129 also sits within the wider NHS assurance picture for digital health products. NHS England’s DTAC guidance explains that DTAC brings together standards and policies that digital health products must meet to be used in the NHS, and it references DCB0129 and DCB0160 as standards that help manage clinical risks in health IT systems.
Clinical safety and the pharmacy mindset
Clinical safety is already familiar territory for pharmacy teams. Pharmacists are used to spotting risk, checking assumptions, reviewing medicines and escalating concerns. DCB0129 gives that same discipline a structured home in software development.
For Virtual Pharmacist, compliance means that clinical safety is considered when a feature is designed, when it is changed, when feedback is received and when incidents or near misses are reviewed. It means hazards are logged. It means mitigations are recorded. It means decisions are traceable.
Most importantly, it means our customers can ask a simple question, “How have you assessed the clinical safety of this system?” and receive a clear answer backed by evidence.
Keeping the safety case current
We will continue to review and maintain our DCB0129 documentation as our systems develop. Clinical pharmacy, digital tools and NHS requirements will keep changing. Our responsibility is to make sure the safety case keeps pace with the product.
Our clinical governance and data security page sets out how this fits our wider assurance framework. For customers or NHS assurance teams who need more information, Virtual Pharmacist will send its DCB0129 clinical safety documentation to your IG or assurance lead for procurement, DTAC review or your own DCB0160 work. Contact us to request it.
