Written by Technical Team | Last updated 06.01.2026 | 18 minute read
General practice is increasingly software-defined. From triage tools and online consultation journeys to prescribing workflows, clinical decision support, cloud telephony integrations and bespoke reporting dashboards, digital systems now shape how clinicians make decisions and how patients experience care. That creates huge opportunities—better access, safer repeat prescribing, faster referrals, smarter population health management—but it also creates new routes to harm if systems are poorly designed, implemented or changed without control.
In the NHS, DCB0129 and DCB0160 are the cornerstone standards for managing clinical risk in health IT. They are often spoken about as “documentation you need to produce”, but the real value is the discipline they bring: a repeatable clinical risk management approach that identifies hazards early, reduces risk through sensible design and operational controls, and provides clear accountability when things change.
For GP practices and primary care organisations building software, commissioning development, configuring platforms, or integrating third-party tools with core GP systems, clinical safety compliance is not a tick-box exercise. It is a way of working that protects patients, protects clinicians, and prevents expensive rework when procurement, IG, cyber and clinical governance requirements collide late in delivery.
This article explains how software development for GP practices can achieve DCB0129 and DCB0160 clinical safety compliance in a practical, modern way—covering the real-world scenarios in primary care, what “good evidence” looks like, and how to embed safety into the full lifecycle from discovery to live service.
DCB0129 applies to the manufacture of health IT systems. In plain terms, if you are creating, significantly modifying, or productising software that will be used in patient care, you need a clinical risk management process that meets DCB0129. That can include a supplier building a triage platform, a development partner creating an integration, or an organisation building an in-house tool that clinicians will rely on.
DCB0160 applies to the deployment and use of health IT systems. If your GP practice, Primary Care Network, federation, ICS service, or hosted primary care provider is implementing, configuring, integrating, maintaining, upgrading or decommissioning a system that affects care, you need a clinical risk management approach that meets DCB0160. Crucially, DCB0160 is not just about “installing software”; it covers how the system behaves in your environment—your workflows, your training, your patient population, your local configurations and your dependencies such as identity, messaging, prescribing and interoperability services.
In primary care, the boundary between “manufacturer” and “deployer” can blur. A GP practice might not write code, yet still “manufactures” risk through configuration, template design, protocol settings, triage pathways, custom forms, reporting logic, automated messaging, and workflow rules. Conversely, a supplier might provide a compliant product, but a poor local rollout can still introduce hazards (for example, misconfigured routing of urgent messages, incomplete staff training, or unsafe downtime procedures).
To make this workable, it helps to map common GP scenarios to the standards:
The most important mindset shift is this: DCB0129 and DCB0160 are not competing standards, and they are not “supplier vs practice” paperwork. They are complementary halves of one safety story. DCB0129 demonstrates that the software has been designed and built with clinical risk management controls; DCB0160 demonstrates that the organisation has implemented and uses it safely in the real world.
Successful compliance starts with a clinical safety management system that is proportionate to the scale of change, but robust enough to survive audits, supplier challenges, incident reviews and staff turnover. In GP settings, the trap is either to over-engineer (creating heavyweight processes no one follows) or to under-engineer (creating documents without operational control). The right approach is a lightweight “spine” of governance that can scale up for major programmes and scale down for small changes.
A practical clinical safety management system typically defines roles, responsibilities, artefacts, escalation routes and decision points. Two roles matter most: a Clinical Safety Officer (CSO) who provides clinical safety leadership and owns safety decisions, and a delivery lead (often product, project or technical lead) who ensures safety activities are planned, funded, and actually happen. In small organisations, these may be part-time responsibilities, but they must be explicit.
A workable system also makes risk visible to non-clinical teams. Clinical safety should not live solely with clinicians; developers, testers, designers, analysts and implementation staff need to understand the hazards their work can introduce. That means safety training that is tailored to roles—enough to build shared language (hazards, mitigations, residual risk, safety incidents) without turning every stand-up into an academic seminar.
The documentation is not the goal, but it matters because it proves that you have done the thinking and made controlled decisions. Most GP-focused programmes succeed when they standardise a small set of artefacts and keep them current as living documents, rather than creating them at the end.
A strong baseline set of artefacts includes:
Finally, GP practices benefit from explicitly connecting clinical safety to existing governance rather than creating a parallel universe. Clinical safety should feed into (and draw from) significant event analysis, complaints, quality improvement, business continuity planning, information governance, and cyber/security change management. When those functions are disconnected, risks fall between gaps: a change may be “technically safe” but operationally unsafe because it breaks a workflow, increases cognitive load, or fails under pressure during peak demand.
DCB0129 is best achieved when it is embedded into the software development lifecycle, not bolted on. For GP-related products and integrations, the highest risks often appear early—during discovery and design—because decisions are made about data flows, user journeys, default settings, and how the system behaves under stress. If you only start “doing clinical safety” during testing, you are usually too late.
During discovery, the goal is to understand how harm could occur in the context of primary care. That means going beyond “what features do users want” and asking: What clinical decisions might be influenced? What information might be missing, delayed, duplicated or misinterpreted? What happens when the system is wrong, slow, or unavailable? What workarounds will people invent under pressure?
In GP settings, a lot of hazards are socio-technical: they arise from the interaction between software, human behaviour, workload, and environment. A triage form that seems fine in a demo can create risk if it increases the volume of free-text, buries red flags, or routes urgent cases into a routine queue. An integration that copies data into the record can create risk if it produces duplicate entries, masks the provenance of information, or overwrites clinician-entered data.
Design controls should therefore include clinical safety requirements as first-class requirements, not implied “quality”. Examples include clear provenance of imported data, safeguarding alerts that remain visible at the right moments, safe defaults for routing and prioritisation, consistent handling of patient identifiers, and robust auditability. Where decision support is involved, design must consider bias, over-reliance, and how to present guidance without nudging clinicians into unsafe certainty.
Development and testing should treat hazard mitigation as testable, verifiable behaviour. If a hazard mitigation says “the system prevents the wrong patient record being updated”, you need explicit test cases that attempt wrong-patient actions, cross-tab with similar names, and simulate the interruptions and context switching typical in GP clinical work. If a mitigation says “urgent cases are flagged and surfaced”, you need to test the entire workflow from patient submission to staff triage to clinician action, including the edge cases such as missing data, ambiguous symptoms, and out-of-hours submissions.
A concise way to operationalise this is to turn hazards into a safety-focused backlog. Each hazard becomes one or more tasks: design changes, technical controls, user interface adjustments, monitoring, training materials, or deployment constraints. Mitigations that rely purely on training are weaker; they can be appropriate, but they should be used deliberately and supported by evidence that the design cannot reasonably reduce the risk further.
For GP practice software, there are several recurring hazard patterns worth addressing explicitly:
When releases are frequent—as they often are with modern cloud products—DCB0129 compliance depends on disciplined release governance. That means defining what counts as a “safety significant” change, requiring clinical safety review before release, and ensuring the hazard log and safety case remain current. It also means understanding the hidden safety implications of non-functional changes: performance regressions, UI redesigns, analytics scripts, infrastructure migrations, and security changes can all alter user behaviour and introduce risk.
A mature DCB0129 approach also recognises that safety is not just prevention, it is resilience. Monitoring, audit trails, anomaly detection, and incident response readiness are safety features. If a system can detect unusual patterns—such as unexpected spikes in failed message delivery, unusually long queue dwell times, or repeated overrides of a safety prompt—it can identify emerging risk before patient harm occurs.
DCB0160 is where many GP programmes succeed or fail, because it is about reality: people, process and local context. Even a well-built product can be deployed unsafely if the organisation does not control configuration, ensure competent use, and manage change over time. DCB0160 therefore needs to be treated as an operational discipline, not a one-off go-live hurdle.
Implementation begins with understanding intended use and local workflows. In primary care, the same system can be used very differently across practices—different triage models, different document workflows, different reception processes, different prescribing roles, and different referral pathways. DCB0160 requires you to identify the clinical hazards that arise from your intended use, and then apply controls that match your environment. Often, the hazards are not “bugs” but mismatches: the software assumes a process that your team does not follow, or your team assumes behaviour the software does not guarantee.
Configuration is a major source of clinical risk. Templates, pathways, routing rules, message categories, default priorities, SNOMED mappings, and auto-populated fields can all shape care. Good DCB0160 practice treats configuration as controlled change. You should know who can change it, how changes are reviewed, how they are tested, how they are communicated, and how to roll back if needed. In GP settings, configuration often evolves organically as staff request tweaks; without control, those tweaks can accumulate into a complex and unsafe system.
Training and competency are equally important. “We sent a guide by email” is not a safety control. Training needs to cover the normal workflow and the abnormal workflow: what to do when something looks wrong, when queues build up, when a patient’s submission is incomplete, when a message fails to file correctly, or when a clinician cannot find the information they need. Primary care also has a frequent challenge with locums, rotating staff, and part-time schedules; DCB0160 controls should therefore include induction processes and quick-reference materials that are easy to keep up to date.
A high-quality DCB0160 approach in GP implementation commonly includes the following operational controls:
The safety case under DCB0160 should not merely restate the supplier’s DCB0129 evidence. It should show how you have assured safe use in your local environment, what additional hazards you identified, what controls you put in place, and why residual risk is acceptable. For example, if a supplier notes a hazard around “misinterpretation of free-text submissions”, the DCB0160 safety case might describe how your practice mitigates it through triage protocols, staff training, and clear rules about when patients must be called.
DCB0160 also matters long after go-live. In primary care, systems change continually: supplier releases, policy changes, new pathways, seasonal demand, staff turnover, and integration updates. Without an ongoing clinical safety rhythm—release assessment, change control, periodic hazard review—compliance becomes stale and risk quietly increases. A good rule of thumb is to treat clinical safety as continuous service management: every significant change triggers safety thinking, and safety documentation evolves alongside the system.
Clinical safety compliance is ultimately demonstrated through evidence. The best evidence is not the longest document; it is the clearest story: what could go wrong, what you did about it, what remains, and who is accountable. For GP practices, the challenge is creating evidence that is robust enough for assurance while still being maintainable with limited time.
The hazard log is the engine room. A high-quality hazard log is structured, consistent, and actively used. It should capture hazards in language that clinicians and technologists both understand, linking each hazard to causes, potential clinical consequences, mitigations/controls, owners, and status. Avoid turning it into a list of generic statements; hazards should be specific to the system and context. “Data could be wrong” is too broad. “A triage submission may file to the wrong record when demographic data is incomplete and manual selection is required” is actionable and testable.
Safety cases are often misunderstood as a final report written at the end. In practice, a strong clinical safety case is built iteratively. It contains claims about safety (“The system is acceptably safe for intended use”), arguments that explain why those claims are justified, and evidence that supports the arguments. Evidence can include design decisions, test results, user research findings, training completion, monitoring plans, and incident response procedures. The key is traceability: a reader should be able to pick a high-risk hazard and see exactly how it has been controlled and verified.
Supplier assurance is a major part of primary care implementations. GP practices should expect relevant DCB0129 evidence from suppliers—particularly for products that influence clinical workflows. However, “supplier provided a safety case” is not the end of the adopter’s responsibility. You need to read and interrogate it, looking for how it matches your intended use, what assumptions it makes, and what local controls it expects you to implement. Where there are gaps—such as new integrations, unusual workflows, or local configuration—those become part of your DCB0160 hazard assessment.
It helps to be explicit about what you need from suppliers and development partners. Procurement and contract language should require timely safety artefacts, release notes that flag safety-significant changes, and clear escalation routes for safety incidents. For bespoke development, it should be clear who is acting as the DCB0129 manufacturer and who will own the ongoing hazard log and safety case maintenance. Ambiguity here is a common cause of compliance failure.
A concise set of “evidence expectations” can improve audit readiness and reduce friction with delivery teams. For example:
Audit readiness is not only about passing formal checks; it is about being able to respond quickly when something goes wrong. If a patient safety incident occurs—say, an urgent message was misrouted or a result was not surfaced—the organisation needs to show what controls existed, how the incident was detected, what immediate actions were taken, and what systemic changes will prevent recurrence. A well-maintained hazard log and safety case make that response faster and more credible.
Finally, clinical safety evidence should evolve as technology evolves. GP practices are seeing increasing use of automation, AI-assisted triage, predictive risk stratification, and advanced messaging. These introduce new hazard classes: over-reliance, explainability gaps, hidden model drift, unsafe prompting, and subtle changes in clinician behaviour. Even if your current system is not “AI”, modern products increasingly incorporate algorithmic features. A forward-looking clinical safety approach plans for that now by strengthening monitoring, transparency, user controls, and governance over safety-significant changes.
Primary care technology ecosystems are interconnected. Your GP clinical system rarely operates alone; it is surrounded by online consultation tools, document management, messaging, telephony, prescribing services, referral systems, analytics platforms, and patient communication channels. Integrations create value, but they also create risk because they distribute responsibility across organisations and increase the number of failure modes.
A common safety pitfall is assuming that “integration risk is purely technical”. In reality, integration risk often manifests clinically: delayed information, duplicated entries, conflicting data, or unclear provenance. When systems disagree, staff may not know which source to trust. When messages fail silently, clinicians may never realise something is missing. When data is imported with the wrong context, it can lead to inappropriate decisions. Sustained compliance therefore requires explicit integration governance: what is integrated, what guarantees exist, how failures are detected, and what staff should do when something looks wrong.
Cloud services and rapid release cycles change the compliance rhythm. With frequent updates, it is unrealistic to produce a heavyweight safety report for every minor change, yet it is unsafe to ignore changes because “it’s just a patch”. The solution is to define a sensible safety impact assessment process: a lightweight triage that classifies changes as safety-significant or not, triggers CSO review when needed, and ensures documentation is updated proportionately. Good release management includes clear communication to practices, particularly for UI changes and workflow changes that alter user behaviour.
Sustaining compliance also depends on good decommissioning practice. In GP settings, systems are often retired gradually: a triage tool replaced, an integration moved, a reporting platform superseded. Decommissioning can create hazards such as loss of historical information, broken links in workflows, or staff confusion about where to look for records. Treat decommissioning as a safety event: plan it, assess hazards, communicate clearly, and ensure safe archiving and access to information where clinically necessary.
Another long-term challenge is ownership. Safety artefacts decay when ownership is unclear, when suppliers change account teams, or when practices merge and governance structures shift. Sustained compliance works best when the organisation explicitly assigns ownership for the hazard log, the safety case, and the operational controls—and when those owners have a cadence for review. In primary care, a practical cadence might include a quarterly safety review of live systems, plus an “on demand” review triggered by incidents, major releases, new integrations, or workflow redesigns.
Cyber and clinical safety also intersect more than many teams expect. Security changes can alter access patterns, authentication journeys, or availability. A system that is secure but unusable under pressure can cause workarounds and create patient risk. Conversely, a system that is easy but poorly controlled can enable inappropriate access or data corruption that becomes a safety issue. Sustained compliance therefore benefits from aligning clinical safety reviews with security reviews and business continuity planning, so that availability, integrity, and usability are treated as patient safety factors rather than separate domains.
Ultimately, the practices that sustain DCB0129 and DCB0160 compliance are the ones that treat clinical safety as part of product and service excellence. They build systems that are clear, resilient and well-monitored; they implement changes in a controlled way; and they make it easy for staff to spot and escalate issues. Over time, this reduces incidents, increases confidence, and speeds up delivery—because teams stop relearning the same safety lessons on every project.
Software development for GP practices is only going to become more complex and more clinically influential. Achieving DCB0129 and DCB0160 clinical safety compliance is the most credible way to ensure that complexity translates into better care rather than hidden risk.
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