This plan gives you a systematic approach to digital clinical safety that actually protects patients and satisfies regulators. You'll appoint a Clinical Safety Officer, build a Clinical Safety Management System, and establish the governance that DCB0160 has required since 2012 (but that most practices still don't have).
If you're not yet familiar with digital clinical safety, 2026 is the year that changes. You've been legally required to have this in place for over a decade, but most practices don't, and until recently most regulators weren't checking. That's now changing. CQC's GP Mythbuster 109 explicitly states inspectors will check for DCB0160 compliance when practices use AI tools. The "nobody's asking" grace period is ending.
The good news: getting compliant isn't as complex as it sounds, and being ahead of enforcement is much easier than catching up under pressure.
Implementation timeframe: 8-12 weeks for foundation compliance; ongoing for mature system
Why This Matters
For Your Practice
Patient safety: Digital system failures have caused patient deaths in the NHS. Coroners have linked fatalities to IT systems that didn't flag critical illness, electronic records that hid vital information, and prescribing alerts that were switched off. These aren't theoretical risks. A 2025 study found that three quarters of digital health tools deployed in NHS organisations lack documented safety assurance. Digital clinical safety is how you systematically manage these risks rather than hoping nothing goes wrong.
Regulatory compliance: DCB0160 is a legally mandated NHS information standard under the Health and Social Care Act 2012. It requires organisations deploying digital health tools to assess clinical risks and implement appropriate controls. Non-compliance isn't just a gap; it's a legal failure that has persisted largely because enforcement was absent. That's changing.
Active regulatory scrutiny: This is no longer "emerging"; it's here. CQC's GP Mythbuster 109 explicitly confirms inspectors will check for DCB0160 compliance when practices use AI tools, including asking about hazard logs, risk assessments, and trained Clinical Safety Officers. ICBs are asking about clinical safety governance before approving AI deployments. The practices that get ahead of this now avoid scrambling later.
Protection when things go wrong: When a digital system contributes to patient harm (and it will happen eventually in any practice) you need evidence of systematic risk management. "We didn't know we needed to do this" isn't a defence. A documented clinical safety approach shows due diligence.
Vendor accountability: Understanding DCB0160 also means understanding DCB0129 (the manufacturer standard). You'll know what to ask vendors, what documentation to require, and how to evaluate whether a system is safe to deploy in your specific environment.
For Your Professional Development
By leading this improvement, you'll demonstrate:
Emerging regulatory expertise: Digital clinical safety is a specialism most practice managers haven't developed. Being ahead of this curve positions you as a forward-thinking leader who anticipates regulatory change.
Risk management capability: Clinical risk management methodology (hazard identification, risk assessment, control measures) is transferable across all practice domains. This develops your systematic risk thinking.
Strategic technology governance: As practices adopt more digital tools, someone needs to own the governance. Leading this work establishes you as the person who ensures technology serves patients safely.
Cross-functional leadership: Digital clinical safety involves clinicians, IT, operations, and governance. Leading this demonstrates your ability to coordinate complex initiatives across professional boundaries.
Add these achievements to your year-end evaluation: "Led implementation of digital clinical safety governance framework ahead of emerging regulatory scrutiny, establishing DCB0160 compliance, coordinating Clinical Safety Officer appointment, and building clinical safety management system, positioning practice for AI adoption with appropriate risk controls."
Prerequisites and Preparation
What You Need Before Starting
Approvals: Partner awareness and support (this isn't optional compliance; it's legally required, just unenforced until now). Budget approval for CSO training if appointing internally (typically £500-800 for accredited training courses).
Stakeholders: Identify your likely Clinical Safety Officer candidate (must be a registered healthcare professional: GP, nurse, pharmacist), IT/systems lead, practice manager, and a GP partner as senior sponsor.
Resources: Time for learning and system development. This is governance work that can't be rushed. Access to your current system inventory (what digital tools does your practice actually use?).
Current state: Honest assessment of where you are. Most practices will be starting from near zero, and that's fine. The point is to build from here.
Understanding the Regulatory Landscape
Before diving into implementation, you need to understand what we're actually talking about.
DCB0160 is an NHS information standard that requires deploying organisations (that's you, the GP practice putting digital systems into clinical use) to manage clinical safety systematically. It's been mandatory since 2012 under the Health and Social Care Act.
DCB0129 is the companion standard for manufacturers: the companies that build the clinical systems you use. They're required to assess and document the safety of their products.
The key insight: a system that's safe in one practice may be unsafe in another. Your configuration, your workflows, your training, your integration with other systems: all of these affect whether a digital tool is safe in your specific environment. That's why the deploying organisation has its own safety responsibilities, not just the vendor.
What DCB0160 requires:
Identify hazards: Document potential harms from your digital systems, such as incorrect patient triage, missed safety alerts, data loss during updates, staff misinterpreting AI-generated information
Implement control measures: Establish safeguards such as training, audits, backup processes, escalation procedures
Track and analyse incidents: Monitor near-misses and incidents to verify controls are working
Appoint a Clinical Safety Officer: Designate a senior clinician with clinical risk management expertise to oversee compliance and authorise deployments
Estimated Time Investment
Total implementation: 8-12 weeks for foundation compliance
Your time commitment:
Weeks 1-4: 4-5 hours/week (learning, planning, system inventory)
Weeks 5-8: 3-4 hours/week (documentation development, CSO coordination)
Weeks 9-12: 2-3 hours/week (embedding processes, first assessments)
Ongoing: 2-4 hours/month (incident monitoring, system reviews, governance)
CSO time: Training (2 days), then 2-4 hours/month ongoing for most practices
Partner/clinical time: 3-4 hours total across meetings and reviews
The Implementation Plan
Phase 1: Education and Awareness (Week 1-3)
This isn't like other compliance areas where you can jump straight into document templates. Digital clinical safety requires genuine understanding before you can implement effectively. Most of your practice leadership won't have encountered this before.
Action: Build Your Own Understanding
Before you can lead this work, you need to understand it yourself.
Essential reading (allow 2-3 hours total):
A Plain English Guide to DCB0160 for Busy Practice Managers: Start here. This explains what DCB0160 actually requires without the jargon. Covers the four core requirements, who must comply, and how it relates to other standards.
What is a Clinical Safety Officer?: Explains the CSO role, including qualifications required, responsibilities, authority, and how to establish the role without extra headcount.
Digital Clinical Safety Management Systems: Explains what a CSMS actually is: the policy, procedures, inventory, assessments, and monitoring you need. Importantly, clarifies that this doesn't require expensive software; documents and spreadsheets are fine.
Key concepts to understand:
Clinical risk in the digital context: How software and technology can contribute to patient harm
Hazard identification: Systematically thinking about what could go wrong
Risk assessment: Evaluating likelihood and severity to prioritise controls
Control measures: Safeguards that reduce risk to acceptable levels
Residual risk: The risk that remains after controls are implemented
Clinical Safety Case: The documented argument that a system is acceptably safe
Note: This learning phase is essential. If you skip it and go straight to creating documents, you'll produce paperwork that doesn't reflect genuine risk understanding, which defeats the purpose and won't protect your practice when scrutinised.
Meeting 1: Practice Leadership Briefing
Attendees: GP partners, practice manager, any clinical leads, potential CSO candidate
Duration: 45-60 minutes
Agenda:
Explain the regulatory requirement (10 min): DCB0160 has been mandatory since 2012. Most practices haven't complied. Regulatory attention is increasing due to AI adoption. We need to address this proactively.
Describe what's required (15 min): Walk through the four core requirements: hazard identification, control measures, incident tracking, CSO appointment. Emphasise this is about systematic safety thinking, not bureaucracy.
Discuss current state (10 min): Be honest: we probably don't have this in place. That's typical. The question is whether we want to be ahead of enforcement or scrambling when asked.
Identify CSO candidate (10 min): Must be registered healthcare professional (GMC, NMC, GPhC or equivalent). Needs clinical credibility and willingness to take on governance responsibility. Doesn't need to be a partner; could be salaried GP, senior nurse, or pharmacist.
Agree to proceed (5 min): Confirm partner support for implementation, agree timeline, commit to CSO training budget if needed.
Outputs:
Partner agreement to establish digital clinical safety governance
Identified CSO candidate (or agreement to recruit/identify one)
Budget approval for CSO training (typically £500-800)
Timeline agreed for implementation
Action: Create Your Digital System Inventory
You can't assess risks for systems you don't know you have. Start documenting what digital tools your practice actually uses.
Inventory categories:
Core clinical systems: Electronic patient record (EMIS, SystmOne, Vision), appointment booking, prescribing modules
Communication platforms: Online consultation tools (eConsult, Patchs, Accurx), video consultation software, patient messaging
Clinical decision support: AI triage tools, symptom checkers, clinical calculators, diagnostic aids
Diagnostic and monitoring: Remote monitoring platforms, diagnostic result systems, wearable integrations
Administrative systems: Document management, recall systems, QOF tools, claims systems
Integration and interfaces: NHS App connections, GP Connect, third-party integrations
For each system, document:
System name and vendor
What it's used for
Who uses it (clinical staff, admin, patients)
What patient data it handles
When it was deployed
Whether you have vendor clinical safety documentation (DCB0129 compliance)
Output: Digital system inventory spreadsheet. This becomes the foundation for your safety assessments.
Phase 2: CSO Appointment and Training (Week 3-6)
Action: Formally Appoint Your Clinical Safety Officer
The CSO role carries real authority and responsibility. This isn't a box-ticking exercise.
CSO requirements under DCB0160:
Professional registration: Must be registered with GMC (doctors), NMC (nurses), GPhC (pharmacists), or equivalent healthcare regulatory body. This ensures clinical credibility and professional accountability.
Clinical experience: Minimum five years clinical practice required. The CSO needs to understand clinical workflows, patient safety, and how things go wrong in healthcare. This isn't a role for newly qualified staff.
Training in clinical safety methodology: Formal training in DCB0129/DCB0160 standards covering hazard identification, risk assessment, Clinical Safety Case development, and Hazard Log maintenance. Typically a 2-day course.
Training options:
Accredited CSO training is available from several providers:
NHS England clinical safety training programmes
PRSB (Professional Record Standards Body) accredited courses
Commercial providers (Ethos, others) offering DCB0129/0160 training
Training typically costs £500-800 and takes 2 days. It covers the practical skills needed to fulfil the CSO role.
Alternative: Shared or External CSO
If you don't have a suitable internal candidate, or want expert support:
PCN-level CSO: Some PCNs are establishing shared CSO arrangements across member practices. Check if your PCN offers this.
External CSO services: Organisations like Protect Clinical provide experienced CSO support for practices that need it. This can be particularly valuable when getting started, as you get expert guidance while building internal capability.
Formal appointment:
Create a simple appointment letter/agreement covering:
Named CSO and their professional registration
Responsibilities (risk oversight, assessment approval, incident review, deployment authorisation)
Authority (can approve or reject system deployments, can escalate concerns)
Time allocation (how much of their role is dedicated to CSO duties)
Reporting line (typically to partners/senior management)
Action: Develop Your Clinical Safety Policy
The policy establishes your practice's commitment to digital clinical safety and how you'll deliver it.
Policy components:
Purpose and scope: Why you have this policy, what systems it covers
Commitment statement: Practice commitment to safe deployment of digital health technology
Roles and responsibilities: CSO role, practice manager role, staff responsibilities
Risk management approach: How you identify, assess, and control clinical risks
Incident reporting: How digital safety incidents are reported and investigated
Change management: How system changes are assessed for safety impact
Review and governance: How the policy is maintained and compliance monitored
Getting help with documentation:
This is a specialist area where most practices need support. Options:
Protect Clinical: A managed solution designed specifically for GP practices. If you want support rather than building everything yourself, see the Additional Resources section below.
NHS England resources: Some resources available through NHS England clinical safety pages, though these are primarily designed for larger organisations and can be complex for primary care.
Manual approach: You can create documentation yourself using the DCB0160 standard as your guide, but this requires significant time investment to understand the requirements and translate them for primary care context.
Phase 3: Building Your Clinical Safety Management System (Week 6-9)
Your Clinical Safety Management System (CSMS) is the documented framework that shows how you manage digital clinical risk. It's not software you buy; it's the collection of policies, procedures, and records that demonstrate systematic safety management.
What Your CSMS Must Include
1. Clinical Safety Policy (developed in Phase 2) Sets organisational commitment and governance framework.
2. Standard Operating Procedures Step-by-step instructions for:
Assessing new digital tools before deployment
Reviewing vendor safety documentation
Investigating digital safety incidents
Approving system changes and updates
Maintaining your hazard log
3. System Inventory (started in Phase 1) Complete list of all clinical digital tools with:
System details and vendor information
Deployment date and current version
Risk assessment status
Assigned owner
4. Clinical Safety Assessments For each system in your inventory, documented evaluation covering:
Identified hazards (what could go wrong?)
Risk assessment (how likely? how severe?)
Existing controls (what safeguards are in place?)
Residual risk (what risk remains after controls?)
Acceptance decision (is this risk acceptable?)
5. Hazard Log Central register of all identified hazards across your digital systems:
Hazard description
Affected system(s)
Risk rating (before and after controls)
Control measures
Status (open, mitigated, closed)
Owner
Example hazard log entry:
Field | Example Entry |
|---|---|
Hazard ID | HAZ-2026-003 |
Description | AI triage tool recommends "routine" priority for chest pain presentation with atypical symptoms, delaying urgent assessment |
System | [Online consultation platform] |
Initial risk | High (Severity: Major, Likelihood: Possible) |
Controls | 1. Chest pain flagged for same-day clinical review regardless of AI recommendation. 2. Reception trained to escalate any patient-reported chest symptoms. 3. Weekly audit of AI triage recommendations for chest pain. |
Residual risk | Low (Severity: Major, Likelihood: Rare) |
Status | Mitigated |
Owner | Dr [CSO Name] |
Review date | Quarterly |
6. Incident Records Documentation of digital safety events:
What happened
Investigation findings
Root cause analysis
Corrective actions taken
Hazard log updates
7. Ongoing Monitoring Evidence of regular safety review:
Periodic system reviews
Inventory updates when systems change
Annual policy review
CSO oversight activities
Action: Prioritise Your Initial Assessments
You don't need to assess every system immediately. Start with highest risk.
Priority 1 (assess in weeks 6-8):
AI-powered tools (triage, clinical decision support, symptom checkers): these are novel, less understood, and under regulatory scrutiny
Online consultation platforms: patient-facing with potential for miscommunication
Any recently deployed systems not yet assessed
Priority 2 (assess in weeks 9-12):
Core clinical system configurations specific to your practice
Prescribing modules and drug interaction checking
Diagnostic result handling systems
Priority 3 (assess in ongoing maintenance):
Administrative systems with lower clinical risk
Established systems with good track record
Vendor-managed systems with strong DCB0129 documentation
Action: Conduct Your First Clinical Safety Assessment
Work with your CSO to assess your highest-priority system. This first assessment is a learning exercise, so take time to understand the methodology.
Assessment process:
System scoping: Define exactly what you're assessing: the system, its configuration, how it's used in your practice, who uses it, what patient interactions it supports.
Hazard identification: Brainstorm what could go wrong. Think about:
Incorrect information provided to patients or clinicians
Delays in care due to system issues
Privacy or confidentiality breaches
Integration failures with other systems
User errors due to poor interface design
System unavailability at critical moments
Risk assessment: For each hazard, estimate:
Likelihood (how often might this occur?)
Severity (if it occurs, how bad could the harm be?)
Combine into overall risk rating (typically using a matrix)
Control measures: For unacceptable risks, identify safeguards:
Training for users
Workflow checks and double-verification
System configuration changes
Backup procedures
Monitoring and audit
Residual risk evaluation: After controls, is the remaining risk acceptable? This is a clinical judgment, and your CSO must approve.
Documentation: Record everything in your hazard log and create a summary assessment document.
Getting expert help:
If this feels complex, that's because it is. Clinical risk assessment is a specialist skill. Options:
Your trained CSO: If they've completed accredited training, they should be able to lead this
PCN support: If your PCN has clinical safety expertise, they may be able to assist
Protect Clinical: Offers structured assessment frameworks and CSO support for practices that want help
The goal for your first assessment is learning the methodology. Don't expect perfection; expect to develop understanding that improves with practice.
Phase 4: Embedding and First DCB0160 Cycle (Week 9-12)
Action: Complete Your First DCB0160 Assessment
A "DCB0160" in common parlance refers to completing the clinical safety assessment process for a system. Your first complete cycle should:
Document the Clinical Safety Case: A summary argument that the system is acceptably safe in your environment, based on your hazard identification, risk assessment, and control measures.
CSO sign-off: Your Clinical Safety Officer formally approves the assessment, confirming the residual risks are acceptable.
Record in your CSMS: File the assessment, update the hazard log, note the system as assessed in your inventory.
Important perspective: Your first DCB0160 assessment doesn't need to be perfect. CQC Mythbuster 109 confirms they'll check for evidence of systematic clinical safety governance, but they're looking for genuine engagement with risk, not polished documentation. What matters is demonstrating systematic thinking about risk, documented assessment process, and clinical oversight.
This is genuinely "learning by doing" territory. Your second assessment will be better than your first. Your system will mature over time. The point is to start: a reasonable first attempt is far better than nothing.
Meeting 2: First Review with CSO and Leadership
Attendees: CSO, Practice Manager, GP Partner sponsor
Duration: 45 minutes
Agenda:
Review first assessment (15 min): Walk through your first completed clinical safety assessment. What hazards did you identify? What controls are in place? What's the residual risk judgment?
Evaluate the process (10 min): Was the methodology workable? What was difficult? What would make it easier next time?
Review CSMS documentation (10 min): Is the policy adequate? Are procedures clear? Is the hazard log structured sensibly?
Plan next assessments (5 min): Which systems are priority 2? What's the timeline?
Governance going forward (5 min): How often does CSO report to partners? What triggers an unscheduled review? How are incidents escalated?
Outputs:
Validated first assessment (CSO approved)
Process improvements noted for future assessments
Assessment schedule for remaining priority systems
Governance rhythm established (typically quarterly CSO update to partners)
Action: Establish Incident Reporting for Digital Safety
Digital safety incidents need to be captured and investigated like any other patient safety event.
What counts as a digital safety incident:
System provides incorrect clinical advice or information
Patient harmed or nearly harmed due to technology failure
Safety alert missed or delayed due to system issue
Data loss or corruption affecting patient care
System unavailable during clinical emergency
User error caused by confusing interface design
Integration failure causing information mismatch
Integration with existing incident processes:
Your significant event analysis (SEA) process should include digital safety events. When an SEA involves digital technology:
Involve the CSO in investigation
Update the hazard log if new hazards identified
Review control measures and strengthen if needed
Consider whether system risk assessment needs revision
Reporting to vendors: If incidents reveal product defects, report to the vendor. They have DCB0129 obligations to investigate and address safety issues in their products.
Phase 5: Continuous Improvement and Maturity (Month 3+)
Action: Build Assessment into Your Technology Governance
Digital clinical safety isn't a one-time project; it's ongoing governance that must be embedded in how you manage technology.
Before deploying any new digital tool:
Add to system inventory
Request vendor's DCB0129 clinical safety documentation
Conduct clinical safety assessment (complexity proportionate to risk)
CSO approves deployment or requires additional controls
Document in CSMS
When systems change significantly:
Vendor notifies of major update
Review whether update affects previous risk assessment
Conduct delta assessment if needed
CSO approves continued use or requires action
Update hazard log and assessment records
Regular review cycle:
Monthly: CSO reviews incident log for digital safety events
Quarterly: CSO reports to partners on CSMS status, incidents, assessments completed
Annually: Full CSMS review covering policy currency, inventory accuracy, assessment coverage, hazard log maintenance
Ongoing Maintenance Tasks
Set up recurring reminders to maintain your CSMS:
Monthly: "CSO review of digital safety incidents" (30 minutes)
Quarterly: "CSO governance report to partners" (prepare 1 hour, present 15 minutes)
Quarterly: "Review system inventory for accuracy" (30 minutes)
Annually: "Full CSMS and policy review" (2 hours)
Annually: "CSO refresher training or CPD" (1 day)
When new AI or digital tools are proposed: Create a task for "Clinical safety assessment for [new system]" with appropriate timeline before deployment.
Common Problems and Solutions
Problem 1: "We don't have anyone suitable to be CSO; all our GPs are too busy"
Why this happens: CSO must be a registered healthcare professional. GPs are obvious candidates but often overstretched. Practices assume it needs to be a partner.
How to address it:
Consider non-GP clinicians: Practice nurses with senior experience, clinical pharmacists, and other registered healthcare professionals can be CSOs. The requirement is professional registration and clinical credibility, not being a doctor.
Salaried GP or ANP: A salaried GP or Advanced Nurse Practitioner may have more capacity than partners and welcome the professional development opportunity.
Shared PCN CSO: Some PCNs are establishing CSO roles that support multiple practices. Check if your PCN offers this or would consider it.
External CSO support: Services like Protect Clinical provide experienced CSO support for practices that can't resource the role internally.
Prevention: When recruiting clinical staff, consider whether they could fulfil CSO responsibilities as part of their role. Digital governance capability is increasingly valuable.
Problem 2: "This feels like bureaucracy for bureaucracy's sake; our systems work fine"
Why this happens: When things are working, safety governance feels like overhead. The value only becomes obvious when something goes wrong.
How to address it:
Reframe as insurance: You don't question car insurance because you haven't crashed. Clinical safety governance is insurance against the day when a digital system contributes to patient harm, and that day will come.
Reference real incidents: Digital system failures have caused patient harm. AI triage tools have given incorrect advice. Systems have lost data during updates. These aren't theoretical risks.
Regulatory reality: "Nobody's checking" is changing. ICBs are asking about clinical safety when practices adopt AI tools. CQC is becoming more aware. Being ahead of this is easier than catching up under pressure.
Professional protection: When something goes wrong, "we had no clinical safety process" is indefensible. "We had systematic governance but this risk wasn't anticipated" is much stronger ground.
Prevention: Frame digital clinical safety as mature technology governance, not compliance burden. Practices that take this seriously are better positioned for digital transformation.
Problem 3: "We don't know what systems we even have; things have been added over the years"
Why this happens: Digital tools accumulate. Someone tries a new online consultation platform. A third-party app gets integrated. Nobody maintains a central register.
How to address it:
Systematic audit: Work through each category (clinical systems, communication, decision support, monitoring, admin). Ask staff what they actually use. Check IT contracts and subscriptions.
Start with obvious and expand: Document the systems you know about. Add others as you discover them. Your inventory doesn't need to be perfect on day one; it needs to improve over time.
Create ownership: Assign each system an owner who's responsible for knowing its status, updates, and safety documentation.
Establish new-system process: Going forward, nothing gets deployed without being added to inventory and assessed. This prevents future accumulation.
Prevention: Inventory maintenance becomes part of IT governance. When contracts are renewed or systems updated, inventory is checked.
Problem 4: "Our vendors don't provide clinical safety documentation when we ask"
Why this happens: Smaller vendors may not understand DCB0129 requirements. International products may not have UK clinical safety documentation. Some vendors resist sharing documentation.
How to address it:
Explain the requirement: Vendors supplying clinical software for NHS use should comply with DCB0129. Explain that you need their Clinical Safety Case Report or equivalent to complete your DCB0160 obligations.
Escalate through procurement: If vendor won't provide documentation, flag this as a contract/procurement issue. Consider whether you should continue using a vendor that can't demonstrate product safety.
Document your concerns: If you proceed without vendor documentation, record this in your assessment. Note that your ability to identify hazards is limited by lack of vendor transparency. This shifts appropriate responsibility.
Consider alternatives: For critical clinical systems, vendor safety documentation should be a procurement criterion. If current vendor can't provide it, evaluate alternatives that can.
Prevention: Include DCB0129 documentation requirement in procurement criteria for new digital tools. Don't adopt systems from vendors who can't demonstrate safety governance.
Problem 5: "CQC has never asked about this; is it really required?"
Why this happens: This was true until recently. CQC hadn't routinely inspected digital clinical safety in primary care. That changed in 2025.
How to address it:
CQC is now checking: GP Mythbuster 109 explicitly confirms inspectors will ask about DCB0160 compliance when practices use AI tools. This includes hazard logs, risk assessments, and CSO appointments. "They've never asked before" is no longer accurate.
Legal requirement: DCB0160 is legally mandated under Health and Social Care Act 2012. Previous lack of enforcement meant practices were getting away with non-compliance. That grace period is ending.
ICB scrutiny: ICBs are increasingly requiring evidence of clinical safety governance before approving AI tool deployments. No governance means no approval.
Professional standards: Regardless of CQC, healthcare professionals have duties to ensure patient safety. Using clinical systems without systematic safety oversight is a professional vulnerability.
Prevention: Treat digital clinical safety as genuine safety governance, not compliance theatre. When CQC asks (and they now will) your mature system demonstrates exactly the kind of proactive safety leadership they want to see.
Success Criteria and Evidence
You'll Know You've Succeeded When:
CSO formally appointed: Named registered healthcare professional with documented authority and responsibility for digital clinical safety oversight
CSO trained or experienced: Your CSO has completed accredited DCB0129/0160 training or has equivalent clinical safety experience
CSMS documented: Complete Clinical Safety Management System including policy, procedures, inventory, hazard log, and incident process
System inventory complete: All clinical digital tools documented with owner, deployment date, and assessment status
Priority assessments completed: High-risk systems (especially AI tools and patient-facing technology) have documented clinical safety assessments with CSO approval
Governance rhythm established: Regular CSO oversight activities occurring, including incident reviews, quarterly reports to partners, annual policy review
Incident process integrated: Digital safety events captured through normal SEA process with CSO involvement and hazard log updates
New system process working: When new tools are proposed, clinical safety assessment happens before deployment
Evidence You Can Show to Regulators:
Documentation:
Clinical Safety Policy with version control and partner approval
CSO appointment letter with named individual and professional registration
Evidence of CSO training (certificate or equivalent experience documentation)
Standard operating procedures for assessment, incident investigation, change management
System inventory with assessment status for each system
Assessment evidence:
Completed clinical safety assessments for priority systems
Hazard logs showing identified risks and control measures
Clinical Safety Case summaries with CSO approval signatures
Vendor DCB0129 documentation where obtained
Ongoing governance:
CSO quarterly reports to partners (meeting minutes)
Incident records for any digital safety events with investigation and actions
Annual CSMS review documentation
Evidence of assessment before new system deployment
If asked by CQC or ICB: "We have a Clinical Safety Officer, Dr [Name], who oversees our digital clinical safety. Here is our Clinical Safety Management System documentation. We've assessed our clinical systems, particularly [AI tool/online consultation platform], and here are the assessments. Our hazard log shows the risks we've identified and how we're controlling them. Here's how we handle incidents and review systems when they change."
This demonstrates exactly the systematic approach regulators are looking for.
Maintaining the Improvement
Monthly activities (1-2 hours total):
CSO incident review (30 min): Check SEA log and complaints for any digital safety events. For each: Was hazard log updated? Are controls adequate? Any pattern emerging?
Vendor communications check (15 min): Review emails/notifications from system vendors. Any safety-related updates? Any requiring delta assessment?
Inventory spot-check (15 min): Ask reception/admin "any new apps or tools being used?" Check IT for any new integrations. Add to inventory if found.
Quarterly activities (2-3 hours total):
CSO governance report (1 hour prep): Document for partners covering: incidents this quarter (count and themes), assessments completed, open hazard log items, any concerns. Keep to one page.
Hazard log review (30 min): For each open item: Is status still accurate? Are controls being followed? Any due for re-assessment?
Assessment pipeline check (30 min): Which priority systems still need assessment? Update schedule if slipping.
Annual activities (4-6 hours total):
Full CSMS audit (2 hours): Is policy still accurate? Have procedures been followed? Evidence check: can you show an assessor the documentation trail for any system?
Complete inventory reconciliation (1 hour): Cross-reference with IT contracts, subscription payments, staff interviews. Identify any undocumented systems.
Assessment refresh review (1 hour): For each assessed system: Any major updates since assessment? Any incidents that suggest reassessment needed?
CSO CPD (1 day separately): Refresher training or attendance at clinical safety event. Document for evidence file.
Annual report to partners (30 min): Summary of year's activity, any concerns, recommendations for coming year.
When adopting new AI or digital tools (case by case):
Add to inventory
Request vendor safety documentation
Conduct clinical safety assessment proportionate to risk
CSO approval before go-live
Document in CSMS
Additional Resources
Protect Clinical
Protect Clinical provides specialist digital clinical safety support for GP practices. Built by My Practice Manager in partnership with an experienced Clinical Safety Officer, it's designed specifically for primary care practices who need to achieve DCB0160 compliance without becoming clinical safety experts themselves.
What Protect Clinical provides:
Governance repository: A structured document library for all the policies and SOPs your clinical risk management system needs, with templates designed specifically for GP practices
AI-assisted documentation: Built-in AI tools to help you generate policies and SOPs if you don't already have them, saving hours of drafting time
Managed hazard log: A fully managed hazard log interface with AI assistants that help when creating and editing hazards, ensuring you capture risks properly without needing deep technical expertise
Expert CSO support: Access to experienced Clinical Safety Officers who can guide your implementation and support complex assessments
Educational resources: Plain English guidance on DCB0160 compliance for practice managers and clinical staff
Ongoing compliance support: Help maintaining your CSMS as systems change and regulatory expectations evolve
If you want to get this right without building everything from scratch, Protect Clinical offers a managed approach to digital clinical safety that's designed for practices exactly like yours.
Useful Protect Clinical articles (free access):
Regulatory Guidance and Standards
The DCB standards:
DCB0160: Clinical Risk Management: Application: The deploying organisation standard (your practice)
DCB0129: Clinical Risk Management: Manufacture: The manufacturer standard (your vendors)
Related frameworks:
DTAC (Digital Technology Assessment Criteria): NHS assessment framework for digital health technologies
DSPT (Data Security and Protection Toolkit): Data security self-assessment (complementary to clinical safety)
NHS England resources:
NHS England Clinical Safety pages: Official guidance and resources
NHS AI and Digital Regulations Service: Guidance on AI in healthcare
Getting Help
Questions about this improvement plan? Email: contact@mypracticemanager.co.uk Subject: "Digital Clinical Safety Plan Query: [Your Practice Name]"
Need specialist clinical safety support? See the Protect Clinical section above for a managed solution designed for GP practices.
CSO training options: Search for "DCB0129 DCB0160 clinical safety officer training" to find accredited courses from NHS England, PRSB, and commercial providers.
This improvement plan is provided as practical guidance for GP practice managers implementing digital clinical safety governance. DCB0160 is a legally mandated NHS information standard, and while regulatory enforcement has historically been limited, practices should treat compliance as a professional and legal obligation. For complex clinical safety assessments or specialist advice, engage appropriately qualified Clinical Safety Officers or specialist services. The regulatory landscape is evolving, so stay informed of developments through NHS England and professional body communications.
Version 1 | Published January 2026 | © My Practice Manager 2026