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A Plain-English Guide to DCB0160 for Busy Practice Managers

Understand the core DCB0160 documents and rhythms you need to keep NHS digital safety evidence in order.

Published · 9 October 2025Topics: compliance, dcb0160, clinical-safety

Executive Overview

DCB0160 is the NHS information standard that tells healthcare organisations how to manage clinical risk when deploying or operating digital systems. For GP practices it is the evidence that technology in daily use has been assessed, controls are in place, and risks are being reviewed. Getting the basics right keeps patients safe, satisfies commissioners and the Care Quality Commission (CQC), and saves time when the next digital change arrives.

Who Needs to Comply and How It Links to Other Standards

  • DCB0160 applies to adopters: GP practices, Primary Care Networks (PCNs), Integrated Care Boards (ICBs), federations, and any NHS body putting a health IT system into live use.
  • DCB0129 applies to suppliers: Vendors must provide their own clinical safety case and hazard information so you can make informed decisions.
  • Digital Technology Assessment Criteria (DTAC) and the Data Security and Protection Toolkit (DSPT) sit alongside DCB0160. Reusing evidence across them avoids duplication.

When onboarding a product, ask for the supplier’s DCB0129 outputs first, then map those assurances into your DCB0160 activities.

Core Documents You Need to Maintain

Document Purpose Owned by Suggested Review
Clinical Risk Management Plan Sets out scope, roles, process, and approval route for each deployment Clinical Safety Officer (CSO) with practice manager support Before go-live and after major change
Hazard Log Records identified hazards, risk ratings, controls, and outstanding actions CSO Monthly while implementing, quarterly once stable
Clinical Safety Case Report Summarises why the system is safe to use, referencing evidence and residual risks CSO and senior partner or accountable director At initial approval and after any significant change
Change and Release Record Tracks supplier releases, configuration changes, test evidence, and approvals Digital lead or practice manager Every change cycle
Training and Competency Log Shows staff have been briefed on safe use and escalation routes Practice manager or training lead After induction sessions and annually

Store everything in a single “safety file” with clear version control so it is easy to share with auditors or commissioners.

Five Practical Steps to Achieve Compliance

  1. Appoint and support your CSO

    • Choose a senior clinician with authority to stop unsafe changes.
    • Agree time in the rota (typically half a day per week during active deployment).
    • Provide recognised training (for example the NHS England online CSO course) and peer support within your PCN.

  2. Build a technology inventory and risk profile

    • List every digital system touching clinical workflows, who owns it, and the patient journeys it supports.
    • Classify systems as high, medium, or low risk based on potential harm if they fail.
    • Prioritise high-risk systems for early hazard assessment and supplier engagement.

  3. Create your baseline documentation

    • Draft the Clinical Risk Management Plan and have it signed off by the CSO and senior partner.
    • Populate the hazard log using supplier assurance packs, local incident history, and staff insight.
    • Write the initial Clinical Safety Case Report summarising evidence gathered so far.

  4. Embed DCB0160 into everyday change control

    • Make clinical safety a standing agenda item in governance and digital meetings.
    • Check supplier release notes against your hazard log before approving updates.
    • Require rollback plans, communication scripts, and testing evidence for every change.

  5. Monitor, learn, and report

    • Review incident logs, near misses, and staff feedback at least monthly.
    • Track metrics such as number of open hazards, time taken to close actions, and staff confidence.
    • Produce a short quarterly summary for partners, PCNs, and commissioners highlighting decisions taken and upcoming risks.

Questions to Ask Every Supplier

  1. Do you have an up-to-date DCB0129 Clinical Safety Case Report and hazard log we can review?
  2. Who is your Clinical Safety Officer and how do we contact them during an incident?
  3. What testing do you run before releases and what do you expect from us locally?
  4. How will you notify us about known issues or urgent fixes?
  5. Which controls must we implement locally for your mitigations to remain valid?
  6. How does your product support DTAC and DSPT evidence so we can reuse it?

Document answers in your safety file and revisit them during annual supplier reviews.

Scenario: Northfield Health Centre

Northfield introduced an online consultation pathway across two sites. The practice manager and CSO:

  • Agreed a shared hazard log with the vendor before launch.
  • Built a 30-minute weekly “digital safety huddle” for the first two months to review incidents and supplier updates.
  • Used the same evidence pack to satisfy ICB assurance and DTAC checks. As a result they cleared their commissioner gateway in one submission and now reuse the templates for every new tool.

Common Pitfalls and How to Avoid Them

  • Treating DCB0160 as paperwork only: Involve frontline teams in hazard identification so the controls match reality.
  • No time assigned for the CSO: Block diary time and name a deputy to cover leave.
  • Missing supplier evidence: Make DCB0129 documents a contractual requirement before you sign.
  • Poor change logging: Capture configuration tweaks and hotfixes as carefully as major releases.
  • Silencing feedback: Encourage staff to log concerns; a rise in reports usually means the process is working.

Action Checklist

  • Nominate a CSO, agree time allocation, and arrange training.
  • Compile your system inventory and set risk levels.
  • Build the safety file with plan, hazard log, and safety case outline.
  • Align change control so no update goes live without CSO sign-off.
  • Schedule monthly safety reviews and share quarterly summaries with stakeholders.

Resources to Bookmark

Key Takeaways

DCB0160 is less about filling in forms and more about proving that clinical risk is identified, controlled, and reviewed. With a clear safety file, an empowered CSO, and regular monitoring, practices can satisfy regulators, reassure partners, and keep digital services dependable for patients and staff.