Digital clinical safety (DCB0160) collaboration in action - A regional case study

We’ve collaborated with Leicestershire, Leicester and Rutland ICB and LLR Patient Care Locally community interest group to roll out a first-of-its-kind, collaborative approach for the DCB0160 of a new GP triage digital system.

This pilot, spanning 10 GP practices, successfully delivered complete clinical safety documentation and post deployment monitoring across all practices in a collaborative approach, at scale.

Background

In England, NHS healthcare organisations are required by law to perform a risk assessment of the health IT systems or digital health solutions that they deploy, in line with the DCB0160 standard, written into the Health and Social Care Act 2012. This process needs to be overseen by an appropriately experienced and qualified Clinical Safety Officer (CSO).

The challenge at the primary care level is that the GP practices may not have the time or resources to appoint an appropriate CSO to carry out these assessments. A CSO at every GP practice could also result in a lot of duplicative work of hugely varying quality. As a result, assurance and risk assessment processes might be tackled at more of regional level, by GP federations or Integrated Care Boards (ICBs).

Problems with the usual approach

1. Lack of time and resources

Very few practices have their own appropriately trained CSO. Many have no DCB0160 clinical risk assessment documentation at all. Those that do rely on outdated and inefficient tools, such as spreadsheets, which are not fit for purpose for risk management work. It can be unclear where ultimate responsibility lies. As a result, there is often:

❌ Lack of appropriate documentation

❌ Duplicated effort of varying quality when the work is done

❌ Little to no post-deployment monitoring after deployment

How technology can help

• Reduces duplication and manual effort
• Efficient tools and workflows save significant time
• Adds audit trails and transparency
• Enables real-time collaboration

2. Lack of collaboration

GP practices often work in silos, and existing systems, process and tools make collaboration across multiple organisations or an entire region nearly impossible:

❌ No shared communication channels between practices and regional hubs

❌ Poor communication between manufacturer and deploying practices

❌ Difficult to share evidence and controls

❌ Minimal post-deployment monitoring

❌ Learning from others and post-deployment monitoring rarely shared

Why collaboration matters

GP practices are already under-resourced, and it can be unrealistic for each one to complete DCB0160 documentation in isolation. A collaborative approach enables practices to:

• Share the workload and reduce duplicative efforts
• Brainstorm risks together and learn from each other
• Share learning and respond collectively to any incidents

As a result

• It typically takes an NHS organisation anywhere from 6 to 12+ months* to go from procurement to go-live with new digital health technology
• For even a simple clinical safety case, an experienced individual will spend at least 24–48 hours* preparing documentation.
• Multiply that by 10 practices, and you’re looking at 240–480 hours of duplicated effort → collaboration is the only sustainable solution.

*survey data from experienced CSOs, and much higher for more complex health IT systems such as EHRs

That’s a huge amount of wasted time and resources and can result in deployment delays - before patients see any benefits.

The solution

At Assuric, we’ve created a purpose-built tool to solve these exact challenges! Designed for efficiency, quality and collaboration.

1. A novel collaborative approach

Through a collaborative approach, learnings can be shared, duplication avoided, and high quality risk assessments. In this pilot we worked with together with the supplier, the ICB and all the practices, which included:

1. Gathering information from the supplier and reviewing the DCB0129 documentation
2. Collecting feedback and perspectives from GP practices via questionnaires
3. Running hazard workshops using Assuric across groups of practices
4. Collaborating on the platform to complete the DCB0160 deliverable documentation - with multiple CSOs contributing to the hazard log
5. Hosting informal drop-in sessions for staff during onboarding and piloting of the GP triage solution
6. Sharing completed DCB0160 documentation across practices - with easy-to-read hazard logs, evidence attached, and transferred controls clearly outlined with appropriate resources.
7. Setting up channels for incident management and post-deployment monitoring, which can be managed centrally in the Assuric workspace.

2. Unlocking this through new technology

This was made ultimately made possible through the use of the Assuric platform, for a number of reasons:

1. A central repository of key clinical safety documentation
2. Clear oversight of open hazards and control implementation
3. Ability to work collaboratively on projects, in real-time
4. Efficient completion of safety case reports automatically linked to the hazard log
5. Efficient review and approval workflows for key documents
6. Easily keeping hazards and risks updated as new information emerged throughout the pilot phase
7. Easily distributing completed or updated documentation for individual GP practice review and records
8. Clear channels for incident reporting and streamlined post-deployment monitoring - creating a central hub for incident monitoring and management

What we found

• Collaboration between organisations means that a group of 10 GP practices can complete this work in a fraction of the time!
• Shared learning enabled additional controls to be shared and implemented between practices efficiently.
• With Assuric the time taken for an individual to complete a clinical safety case reduces by over 50%
• Most importantly, this approach could ultimately result in a reduction in overall risk across all practises involved.

🚀 What can you do?

Talk to the GP practices and organisations around you to see how digital clinical safety is currently managed - work together to solve this problem!

We’re here to help. Get in touch, and we’ll show you how to get started.

💡 The Future of Digital Health Compliance

This case study covers just one project across a group of ten GP practices. But the potential goes much further.

With Assuric you can:

✅ Manage 10s to 100s of suppliers and projects in one platform

✅ Collaborate across a large number of practices and contributors

✅ Produce key deliverables in an efficient automated way

✅ Track all live risks and incidents in one place

✅ Eliminate duplication of work

✅ Store all key evidence (DPIAs, Cyber Essentials certificates, DSPT certificates, DTAC forms)

✅ Manage supplier agreements

✅ Automate suppliers questionnaires and assurance checklists

And so much more!

Get in touch if you’d like to learn more, or if you’d like to receive the outputs of the above case study!

Collaboration through technology isn’t just better, it’s the only sustainable path forward to ensure the safety of new digital health solutions.