The compliance gap your vendor can't fill.
Your clinical software is DCB0129 compliant. But DCB0160, the standard for how you deploy it, is your responsibility. Most GP practices don't know this yet.
Your Compliance Status
Action neededTwo standards. Two responsibilities.
Your vendor handles one. The other is yours.
DCB0129
“Is this product safe as designed?”
The vendor assesses hazards based on how they expect the product to be used generally. This is about the product itself.
DCB0160
“Is this product safe as deployed in your practice?”
How you've configured it. Your workflows. Your staff training. Your integration with other systems. That's on you.
Here's the thing: your vendor can't assess the safety of your specific deployment. They don't know how you've configured their system, what workarounds your team uses, or how it fits with everything else you do. That assessment is yours to make.
Four things you need.
It's not as daunting as it sounds, especially with the right tools and support.
Clinical Safety Management System
A documented approach to managing clinical safety in your organisation. Your processes, responsibilities, and incident handling.
Clinical Safety Officer
A named clinician who takes responsibility for clinical safety. Typically a GP partner or clinical lead at your practice.
Hazard Logs
For each clinical system you use, identify potential hazards, assess the risks, and document the controls you have in place.
Safety Cases
A structured argument, with evidence, that your deployment is acceptably safe. Reviewed and signed off by your CSO.
You don't have to figure this out alone.
Our Clinical Safety Officer, Charlotte Caws, brings years of NHS and health tech clinical safety experience to every practice she works with.
Whether you need mentorship to build your own capability, a review of your safety case, or a fully outsourced CSO service: we can help.
Mentorship
Build your internal capability with guided support
Safety Case Review
Expert review and feedback on your work
Outsourced CSO
Full clinical safety officer services for your practice
Charlotte Caws
Clinical Safety Officer
"I've seen too many practices struggle with clinical safety compliance. Not because they don't care, but because the standards weren't clear for them. My job is to make this manageable."
Ready to close the gap?
Get started with Protect Clinical today. Book a demo to see how we can help your practice achieve DCB0160 compliance.