Securing budget for AI is a real achievement. The next question is how to spend it so the tool actually helps your team and doesn't quietly create work, cost or liability. A short pause for the right questions, often before a contract is signed, tends to save far more time than it takes. We cover six essential compliance questions to ask before you buy covering MHRA status, DCB0129, DCB0160, DTAC, DPIA and what the CQC expects and share our free five-minute assessment tool so you can see your own CQC readiness.
1. Is this tool a medical device and is it registered with the MHRA?
If a piece of software is intended to prevent, diagnose, monitor or treat a disease then it likely counts as a medical device under MHRA rules, and the classification should be stated in the product's instructions for use. CQC's GP mythbuster 109 is explicit on this point. You can check whether a device is registered on the MHRA's public registration database (PARD), and the supplier should be able to tell you its status without hesitation.
For background on how software and AI are regulated as devices, the MHRA's guidance on software and AI as a medical device is the reference point.
2. Can the supplier show you a DCB0129 clinical safety case?
DCB0129 is the standard that applies to the people who make software or tools used in health. Any tool which influences, supports or manages the direct care of patients/service users falls under the scope of these requirements. A credible supplier of a clinical tool must hold a DCB0129 clinical safety case and be willing to share evidence of it. If they can't provide it, walk away.
3. Who will complete our DCB0160 deployment assessment?
DCB0129 covers the product; DCB0160 covers how you deploy it in your practice, with your patients, workflows, team and existing systems. No supplier can do this part for you, because they don't know your setting. It has been an NHS requirement for over a decade, and it needs a named Clinical Safety Officer to oversee it.
A quick way to see where you stand across the tools you already use is Curistica's free five-minute Assess tool. It's a low-stakes way to map what you have and what state it's in before you add something new.
4. Has the tool been through DTAC?
The Digital Technology Assessment Criteria (DTAC) is a helpful consolidation of all the things you need to make sure are in place before you can use a new tool/software in your clinical setting. It brings together data protection (GDPR), cybersecurity and clinical safety as well as important patient-facing items such as accessibility and equity - all things the CQC often looks out for.
5. What will CQC expect us to show?
The CQC isn't looking to catch practices out for using technology. Quite the opposite, as it actively encourages innovation that benefits patients. What it looks for is that you procured, deployed and are monitoring the tool sensibly. The CQC’s Mythbuster 109 says assessments will focus on your systems and processes for safe use, including procurement in line with DCB0160, DTAC and MHRA registration where relevant, and evidence of ongoing governance. Building that evidence trail as you buy is far easier than reconstructing it later.
6. What's the true ongoing cost, not just the licence?
Getting a tool live is only the first part. Keeping it safe is the second: monitoring how it performs, training new staff, auditing, applying updates, and decommissioning cleanly if you switch products. These aren't reasons to hold back; they're simply part of the true cost, and worth factoring into the budget conversation now rather than discovering later.
Where the money tends to go furthest
In practice, the tools that pay off are often not the ones which are the cheapest upfront. They're the ones where the ongoing costs are minimised. This is often achieved by the supplier doing the manufacturer-side safety work properly, where deployment risks and challenges are assessed honestly and mitigated properly, and where someone in (or alongside) the practice owns the ongoing governance. That combination is what turns a promising pilot into something you can stand behind at inspection and what stops budget being spent twice.
Not sure where your current tools stand? Start with the free five-minute Assess tool to see what you have and how ready it is.
Planning a purchase and want a second pair of eyes? Book a free 20-minute call, or read more about CQC readiness.
