Why AI in General Practice Needs Certification – And What It Means for You
InTouchNow.ai is now a certified Class I Medical Device. But what does that actually mean – and why should it matter to GP practices using AI to support patient access?
At first glance, this might sound like overkill – after all, our platform is a non-clinical, administrative tool. It doesn’t diagnose, treat, or make clinical decisions. It’s built to do what your reception team does – answer calls, follow call flows, complete triage admin, and book appointments or escalate when needed.
So why go through the process of becoming a certified Class I Medical Device?
Because the reality is: there’s a grey area here – and we believe when it comes to patient safety, the right approach is to be proactive.
The blurred line between admin and care
There’s an ongoing debate in health tech circles – and even among regulators – about what exactly counts as a medical device when AI is involved.
Some argue that systems like ours, which follow predefined scripts and triage flows, are no different from human receptionists following a protocol. After all, receptionists routinely ask symptom-based questions, direct patients to the most appropriate service, or help them navigate options like Pharmacy First.
Others point out that once software starts influencing the direction of a patient’s care journey – even if it’s just by following agreed signposting or triage steps – it could be seen as supporting clinical decision-making, especially if there’s no immediate human review.
And that’s where the grey area lies.
Is it admin? Is it clinical? Is it both?
Rather than make assumptions, we’ve chosen to treat the responsibility seriously.
Why we decided to certify as a medical device
At InTouchNow.ai, we asked ourselves one simple question:
“If this platform is guiding patients through key parts of their care journey – even if it’s just capturing triage details or suggesting the next step – shouldn’t it be held to the same standard as anything else used in that process?”
For us, the answer was yes.
That’s why we chose to go through the full Class I Medical Device process – including compliance with NHS clinical safety standards (DCB 0129 and DCB 0160) and robust internal governance.
It wasn’t a checkbox exercise – it was a deliberate decision to align with best practice, and a way to futureproof our technology as regulation evolves.
What does it mean for your practice?
For practices already using InTouchNow.ai, this certification formalises what you’ve already seen:
- A platform that’s built for safety and consistency
- A system that knows when to escalate to a human
- Clear documentation, accountability, and process oversight
- Confidence that you’re not exposing your patients or practice to unnecessary risk
And for those exploring AI options?
We believe certification should become the minimum standard in this space – especially for tools that play a visible role in patient access, triage, and navigation.
Why this matters now more than ever
AI in primary care is no longer on the horizon – it’s here.
The NHS’s 10-Year Health Plan calls for AI-driven navigation and triage at scale. That momentum is growing. But with it comes the need for stronger safety signals.
We’ve all seen what happens when innovation outpaces oversight. Healthcare doesn’t have that luxury.
If a tool is involved in shaping a patient’s access, journey, or response – even if it doesn’t give medical advice – it deserves the same scrutiny as anything else in that pathway.
Certification is how we make that happen.
Final thought: in grey areas, choose clarity
We’re not here to tell others what to do. Some AI vendors may continue to argue that because they’re non-clinical, they don’t need medical device oversight. Maybe they’re right – under some interpretations.
But we believe trust is earned by doing more than the minimum.
So we chose clarity over ambiguity. Certification over assumption. Because if the work you do even might affect someone’s care, it should be held to the highest standard.
Thanks for reading,
The InTouchNow.ai Team