When choosing AI note-taking software, most dentists ask: Does it save time? Is it accurate? Will my team find it easy to use?
But there's a more fundamental question: Is it actually compliant with UK regulations?
Kiroku has achieved both DCB0129 and MHRA Class 1 medical device compliance. Here's why it matters.
What This Actually Means
DCB0129 is the UK standard for clinical risk management of health IT systems. It ensures software used in healthcare has been rigorously assessed for clinical safety.
MHRA Class 1 medical device registration means Kiroku is officially recognised as a medical device by the UK's Medicines and Healthcare products Regulatory Agency.
In plain English: Kiroku meets the same safety and quality standards required of medical devices used across the NHS and private healthcare.
Why We Did This
Many AI note-taking providers operate without formal compliance. It's faster to market and less expensive. So why did we invest months and significant resources to achieve these standards?
Your Professional Registration Depends on Good Records
The GDC is clear: maintaining accurate, contemporaneous clinical records isn't optional. If you're using non-compliant software and something goes wrong, the question won't be "did the software fail?" It will be "why did you choose unregulated software?"
Complaints and Litigation Are Increasing
Dental legal advisors are already seeing it: patients using AI to generate complaint letters, solicitors scrutinising records more intensively, and questions about AI-generated notes moving from theoretical to real.
As Julie-Anne Conway, Dentolegal Advisor from Densura, told us, in terms of AI notes and claims:
"We're in the very early days of AI; there are lots of unanswered questions about the future. Whatever happens in terms of data protection or legal questions, it's never going to change that we own our records and are responsible for whatever the AI has supported us with."
Clinical Safety Isn't Negotiable
AI is powerful but not infallible. DCB0129 compliance means we have robust processes to identify risks, monitor for issues, and respond quickly when problems arise.
What This Means for You
Professional Protection
- Demonstrate due diligence in your software choice
- Evidence of using regulated, safety-validated technology
- Support during CQC inspections or regulatory reviews
- Peace of mind that your tool meets professional standards
Risk Mitigation
- Clear audit trail of clinical safety measures
- Ongoing safety monitoring and updates
- Access to incident reporting processes
Future-Proofing
- Positioned for potential NHS AI requirements
- Prepared for increased regulatory scrutiny
- Protected against retrospective compliance challenges
Questions to Ask Any Provider
When evaluating AI note-taking software, ask:
- Is it DCB0129 compliant? Ensures clinical risk management processes are in place
- Is it MHRA registered? Confirms it meets medical device standards
- How is patient data protected? Critical for GDPR compliance and patient trust
- Is audio stored? Affects consent requirements and data obligations
- What happens if something goes wrong? You need clear incident reporting and resolution
Not all providers can answer these questions positively - and that should inform your decision.
The Defensive Dentistry Perspective
Every clinical decision you make could be scrutinised years later. AI note-taking can be powerful defensive dentistry, but only if implemented properly.
Compliant AI notes help because they:
- Capture more detail than you'd have time to write
- Maintain consistent structure and completeness
- Document conversations that often get missed
- Provide contemporaneous records (not end-of-day notes)
Non-compliant tools create risk because:
- You can't demonstrate due diligence in your choice
- No formal process to identify and correct errors
- Data security vulnerabilities could expose patient information
- You have no recourse if the provider's claims don't hold up
The Reality Check
AI in dentistry isn't going away. It will become more prevalent and more integrated into clinical workflows.
As one DSO director put it:
"AI is not a threat to those people who use it. It's a threat to those that don't."
But we'd add: compliant AI is not a threat. Unregulated AI tools introduce new risks while claiming to solve old problems.
The regulatory landscape will only get stricter. The NHS has published guidance on ambient technologies. The CQC is developing AI oversight frameworks. Professional bodies are clarifying expectations.
Dentists who choose compliant tools now are ahead of this curve. Those using unregulated software may face retrospective compliance challenges, requirements to switch systems, and questions about historical record-keeping.
Your Responsibility
Ultimately, you're responsible for your records. The software you choose should support that responsibility, not create new vulnerabilities.
Whether you choose Kiroku or another provider, ask about compliance. Request documentation, such as Kiroku's Trust Centre. Understand what protections are in place.
Because in an increasingly litigious environment where AI-generated notes will soon be scrutinised in claims, compliance isn't bureaucracy - it's essential protection.
Quick FAQs
Do I need patient consent?
Legally, if audio isn't stored (as with Kiroku), consent isn't required. However, we recommend informing patients as professional courtesy: "I'm using technology to help with notes - not recording audio, just transcribing what we discuss."
What if the AI makes an error?
You remain professionally responsible for all notes. Kiroku provides easy editing, and our compliance processes mean we continuously monitor for systematic errors. But you must review and approve all notes.
Will this affect my indemnity insurance?
Using compliant, validated software demonstrates professional due diligence. We recommend asking your indemnity provider about AI note-taking tools, regardless of the software you use.
Kiroku customers indemnified with Densura also benefit from up to 10% off their medical malpractice premium.
Experience Compliant AI Note-Taking
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