Building Trust in AI and Ambient Technology: How Diktamen Ensures Compliance and Clinical Safety for Healthcare

As the NHS and broader healthcare sector explore the transformative potential of AI and ambient clinical technology, the importance of compliance, safety, and governance has never been greater.

At Diktamen, we understand that delivering AI-driven documentation tools—such as our Ambient Writer plug-in—requires more than just technical capability. It demands a deep commitment to regulatory alignment, clinical risk management, and transparency.

That’s why we are taking clear, proactive steps to ensure our AI and ambient solutions are built on a foundation of compliance, trust, and clinical integrity.

A Compliance-First Approach to AI in Healthcare

NHS Trusts are rightly prioritising safe and standards-aligned digital tools. As AI and ambient solutions move closer to frontline clinical workflows, the need for suppliers to meet regulatory and safety obligations is growing fast.

Diktamen is rising to this challenge by focusing on three key areas:

1. Collaborating with Accredited Clinical Safety Partners

We are working with UK-based, NHS-accredited Clinical Safety Officers (CSOs) to ensure our products—particularly those supporting documentation and workflow automation—comply with DCB 0129 and DCB 0160 standards.

This includes:

• Producing Clinical Safety Case Reports
• Conducting clinical risk assessments
• Maintaining safety audits for all AI features

These efforts give Trusts assurance that our solutions are rigorously assessed for clinical safety and ready for real-world use.

2. Pursuing Certification Where Required

We are actively reviewing the regulatory classification of our AI and ambient features, particularly where structured note generation or automation may intersect with Software as a Medical Device (SaMD) regulations.

Our roadmap includes:

• Determining UKCA or CE marking requirements under UK MDR
• Working with compliance specialists to update technical files and risk documentation
• Aligning with MHRA guidance on AI tools in health and care

Our aim is to remove uncertainty for healthcare clients by offering clearly defined, certified, and regulation-ready products.

3. Aligning with NHS Procurement and IG Standards

To support NHS procurement teams, we have aligned our operations with core compliance frameworks, including:

• Data Security and Protection Toolkit (DSPT)
• NHS Digital’s IG and hosting standards
• Technical and commercial readiness for NHS frameworks and procurement hubs

We are also preparing standardised compliance packs to help NHS buyers easily assess:

• Data processing and hosting credentials
• Safety and governance oversight
• Product lifecycle and update protocols

Responsible AI Starts with Accountability

We believe that innovation in healthcare is only valuable if it is safe, transparent, and ethically grounded. By investing in compliance and certification, Diktamen is making sure our ambient AI tools are as trustworthy as they are effective.

This isn’t just about meeting regulatory obligations—it’s about being a responsible partner to the NHS, clinicians, and the patients they serve.

The Future of Ambient AI, Done Right

As interest in AI-powered ambient documentation grows, so too does the expectation for solutions that are clinically safe, legally compliant, and implementation-ready.

Diktamen is proud to be leading the way by:

• Building AI tools that enhance rather than disrupt existing workflows
• Partnering with clinical safety specialists
• Proactively pursuing the certifications and governance NHS buyers require

For healthcare organisations looking to embrace the benefits of ambient AI without compromising on compliance, Diktamen offers a secure, sustainable path forward.