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Step 1 - Register for Clinical Safety Compliance (DCB0160)

Before EMMA can go live in your practice, NHS regulations require completion of DCB0160 clinical safety compliance. This is a mandatory national standard for all digital products used in patient care.

We recognise that this step can feel like a lot, particularly for busy practices or for teams who may not have completed DCB0160 before. That’s completely normal. Our aim is to ensure you are fully supported through this process so compliance can be completed smoothly and EMMA can go live as quickly as possible.

What is DCB0160? 

DCB0160 is the NHS clinical safety standard that ensures digital systems:

  • Are safe for use in patient-facing environments
  • Have been clinically risk assessed
  • Include appropriate governance, oversight, and documentation

This process helps protect patients, staff, and your practice, and is required for any system that interacts with patients.

Clinical Safety Support: Bordercross Health

We’ve partnered with Bordercross Health because we have worked with them to support practices and trust their clinical safety expertise.

Bordercross Health has extensive experience supporting GP practices and NHS organisations across England with DCB0160 compliance for a wide range of digital health, technology, and AI-enabled products. They understand the realities of general practice, the pressures teams are under, and how to make the compliance process as practical and proportionate as possible.

Many practices have limited time or haven’t completed this type of compliance work before. Bordercross Health will guide you step by step, explain what’s required in clear, non-technical language, and provide hands-on support throughout.

What You Need to Do

1. Register your practice with Bordercross Health

2. Follow the steps they provide. Bordercross Health will:

  • Clearly explain what information is required and why

  • Provide templates and structured guidance

  • Support completion of the required documentation

  • Help you reach clinical safety sign-off

  • You are not expected to have prior clinical safety expertise to complete this step.

Why This Matters

  • DCB0160 compliance is required before EMMA can be activated
  • Early registration helps prevent delays later in onboarding
  • Completing this step keeps your implementation on schedule

Deadline

Please register within 48 hours of receiving this onboarding step.

If you have any questions or concerns at any point, contact the QuantumLoop AI team — we are here to support you through every stage of the process.