DCB0160 Clinical Risk Management for AI Products – Support for Practices (new products added 20.05.26)

Posted by: Sarah - Posted on:

In response to the requirement for a DCB0160 (Clinical Risk Management) prior to deploying AI products, N3i and the ICB have been working together to provide a DCB0160 for selected AI products. These resources are intended to support any of our practices wishing to adopt AI solutions.

We understand that not all practices have a Clinical Safety Officer and that the DCB0160 is a large piece of work so our aim was to produce a set of core documents, signed off by our clinical safety officer, that any of N3i’s practices can request and adapt to suit their specific context. While local tailoring will be necessary, the foundational documentation will be ready to use.

Earlier this year we circulated an AI questionnaire to all practices in the area. The responses helped us identify which AI products are currently in use or under consideration, allowing us to prioritise those for a DCB0160. As a result, Heidi Health is the first product for which a DCB0160 is now available to practices who have not yet undertaken their own assessment.

AI products with DCB0160 support (1)

Based on interest expressed by practices, the following products are being prioritised:

Heidi Health: available now – email n3i.dpo@nhs.net to request documentation

Anima Document Management: available now – email n3i.dpo@nhs.net to request documentation

Accurx Scribe: available now – email n3i.dpo@nhs.net to request documentation

Surgery Intellect (X-on powered by Tortus): available now – email n3i.dpo@nhs.net to request documentation

Due to the large number of AI products currently available, we are focusing our efforts on those with significant interest. Practices are welcome to undertake their own DCB0160 for products that are not listed above.

Responsibilities

While the documentation will be signed off by our Clinical Safety Officer, each practice remains responsible for:

  • completing and implementing the requirements in the provided document set
  • monitoring any issues that arise during live use
  • identifying and responding to any significant changes to the system

Thank you

Our Clinical Safety Officer can only produce these document sets for all to use when a pilot practice agrees to work with her, so many thanks to the pilot practices who have been involved with this process so far.

Update 20th May 2026

We have made some changes to the way we provide clinical safety support to practices, and we are pleased to introduce Emma Couch as our new in-house Clinical Safety Officer. Many of you will already know Emma as a valued member of our DOTS team though you may not be aware that she also had a clinical qualification that has enabled her to successfully complete her clinical safety training. She will be continuing to support practices with DCB0160 assessments in our current format, and will be reaching out to practices who are willing to attend hazard workshops.

Thank you to those who submitted their requests for DCB0160 support with AI products through our latest AI survey.

The AI products with the highest levels of interest are shown below. Because we now have the capacity to work on more than one product at a time, the order of completion will depend on engagement from both manufacturers and potential users. Other requested products may be added to the list when the manufacturer meets the standards set out by NHSE.

AI products with DCB0160 support (2) (in no particular order):

Lexacom (scribe)

Emma AI (telephony)

GP Autopilot (document management)

Health Orbit (scribe)

Accurx Navigator (does not use AI, but DCB0160 undertaken at ICB’s request as main product is widely used across the region)

We will inform all practices when the DCB0160 for the products listed above becomes available.