DCB0160 Clinical Risk Management for AI Products – Support for Practices

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

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

Tortus: all practices will be emailed when this becomes available

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.