Step by step guidance

DCB 0129 and DCB 0160 are 'Information standards', as defined in section 250(2) of the Health and Social Care Act 2012. As set out in section 250 (6) (c) and (d) of the Health and Social Care Act 2012, the following organisations must take account of 'Information standards': 

(c) any public body which exercises functions in connection with the provision of health services or of adult social care in England;

(d) any person (other than a public body) who provides health services, or adult social care in England, pursuant to arrangements made with a public body exercising functions in connection with the provision of such services or care.

In determining the applicability of DCB 0129 and DCB 0160, organisations must consider the customers, commissioners and intended users of the 'Digital product' and whether (c) or (d) above apply.

DCB 0129 and DCB 0160 represent best practice in 'Clinical risk management' of 'Digital products' and even if (c) and (d) above do not apply it is strongly recommended that 'Deployment organisations' specify compliance in their contracting mechanisms.

It is recommended that both 'Manufacturers' and 'Deployment organisations' consider the Digital Technology Assessment Criteria (DTAC).

'Digital products' that are developed with private funding but are subsequently deployed in a publicly commissioned care service would fall within scope of section 250 (6) of the Health and Social Care Act 2012.

'Digital products' that are totally privately funded (developed and deployed) fall outside of the section 250 (6) of Health and Social Care Act 2012 but NHS Digital strongly recommend that DCB 0129 and DCB 0160 are adopted.

As in Step 1, the Health and Social Care Act 2012 only applies in the context of 'Publicly funded' health and/or adult social care services in England.  

'Digital products' that provide wellbeing or lifestyle advice fall outside of scope. 

Examples of such apps include Becca, the breast cancer support app and Brush DJ, the app that makes brushing your teeth fun. 

However, NHS Digital strongly recommend that DCB 0129 and DCB 0160 are adopted. 

DCB 0129 / DCB 0160 only applies 'Digital products' that influence the real-time or near-real time direct care of 'Patients / 'Service users'.  

Population health 'Digital products', for example those that are used for statistical reporting purposes, fall out of scope of DCB 0129 and DCB 0160.

However, NHS Digital strongly recommend that DCB 0129 and DCB 0160 are adopted especially where such products are used to make care commissioning decisions.

If the 'Digital product' is not placed on the market as a 'Medical device' nor is an accessory to a 'Medical device', and it meets criteria 1, 2 and 3, then it falls within scope of DCB 0129 and DCB 0160.  

Note: this applies to in-house 'Digital products' that qualify as 'Medical devices' but are not subject to UK Medical Device Regulations 2002 (devices manufactured and used within a Health Institution).

If the 'Digital product' is placed on the market as a 'Medical device' or an accessory to a 'Medical device', then the Medical Device Regulations appropriate to its classification must be followed.

If the 'Medical device' or an accessory to a 'Medical device' is 'Implemented' within a 'Health IT system', then that functionality also falls within the scope of DCB 0129 / DCB 0160.

An example of this would be the implementation of a QRisk3 calculator in a primary care desktop application.

Conversely, an example where DCB 0129 / DCB 0160 would not apply would be software based dosing algorithms that are implemented within a physical infusion pump.

If the 'Medical device' or an accessory to a 'Medical device' is 'Integrated' within an IT network then a deploying organisation may wish to consider using ISO - IEC 80001-1:2021 to manage the clinical risk of 'Integration'.

ISO - IEC 80001-1:2021 specifies general requirements for organisations in the application of 'Risk management' before, during and after the connection of a 'Health IT system' within a 'Health IT infrastructure'.