DCB 0129 and DCB 0160 set out the requirements for managing clinical risk in health IT systems in England. Unfortunately, the array of different documents often causes confusion. There are several documents, several versions of those documents, periodic renaming and different places on the web they are stored. Let me try to put that confusion to rest starting with the history:

The standards were first issued by Connecting for Health (CfH) in 2009. From the outset there were two back-to-back standards; one aimed at the manufacturer of health IT systems and the other at healthcare organisations implementing those systems. In the early days the standards were known as DSCN 14/2009 for the manufacturer and DSCN 18/2009 for the healthcare organisation.

It’s safe to say (pardon the pun) that the original version of the standard was somewhat overwhelming and cumbersome for those of us with a clinical background. Uptake was slow and putting the requirements into practise required the skills of an experienced safety engineer. By 2012 CfH had realised that all was not well and a much-needed revision relieved the misery. Following a consultation exercise, CfH (soon to become HSCIC) re-issued the two standards in their current form. Around the same time, new names for the standards were adopted – ISB 0129 and ISB 0160.

The revision resulted in two significant changes. Firstly, the language used to describe the requirements was greatly simplified. The documents suddenly became far more accessible to clinicians and those without a safety background. Secondly, each standard was essentially split into two documents; one containing the normative specification (i.e. the things that MUST be done) and one setting out the informative guidance (i.e. what might be considered good practice but not necessarily be the prescriptive approach).

In 2016, HSCIC (now NHS Digital) again renamed the standards this time to SCCI 0129 and SCCI 0160 – the standards themselves remained unchanged. Finally in 2018, NHS Digital added clarification regarding the relationship between the standards and Medical Device legislation and the documents were renamed DCB 0129 and DCB 0160.

So, in summary, there are a total of four current documents. The links below take you to the correct version, in the correct location. I will endeavour to keep this blog post up-to-date should they move again.

The latest specification for manufacturers – DCB 0129 specification
The latest guidance for manufacturers – DCB 0129 guidance
The latest specification for healthcare organisations – DCB 0160 specification
The latest guidance for healthcare organisations – DCB 0160 guidance

If you only intend to read a single document, then my advice is as follows:

Manufacturers – read this
Healthcare organisations – read this

…and that’s about the limit of my simplification.