ISB 0129 Clinical Risk Management: its Application in the Manufacture of Health IT Systems - Post Implementation Review

Closed 21 Oct 2013

Opened 22 Jul 2013


Since November 2009 there have been two Safety Standards to define how clinical risk management should be applied and managed in both the manufacture (ISB 0129) and the deployment (ISB 0160) of health software in the NHS.

As part of the normal maintenance cycle for NHS standards, an assessment has been made of the implementation of these two standards. Based on the results of this assessment, the standards were revised to create simpler and more structured documentation; with the Specification containing requirements and second document providing implementation guidance.

February 2013 saw the launch of the updated Safety Standards. The primary focus of this consultation process is to learn whether the revised Standards are usable, easy to apply and improve the effectiveness of clinical risk management in the broader setting of Health IT Systems.

Why your views matter

This consultation has been initiated by the Health and Social Care Information Centre (HSCIC), on behalf of the Information Standards Board (ISB) to:

  1. Quantify whether the new structure and the separation of requirements from guidance material has resulted in documents which are easier to read and implement
  2. Identify potential areas for further enhancement in a future iteration of the standards.

The consultation is being run to obtain wider feedback from users of the standard.


  • All Areas


  • Heads of Information
  • Information Managers


  • Clinical Safety
  • Clinical Risk Management