National review of clinical risk management standards DCB0129 and DCB0160

Overview

Help shape the future of patient safety

We are seeking views from manufacturers and users of health and social care technology products to help us improve the clinical risk management standards DCB0129 and DCB0160.

While we are keen to hear from wider audiences, this is primarily a technical consultation aimed at individuals with current experience or knowledge of the clinical risk management standards.

What are these standards and why do they matter?

These mandatory standards protect patients by ensuring all health IT systems (for example, electronic patient records and clinical decision support systems) are properly assessed for clinical risks before they are used in patient care. DCB0129 sets out requirements for technology manufacturers and DCB0160 covers how health and social care organisations deploy and use these systems safely.

Why are we reviewing these standards?

The revised standards must reflect advances in healthcare technology. For example, artificial intelligence supporting clinical decisions, complex interconnected systems sharing data across organisations, and new technologies like voice recognition and machine learning becoming routine in patient care.

Before you begin

Participation in this consultation is voluntary, and all findings will be anonymised.

You must read the supporting information before answering the questions. This provides essential context about:

• our findings from focus groups with healthcare professionals, technology suppliers and clinical safety officers (CSOs)
• the current challenges
• the key areas we are considering for improvement

The questionnaire is divided into 3 sections

1. information about you (these questions require a response)
2. requirements established in the specifications (most of these questions require a response)
3. implementation guidance and wider support of the specifications (these questions are optional).

Please note it is likely that any changes made to the specifications will be in direct response to the analysis of the second set of questions.

Please provide as much information as possible in support of your responses.