NHS service standard - 16. Make your service clinically safe

Digital information, tools and services have the potential to cause patient harm.

Make sure that you actively manage any safety risks associated with your content, service and processes.

Why it's important

Clinical risk management is key to creating safe digital services. Work with your clinical safety officer to consider what could go wrong, how serious it could be, and how likely it is, so that you can minimise the risk of harm.

What you should do

Your team should be able to show that you:

• have a nominated clinical safety officer - in other words, a clinician with a current professional registration who has been trained in clinical risk management and is accountable for clinical safety
• have qualified clinicians check your clinical information and make sure that it is accurate, evidence-based and clinically safe
• meet the needs of your most vulnerable users, for example, by allowing patients to request a translator or flagging safeguarding needs
• if appropriate, work to DCB0129 (the safety standard for manufacturers of health IT software) or DCB0160 (the standard that helps health and care organisations manage the risks of using new or changed health software), or both
• have processes for developing and maintaining your service and managing live safety incidents that comply with the relevant clinical safety standard
• have processes to make sure that any data you collect is up to date and error free
• where appropriate, comply with NICE's Evidence standards framework for digital health technologies

If you provide online primary care services, you must register with the Care Quality Commission.

If your app is a medical device, you must follow the guidance on medical devices from the Medicines and Healthcare products Regulatory Agency (MHRA).

Guidance

NHS service manual

See also service standard points:

• 9. Respect and protect users' confidentiality and privacy
• 10. Define what success looks like and be open about how your service is performing - which deals with health and other outcomes
• 15. Support a culture of care

GOV.UK resources

This point is not in the Government service standard.

Read more about this

• Medical devices: software applications (apps) (MHRA, on GOV.UK)
• Online primary care services (Care Quality Commission) and how the CQC monitors, inspects and regulates them
• Safeguarding (NHS England)

Other help

• Talk to us on the service manual Slack channel or email the standards team at service-manual@nhs.net.
• Contact the NHS Digital Clinical Safety team at assurance@nhs.net or on 0300 303 5678.
• Take up NHS Digital clinical risk management training.