Box 3.

Principles for digital clinical safety

  • Collaboration: Partnership working between health and care organisations, regulators, industry, the scientific community and patients and citizens to ensure risks are understood and managed effectively.

  • Openness: Sharing of important information on potential risks to ensure appropriate escalation and mitigation activity.

  • Iterative change: Identifying learning from events to ensure systems are safe and using feedback loops wherever possible.

  • Proportionality: Developing processes that are proportionate to the scale, complexity and level of clinical risk associated with the programme of work. Proportionality ensures that risks are mitigated and controlled in accordance with their likelihood and severity.

  • Inclusion: Encouraging active co-production in digital safety processes to put patients, staff and the public at the heart of digital safety.