Overview of NHS Digital Clinical Risk Management Standards
The NHS has established two key standards for clinical risk management in digital health:
- DCB0129: Clinical Risk Management in the Manufacture of Health IT Systems
- DCB0160: Clinical Risk Management in the Deployment and Use of Health IT Systems
These standards are mandatory under the Health and Social Care Act 2012 and are crucial for ensuring patient safety in the digital health landscape.
DCB0129: Manufacturer Responsibilities
DCB0129 outlines requirements for manufacturers of digital health systems:
- Establishes a framework for effective clinical risk management
- Applies to all stages of product development
- Ensures safety considerations are integrated into the manufacturing process
DCB0160: Healthcare Organisation Responsibilities
DCB0160 mirrors DCB0129 but focuses on healthcare organisations:
- Guides the safe deployment, use, maintenance, and decommissioning of digital health systems
- Requires organisations to implement clinical risk management processes
- Ensures ongoing safety monitoring and management
Importance in the Growing Digital Health Market
With the rapid expansion of digital health solutions, these standards are more critical than ever:
- Address potential increases in clinical safety incidents
- Require robust clinical risk management (CRM) processes
- Necessitate comprehensive risk management documentation
Professional Support for Compliance
To meet these standards effectively, organisations can benefit from:
- Expert teams including Clinical Safety Officers and Regulatory Affairs Specialists
- Professionals with extensive healthcare sector experience
- Comprehensive clinical safety activity management
- Access to a broad network of digital health experts
By prioritising compliance with DCB0129 and DCB0160, digital health manufacturers and healthcare organisations can ensure they are delivering safe, effective solutions that protect patient safety and meet regulatory requirements.