Clinical Risk Management Governance

Overview

Clinical Risk Management (CRM) governance is crucial in the development, deployment, and use of digital health technologies within the UK healthcare sector. It ensures that these technologies are safe, effective, and aligned with clinical needs, thereby safeguarding patient health and enhancing care delivery.

Importance of CRM Governance

1. Patient Safety: CRM governance ensures that digital health technologies do not pose undue risks to patients. By identifying, assessing, and mitigating potential hazards, it minimises the likelihood of adverse events.
2. Regulatory Compliance: Adhering to CRM governance helps healthcare organisations comply with legal and regulatory standards, such as those mandated under the Health and Social Care Act.
3. Quality Assurance: It provides a structured approach to continuously monitor and improve the safety and effectiveness of digital health systems.
4. Stakeholder Confidence: Robust CRM governance builds trust among patients, healthcare professionals, and regulatory bodies by demonstrating a commitment to safety and quality.

Purpose of CRM Governance

1. Risk Identification and Mitigation: To systematically identify potential risks associated with digital health technologies and implement measures to mitigate them.
2. Continuous Monitoring: To establish ongoing surveillance mechanisms that ensure the continued safety and effectiveness of deployed technologies.
3. Incident Management: To provide clear protocols for managing and learning from incidents, ensuring that similar issues are prevented in the future.
4. Stakeholder Engagement: To involve various stakeholders, including patients, in the governance process, ensuring that their perspectives and needs are considered.

Integrating CRM Governance into Existing Structures

To effectively integrate CRM governance into healthcare organizations, several essential requirements must be met:

1. Organisational Governance: Establish a clear governance model that includes board-level assurance and policy oversight. This ensures that CRM processes are aligned with the organisation’s strategic goals and regulatory requirements .
2. Dedicated CRM Groups: Form specialised groups such as Clinical Safety Groups (CSG) and Digital Safety Steering Groups (DSSG) to oversee the CRM processes. These groups should have the authority to make decisions, provide support, and escalate issues as necessary .
3. Defined Processes and Procedures: Develop and implement standard operating procedures (SOPs), service level agreements (SLAs), and terms of reference that outline the CRM processes. This includes hazard identification, risk assessment, incident management, and mitigation strategies .
4. Stakeholder Representation: Ensure that there is patient representation and input from various stakeholders in the CRM governance structure. This helps in making informed decisions that reflect the needs and concerns of all parties involved .
5. Training and Support: Provide comprehensive training for staff on CRM processes and the use of digital health technologies. Establish support mechanisms such as service desks and incident management systems to assist users .
6. Continuous Review and Improvement: Regularly review and update the CRM processes and governance structures to adapt to new challenges and technological advancements. Conduct audits and generate reports to ensure compliance and identify areas for improvement .

Best Practices

The attached documents provide examples of best practices in Clinical Risk Management governance:

• Digital Health Governance Model: Highlights the integration of CRM governance into organisational functions and processes, including strategy, decision-making, and risk ownership .
• ICB Digital Clinical Safety Structure: Illustrates the hierarchical structure and authority of various CRM groups, ensuring clear lines of support, guidance, and escalation.

By adopting these best practices, healthcare organisations can effectively manage clinical risks associated with digital health technologies, ensuring the safety and well-being of patients.

By partnering with DPM Digital Health, healthcare organisations and digital health providers can navigate the complex regulatory landscape with confidence, ensuring their systems are not only compliant but also optimised for safety and efficiency in the ever-evolving healthcare environment.