Healthcare is at the beginning of rapid digital transformation. Innovative clinical and administrative technologies, often driven by Artificial Intelligence, is altering the future of the health and social care sector, driving more quicker, efficient, and more personalised care.
How can we drive innovation without affecting patient safety?
Clinical risk management seeks to balances both efficacy and safety. Done well, it is not a box ticking exercise, but a sensible, systematic method for the assessment of your product’s safety profile. It allows us to assure ourselves of the new technologies benefit against quantifiable risk.
Aligning risk management processes alongside design, development and deployment processes allows you to implement innovative solutions that are safe, scalable, and most importantly, reliable.
Understanding Clinical Risk Management
Clinical Risk Management (abbreviated to CRM) is an ongoing activity that identifies, analyses, evaluates, and manages risks related to health information technology implementation systems. Its first aim is to ensure that digital health solutions do not harm to patients.
Clinical risk management is not a one-time project that is completed just before system deployment, but instead a continuous safety method that operates throughout the entire lifecycle of the digital health project, from the initial ideation and design, into development, testing and deployment stages and then deployment and final decommissioning.
With apps, AI, and sophisticated software entering the healthcare sector, we must proactively work together to try to identify and mitigate patient risk before they occur, be it incorrect diagnoses, medication mistakes, or a postponement in treatment, with the goal to ensure technologies assists not impair clinical care.
The 5 Essential Pillars of an Effective Clinical Risk Management Process
Effective Clinical Risk Management is a cyclical and systematic process. It consists of five fundamental steps:
- Hazard Identification: This is the first stage of identifying possible failures. The ways in which something might go wrong are determined by conducting workshops, reviewing past issues, and understanding the workings of the system.
- Risk Analysis and Evaluation: Risk: The risk has to be estimated for each of the identified hazards. This is usually determined along two axes: the severity of potential damage (from minor to catastrophic) and the likelihood of its occurrence (from improbable to daily). This allows for the prioritisation of the most significant hazards and the quantification of the technology’s risk profile.
- Risk Control: After risk quantification of risks it is time to identify how these can be mitigated to a manageable level. Successful risk control is more likely by design changes. The weakest controls are those which depend on human behavioural changes, such a straining and business procedures.
Hazard, risk ratings and controls are documented in the product’s Hazard Log.
- Risk Management Implementation and Verification: This is where we put in place the safety measures and ensure that they are doing what they are supposed to do, whether they are in practice or real-life situations. It entails intensive tests, verification, and confirmation that all the safety mechanisms are appropriately integrated in the live system.
- Monitoring and Continuous Improvement: CRM does not stop once it has been deployed. The system has to be monitored continuously during its operation. The hazard log is a live document that records all the hazards identified, their level of risk, and actions undertaken, and is updated with new hazards, such as system updates or incident reports.
Why Your Safety Culture Matters
Unfortunately, the perception of CRM and the DCB 0129 & 0160 Standards in many organisations is of mandatory regulation that serves little more than compliance paperwork. A list of documents created to please the regulators, NHS England, and procurement.
Risk management is a team game – without the contributions of everyone, it cannot take place effectively.
- Leadership Buy-In: Safety should be placed at the top levels, and there should be sufficient resources and powers for the clinical safety specialists.
- Proactive attitude: It is necessary to be more proactive rather than reactive when incidents occur, and to prevent them by means of strict hazard detection.
- Shared Responsibility: When all the parties are involved, the developers, project managers, clinicians, and end-users, it comes with the advantage of having multi-disciplinary skillset and a range of safety opinions and experiences.
Clinical Risk Management should form the basis of your organisation’s cultural pillar, ensuring all decisions are guided by patient welfare.
Tools & Frameworks
Clinical Risk Management is regulated by two main standards, which apply across England, Wales & Northern Ireland.
DCB0129 (Clinical Risk Management: Application Design): This standard is used by health IT system manufacturers. It requires safety to be built into their products from the very beginning, a specified process, and a Clinical Safety Case Report and Hazard Log to demonstrate that every sensible measure has been taken to reduce risk.
DCB0160 (Clinical Risk Management: Deployment and Use): This standard is relevant to health care organisations using such systems. It involves the management of the clinical risks related to their deployment, configuration, and usage in their particular environment.
These frameworks provide a unified language and methodology, ensuring alignment between those who create and those who use digital health solutions in their efforts to ensure patient safety.
The Hazard Log: A Living Safety Document
Hazard logs can mistakenly be viewed as a fixed document that will be stored after the project. As a matter of fact, it forms the backbone of a sound CRM system, a living safety record that provides an exhaustive, auditable account of the safety process of a system.
A well‑maintained hazard log:
- Tracks the lifecycle of a hazard: Identification, mitigation, and final status.
- Reports to decision-making: presents evidence so that the Clinical Safety Officer can certify that a system is safe.
- Enables learning: It is used as a knowledge base in future projects and system updates, minimising the chances of experiencing the same risks.
Reshaping the Future of the NHS’ Digital Transformation, Together.
Clinical Risk Management is not an attempt to slow down and delay innovation. Clinical Risk Management ensures the appropriate safeguards are in place to allow new technologies to flourish and scale with confidence.