Since the digital systems have become more integrated in clinical processes, such as electronic prescribing or decision support and AI-based tools, the need to prove safety in a structured and transparent manner has become a more significant concern.
The clinical safety case is not merely a document produced at the end of a regulatory process. It is a systematic, evidence-based argument, which proves that a system is safe to do what it is designed to do, and all risk management procedures have been completed..
Although national standards and guidance are available, the quality of clinical safety cases differs greatly across organisations and suppliers. There are those that give clear and defensible assurance as required by regulations and those that do not meet expectations because of poor structure, lack of sufficient evidence or inadequate clinical involvement.
Here we try to explain what makes a good (or bad) clinical safety case.
The relevance of clinical safety cases in digital healthcare.
Compliance with DCB0129 and DCB0160 standards ensure organisations demonstrate how risks linked to digital health systems have been systematically identified, assessed and controlled.
Beyond compliance, a well-developed safety case enables businesses to:
- Show that the risks of patient safety are known and addressed.
- Fulfil their obligations to deliver safe digital.
- Promote the continued use of digital systems.
A weak clinical safety cases, undermines a projects safety profile, with risks being misjudged, ignored or poorly managed.
What a good clinical safety case development would look like.
Quality clinical safety cases are defined by their clarity, structure, and evidence base. They are not too complicated, but they are complete, proportional, and consistent with the accepted standards. It should articulate a clear and coherent story logically describing:
- The extent and purpose of the system.
- The safety claims being made.
- The reasons behind these assertions
- The supporting evidence of every argument.
This framework enables reviewers to understand the Clinical Safety Officer’s argument and how the safety conclusions have been drawn. Inadequate structure is usually among the first signs of poor work, and it is hard to determine whether the risks have been properly managed.
Comprehensive risk recognition.
The basis of any safety case is the identification of hazards. Good methodical practice takes into consideration:
- Clinical processes and practice.
- Technical system behaviour and failure modes.
- Human factors, such as human interaction and misuse.
- Connection points to other systems and services.
Good safety cases do not just list hazards but also describe them, indicate when they occur and how they may result in patient harm.
A weak safety case can have unspecified or generalized hazards which are not representative of the real system or use.
Strong and clear risk management.
A description of the risk management methodology is an essential component of a high-quality safety cases. It should detail:
- Risk scoring methodologies used regularly.
- Good connection between hazards, causes, consequences and controls.
- Detection and establishment of the right mitigation measures, and who is responsible for their implementation.
- Residual risk assessment and reporting.
Good, traceable evidence base.
A clinical safety case report is meaningless with the provision of evidence to support your safety argument. All safety claims must be backed with the right evidence, that is current, relevant and traceable between hazards, controls and assurance activities.
Examples of evidence can be system testing outcomes, clinical validation research, user training documentation and governance approvals. Weak safety cases are based on assumptions or unsubstantiated statements and this compromises their credibility and utility.
Reasonable and realistic Risk Benefit Analysis
The art of clinical risk management is in the reasoned comparison of a systems risk against the anticipated benefits. Quantification of potential harm is dependent on the digital system’s use case, and can change depending on the level of human oversight and the patient population involved.
Typical signs of poor development of safety cases.
Weak cases tend to have common problems.
- Little clinician participation.
- Poorly defined hazards
- Absence of clinical validation or review.
- Lack of consideration of real-life workflows and constraints.
- Insufficient evidence
- Uneven implementation of risk processes.
How to implement this in practice
The most important step in putting together a defensible and effective clinical safety case is to hire a Clinical Safety Officer you can trust to provide independent and objective risk appraisal and mitigation services. Your CSO is responsible for ensuring compliance with the NHS’ DCB safety standards, abd therefore must be knowledgeable in digital product development, implementation and clinical workflows. They work seamlessly with subject matter experts to produce a compelling safety argument.
At BMS Digital Safety we pride ourselves in providing bespoke clinical safety officer services, that are tailored to your company’s unique needs. We believe that no two risk management projects are the same, and produce safety cases to reflect the unique benefits of your digital solution.