The Role of Explainability in Assuring Safety of Machine Learning in Healthcare

Established approaches to assuring safety-critical systems and software are difficult to apply to systems employing machine learning (ML). In many cases, ML is used on ill-defined problems, e.g. optimising sepsis treatment, where there is no clear, pre-defined specification against which to assess validity. This problem is exacerbated by the "opaque" nature of ML where the learnt model is not amenable to human scrutiny. Explainable AI methods have been proposed to tackle this issue by producing human-interpretable representations of ML models which can help users to gain confidence and build trust in the ML system. However, there is not much work explicitly investigating the role of explainability for safety assurance in the context of ML development. This paper identifies ways in which explainable AI methods can contribute to safety assurance of ML-based systems. It then uses a concrete ML-based clinical decision support system, concerning weaning of patients from mechanical ventilation, to demonstrate how explainable AI methods can be employed to produce evidence to support safety assurance. The results are also represented in a safety argument to show where, and in what way, explainable AI methods can contribute to a safety case. Overall, we conclude that explainable AI methods have a valuable role in safety assurance of ML-based systems in healthcare but that they are not sufficient in themselves to assure safety.

A Framework for Assurance of Medication Safety using Machine Learning

Medication errors continue to be the leading cause of avoidable patient harm in hospitals. This paper sets out a framework to assure medication safety that combines machine learning and safety engineering methods. It uses safety analysis to proactively identify potential causes of medication error, based on expert opinion. As healthcare is now data rich, it is possible to augment safety analysis with machine learning to discover actual causes of medication error from the data, and to identify where they deviate from what was predicted in the safety analysis. Combining these two views has the potential to enable the risk of medication errors to be managed proactively and dynamically. We apply the framework to a case study involving thoracic surgery, e.g. oesophagectomy, where errors in giving beta-blockers can be critical to control atrial fibrillation. This case study combines a HAZOP-based safety analysis method known as SHARD with Bayesian network structure learning and process mining to produce the analysis results, showing the potential of the framework for ensuring patient safety, and for transforming the way that safety is managed in complex healthcare environments.