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Register a new userFormalism for Supporting the Development of Verifiably Safe Medical Guidelines with Statecharts
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Chunhui Guo
Publication date
2019
fields
Informatics Engineering
and research's language is
English
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Improving the effectiveness and safety of patient care is the ultimate objective for medical cyber-physical systems. Many medical best practice guidelines exist, but most of the existing guidelines in handbooks are difficult for medical staff to remember and apply clinically. Furthermore, although the guidelines have gone through clinical validations, validations by medical professionals alone do not provide guarantees for the safety of medical cyber-physical systems. Hence, formal verification is also needed. The paper presents the formal semantics for a framework that we developed to support the development of verifiably safe medical guidelines. The framework allows computer scientists to work together with medical professionals to transform medical best practice guidelines into executable statechart models, Yakindu in particular, so that medical functionalities and properties can be quickly prototyped and validated. Existing formal verification technologies, UPPAAL timed automata in particular, is integrated into the framework to provide formal verification capabilities to verify safety properties. However, some components used/built into the framework, such as the open-source Yakindu statecharts as well as the transformation rules from statecharts to timed automata, do not have built-in semantics. The ambiguity becomes unavoidable unless formal semantics is defined for the framework, which is what the paper is to present.
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Improving patient care safety is an ultimate objective for medical cyber-physical systems. A recent study shows that the patients death rate can be significantly reduced by computerizing medical best practice guidelines. To facilitate the development of computerized medical best practice guidelines, statecharts are often used as a modeling tool because of their high resemblances to disease and treatment models and their capabilities to provide rapid prototyping and simulation for clinical validations. However, some implementations of statecharts, such as Yakindu statecharts, are priority-based and have synchronous execution semantics which makes it difficult to model certain functionalities that are essential in modeling medical guidelines, such as two-way communications and configurable execution orders. Rather than introducing new statechart elements or changing the statechart implementations underline semantics, we use existing basic statechart elements to design model patterns for the commonly occurring issues. In particular, we show the design of model patterns for two-way communications and configurable execution orders and formally prove the correctness of these model patterns. We further use a simplified airway laser surgery scenario as a case study to demonstrate how the developed model patterns address the two-way communication and configurable execution order issues and their impact on validation and verification of medical safety properties.
Improving effectiveness and safety of patient care is an ultimate objective for medical cyber-physical systems. A recent study shows that the patients death rate can be reduced by computerizing medical guidelines. Most existing medical guideline models are validated and/or verified based on the assumption that all necessary medical resources needed for a patient care are always available. However, the reality is that some medical resources, such as special medical equipment or medical specialists, can be temporarily unavailable for an individual patient. In such cases, safety properties validated and/or verified in existing medical guideline models without considering medical resource availability may not hold any more. The paper argues that considering medical resource availability is essential in building verifiably correct executable medical guidelines. We present an approach to explicitly and separately model medical resource availability and automatically integrate resource availability models into an existing statechart-based computerized medical guideline model. This approach requires minimal change in existing medical guideline models to take into consideration of medical resource availability in validating and verifying medical guideline models. A simplified stroke scenario is used as a case study to investigate the effectiveness and validity of our approach.
Improving patient care safety is an ultimate objective for medical cyber-physical systems. A recent study shows that the patients death rate is significantly reduced by computerizing medical best practice guidelines. Recent data also show that some morbidity and mortality in emergency care are directly caused by delayed or interrupted treatment due to lack of medical resources. However, medical guidelines usually do not provide guidance on medical resource demands and how to manage potential unexpected delays in resource availability. If medical resources are temporarily unavailable, safety properties in existing executable medical guideline models may fail which may cause increased risk to patients under care. The paper presents a separately model and jointly verify (SMJV) architecture to separately model medical resource available times and relationships and jointly verify safety properties of existing medical best practice guideline models with resource models being integrated in. The SMJV architecture allows medical staff to effectively manage medical resource demands and unexpected resource availability delays during emergency care. The separated modeling approach also allows different domain professionals to make independent model modifications, facilitates the management of frequent resource availability changes, and enables resource statechart reuse in multiple medical guideline models. A simplified stroke scenario is used as a case study to investigate the effectiveness and validity of the SMJV architecture. The case study indicates that the SMJV architecture is able to identify unsafe properties caused by unexpected resource delays.
Nowadays, systems containing components based on machine learning (ML) methods are becoming more widespread. In order to ensure the intended behavior of a software system, there are standards that define necessary quality aspects of the system and its components (such as ISO/IEC 25010). Due to the different nature of ML, we have to adjust quality aspects or add additional ones (such as trustworthiness) and be very precise about which aspect is really relevant for which object of interest (such as completeness of training data), and how to objectively assess adherence to quality requirements. In this article, we present the construction of a quality model (i.e., evaluation objects, quality aspects, and metrics) for an ML system based on an industrial use case. This quality model enables practitioners to specify and assess quality requirements for such kinds of ML systems objectively. In the future, we want to learn how the term quality differs between different types of ML systems and come up with general guidelines for specifying and assessing qualities of ML systems.
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