Process-oriented analysis for medical devices

Medical Cyber Physical Systems are widely used in modern healthcare environments. Such systems are considered life-critical due to the severity of consequences that faults may cause. Effective methods, techniques and tools for modeling and analyzing medical critical systems are of major importance for ensuring system reliability and patient safety. This work is looking at issues concerning different types of medical industry needs including safety analysis, testing, conformance checking, performance analysis and optimization. We explore the possibility of addressing these issues by exploiting information recorded in logs generated by medical devices during execution. Process-oriented analysis of logs is known as process mining, a novel field that has gained considerable interest in several contexts in the last decade. Process mining techniques will be applied to an industrial use case provided by Fresenius, a manufacturer of medical devices, for analyzing process logs generated by an infusion pump.Postprint (published version

Study of a Context Quality Model for UbiPri Middleware

With the growth of ubiquitous computing, context-aware computing-based applications are increasingly emerging, and these applications demonstrate the impact that context has on the adaptation process. From the context, it will be possible to adapt the application according to the requirements and needs of its users. Therefore, the quality of the context information must be guaranteed so that the application does not have an incorrect or unexpected adaptation process. But like any given data, there is the possibility of inaccuracy and/or uncertainty and so Quality of Context (QoC) plays a key role in ensuring the quality of context information and optimizing the adaptation process. To guarantee the Quality of Context it is necessary to study a quality model to be created, which will have the important function of evaluating the context information. Thus, it is necessary to ensure that the parameters and quality indicators to be used and evaluated are the most appropriate for a given type of application. This paper aims to study a context quality model for the UbiPri middleware, defining its quality indicators to ensure its proper functioning in the process of adaptation in granting access to ubiquitous environments. Keywords: QoC, Model, Context-Aware, Data, Privac

Towards Regulatory-Compliant MLOps: Oravizio’s Journey from a Machine Learning Experiment to a Deployed Certified Medical Product

Peer reviewe

High assurance interactive computing systems

If interactive computing systems development is to be considered an engineering discipline, we need methods and tools to help us reason about and predict the quality of systems, from early in the design process. This paper provides a brief overview of work we have been carrying out in the general area of evaluating and ensuring the quality of interactive computing. systems. Some of the work currently being carried out is also discussed. Discussed approaches range from the formal verification of user interface models through model checking, to the reverse engineering and model based testing of implemented interactive computing systems

Impact of EU Medical Device Directive on Medical Device Software

Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls

Data trust framework using blockchain and smart contracts

Lack of trust is the main barrier preventing more widespread data sharing. The lack of transparent and reliable infrastructure for data sharing prevents many data owners from sharing their data. Data trust is a paradigm that facilitates data sharing by forcing data controllers to be transparent about the process of sharing and reusing data. Blockchain technology has the potential to present the essential properties for creating a practical and secure data trust framework by transforming current auditing practices and automatic enforcement of smart contracts logic without relying on intermediaries to establish trust. Blockchain holds an enormous potential to remove the barriers of traditional centralized applications and propose a distributed and transparent administration by employing the involved parties to maintain consensus on the ledger. Furthermore, smart contracts are a programmable component that provides blockchain with more flexible and powerful capabilities. Recent advances in blockchain platforms toward smart contracts' development have revealed the possibility of implementing blockchain-based applications in various domains, such as health care, supply chain and digital identity. This dissertation investigates the blockchain's potential to present a framework for data trust. It starts with a comprehensive study of smart contracts as the main component of blockchain for developing decentralized data trust. Interrelated, three decentralized applications that address data sharing and access control problems in various fields, including healthcare data sharing, business process, and physical access control system, have been developed and examined. In addition, a general-purpose application based on an attribute-based access control model is proposed that can provide trusted auditability required for data sharing and access control systems and, ultimately, a data trust framework. Besides auditing, the system presents a transparency level that both access requesters (data users) and resource owners (data controllers) can benefit from. The proposed solutions have been validated through a use case of independent digital libraries. It also provides a detailed performance analysis of the system implementation. The performance results have been compared based on different consensus mechanisms and databases, indicating the system's high throughput and low latency. Finally, this dissertation presents an end-to-end data trust framework based on blockchain technology. The proposed framework promotes data trustworthiness by assessing input datasets, effectively managing access control, and presenting data provenance and activity monitoring. A trust assessment model that examines the trustworthiness of input data sets and calculates the trust value is presented. The number of transaction validators is defined adaptively with the trust value. This research provides solutions for both data owners and data users’ by ensuring the trustworthiness and quality of the data at origin and transparent and secure usage of the data at the end. A comprehensive experimental study indicates the presented system effectively handles a large number of transactions with low latency