Modelling bio-compatible and bio-integrative medical devices

International audienceDeveloping and producing medical devices and healthcare systems is a crucial issue, both for the economy and for providing safe advances in healthcare delivery. We propose a taxonomy of medical human machine systems and we define classes of healthcare applications for identifying a number of approaches and to overcome difficulties of bio-compatibility and bio-integration. Our aim is to demonstrate how medical devices design, and more generally human-machine system concepts and epistemology, depend on our skills to think and conceptualize generally human system integration. We claim that it is necessary to reclaim these concepts for ensuring correct by construction medical devices bio-compatibility and biointegrative properties from the early stage of the design process

Using Ontologies in Formal Developments Targeting Certification

This is the author accepted manuscript. The final version is available from Springer Verlag via the DOI in this recordIFM 2019: 15th International Conference on integrated Formal Methods, 4-6 December 2019, Bergen, NorwayA common problem in the certification of highly safety or security critical systems is the consistency of the certification documentation in general and, in particular, the linking between semi-formal and formal content of the certification documentation. We address this problem by using an existing framework, Isabelle/DOF, that allows writing certification documents with consistency guarantees, in both, the semi-formal and formal parts. Isabelle/DOF supports the modeling of document ontologies using a strongly typed ontology definition language. An ontology is then enforced inside documents including formal parts, e.g., system models, verification proofs, code, tests and validations of corner-cases. The entire set of documents is checked within Isabelle/HOL, which includes the definition of ontologies and the editing of integrated documents based on them. This process is supported by an IDE that provides continuous checking of the document consistency. In this paper, we present how a specific software-engineering certification standard, namely CENELEC 50128, can be modeled inside Isabelle/DOF. Based on an ontology covering a substantial part of this standard, we present how Isabelle/DOF can be applied to a certification case-study in the railway domain.IRT System

Standardisation of Practices in Open Source Hardware

Standardisation is an important component in the maturation of any field of technology. It contributes to the formation of a recognisable identity and enables interactions with a wider community. This article reviews past and current standardisation initiatives in the field of Open Source Hardware (OSH). While early initiatives focused on aspects such as licencing, intellectual property and documentation formats, recent efforts extend to ways for users to exercise their rights under open licences and to keep OSH projects discoverable and accessible online. We specifically introduce two standards that are currently being released and call for early users and contributors, the DIN SPEC 3105 and the Open Know How Manifest Specification. Finally, we reflect on challenges around standardisation in the community and relevant areas for future development such as an open tool chain, modularity and hardware specific interface standards.Comment: 9 Pages without abstract and references (else 13), no figure

Isabelle/DOF: Design and Implementation

This is the author accepted manuscript. The final version is available from Springer Verlag via the DOI in this record17th International Conference, SEFM 2019 Oslo, Norway, September 18–20, 2019DOF is a novel framework for defining ontologies and enforcing them during document development and evolution. A major goal of DOF is the integrated development of formal certification documents (e. g., for Common Criteria or CENELEC 50128) that require consistency across both formal and informal arguments. To support a consistent development of formal and informal parts of a document, we provide Isabelle/DOF, an implementation of DOF on top of the formal methods framework Isabelle/HOL. A particular emphasis is put on a deep integration into Isabelleâs IDE, which allows for smooth ontology development as well as immediate ontological feedback during the editing of a document. In this paper, we give an in-depth presentation of the design concepts of DOFâs Ontology Definition Language (ODL) and key aspects of the technology of its implementation. Isabelle/DOF is the first ontology language supporting machine-checked links between the formal and informal parts in an LCF-style interactive theorem proving environment. Sufficiently annotated, large documents can easily be developed collabo- ratively, while ensuring their consistency, and the impact of changes (in the formal and the semi-formal content) is tracked automatically.IRT SystemX, Paris-Saclay, Franc

Cybersecurity must come to IT systems now

International audienceAfter decades of apparently low-intensity cyber attacks, during which security was not really thought of on most IT systems, recent years have brought a flurry of well-organized, larger-scale attacks that have caused billions of Euros of damage. This was made possible by the plethora of IT systems that have been produced with no or low security, a trend that has further increased with the rise of ubiquitous computing, with smartphones, IoT and smart-* being everywhere with extremely low control. However, although the current situation in IT systems can still be considered as critical and very much working in favour of cyber attackers, there are definitely paths to massive but doable technical improvements that can lead us to a much more secure and sovereign IT ecosystem, along with strong business opportunities in Europe

Formal Analysis of CRT-RSA Vigilant's Countermeasure Against the BellCoRe Attack: A Pledge for Formal Methods in the Field of Implementation Security

In our paper at PROOFS 2013, we formally studied a few known countermeasures to protect CRT-RSA against the BellCoRe fault injection attack. However, we left Vigilant's countermeasure and its alleged repaired version by Coron et al. as future work, because the arithmetical framework of our tool was not sufficiently powerful. In this paper we bridge this gap and then use the same methodology to formally study both versions of the countermeasure. We obtain surprising results, which we believe demonstrate the importance of formal analysis in the field of implementation security. Indeed, the original version of Vigilant's countermeasure is actually broken, but not as much as Coron et al. thought it was. As a consequence, the repaired version they proposed can be simplified. It can actually be simplified even further as two of the nine modular verifications happen to be unnecessary. Fortunately, we could formally prove the simplified repaired version to be resistant to the BellCoRe attack, which was considered a "challenging issue" by the authors of the countermeasure themselves.Comment: arXiv admin note: substantial text overlap with arXiv:1401.817