Integrating formal methods into medical software development: The ASM approach

Authors Paolo Arcaini
Silvia Bonfanti
Angelo Gargantini
Atif Mashkoor
Elvira Riccobene
Editors
Title Integrating formal methods into medical software development: The ASM approach
Type article
Journal Science of Computer Programming
Publisher Elsevier
Volume 158
DOI 10.1016/j.scico.2017.07.003
Month July
Year 2017
Pages 148-167
SCCH ID# 17062
Abstract

Medical devices are safety-critical systems since their malfunctions can seriously compromise human safety. Correct operation of a medical device depends upon the controlling software, whose development should adhere to certification standards. However, these standards provide general descriptions of common software engineering activities without any indication regarding particular methods and techniques to assure safety and reliability.

This paper discusses how to integrate the use of a formal approach into the current normative for the medical software development. The rigorous process is based on the Abstract State Machine (ASM) formal method, its refinement principle, and model analysis approaches the method supports. The hemodialysis machine case study is used to show how the ASM-based design process covers most of the engineering activities required by the related standards, and provides rigorous approaches for medical software validation and verification.