The use of formal methods is often recommended to guarantee the provision of necessary services and to assess the correctness of critical properties, such as functional safety, cybersecurity, and reliability, in medical and health care devices. In the past, several formal and rigorous methods have been proposed and consequently applied for trustworthy development of medical software and systems. In this paper, we perform a systematic literature review on the available state of the art in this domain. We collect the relevant literature on the use of formal methods for modeling, design, development, verification, and validation of software-intensive medical systems. We apply standard systematic literature review techniques and run several queries in well-known repositories to obtain information that can be useful for people who are either already working in this field or planning to start. Our study covers both quantitative and qualitative aspects of the subject.
KEYWORDSformal methods, systematic literature review, medical device software
INTRODUCTIONIn modern medical devices, human safety depends upon the correct operation of software controlling the device: Software malfunctioning can cause injuries to, or even the death of, patients. A crucial issue is how to guarantee that medical software has all the qualities (eg, safety, security, and dependability) expected for critical components. One way to improve and assess software quality, as suggested by literature, 1-3 is to use formal methods or in general rigorous methods for design, validation, and verification of medical software. Some processes for improvement of medical standards, based on formal approaches, have already been proposed, 4-6 although their adoption in industrial applications is rather limited.The overall aim of this paper is twofold: (1) to provide guidance to researchers starting to work on this topic and (2) to assess the state of the art that is more useful for researchers already working on this subject. We have applied a systematic literature review (SLR) process to the topic of rigorous methods for designing and validation of medical software and systems by following the guidelines presented in literature 7-9 with slight improvements such as a wider range of repositories is queried for information retrieval and the subject is covered from both quantitative and qualitative aspects. Through this analysis, we give an overview of the research literature about formal methods applications to model, to verify, and to validate medical systems. Moreover, we include processes and tools that translate models written using formal languages in machine code. We would like to underline that the SLR carried out in this work considers only formal methods applied to medical device/software. Other processes applied to medical device/software are outside of our goal (eg, code implementation, testing, 8 and hardware configuration).The goals of our SLR are (1) to gather a sufficient number of relevant articles, (2) to perform a series of analyses, and (3) to p...
