A Product-Focused Approach to Software Certification

Maibaum, Tom; Wassyng, Alan

doi:10.1109/mc.2008.37

Cited by 33 publications

(20 citation statements)

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“…It has been criticized that typical software quality assurance and certification efforts focus mainly on product development processes, rather than on evidence about the actual products [9]. Structured software safety assurances cases are among several methods proposed to provide a more product-based approach to software certification [10].…”

Section: Discussionmentioning

confidence: 99%

A preliminary study of apparent causes and outcomes of reported failures with patient management software

Weber-Jahnke

2011

Proceedings of the 3rd Workshop on Software Engineering in Health Care

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Patient management software (PMS) plays an increasingly critical role in the operation of modern health care systems. While more PMS systems are coming online, many practitioners have raised concerns regarding the quality of such systems, in particular with respect to safety. Recently, the software engineering research community has stepped up efforts investigating the specific challenges in health care in order to translate best engineering practices to this domain. While incidental reports about failures of PMS have been published, little information is available about their outcome and severity. Such evidence would be useful for focusing research efforts. In this paper, we report on a study that seeks to contribute to building up such evidence. We analyzed FDA records of safety incidents with PMS that were submitted over a period of two years. This paper reports on our findings and shows that patient misidentification, end-user customization, and HCI issues are among the most frequent causes for failure.

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Section: Discussionmentioning

confidence: 99%

A preliminary study of apparent causes and outcomes of reported failures with patient management software

Weber-Jahnke

2011

Proceedings of the 3rd Workshop on Software Engineering in Health Care

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“…Maibaum and Wassyng pointed out that process oriented software process quality does not necessarily translate into good software product quality [21]. The certification of insulin pump software poses some additional challenges:…”

Section: Challenges For Certificationmentioning

confidence: 99%

Insulin Pump Software Certification

Chen

Lawford

Wang

et al. 2014

Foundations of Health Information Engineering and Systems

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Abstract. The insulin pump is a safety-critical embedded medical device used for treatment of type 1 and insulin treated type 2 diabetes. Malfunction of the insulin pump will endanger the user's life. All countries impose some regulation on the sale and use of medical devices. The purpose of such regulation is to protect the public by imposing standards of safety for medical devices, including insulin pumps. The regulator in the USA, the USA Food and Drug Administration (FDA), actually goes further, and includes efficacy in the regulatory requirement. Until recently, regulatory approval was dependent on process based guidance. However, this has proven to be inadequate in some (most) cases where the device depends on software for its safe and effective operation, and the FDA recently changed its approval process for infusion pumps (including insulin pumps), so that the production of an assurance case that demonstrates that the device is safe and effective is now a strongly suggested regulatory requirement. However the current regulatory guidance does not recommend any particular software development methodology, and does not include definitive guidance on the evaluation component of the certification process. In this paper, we briefly review the related USA regulatory standards for insulin pumps, highlight development and certification challenges, briefly discuss attributes of a safe, secure and dependable insulin pump, and propose an effective certification process for insulin pumps.

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“…The bulk of the current research literature on software certification is emphasizing the development process, or the software engineers. Maibaum and Wassyng [11] have argued for an increase in research on productbased software certification, since process-based assurances fall short off providing a good measure for the quality of the actual products. An adoption of ALI's principles will likely lead to an increasing interest in product-based certification methods.…”

Section: Product-based Software Certification and Liability Insurancementioning

confidence: 99%

The American law institute's principles on software contracts and their ramifications for software engineering research (NIER track)

Williams

Weber-Jahnke

2011

Proceedings of the 33rd International Conference on Software Engineering

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The American Law Institute has recently published principles of software contracts that may have profound impact on changing the software industry. One of the principles implies a nondisclaimable liability of software vendors for any hidden material defects. In this paper, we describe the new principle, first from a legal and then from a software engineering point of view. We point out potential ramifications and research directions for the software engineering community.

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A Product-Focused Approach to Software Certification

Cited by 33 publications

References 0 publications

A preliminary study of apparent causes and outcomes of reported failures with patient management software

A preliminary study of apparent causes and outcomes of reported failures with patient management software

Insulin Pump Software Certification

The American law institute's principles on software contracts and their ramifications for software engineering research (NIER track)

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