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Process-based derivation of requirements for medical devices

Published: 11 November 2010 Publication History

Abstract

One goal of medical device certification is to show that a given medical device satisfies its requirements. The requirements that should be met by a device, however, depend on the medical processes in which the device is to be used. Such processes may be complex and, thus, critical requirements may be specified inaccurately or incompletely, or even missed altogether. We are investigating a requirement derivation approach that takes as input a model of the way the device is used in a particular medical process and a requirement that should be satisfied by that process. This approach tries to produce a derived requirement for the medical device that is sufficient to prevent any violations of the process requirement. Our approach combines a method for generating assumptions for assume-guarantee reasoning with one for interface synthesis to automate the derivation of the medical device requirements. The proposed approach performs the requirement derivation iteratively by employing a model checker and a learning algorithm. We implemented this approach and evaluated it by applying it to two small case studies. Our experiences showed that the proposed approach could be successfully applied to abstract models of portions of real-world medical processes and that the derived requirements of the medical devices appeared useful and understandable.

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Cited By

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  • (2013)Modal abstraction view of requirements for medical devices used in healthcare processesProceedings of the 5th International Workshop on Software Engineering in Health Care10.5555/2663575.2663582(24-27)Online publication date: 20-May-2013
  • (2013)Modal abstraction view of requirements for medical devices used in healthcare processes2013 5th International Workshop on Software Engineering in Health Care (SEHC)10.1109/SEHC.2013.6602473(24-27)Online publication date: May-2013
  • (2013)Requirements engineering meets physiotherapyProceedings of the 19th international conference on Requirements Engineering: Foundation for Software Quality10.1007/978-3-642-37422-7_23(315-330)Online publication date: 8-Apr-2013
  • Show More Cited By

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cover image ACM Other conferences
IHI '10: Proceedings of the 1st ACM International Health Informatics Symposium
November 2010
886 pages
ISBN:9781450300308
DOI:10.1145/1882992
Permission to make digital or hard copies of all or part of this work for personal or classroom use is granted without fee provided that copies are not made or distributed for profit or commercial advantage and that copies bear this notice and the full citation on the first page. Copyrights for components of this work owned by others than ACM must be honored. Abstracting with credit is permitted. To copy otherwise, or republish, to post on servers or to redistribute to lists, requires prior specific permission and/or a fee. Request permissions from [email protected]

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Publication History

Published: 11 November 2010

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Author Tags

  1. learning algorithms
  2. medical devices
  3. medical processes
  4. model checking
  5. requirement specifications

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IHI '10
IHI '10: ACM International Health Informatics Symposium
November 11 - 12, 2010
Virginia, Arlington, USA

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Cited By

View all
  • (2013)Modal abstraction view of requirements for medical devices used in healthcare processesProceedings of the 5th International Workshop on Software Engineering in Health Care10.5555/2663575.2663582(24-27)Online publication date: 20-May-2013
  • (2013)Modal abstraction view of requirements for medical devices used in healthcare processes2013 5th International Workshop on Software Engineering in Health Care (SEHC)10.1109/SEHC.2013.6602473(24-27)Online publication date: May-2013
  • (2013)Requirements engineering meets physiotherapyProceedings of the 19th international conference on Requirements Engineering: Foundation for Software Quality10.1007/978-3-642-37422-7_23(315-330)Online publication date: 8-Apr-2013
  • (2012)Smart checklists for human-intensive medical systemsIEEE/IFIP International Conference on Dependable Systems and Networks Workshops (DSN 2012)10.1109/DSNW.2012.6264661(1-6)Online publication date: Jun-2012
  • (2012)Formal Verification of Medical Monitoring Software Using Z LanguageJournal of Medical Systems10.1007/s10916-011-9739-536:4(2633-2648)Online publication date: 1-Aug-2012

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