Abstract
This paper addresses the problem of high-assurance operation for medical cyber-physical systems built from interoperable medical devices. Such systems are different from most cyber-physical systems due to their “plug-and-play” nature: they are assembled as needed at a patient’s bedside according to a specification that captures the clinical scenario and required device types. We need to ensure that such a system is assembled correctly and operates according to its specification. In this regard, we aim to develop an alarm system that would signal interoperability failures. We study how plug-and-play interoperable medical devices and systems can fail by means of hazard analysis that identify hazardous situations that are unique to interoperable systems. The requirements for the alarm system are formulated as the need to detect these hazardous situations. We instantiate the alarm requirement generation process through a case-study involving an interoperable medical device setup for airway-laser surgery.
This work was partially funded by NIH grant 1U01EB012470 and NSF grants CNS 1224007, CNS 1239543, and CNS 1253930.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Arney, D., Weininger, S., Whitehead, S.F., Goldman, J.M.: Supporting medical device adverse event analysis in an interoperable clinical environment: design of a data logging and playback system. In: ICBO (2011)
ASTM 2761: Medical devices and medical systems – essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) (2013)
Avizienis, A., Laprie, J., Randell, B., Landwehr, C.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secure Comput. 1(1), 11–33 (2004)
Clarke, M., Bogia, D., Hassing, K., Steubesand, L., Chan, T., Ayyagari, D.: Developing a standard for personal health devices based on 11073. In: EMBS (2007)
Hatcliff, J., King, A., Lee, I., Macdonald, A., Fernando, A., Robkin, M., Vasserman, E., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: ICCPS (2012)
Health Level Seven International. http://www.hl7.org/
IEC. Medical electrical equipment - Part 1–8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (2008)
IEC. Application of risk management for IT-networks incorporating medical devices - Part 2–5: Application guidance - Guidance for distributed alarm systems (2014)
Integrating the healthcare enterprise. http://www.ihe.net/
Kang, W., Wu, P., Rahmaniheris, M., Sha, L., Berlin, R., Goldman, J.: Towards organ-centric compositional development of safe networked supervisory medical systems. In: CBMS (2013)
King, A., Arney, D., Lee, I., Sokolsky, O., Hatcliff, J., Procter, S.: Prototyping closed loop physiologic control with the medical device coordination framework. In: SEHC (2010)
Lesh, K., Weininger, S., Goldman, J., Wilson, B., Himes, G.: Medical device interoperability – assessing the environment. In: HCMDSS-MDPnP (2007)
Prisaznuk, P.J.: ARINC 653 role in integrated modular avionics (IMA). In: DASC (2008)
Tolk, A., Diallo, S., Turnitsa, C.: Applying the levels of conceptual interoperability model in support of integratability, interoperability, and composability for system-of-systems engineering. Journal of Systemics, Cybernetics and Informatics, vol. 5, no. 5 (2007)
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer International Publishing Switzerland
About this paper
Cite this paper
Venkatasubramanian, K.K., Vasserman, E.Y., Sfyrla, V., Sokolsky, O., Lee, I. (2015). Requirement Engineering for Functional Alarm System for Interoperable Medical Devices. In: Koornneef, F., van Gulijk, C. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2014. Lecture Notes in Computer Science(), vol 9337. Springer, Cham. https://doi.org/10.1007/978-3-319-24255-2_19
Download citation
DOI: https://doi.org/10.1007/978-3-319-24255-2_19
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-24254-5
Online ISBN: 978-3-319-24255-2
eBook Packages: Computer ScienceComputer Science (R0)