Abstract
This position paper gives an overview on the OR.NET project which focuses on the dynamic and safe interconnection of medical devices in an operating room. A brief overview of the legal situation for the approval of medical devices is given to highlight today’s limitations of the dynamic interconnection of safety critical devices in hospitals. A collection of methods equipped with a methodology is presented and discussed, which is intended to replace current integration tests at runtime.
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References
Association for the Advancement of Medical Instrumentation: Medical Device Interoperability (AAMI MDI/March 30, 2013) (2013)
Turnitsa, C.D.: Extending the Levels of Conceptual Interoperability Model. In: Proceedings IEEE 2005 Summer Computer Simulation Conference, IEEE CSP (2005)
C4ISR Architecture Working Group: Levels of Information Systems Interoperability, LISI (1998)
National Committee on Vital and Health Statistics (NCVHS): Report on Uniform Data Standards for Patient Medical Record Information (2000)
Hatcliff, J., King, A.L., Lee, I., Macdonald, A., Fernando, A., Robkin, M., Vasserman, E.Y., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: IEEE ICCPS, pp. 3–12 (2012)
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169 (July 12, 1993)
Directive 98/79/EC of the European Parliament and of the Council of 27 Oct 1998 on in vitro diagnostic medical devices. OJ L 331 (July 12,1998)
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. OJ No L 189 (July 20, 1990)
Johner, C., Hölzer-Klüpfel, M., Wittorf, S.: Basiswissen Medizinische Software: Aus- und Weiterbildung zum Certified Professional for Medical Software. Dpunkt (2011)
Medical devices - Quality management systems - Requirements for regulatory purposes (EN ISO 13485:2003)
Medical devices - Application of risk management to medical devices (ISO 14971) (2007), Corrected version (January 10, 2007)
Medical device software - Software life-cycle processes (IEC 62304) (2006)
Medical devices - Application of usability engineering to medical devices (IEC 62366) (2007)
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6) (2010)
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1) (2010)
de Alfaro, L., Henzinger, T.A.: Interface automata. In: ESEC / SIGSOFT FSE, pp. 109–120. ACM (2001)
Masson, B., Hélouët, L., Benveniste, A.: Compatibility between DAXML Schemas (March 2011)
King, A.L., Feng, L., Sokolsky, O., Lee, I.: A modal specification approach for on-demand medical systems. In: Preproceedings of FHIES (2013)
Takeuchi, K., Honda, K., Kubo, M.: An interaction-based language and its typing system. In: Halatsis, C., Philokyprou, G., Maritsas, D., Theodoridis, S. (eds.) PARLE 1994. LNCS, vol. 817, pp. 398–413. Springer, Heidelberg (1994)
Pnueli, A.: The temporal logic of programs. In: Proceedings of the 18th IEEE Symposium on the Foundations of Computer Science (FOCS 1977), pp. 46–57. IEEE (1977)
Raskin, J.F.: Logics, Automata and Classical theories for Deciding Real Time. Thèse de doctorat, FUNDP, Namur, Belgium (June 1999)
Leucker, M., Schallhart, C.: A brief account of runtime verification. JLAP 78(5), 293–303 (2009)
Kühn, F.: Pink states for runtime verification. Master’s thesis, Univ. of Lübeck (2013)
Leucker, M.: Sliding between model checking and runtime verification. In: Qadeer, S., Tasiran, S. (eds.) RV 2012. LNCS, vol. 7687, pp. 82–87. Springer, Heidelberg (2013)
Gruber, T.R.: A translation approach to portable ontology specifications. Knowledge Acquisition 5, 199–220 (1993)
Bennaceur, A., Chilton, C., Isberner, M., Jonsson, B.: Automated mediator synthesis: Combining behavioural and ontological reasoning. In: Hierons, R.M., Merayo, M.G., Bravetti, M. (eds.) SEFM 2013. LNCS, vol. 8137, pp. 274–288. Springer, Heidelberg (2013)
Leucker, M.: Checking and enforcing safety: Runtime verification and runtime reflection. ERCIM News 2008(75) (2008)
Vasserman, E.Y., Venkatasubramanian, K.K., Sokolsky, O., Lee, I.: Security and interoperable-medical-device systems, part 2: Failures, consequences, and classification. IEEE Security & Privacy 10(6), 70–73 (2012)
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Kühn, F., Leucker, M. (2014). OR.NET: Safe Interconnection of Medical Devices. In: Gibbons, J., MacCaull, W. (eds) Foundations of Health Information Engineering and Systems. FHIES 2013. Lecture Notes in Computer Science, vol 8315. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-53956-5_13
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DOI: https://doi.org/10.1007/978-3-642-53956-5_13
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