Challenges in the regulatory approval of medical cyber-physical systems

Oleg Sokolsky; Insup Lee; Mats Heimdahl

doi:10.1145/2038642.2038677

Challenges in the regulatory approval of medical cyber-physical systems

Oleg Sokolsky
, Insup Lee
, Mats Heimdahl

Computer Science and Engineering

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution

17 Scopus citations

Abstract

We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which offer the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems.

Original language	English (US)
Title of host publication	Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11
Pages	227-232
Number of pages	6
DOIs	https://doi.org/10.1145/2038642.2038677
State	Published - 2011
Event	Embedded Systems Week 2011, ESWEEK 2011 - 9th ACM International Conference on Embedded Software, EMSOFT'11 - Taipei, Taiwan, Province of China Duration: Oct 9 2011 → Oct 14 2011

Publication series

Name	Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11

Other

Other	Embedded Systems Week 2011, ESWEEK 2011 - 9th ACM International Conference on Embedded Software, EMSOFT'11
Country/Territory	Taiwan, Province of China
City	Taipei
Period	10/9/11 → 10/14/11

Keywords

Assurance cases
CertFication
Medical cyber-physical systems
Virtual medical devices

Publisher link

10.1145/2038642.2038677

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Sokolsky, O., Lee, I., & Heimdahl, M. (2011). Challenges in the regulatory approval of medical cyber-physical systems. In Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11 (pp. 227-232). (Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11). https://doi.org/10.1145/2038642.2038677

Challenges in the regulatory approval of medical cyber-physical systems. / Sokolsky, Oleg; Lee, Insup; Heimdahl, Mats.
Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11. 2011. p. 227-232 (Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution

Sokolsky, O, Lee, I & Heimdahl, M 2011, Challenges in the regulatory approval of medical cyber-physical systems. in Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11. Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11, pp. 227-232, Embedded Systems Week 2011, ESWEEK 2011 - 9th ACM International Conference on Embedded Software, EMSOFT'11, Taipei, Taiwan, Province of China, 10/9/11. https://doi.org/10.1145/2038642.2038677

Sokolsky O, Lee I, Heimdahl M. Challenges in the regulatory approval of medical cyber-physical systems. In Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11. 2011. p. 227-232. (Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11). doi: 10.1145/2038642.2038677

Sokolsky, Oleg ; Lee, Insup ; Heimdahl, Mats. / Challenges in the regulatory approval of medical cyber-physical systems. Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11. 2011. pp. 227-232 (Embedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11).

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Challenges in the regulatory approval of medical cyber-physical systems

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