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Risk management of medical IT networks: an ISO/IEC 15504 compliant approach to asessment against IEC 80001-1

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conference contribution
posted on 2013-06-27, 14:11 authored by Silvana Togneri MacMahon, Fergal Mc Caffery, Frank Keenan
The incorporation of a medical device into an IT network can introduce risks that may not have been addressed during the design and manufacture of the device. IEC 80001-1 is a lifecycle risk management standard which was developed to address these risks. This paper presents research which has been performed to date which has led to the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) which can be used by Healthcare Delivery Organisations to assess themselves against IEC 80001-1. This paper also presents future work in this area which includes the development of an assessment method for IEC 80001-1 and the validation of the PRM, PAM and assessment method.

History

Publication

ICSSP 2013 Proceedings of the 2013 International Conference on Software and System Process;pp. 156-60

Publisher

Association for Computing Machinery

Note

peer-reviewed

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SFI

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"© ACM, 2013. This is the author's version of the work. It is posted here by permission of ACM for your personal use. Not for redistribution. The definitive version was published in ICSSP 2013 Proceedings of the 2013 International Conference on Software and System Process, 2013, pp. 156-60. http:dx.doi.org/10.1145/2486046.2486074

Language

English

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