Risk Management of Medical IT Networks: An ISO/IEC 15504 Compliant Approach to Assessment against IEC 80001-1

MacMahon, Silvana Togneri and McCaffery, Fergal and Keenan, Frank (2013) Risk Management of Medical IT Networks: An ISO/IEC 15504 Compliant Approach to Assessment against IEC 80001-1. In: International Conference on Software and Systems Processes ICSSP 2013, San Francisco, CA, USA. (Submitted)

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Abstract

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.

Item Type:	Conference or Workshop Item (Paper)
Uncontrolled Keywords:	Medical devices; Risk Management; Medical IT networks; IEC 80001-1; ISO/IEC 15504-2; Process Assessment.
Subjects:	Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Sean McGreal
Date Deposited:	23 Sep 2015 12:20
Last Modified:	23 Sep 2015 12:20
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/486

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