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Development of a process assessment model for assessing medical IT networks against IEC 80001-1

MacMahon, Silvana Togneri orcid logoORCID: 0000-0003-0179-2436, McCaffery, Fergal, Eagles, Sherman, Keenan, Frank, Lepmets, Marion and Renault, Alain orcid logoORCID: 0000-0001-8198-8708 (2012) Development of a process assessment model for assessing medical IT networks against IEC 80001-1. In: Software Process Improvement and Capability Determination: 12th International Conference, SPICE 2012, Proceedings, 29 - 31 May 2012., Palma de Mallorca, Spain. ISBN 978-3-642-30439-2

Abstract
Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1.
Metadata
Item Type:Conference or Workshop Item (Paper)
Event Type:Conference
Refereed:Yes
Uncontrolled Keywords:IEC 80001-1; ISO/IEC 15504 – Process Assessment; Service Management; ISO/IEC 20000-1; TIPA; ITIL
Subjects:Computer Science > Information technology
Medical Sciences > Health
DCU Faculties and Centres:DCU Faculties and Schools > Faculty of Engineering and Computing > School of Computing
Research Initiatives and Centres > Lero: The Irish Software Engineering Research Centre
Published in: Mas, Antonia, Mesquida, Antoni, O'Connor, Rory and Dorling, Alec, (eds.) Software Process Improvement and Capability Determination 12th International Conference, SPICE 2012 Proceedings. Communications in Computer and Information Science (CCIS) 290. Springer. ISBN 978-3-642-30439-2
Publisher:Springer
Official URL:https://doi.org/10.1007/978-3-642-30439-2_14
Copyright Information:© 2012 Springer
Funders:Science Foundation Ireland (SFI) Stokes Lectureship Programme, grant 07/SK/I1299,, Science Foundation Ireland (SFI) Principal Investigator Programme, grant 08/IN.1/I2030 co-funded by the Irish Government and European Regional Development Fund, Lero - Science Foundation Ireland Research Centre for Software grant 10/CE/I1855.
ID Code:28409
Deposited On:21 Jun 2023 14:38 by Silvana Macmahon . Last Modified 28 Nov 2023 12:30
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