title: Development of a process assessment model for assessing medical IT networks against IEC 80001-1
creator: MacMahon, Silvana Togneri
creator: McCaffery, Fergal
creator: Keenan, Frank
creator: Lepmets, Marion
creator: Eagles, Sherman
creator: Renault, Alain
subject: Computer Science
subject: Computer Software
description: 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.
date: 2012
type: Conference or Workshop Item
type: PeerReviewed
format: application/pdf
identifier: http://eprints.dkit.ie/488/1/SPICE%20Paper%20Version%201.6%20-%20Final%2027-01-2012.pdf
identifier:   MacMahon, Silvana Togneri and McCaffery, Fergal and Keenan, Frank and Lepmets, Marion and Eagles, Sherman and Renault, Alain  (2012) Development of a process assessment model for assessing medical IT networks against IEC 80001-1.  In: Software Process Improvement and Capability dEtermination (SPICE), 29th to 31st May 2012, Majorca, Spain.    (Submitted)  
relation: http://eprints.dkit.ie/488/