creators_name: MacMahon, Silvana Togneri
creators_name: McCaffery, Fergal
creators_name: Keenan, Frank
creators_name: Lepmets, Marion
creators_name: Eagles, Sherman
creators_name: Renault, Alain
creators_id: silvana.macmahon@dkit.ie
creators_id: fergal.mccaffery@dkit.ie
creators_id: frank.keenan@dkit.ie
creators_id: marion.lepmets@dkit.ie
creators_id: seagles@softwarecpr.com
creators_id: alain.renault@tudor.lu
type: conference_item
datestamp: 2015-09-23 12:07:39
lastmod: 2015-12-04 14:13:40
metadata_visibility: show
title: Assessing against IEC 80001-1
ispublished: submitted
subjects: subject_computerscience
subjects: subject_software
full_text_status: public
pres_type: paper
keywords: Medical Devices; IEC 80001-1; ISO/IEC 15504 – Process Assessment; Service Management; ISO/IEC 20000-1; TIPA; ITIL.

abstract: Medical devices are designed and produced subject to various standards. These standards are recognized by the regulatory authorities within the region in which they are going to be marketed. Traditionally medical devices were placed on a proprietary network; however emergent technology is increasingly seeing medical devices being included on to the general hospital IT network. The incorporation of a medical device into an IT network can introduce risks which can impact the safety, effectiveness & security of the medical device. 80001-1: Application of Risk Management for IT networks incorporating Medical Devices addresses the risk that healthcare can be compromised when a medical device is incorporated into an IT network. In order to address these risks, an assessment of the network against IEC 80001-1 must be performed. 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. This paper examines how a process assessment model could be developed to assess against IEC 80001-1.

date: 2013
date_type: submitted
event_title: 6th International conference on Health Informatics
event_type: conference
refereed: TRUE
citation:   MacMahon, Silvana Togneri and McCaffery, Fergal and Keenan, Frank and Lepmets, Marion and Eagles, Sherman and Renault, Alain  (2013) Assessing against IEC 80001-1.  In: 6th International conference on Health Informatics.    (Submitted)  
document_url: http://eprints.dkit.ie/485/1/Standards%20Short%20Paper%20Final%20%28updated%29.pdf