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Development of a Process Assessment Model for Assessing Medical IT Networks against IEC 80001-1 [chapter]

Silvana Togneri MacMahon, Fergal McCaffery, Sherman Eagles, Frank Keenan, Marion Lepmets, Alain Renault
2012 Communications in Computer and Information Science  
It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1.  ...  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.  ...  ITIL® is a registered trade mark of the Cabinet Office. TIPA® is a Registered Trade Mark of the CRP Henri Tudor  ... 
doi:10.1007/978-3-642-30439-2_14 fatcat:jfa4smr2lnbrvd3jjfiyj2zeui

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

Silvana Togneri MacMahon, Fergal McCaffery, Frank Keenan
2013 Proceedings of the 2013 International Conference on Software and System Process - ICSSP 2013  
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.  ...  IEC 80001-1 applies when a medical IT network is established. A medical IT network is defined within IEC 80001-1 as an IT network that contains a medical device.  ... 
doi:10.1145/2486046.2486074 dblp:conf/ispw/MacMahonMK13 fatcat:kj6iap72rfh3vcx44ewk53c5ji

The Approach to the Development of an Assessment Method for IEC 80001-1 [chapter]

Silvana Togneri MacMahon, Fergal McCaffery, Frank Keenan
2013 Communications in Computer and Information Science  
Our research in the area of IEC 80001-1 has to date been focused on the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) for assessment against IEC 80001-1.  ...  IEC 80001-1 is a risk management standard that addresses the risks associated with the incorporation of a medical device into an IT network.  ...  Approach to the development of the Assessment Method for IEC 80001-1 In order to perform an assessment against the requirements of IEC 80001-1, a PRM and PAM are not sufficient.  ... 
doi:10.1007/978-3-642-38833-0_4 fatcat:jtloep5ts5f2beii65dtp6osf4

Development and validation of the MedITNet assessment framework: improving risk management of medical IT networks

Silvana Togneri MacMahon, Fergal Mc Caffery, Frank Keenan
2015 Proceedings of the 2015 International Conference on Software and System Process - ICSSP 2015  
The MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001-1.  ...  Traditionally, medical devices were placed onto a proprietary IT network provided by the manufacturer of the device.  ...  While ISO/IEC 15504-2 compliant process assessment models have been developed for Service Management standards, which are similar to IEC 80001-1 in their lifecycle approach, no such model had been developed  ... 
doi:10.1145/2785592.2785599 dblp:conf/ispw/MacMahonMK15 fatcat:jrnjja5p4bbp3hmu272hdi3sra

Improving Safety in Medical Devices from Concept to Retirement [chapter]

Martin McHugh, Fergal McCaffery, Silvana Togneri MacMahon, Anita Finnegan
2013 Handbook of Medical and Healthcare Technologies  
In order to address this, a Process Assessment Model (PAM) has been developed to allow for assessment against IEC 80001-1.  ...  IEC 80001-1 Process Reference Model & Process Assessment Model The PRM for assessment against IEC 80001-1 contains 2 main process categories -Primary Processes and Organizational Processes.  ...  Research to date has focused on the development of a PRM and PAM for assessment against IEC 80001-1.  ... 
doi:10.1007/978-1-4614-8495-0_21 fatcat:wmcyzec63bf67ekreddt6xh3mu

Revising IEC 80001-1: Risk management of health information technology systems

Silvana Togneri MacMahon, Todd Cooper, Fergal McCaffery
2018 Computer Standards & Interfaces  
IEC 80001-1: Application of risk management for IT-networks incorporating medical devices [28] was published in 2010 to address the risks associated with the incorporation of a medical device into an IT  ...  IEC 80001-1 was published in 2010 and is now undergoing revision. Feedback gathered on the adoption of the standard has revealed a number of barriers that have impacted its adoption.  ...  ISO/TR 80001-2-7 uses a process approach and outlines the requirements of IEC 80001-1 in the form of a Process Reference Model (PRM), Process Assessment Model (PAM) and assessment method which can be used  ... 
doi:10.1016/j.csi.2018.04.013 fatcat:2av5fowdlbdh5bdm3cax6nx47m

The MedITNet assessment framework: development and validation of a framework for improving risk management of medical IT networks

Silvana Togneri MacMahon, Fergal McCaffery, Frank Keenan
2016 Journal of Software: Evolution and Process  
The MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001-1.  ...  Medical devices are increasingly designed for incorporation into a hospital's IT network allowing devices to exchange critical information.  ...  While ISO/IEC 15504-2 compliant process assessment models have been developed for Service Management standards, which are similar to IEC 80001-1 in their lifecycle approach, no such model had been developed  ... 
doi:10.1002/smr.1782 fatcat:x2numwf5evaedat3xwuy635coi

Assessing a Hospital's Medical IT Network Risk Management Practice with 80001-1

Francis J. Hegarty, Silvana Togneri MacMahon, Patricia Byrne, Fergal McCaffery
2014 Biomedical Instrumentation & Technology  
The level of compliance with the IEC 80001-1 standard was determined using an assessment framework developed by the Regulated Software Research Centre (RSRC).  ...  This has lead to a shift towards placing more medical devices onto IT networks.  ...  IEC 80001-1 describes specific roles assigned to individuals such as the Medical IT Network Risk Manager.  ... 
doi:10.2345/0899-8205-48.1.64 pmid:24548041 fatcat:ccfjfkzgjraw5ku6qo6awk4dqe

Cybersecurity and medical devices: Are the ISO/IEC 80001-2-2 technical controls up to the challenge?

Scott Anderson, Trish Williams
2018 Computer Standards & Interfaces  
The international standard ISO/IEC 80001 -Application of risk management for IT-networks incorporating medical devices presents a unified and amalgamated approach to the safety of medical devices connected  ...  to IT networks.  ...  ISO/IEC 80001 is a multipart standard for the protection of medical devices on networks using risk assessment techniques.  ... 
doi:10.1016/j.csi.2017.10.001 fatcat:phlnmqcvtfdmtjuuswbska3gjq

Improving Communication in Risk Management of Health Information Technology Systems by means of Medical Text Simplification

Silvana Togneri MacMahon, Marco Alfano, Biagio Lenzitti, Giosue Lo Bosco, Fergal McCaffery, Davide Taibi, Markus Helfert
2019 2019 IEEE Symposium on Computers and Communications (ISCC)  
of their use in a ten step risk management process Keywords-Risk Management, IEC 80001-1, Medical Terminology Simplification I.  ...  These systems have been developed in response to the changing models of care to an ongoing relationship between patient and care team, supported by the use of technology due to the increased instance of  ...  ACKNOWLEDGMENT This work was partially supported with the financial support of the Science Foundation Ireland grant 13/RC/2094 and co-funded under the European Regional Development Fund through the Southern  ... 
doi:10.1109/iscc47284.2019.8969670 dblp:conf/iscc/MacMahonALBMTH19 fatcat:6roirdqyz5esffqmuzvy2fmhzq

A Process Framework Combining Safety and Security in Practice [chapter]

Fergal McCaffery, Özden Özcan-Top, Ceara Treacy, Pangkaj Paul, John Loane, Jennifer Crilly, Arthur Mc Mahon
2018 Communications in Computer and Information Science  
This article describes a safety and security framework that could be implemented when building cyber physical systems for the safety critical medical device domain.  ...  Given the complexity of cyber physical systems, it is important to ensure the safety and security of such systems.  ...  It can be used for CPSs in the medical device domain as it combines regulatory process development with product centric risk assessment.  ... 
doi:10.1007/978-3-319-97925-0_14 fatcat:7nega6usafhetidrvterareyuy

Towards Design and Development of a Data Security and Privacy Risk Management Framework for WBAN Based Healthcare Applications

Pangkaj Chandra Paul, John Loane, Fergal McCaffery, Gilbert Regan
2021 Applied System Innovation  
Assuring security and privacy of data is a key challenge for organizations when developing WBAN applications.  ...  The reasons for this challenge include (i) developers have limited knowledge of market-specific regulatory requirements and security standards, and (ii) there are a vast number of security controls with  ...  • IEC 80001-1:2010: IEC 80001-1-Application of risk management for IT-networks incorporating medical devices was introduced in 2010 to address risks associated with medical devices when connecting to  ... 
doi:10.3390/asi4040076 fatcat:ixgextpbene7dpjtd5uia3zm3u

Networked Medical Devices: Essential Collaboration for Improved Safety

Steven R. Rakitin
2009 Biomedical Instrumentation & Technology  
Figure 1 illustrates a clinical use case developed by blood banking technicians for a portion of what they do in a blood bank.  ...  The IEC/CD2 80001 draft defines the role of the IT risk manager. While this is a good start, the draft standard doesn't go far enough.  ... 
doi:10.2345/0899-8205-43.4.332 pmid:19670949 fatcat:ny6o2zwee5fxtoz3ilh5ar4hrm

Design and Deployment Of Wireless Healthcare IT Networks

Phil Raymond, Rick Hampton
2011 Biomedical Instrumentation & Technology  
The security risk of not upgrading would be compared against the clinical risk of a down network.  ...  Prior to the upgrade, confirmation of verification testing for compatibility with all critical systems should be made, or at least assess the risk of not having that testing.  ...  For more information, please see IEC 80001-2-1 Step by step risk management of medical IT-networks; Practical applications and examples.  ... 
doi:10.2345/0899-8205-45.s2.53 pmid:21992048 fatcat:mifqnt3tdjg5teoxrncivnw5g4

Healthcare Depends on Quality Network Management

Jeff Kabachinski
2010 Biomedical Instrumentation & Technology  
It focuses on risk management's means and processes for the entire life cycle of the medical IT network. We'll save the details of IEC 80001-1 for another IT World.  ...  Networks are not bulletproof: Things will go wrong, resources will fail, and users will make mistakes. These are among the reasons for the new network risk management standard, IEC 80001-1.  ...  It focuses on risk management's means and processes for the entire life cycle of the medical IT network. We'll save the details of IEC 80001-1 for another IT World.  ... 
doi:10.2345/0899-8205-44.6.490 pmid:21142517 fatcat:t4j7tcds4zbtzj7di3wh5temkm
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