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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  
In this paper we present the approach to the next phase of our research which focuses on the development of an assessment method which will be used to perform an assessment using the IEC 80001-1 PAM.  ...  IEC 80001-1 PRM and PAM Approach to the Development of the PRM and PAM for IEC 80001-1 Research to date has focused on the development of a PRM and PAM for IEC 80001-1.  ...  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

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  
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.  ...  Organisations to assess themselves against IEC 80001-1.  ...  The following section discusses the approach to the development of the PRM and PAM for IEC 80001-1.  ... 
doi:10.1145/2486046.2486074 dblp:conf/ispw/MacMahonMK13 fatcat:kj6iap72rfh3vcx44ewk53c5ji

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.  ...  While the IEC 80001-1 standard has been developed to aid Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs may struggle to understand and implement the requirements.  ...  Q4 -To what degree do you feel that use of the Assessment Method will contribute to the adoption of IEC 80001-1?  ... 
doi:10.1145/2785592.2785599 dblp:conf/ispw/MacMahonMK15 fatcat:jrnjja5p4bbp3hmu272hdi3sra

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  
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.  ...  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  ...  /I2030 (the funding of this project was awarded by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund), and supported in part by Lero  ... 
doi:10.1007/978-3-642-30439-2_14 fatcat:jfa4smr2lnbrvd3jjfiyj2zeui

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  ...  Finally, the IEC 80001-1 standard was considered to be too complicated and complex to implement.  ...  This research is supported by Science Foundation Ireland through Lero -the Irish Software Engineering Research Centre (http://www.lero.ie) grant 13/RC/2094.  ... 
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.  ...  While the IEC 80001-1 standard has been developed to aid Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs often struggle to understand and implement the requirements.  ...  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

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  
Future Validation and Development of the Assessment Framework The next stage once complete will allow for assessment against IEC 80001-1 using an assessment method.  ...  The final PRM, PAM and assessment method will allow for assessment against IEC 80001-1.  ...  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

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 purpose of this exercise was, to test and inform the development of an assessment method that is part of the assessment framework for this standard, and also, to identify how the management of such  ...  The level of compliance with the IEC 80001-1 standard was determined using an assessment framework developed by the Regulated Software Research Centre (RSRC).  ...  The level of compliance with the IEC 80001-1 standard was determined using an assessment framework developed by the Regulated Software Research Centre (RSRC).  ... 
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  ...  Highlights  An analysis of technical guidance for cybersecurity of ISO 80001-2-8 is presented  ISO 80001-2-8 technical security controls have significant gaps in areas  ISO 80001-2-8 presents an effective  ...  The inclusion of the Break-Glass -An Approach to Granting Emergency Access to Healthcare Systems (Brucker & Petritsch, 2009 ) whitepaper on reactive break-glass access would provide an alternative method  ... 
doi:10.1016/j.csi.2017.10.001 fatcat:phlnmqcvtfdmtjuuswbska3gjq

A Proposed Approach to the Revision of IEC 80001-1 Following Annex SL [chapter]

Silvana Togneri MacMahon, Todd Cooper, Fergal McCaffery
2017 Communications in Computer and Information Science  
The Role of International Standards to Corroborate Artefact Development and Evaluation: Experiences from a Design Science Research Project in Process Assessment . . . . . . . . . . . . . . . . . . . .  ...  Vincent Leilde Evaluation Model of PRO2PI-WORK4E Method for Teaching Software Process Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 507 Clenio F.  ... 
doi:10.1007/978-3-319-67383-7_22 fatcat:hlsnczhsmbeafcz2yayutkxhse

Framework to Assist Healthcare Delivery Organisations and Medical Device Manufacturers Establish Security Assurance for Networked Medical Devices [chapter]

Anita Finnegan, Fergal McCaffery, Gerry Coleman
2013 Communications in Computer and Information Science  
This paper introduces an assurance framework for networked medical device development.  ...  There is currently no governance for the development of secure medical devices in place and so, this work sets out to resolve this problem by increasing the awareness of medical device security risks,  ...  Currently there is no method to specifically address security assurance for the development processes for networked medical devices.  ... 
doi:10.1007/978-3-642-39179-8_28 fatcat:ds6rhhmp7ncptkutbkzx652orq

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  
We also provide details of how this framework was implemented in an organisation, STATSports Group, which develops cyber physical systems for performance monitoring of elite athletes to the specification  ...  Given the complexity of cyber physical systems, it is important to ensure the safety and security of such systems.  ...  Further mapping of the six standards utilized in IEC/TR 80001-2-8 development was completed to address the gap.  ... 
doi:10.1007/978-3-319-97925-0_14 fatcat:7nega6usafhetidrvterareyuy

A Process Assessment Model for Security Assurance of Networked Medical Devices [chapter]

Anita Finnegan, Fergal McCaffery, Gerry Coleman
2013 Communications in Computer and Information Science  
This paper presents work to develop a framework to assure the security of medical devices being incorporated into an IT network.  ...  It begins by looking at the development processes and the assurance of these through the use of a Process Assessment Model with a major focus on the security risk management processes.  ...  of this project was awarded by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund), and supported in part by Lero -the Irish Software  ... 
doi:10.1007/978-3-642-38833-0_3 fatcat:bsq2vdp3qvb2hfdpco6cmxj5te

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  
To address these challenges, we have developed a WBAN data security and privacy risk management framework. The goal of this paper is trifold.  ...  Assuring security and privacy of data is a key challenge for organizations when developing WBAN applications.  ...  • 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

OR.NET - Approaches for Risk Analysis and Measures of Dynamically Interconnected Medical Devices

Franziska Kühn, Martin Leucker, Alexander Mildner, Marc Herbstritt
2014 Workshop on Medical Cyber-Physical Systems  
The approach is to develop a method for a risk analysis for interconnected medical devices, which is structured modular and consists of a risk assessment of the standalone device and a risk analysis for  ...  This situation leads to confusing operating rooms and inefficient operations. Thus, new strategies need to be developed for the authorization of dynamically interconnected medical devices.  ...  Primarily, those concern of an acquisition and methodological adaption of new requirements and risks resulting from Approaches for Risk Analysis and Measures The aim is to develop a method to consider  ... 
doi:10.4230/oasics.mcps.2014.133 dblp:conf/mcps/KuhnLM14 fatcat:lf6zecioxfhx7nsx2pfqksbfzy
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