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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  ...  SL and aligned risk management standards as a means to overcome these barriers. information technology [7] [8] [9] [10] .  ...  which are related to health information technology systems to be integrated with more generic risk management processes within the HDO.  ... 
doi:10.1016/j.csi.2018.04.013 fatcat:2av5fowdlbdh5bdm3cax6nx47m

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.  ...  Health Information Technology Systems (HITS) are increasingly used to improve the quality of patient care while reducing costs.  ...  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

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.  ...  The potential benefits of the use of interoperable medical devices and Health Information Technology (HIT), such as Electronic Health Records (EHRs), has resulted in government incentives to promote their  ... 
doi:10.1145/2785592.2785599 dblp:conf/ispw/MacMahonMK15 fatcat:jrnjja5p4bbp3hmu272hdi3sra

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.  ...  IEC 80001-1.  ... 
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  
IEC 80001-1 advocates a life cycle approach to risk management.  ...  IEC 80001-1.  ...  IEC 80001-1 takes a life cycle approach to risk management of IT networks which incorporate medical devices.  ... 
doi:10.1007/978-1-4614-8495-0_21 fatcat:wmcyzec63bf67ekreddt6xh3mu

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  ...  Whilst this standard presents a guide for security and risk management in health delivery organisations, its effectiveness with regard to contemporary cybersecurity is unknown.  ...  dealing with technical controls and specifications to support the implementation of ISO/IEC 80001-1.This sub-parts cover guidance for specific risk management aspects and strategies.  ... 
doi:10.1016/j.csi.2017.10.001 fatcat:phlnmqcvtfdmtjuuswbska3gjq

Getting with the Program to Beef Up Cybersecurity

Gavin Stern
2017 Biomedical Instrumentation & Technology  
IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices-Part 1: Roles, responsibilities and activities • ISO/ IEC 29147:2014, Information technology-  ...  Ensuring that their personal health information is protected is a big part of that."  ...  This revised textbook is the go to resource for new and seasoned biomedical professionals.  ... 
doi:10.2345/0899-8205-51.1.70 pmid:28103087 fatcat:elxb2nofvncjroc4s4zjd4le5i

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.  ...  Second, we present the findings from an initial validation of the framework's usability and effectiveness of the security and privacy controls.  ...  • 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

Cybercrimes Pose Growing Threat to Medical Devices

Axel Wirth
2011 Biomedical Instrumentation & Technology  
S ecuring medical devices against cyberattacks or malware outbreaks and safeguarding protected health information (PHI) stored on devices or exchanged between a device and the provider's network is a growing  ...  challenge for clinical engineers and hospital information technology (IT) professionals. 1 This article will analyze two general trends with regard to their impact on a medical device security strategy  ...  General guidelines for the management of medical devices in a healthcare network are provided via the IEC 80001-1 standard, Application of Risk Management for ITnetworks Incorporating Medical Devices.  ... 
doi:10.2345/0899-8205-45.1.26 pmid:21322805 fatcat:stozp4v3o5esrpvc7jz74kdune

Safety cases for medical devices and health information technology: Involving health-care organisations in the assurance of safety

Mark A Sujan, Floor Koornneef, Nick Chozos, Simone Pozzi, Tim Kelly
2013 Health Informatics Journal  
The regulatory processes in Europe and in the US have been challenged as to their ability to protect patients effectively from unreasonable risk and harm.  ...  Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers.  ...  Acknowledgements This work was funded in part by a research grant from the Health Foundation (Registered Charity Number: 286967).  ... 
doi:10.1177/1460458212462079 pmid:23981393 fatcat:3qpvtee2wfdznndxwcydyktuly

Influence of Human Factors on Cyber Security within Healthcare Organisations: A Systematic Review

Sokratis Nifakos, Krishna Chandramouli, Charoula Konstantina Nikolaou, Panagiotis Papachristou, Sabine Koch, Emmanouil Panaousis, Stefano Bonacina
2021 Sensors  
In complement to cyberattacks, which have been targeted against the vulnerabilities of information technology (IT) infrastructures, a new form of cyber attack aims to exploit human vulnerabilities; such  ...  WoS), using key words related to cybersecurity awareness, training, organisation risk assessment methodologies, policies and recommendations adopted as counter measures within health care.  ...  Segmentation of Medical Devices: A Focus Group Study [19] 6 4 7 8 8 6 Proactive Role of Clinical Engineering in the Adoption of ISO/IEC 80001-1 within Healthcare Delivery Organization [51] 10  ... 
doi:10.3390/s21155119 fatcat:opxkchww7vbunatnrj723p42ry

ICSSP 2018—Special issue introduction

Rory V. O'Connor, Dan Houston, Regina Hebig, Marco Kuhrmann
2019 Journal of Software: Evolution and Process  
The goal of the presented framework is to support Healthcare Delivery Organizations in applying the IEC 80001-1 standard to assess and manage risks in medical IT networks, by providing companies with a  ...  of!the!MedITNet!Assessment!Framework:!Improving!Risk! Management!of!Medical!IT!Networks,![11]! •! Integrated!Systems!Engineering!and!Software!Requirements!Engineering!for!Technical!Systems,! [7]!  ... 
doi:10.1002/smr.2174 fatcat:w2zuocoz2bf3zcjaiyxhhoh72u

ICSSP 2015-Special Issue Introduction

Dietmar Pfahl, Marco Kuhrmann, Reda Bendraou, Richard Turner
2016 Journal of Software: Evolution and Process  
The goal of the presented framework is to support Healthcare Delivery Organizations in applying the IEC 80001-1 standard to assess and manage risks in medical IT networks, by providing companies with a  ...  of!the!MedITNet!Assessment!Framework:!Improving!Risk! Management!of!Medical!IT!Networks,![11]! •! Integrated!Systems!Engineering!and!Software!Requirements!Engineering!for!Technical!Systems,! [7]!  ... 
doi:10.1002/smr.1786 fatcat:w4bryxapjreuldczmgmqjdls74

Safety Critical Software Development – Extending Quality Management System Practices to Achieve Compliance with Regulatory Requirements [chapter]

Andrzej Beniamin Bujok, Silvana Togneri MacMahon, Fergal McCaffery, Dick Whelan, Bernard Mulcahy, William J. Rickard
2016 Communications in Computer and Information Science  
A literature review was conducted which examines the relevant Quality management system, Risk Management and Software development standards across the safety critical domains.  ...  In addition, an interview was conducted with a consultancy company who have experience in the implementation and maintenance of Quality management systems in small and medium enterprises.  ...  process assessment model for assessing medical IT networks against IEC 80001-1 [28] , Investigation of traceability within a medical device organization [29, 30] , and others.  ... 
doi:10.1007/978-3-319-38980-6_2 fatcat:4jgifitbwbdwjbtyyelzbzeqaa

◾ Developing Equipment Support Plans in the Context of the HTM Programme [chapter]

2017 Healthcare Technology Management - A Systematic Approach  
IEC 62366-1. Medical devices -Application of usability engineering to medical devices. IEC 80001-1.  ...  Application of risk management to medical devices ISO/IEC 80001-1 Application of risk management for IT-networks incorporating medical devices -Part 1: Roles, responsibilities and activities SELF-DIRECTED  ...  IEC 62366-1 Medical devices, application of usability engineering to medical devices IEC 80001-1 Application of risk management for IT-networks incorporating medical devices -roles, responsibilities and  ... 
doi:10.1201/9781315371771-13 fatcat:smmtvyphpjd6xbylp77dgowy24
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