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Revising IEC 80001-1: Risk management of health information technology systems
2018
Computer Standards & Interfaces
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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
2019
2019 IEEE Symposium on Computers and Communications (ISCC)
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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
2015
Proceedings of the 2015 International Conference on Software and System Process - ICSSP 2015
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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
2016
Journal of Software: Evolution and Process
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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]
2013
Handbook of Medical and Healthcare Technologies
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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?
2018
Computer Standards & Interfaces
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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
2017
Biomedical Instrumentation & Technology
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• 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
2021
Applied System Innovation
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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
2011
Biomedical Instrumentation & Technology
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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
2013
Health Informatics Journal
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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
2021
Sensors
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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
2019
Journal of Software: Evolution and Process
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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
2016
Journal of Software: Evolution and Process
Preserved Fulltext
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The file type is application/pdf.
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]
2016
Communications in Computer and Information Science
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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
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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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