Authors:
Silvana Togneri MacMahon
1
;
Fergal Mc Caffery
1
;
Sherman Eagles
2
;
Frank Keenan
1
;
Marion Lepmets
3
and
Alain Renault
3
Affiliations:
1
Dundalk Institute of Technology & Lero, Ireland
;
2
SoftwareCPR, United States
;
3
Public Research Centre Henri Tudor, Luxembourg
Keyword(s):
IEC 80001-1, ISO/IEC 15504 – Process Assessment, Service Management, ISO/IEC 20000-1, TIPA, ITIL.
Related
Ontology
Subjects/Areas/Topics:
Artificial Intelligence
;
Biomedical Engineering
;
Cardiovascular Technologies
;
Collaboration and e-Services
;
Complex Systems Modeling and Simulation
;
Computing and Telecommunications in Cardiology
;
Data Engineering
;
Design and Development Methodologies for Healthcare IT
;
e-Business
;
Electronic Health Records and Standards
;
Enterprise Information Systems
;
Health Engineering and Technology Applications
;
Health Information Systems
;
Integration/Interoperability
;
Interoperability
;
Knowledge Management and Information Sharing
;
Knowledge-Based Systems
;
Medical and Nursing Informatics
;
Ontologies and the Semantic Web
;
Sensor Networks
;
Simulation and Modeling
;
Software Agents and Internet Computing
;
Software and Architectures
;
Symbolic Systems
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 ho
w a process assessment model could be developed to assess against IEC 80001-1.
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