Development of the MedITNet Assessment Method. Enabling Healthcare Delivery Organisation Self Assessment against IEC 80001-1

MacMahon, Silvana Togneri and McCaffery, Fergal and Keenan, Frank (2015) Development of the MedITNet Assessment Method. Enabling Healthcare Delivery Organisation Self Assessment against IEC 80001-1. In: The First International Conference on Fundamentals and Advances in Software Systems Integration FASSI 2015 August 23 - 28, 2015 - Venice, Italy.

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Abstract

The provision of care to patients has moved away from episodic acute care due to the increase in chronic diseases such as diabetes. This has changed the relationship between the patient and the care team. The management of chronic disease requires the use of information technology including networked medical devices to facilitate the establishment of an ongoing relationship between the patient and care team. The use of networked medical devices can provide benefits to patients such as reduced cost of care, reductions in adverse events and improved care through the provision of accurate and up-to-date information. However, the placement of a medical device onto an IT network can lead to risks to the device. These risks may lead to incorrect or degraded performance of the device impacting patient care and negating the potential benefits of using the device. While, IEC 80001-1 was developed to assist Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs may struggle in implementing the requirements of the standard. This paper discusses the development of an Assessment Method which forms part of MedITNet, an assessment framework which can be used by HDOs to assist them in implementing the requirements of the standard by providing a flexible, consistent and repeatable approach to assessing the capability of their risk management processes relating to networked medical devices. The assessment highlights weaknesses in the process and can be used as a foundation to improve these processes.

Item Type:	Conference or Workshop Item (Paper)
Uncontrolled Keywords:	Medical devices; Risk Management; Medical IT Networks; IEC 80001-1; MedITNet; Assessment Framework; Assessment Method.
Subjects:	Computer Science Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Sean McGreal
Date Deposited:	23 Sep 2015 10:49
Last Modified:	04 Dec 2015 14:09
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/483

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