Abstract The use of networked medical devices can provide a number of benefits such as improved patient safety, a reduction in adverse events and reduced costs of care. Today, medical devices are increasingly designed for incorporation into a hospital's general IT network, which allows devices to exchange critical information. However, connecting devices in this way can introduce risks potentially negating the benefits to patients. 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. 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. MedITNet provides a flexible assessment framework enabling HDOs to gain a greater understanding of the requirements of the standard and to improve risk management processes by determining their current state and highlighting areas for improvement. This paper examines the challenges faced by HDOs in the risk management of medical IT networks and briefly explains the components of the MedITNet framework and how the framework addresses these challenges. The use of Action Design Research (ADR) in the development and validation of MedITNet is also discussed focusing on a pilot implementation of the assessment method and expert review of the overall framework. The changes to the framework and its components as a result of the validation process are also discussed. Copyright © 2016 John Wiley & Sons, Ltd.

The use of networked medical devices can provide a number of benefits such as improved patient safety, reduced costs of care and a reduction in adverse events. Traditionally, medical devices were placed onto a proprietary IT network provided by the manufacturer of the device. Today, medical devices are increasingly designed for incorporation into a hospital’s general IT network enabling devices to exchange critical information. However, this can introduce risks and negate the potential benefits to patients. 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 MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001-1. MedITNet provides a flexible assessment framework enabling HDOs to gain a greater understanding of the requirements of the standard and to improve risk management processes by determining their current state and highlighting areas for improvement. This paper examines the challenges faced by HDOs in the risk management of medical IT networks and briefly explains the components of the MedITNet framework and how the framework addresses these challenges. This paper also details how Action Design Research (ADR) was used in the development and validation of MedITNet.

The incorporation of a medical device into an IT network can introduce risks that may not have been addressed during the design and manufacture of the device. IEC 80001-1 is a lifecycle risk management standard which was developed to address these risks. This paper presents research which has been performed to date which has led to the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) which can be used by Healthcare Delivery Organisations to assess themselves against IEC 80001-1. 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.

Developing software using a well-defined, well-understood process improves the likelihood of delivering a product with the required quality. Enhancing that process to meet recognised process standards, such as CMMI and ISO 9000, can further facilitate the development of complex systems in a repeatable and predictable way. There are tradeoffs involved, however. In particular, because projects differ in their scale, scope, and technical challenge, the same process will not suit all circumstances. Agile approaches to development, such as Extreme Programming (XP), SCRUM and Crystal Methodologies, recognise this dilemma and suggest that processes be tailored to each situation. The research problem for postgraduate investigation is to determine in detail how this can be achieved successfully. This will include a consideration of how best to define, maintain and give access to a knowledge base recording details of process concepts, techniques and experience.