Development and validation of the MedITNet assessment framework: improving risk management of medical IT networks

Abstract

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 MedITNet assessment framework: development and validation of a framework for improving risk management of medical IT networks

“…This phase of the ADR process is discussed in depth in and focused on the following areas: The utility of the assessment framework (MedITNet) within the IEC 80001‐1 family of standards; The usability of the assessment framework for self‐assessment of risk management processes within a Healthcare Delivery Organisation; The scalability and generalisability of the assessment framework; The coverage of the requirements of IEC 80001‐1 by ISO/TR 80001‐2‐7; Suggestions for improvements to the assessment framework. …”

“…While the approach to the development and validation of various components have been published previously, e.g. the PRM and PAM and the Assessment Method as well as experiences in implementing the assessment method , this paper examines how the MedITNet framework was developed to address these challenges by using the ADR process to combine the findings from the expert review of the framework as described in and examines how this was combined with learnings from a pilot implementation of the assessment method in order to develop the framework and validate its utility for use in a specific HDO context and across a range of contexts.…”

ICSSP 2015–Special Issue Introduction

“…Among the many high‐quality papers selected for presentation at the conference, reviewers selected the following six papers for inclusion in this special issue: Piloting MDevSPICE®: The Medical Device Software Process Assessment Framework, Development and Validation of the MedITNet Assessment Framework: Improving Risk Management of Medical IT Networks, Integrated Systems Engineering and Software Requirements Engineering for Technical Systems, (Winner of the ICSSP Best Paper Award 2015) Tailoring Process Requirements for Software Product Assurance, (Winner of the ICSSP Best Short Paper Award 2015) Software Process Line Discovery, Towards a Change‐aware Process Environment for System and Software Process, …”