Silvana Togneri MacMahon

Assessing a hospital's medical IT network risk management practice with 80001-1.

Medical device interoperability has been identified as a key way of decreasing healthcare costs while improving patient care. 1 This has led to a shift toward placing more medical devices onto information technology (IT) networks. However, placing medical devices onto an IT network may lead to additional risks to safety, effectiveness and security of the devices, the network, and the data. ANSI/AAMI/IEC 80001-1 addresses the roles, responsibilities, and activities that need to be carried out when managing these risks. In this article, we describe an exercise undertaken to assess the medical IT network risk management practice implemented within a hospital to control risk associated with a clinical information system (CIS). The level of compliance with the 80001-1 standard was determined using an assessment framework developed by the Regulated Software Research Centre. The purpose of this exercise was to test and inform the development of an assessment method that is part of the assessment framework for this standard. The exercise also sought to identify how the management of such an existing CIS project meets the requirements of 80001-1.

Development of a Process Assessment Model for Assessing Medical IT Networks against IEC 80001-1

Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order 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. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1.

Risk management of medical IT networks: an ISO/IEC 15504 compliant approach to assessment against IEC 80001-1

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.

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

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 Approach to the Development of an Assessment Method for IEC 80001-1

IEC 80001-1 is a risk management standard that addresses the risks associated with the incorporation of a medical device into an IT network. Our research in the area of IEC 80001-1 has to date been focused on the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) for assessment against IEC 80001-1. In this paper we present the approach to the next phase of our research which focuses on the development of an assessment method which will be used to perform an assessment using the IEC 80001-1 PAM. The assessment method will ensure a standardized approach to performing an assessment while identifying key success and will contain a list of questions which will allow assessors to determine the capability level of processes within the PAM. The results of the assessment can be used as a basis for process improvement.

Improving Safety in Medical Devices from Concept to Retirement

As with many domains the use of software within the healthcare industry is on the rise [1, 2] within the last 20 years.

Revising IEC 80001-1: Risk management of health information technology systems

Abstract IEC 80001-1 was published in 2010 and is now undergoing revision. Feedback gathered on the adoption of the standard has revealed a number of barriers that have impacted its adoption. The standard provides requirements related to the roles, responsibilities and activities that need to be performed for the risk management of medical IT networks. One reported barrier is a lack of drivers to motivate Top Management to implement the standard. In addition, there is a lack of alignment between IT and biomedical engineering departments within hospitals. Finally, the IEC 80001-1 standard was considered to be too complicated and complex to implement. This paper presents the barriers identified in the feedback and presents an approach to the revision of the standard as a process based standard following the structure outlined in ISO/IEC Directives Annex SL and aligned risk management standards as a means to overcome these barriers.

Approach to the development of a Unified Framework for Safety Critical Software Development

Software is increasingly being used to provide functionality in safety critical domains. The complexity involved in the development of software for these domains can bring challenges concerned with safety. International standards are published, providing information on practices which must be implemented in order to satisfy the regulations. This paper details an investigation of the relevant standards that companies need to implement in order to satisfy the regulatory requirements. A literature review was conducted which examines the relevant Quality Management System, Risk Management and Software Development standards across the safety critical domains; and examines the challenges faced by software development organizations with standard and multiple standard implementation. The existing approaches to standards consolidation, integration and harmonization were also examined. To investigate the challenges in implementing these standards, interviews were conducted with a medical device software development company having a Quality Management System in place and beginning to implement the relevant Software Development standards. In addition, an interview was conducted with a consultancy company who has experience in the implementation and maintenance of Quality Management Systems in small and medium enterprises. Following the literature review and interviews conducted, a comparison of the standards was conducted to investigate the similarities and differences in the structure of sections and subsections and to estimate the potential for the further consolidation of these standards. Following the results of the comparisons, a detailed mapping of standard requirements was conducted, mapping requirements of generic and domain specific Quality Management System standards. Future work will focus on the consolidation and integration of standards practices which need to be implemented by companies developing safety critical software and development of Unified Framework that incorporates all necessary requirements to comply with regulatory requirements. There is need for multiple International standards implementation in Safety Critical Software Development to fulfil Regulatory requirements.There are existing approaches of standards harmonization, consolidation or integration to address challenges with multiple standards implementation.A Unified framework will be developed across the multiple standards to comply with regulations in safety critical domains.

Safety Critical Software Development – Extending Quality Management System Practices to Achieve Compliance with Regulatory Requirements

Software is increasingly being used to provide functionality in safety critical domains. The complexity involved in the development of software for these domains can bring challenges concerned with safety and security. International standards are published, providing information on practices which must be implemented in order to satisfy the regulations. This paper details an investigation of the relevant standards that companies need to implement in order to satisfy the regulatory requirements. A literature review was conducted which examines the relevant Quality management system, Risk Management and Software development standards across the safety critical domains. To examine the challenges in implementing these standards, interviews were conducted with a medical device software development company having a Quality management system in place and beginning to implement the relevant Software development standards. 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. Future work will focus on the integration of practices which need to be implemented by companies developing safety critical software.

Taxonomy-based testing and validation of a new defect classification for health software

Defect‐based testing is a powerful tool for finding errors in software. Many software manufacturers avoid this method because it requires a detailed defect taxonomy that is expensive to construct and difficult to validate. The Association for the Advancement of Medical Instrumentation is developing SW91, a defect taxonomy to be published as a standard for health software. This paper details three methods to validate SW91 for its comprehensiveness. The initial validations of SW91 were conducted via mapping vulnerabilities from the common weakness enumeration and a dataset from a medical device software development company in Ireland. Taxonomy‐based testing is another validation method proposed in this research, and its applicability was investigated using empirical data from a medical device software development company in Ireland. Finally, the paper details future plans to implement taxonomy‐based testing to improve software quality in medical device software and to validate SW91. This validation will focus on the efficiency, reliability, and ability to perform useful analyses and defect coverage of SW91.