Transforming requirements of IEC 80001-1 into an ISO/IEC 15504-2 compliant process reference model and process assessment model

Efficiencies in patient care can be achieved through interoperability of medical devices. Patient safety is the key concern during the design and manufacture of medical devices with medical devices being subject to stringent regulation in the region in which the device is to be marketed. However, with medi-cal devices increasingly being designed to be incorporated into an IT network, the process of network-ing the device can introduce risks that may not have been considered during the design and manufac-ture stage. IEC 80001-1 was developed to address the risks associated with the incorporation of a medical device into an IT network. This paper presents how the requirements of IEC 80001-1 were used to develop a Process Reference Model (PRM) and Process Assessment Model (PAM) which are compliant with the requirements for PRMs and PAMs as outlined in ISO/IEC 15504-2

Risk management of medical IT networks: an ISO/IEC 15504 compliant approach to asessment 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

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

Towards a process assessment model for IEC 80001-1

Medical Devices are widely used in patient care for both diagnosis and treatment purposes. Typically, modern medical devices are intended to be networked at their point of use. The incorporation of medical devices opens up new opportunities and new vulnerabilities to patients and medical facilities. In 2010, the first standard to address the risks of incorporating a medical device into an IT network was published in the form of IEC 80001-1. Currently no method exists to allow responsible organisations - entities that operate and maintain a network that incorporates a medical device- to assess themselves against this standard. This paper discusses the how healthcare providers can be assessed against IEC 80001-1. This paper discusses the work carried out to date to develop a Process Reference Model and future work to allow this Process Reference Model to be extended to form a Process Assessment Model is also presented within this paper

Assessing against IEC 80001-1

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 how a process assessment model could be developed to assess against IEC 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