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.