An Assessment Framework for 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 Process Assessment Model and Assessment Method which can be used by Healthcare Delivery Organisations to assess themselves against IEC 80001-1. These models are under development as a technical report in the IEC 80001 family of standards – IEC NP TR 80001-2-7. This paper also presents future work in this area which includes the continuing development of the technical report and the validation of the models.