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.