The MedITNet Assessment Method – Development and Validation using Action Design Research. Self Assessment against IEC 80001-1

The provision of care to patients has moved away from episodic acute care due to the increase in chronic diseases such as diabetes. This has changed the relationship between the patient and the care team. The management of chronic disease requires the use of information technology including networked medical devices to facilitate the establishment of an ongoing relationship between the patient and care team. The use of networked medical devices can provide benefits to patients such as reduced cost of care, reductions in adverse events and improved care through the provision of accurate and up-to-date information. However, the placement of a medical device onto an IT network can lead to risks to the device. These risks may lead to incorrect or degraded performance of the device impacting patient care and negating the potential benefits of using the device. While, IEC 80001-1 was developed to assist Healthcare Delivery Organisations in addressing these risks, HDOs may struggle in implementing the requirements of the standard. This paper discusses the development of an Assessment Method that forms part of MedITNet, an assessment framework that can be used by Healthcare Delivery Organisationss to assist them in implementing the requirements of the standard by providing a flexible, consistent and repeatable approach to assessing the capability of their risk management processes relating to networked medical devices. The assessment highlights weaknesses in the process and can be used as a foundation to improve these processes. This paper also discusses the development and validation of the Assessment Method using Action Design Research