SMART is a safety modelling, assurance and reporting tool. It has been developed to help manufacturers and deploying health organisations of health IT to evidence the clinical safety of their product.
It provides a structured journey for users to work through to help ensure clinical risk management is included in the development and maintenance of health IT systems for use within the health and care environment.
SMART enables clinicians and engineers to integrate the designs of their digital health system, the modelling of the care process and the safety analysis evidence into a partly automated assurance environment.
To comply with the NHS clinical safety standards DCB0129 and DCB0160 users need to generate a hazard log and a Clinical Safety Case Report (CSCR). The hazard log is used for recording the ongoing identification, analysis and resolution of hazards associated with the system and the CSCR documents an argument supported by evidence to show why the health IT is safe.
SMART has been developed jointly by the University of York and NHS Digital. It is currently being evaluated against different national and local systems, including artificial intelligence in the form of machine learning.
SMART will be available to download from August 2020.