Clinical Safety Management System for IT Software
Information Standards Notice (ISN) Mandate (nee DSCN 14, 18)
Axon Software
Axon creates a Safety Case (hazard mitigation) for each of its healthcare related service applications.
Axon Risk Assessment of Health IT Software Service
Axon provides a unique safety-portal through which the accredited clinician, Clinical Safety Officer (CSO), is able to administer IT infrastructure and clinical specialist assessments.
Modus Operandi
- Axon sets up your details (e.g. PCT, Trust, Hospital, GP practice) and sends the login details (URL address) to the CSO administrator
- The CSO sets up and assigns a number of specialist administrators who work through the on-line assessments; such as information technology infrastructure, cardiology and pathology, and so on
- Each risk assessment has been designed with experts
- Potential hazards are recorded
- Creates a Safety Case describing potential hazards and how they are mitigated
- Creates a Safety Closure Report that provides evidence that hazards have been addressed diligently
- During the assessment phase there is a graphical interface showing both the user, of the assessments, and administrator progress and a risk score
- An audit is kept of all interactions with the system
For further information see Risk Assessment of Health IT Software (AfITs®)