Hosting & data location
Define whether the system will run on premises or in the cloud, where data may be processed and which providers are permitted.
Data & deployment
Agree the boundaries before the build.
Medical AI projects need a shared plan for data, evaluation and operations. These are the requirements to settle with your clinical and IT teams during scoping.
Access & traceability
Agree user roles, authentication, audit requirements and the people authorised to access project data.
Transfer & retention
Specify the transfer route, de-identification requirements, retention period and deletion or return of data at the end of the engagement.
Evaluation & intended use
Define the clinical task, representative evaluation data, acceptance criteria and clinician review. Establish any applicable regulatory requirements for the intended use.
Operations & handover
Agree monitoring, backups, incident contacts, support responsibilities and the documentation needed by your team.
These are project scoping topics. The controls, responsibilities and evidence for your system are defined in the engagement; the portfolio alone does not establish clinical performance or regulatory clearance.