Software as a medical device
Software that is regulated as a medical device because its intended use is to diagnose, treat, prevent, or inform clinical decisions. What the software claims to do often matters more for regulation than how it is built.
A tool that flags suspected intracranial hemorrhage on head CT was bought to move those scans up the worklist, and its stated intended use is exactly that, prioritization with every scan still read. An overstretched night service then proposes leaving unflagged scans until morning, which turns the same software into a rule-out tool, a use its evidence and its regulatory status do not cover. Read the intended use statement before changing what you rely on a tool's output for, and take any such change back through governance as a new deployment.
Terms like this come up in real clinical scenarios across the HelloAI courses: bite-sized modules with verifiable certificates. An account takes one minute, no password needed.
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