SaMD
Definition
Software performing medical purposes without hardware.
Compliance Relevance
FDA regulated. California laws add transparency layers.
Why It Matters
Know if your tool is SaMD or just CDS. The legal burden differs.
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Related Terms
Algorithmic Bias
Systematic and repeatable errors in a computer system that create unfair outcomes, such as privileging one arbitrary group of users over others.
Artificial Intelligence (AI)
Any computational system that performs tasks indicative of human intelligence, broadly defined in legislation to distinguish valid tools from misleading automation.
Clinical Decision Support (CDS)
Health IT tools providing clinical knowledge and patient-related information to enhance health care.
Is your SaMD compliant?
California's new regulations are strict. Use our automated checker to see if you meet the requirements for SaMD and other critical standards.
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