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    Apr 15, 2024·SPDX (Linux Foundation) · SpecificationActiveMedium impact

    SPDX 3.0 final published - adds AI and dataset profiles

    SPDX 3.0 introduces profiles (Software, Security, AI, Dataset) that align directly with SaMD and PCCP cybersecurity expectations.

    What changed

    • AI profile lets you describe model components, training data, and security properties in the SBOM.
    • Profiles can be mixed-and-matched per document.

    Action for manufacturers

    If you ship AI/ML SaMD, evaluate SPDX 3.0 AI profile output - reviewers asking about model provenance will accept it well.

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