Using IVD software and AI safely means confining each system to its intended purpose and backing it with objective evidence of clinical benefit or utility, or failing that of better accuracy, efficiency or decision-making; training staff to use it, to know its limits and to apply their own judgement to AI-assisted output; checking that staff stay within role and scope when they use it; naming, inside the supervision and delegation framework, who reviews, corrects and approves AI-assisted results; being open with patients, where clinically appropriate, that AI played a part in interpreting a test or writing a report, without lessening the doctor's responsibility for the result; and documenting, investigating and reporting significant AI-related incidents under the regulatory and governance rules.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.