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    Medical & Pharma AI Compliance Gate

    2

    Audit AI-assisted medical and pharma content for compliance-readiness before it enters formal MLR review or journal submission. It checks claim substantiation and on-label scope, reference integrity (the acute AI risk: fabricated or misrepresented citations), fair balance and safety, AI-use disclosure, ICMJE authorship and GPP, COI and funding, data integrity and patient privacy, and adverse-event flags — then returns a PASS / REVISE / BLOCK verdict with the must-fix list. A readiness pre-check built for the regulated reality of medical communications — not a replacement for formal review.

    Free

    1 installSecurity scanned
    Medical & Pharma AI Compliance Gate

    Medical & Pharma AI Compliance Gate

    Example session with this skill installed

    "Check this AI-drafted congress abstract before it goes to MLR."

    • Read your context and instructions
    • Compiled the medical & pharma

    A BLOCK verdict: the "significantly outperformed" wording exceeds what a single-arm result supports (soften to the data); two citations verify but the third can't be confirmed and may be fabricated (verify against the primary source before use); AI assistance and medical-writing support aren't disclosed (add per GPP/ICMJE). A prioritized must-fix list, ending "BLOCK until the citation is verified and the claim is on-label" — with the reminder that this is a pre-check, not formal MLR sign-off.

    Connects securely to your tools. The creator never sees your data.

    About this skill

    This catches the issues that get medical content rejected at MLR or by a journal — before it goes to formal review — so AI-assisted drafts don't bounce or ship something unsupportable.

    It is a readiness pre-check (not a replacement for formal MLR, qualified medical/regulatory review, or human accountability) and it defers to your applicable codes and SOPs (FDA/OPDP, ABPI, EMA, IFPMA, ICMJE, GPP 2022).

    It checks:

    • Claim substantiation & on-label scope — nothing stronger than its evidence, nothing off-label
    • Reference integrity — the acute AI risk: fabricated citations, or real ones that don't actually support the claim (verified or flagged for primary-source check, never passed blind)
    • Fair balance & safety information
    • AI-use disclosure & human accountability (AI is never an author)
    • ICMJE authorship & GPP 2022 publication practice — no ghost/guest authorship, writing support disclosed
    • COI & funding disclosure
    • Data integrity & patient privacy (no fabricated data, no PHI)
    • Adverse-event flags routed to pharmacovigilance
    • Permissions and promotional-vs-non-promotional classification

    You get a PASS / REVISE / BLOCK verdict with the must-fix list — what a reviewer would catch, caught early.

    How to install

    Works the same in every agent - Claude, Cursor, Codex, Copilot and 20+ more.

    ~30 seconds
    1. 1

      Download the ZIP

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    2. 2

      Unzip into your skills folder

      Every agent reads skills from one folder on your machine. Drop the unzipped folder in there.

    3. 3

      Ask your agent to use it

      Restart the agent if it was already running. It picks the skill up automatically - no config needed.

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    Listed3 months ago
    Updated1 month ago

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