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Medical & Pharma AI Compliance Gate
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
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.
- 1
Download the ZIP
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- 2
Unzip into your skills folder
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- 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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Click the path to copy it. Create the folder if it does not exist yet.
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