Plain-language rules for patient materials and consent forms
Federal rules require consent forms, Medication Guides and privacy notices to be understandable. None of them sets a reading grade. This page shows what each rule says, with links.
General information, not legal advice. Laws change and differ by place. Check the official source linked in each row and ask your own lawyer or compliance team. Sources last checked November 10, 2026.
What the rules say
Federal rules for consent forms, Medication Guides and privacy notices ask for language the reader can understand. None of them sets a reading grade or names a formula.
The grade targets you often see are guidance, not law. Peer-reviewed studies attribute a 6th-grade target for patient materials to the American Medical Association and an 8th-grade target to the National Institutes of Health. Our patient information readability guide covers these targets and their sources.
For health writing, SMOG is a common choice, because it is set to full understanding.
One FDA guidance document does name a range. Its 2006 guidance on Consumer Medication Information suggests the sixth to eighth grade reading level. Guidance is not binding, but it is the closest thing to a federal number for patient drug information.
Requirements and sources
| Requirement | Formula or metric | Threshold | Source |
|---|---|---|---|
| Informed consent (FDA-regulated research) | None named: “language understandable to the subject” | No grade set | 21 CFR 50.20 |
| Informed consent (federally funded research, Common Rule) | None named: understandable language; key information first | No grade set | 45 CFR 46.116 |
| Medication Guides | None named: “nontechnical, understandable language” | No grade set | 21 CFR 208.20 |
| Consumer Medication Information (FDA guidance, not binding) | Grade level | “sixth to eighth grade reading level” (suggested) | FDA, Useful Written CMI, July 2006 |
| HIPAA notice of privacy practices | None named: “written in plain language” | No grade set | 45 CFR 164.520 |
Check your document
Open the free checker with the Patient materials (grade 8 or lower) target already set. Scores are estimates: the laws below may set their own counting rules, so the calculator is a first check, not the official score.
Check a document (Patient materials (grade 8 or lower))
How to make an evidence sheet for this document
- Open the calculator with the right target. Use the button above. It opens the free checker with the target reader set for this kind of document.
- Add your document. Paste the text, or open a Word, PDF or text file. Everything is scored in your browser and nothing is uploaded.
- Fix the hardest sentences. Sentences are marked easy, borderline or hard. Rewrite the hard ones, then check the scores again.
- Print the evidence sheet. Choose Evidence sheet, add the document name, and print or save it as a PDF. It records the date, the six scores, the target and a SHA-256 fingerprint of the text.
- File it with your records. Keep the sheet with the document version you scored. If the text changes, the fingerprint will not match, so score the new version too.
The sheet records a measurement on the date shown; it does not certify compliance with any law, regulation or standard.
Frequently asked questions
Is there a legal reading level for patient materials?
No federal rule we checked sets a grade level. Consent, Medication Guide and HIPAA rules ask for understandable or plain language without a number. FDA guidance on consumer medication information suggests 6th to 8th grade, but guidance is not binding.
Where does the 6th-grade target come from?
Peer-reviewed studies attribute it to the American Medical Association, and an 8th-grade target to the National Institutes of Health. They are widely cited targets, not legal requirements.
Which formula is best for health materials?
A 2013 review found SMOG best suited to health care. SMOG is set to full understanding, which suits material where readers need every step.
What does the Common Rule require for consent forms?
Consent must be in language the person can understand, and the form must begin with a concise and focused summary of the key information.
Does a low grade make a consent form compliant?
No. Readability is only one part. Content, review by the oversight board and other rules still apply. An evidence sheet records a measurement only.