For regulatory, labeling, patient-services, medical-information and MLR leads
FDA reads your risk text the way a patient does. So should your review.
FDA's ad office had posted 61 letters by October 2025, up from 5 a year in 2023 and 2024. Its regulatory agenda lists the Patient Medication Information final rule for December 2026. HealthLiteracyCopilot scores risk statements, medication guides and patient-support materials before MLR. Each draft cites your approved sources, and protected terms and approved disclaimers stay word for word.
Send a blank template, not a copy with a patient's or member's details.
HealthcareGPS is SOC 2 Type II audited and HIPAA compliant. How we protect your documents
61
letters posted by FDA's ad office (OPDP) by late October 2025, up from 5 a year in 2023 and 2024.
Source: FDA OPDP data, as reported by Hall Render (2025-12-22) and ProPharma (2025)
Dec 2026
FDA's target date for the final Patient Medication Information rule: a one-page guide for prescription drugs used on an outpatient basis.
Source: Unified Agenda of Federal Regulatory Actions, FDA, RIN 0910-AH68
About $290 billion
a year in avoidable US costs is linked to medication non-adherence
Source: NEHI (New England Healthcare Institute) (2009)
What we fix
Patient materials ready for MLR review
- Product names and safety language kept word for word.
- Every edit tracked with its reason.
- Medical, legal and regulatory reviewers see what changed and why.
Illustrative example.
FDA reads your ads like a patient does
FDA's ad office, OPDP, sent 5 letters a year in 2023 and 2024. By late October 2025, it had posted 61. Many cite risk text that is hard to read or easy to misread. One noted risk text that was hard for seniors to read.
Score risk information before it goes to MLR. HealthLiteracyCopilot checks reading level, sentence length and plain wording in each risk statement. Your reviewers see each change and the reason for it.
Before it goes to MLR
| Year | Letters |
|---|---|
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 61 by October 28 |
| 2026 | 21 untitled letters by July 28 |
Source: Hall Render (2025-12-22); ProPharma (2025); FDA Law Blog (2026-07); King & Spalding (2025).
A one-page medication guide for outpatient prescription drugs
FDA proposed the Patient Medication Information rule in 2023. It would replace Medication Guides and patient package inserts with a one-page guide in a standard format, written for patients, for prescription drugs, including biologics, used, dispensed or given on an outpatient basis. FDA's regulatory agenda lists the final rule for December 2026.
Outpatient prescription drugs, brand and generic, would need new patient labeling. HealthLiteracyCopilot writes medication guides to a target grade, keeps protected terms and approved wording word for word, and records each reviewer's decision.
Source: FDA, Medication Guides: Patient Medication Information proposed rule (Federal Register, 2023-05-31); Unified Agenda of Federal Regulatory Actions, RIN 0910-AH68.
Non-adherence is costly
About $290 billion a year in avoidable US health costs is tied to medicines not taken as prescribed. Clear instructions are one way to help. They show people how and when to take a medicine.
About $290 billion
a year in avoidable US costs is linked to medication non-adherence
From grounded draft to release
Step 1: Ground
Draft from your approved sources in the knowledge base. Every claim carries a citation.
Step 2: Assess
Grade level, PEMAT and N-PLAT scores.
Step 3: Revise
Plain language. Protected terms and approved disclaimers stay word for word.
Step 4: MLR review
Medical, legal, regulatory and safety reviewers, in series or in parallel.
Step 5: Sign
Part 11-style e-signatures and an append-only audit trail.
Step 6: Release
Release gate, then hand-off to Veeva.
Every step leaves a record in the version history.
Built for the materials you ship
- DTC risk information for web, print, social and video scripts.
- Medical-information answers to patient questions, readable and on record.
- Lay summaries of clinical trial results, written for the public.
- Medication guides and patient information at a target grade.
- Patient-support and REMS materials, with clear steps and warnings.
- Spanish measured with Spanish formulas, such as Fernández-Huerta and INFLESZ, not English ones.
- Content in 45 languages and regional variants, with a human hand-off for risky segments.
Measures this work supports
Part D adherence counts 3x in the 2027 Star Ratings, so health plans look to patient-support programs too. Clear instructions support measures of whether people take a medicine and stay on it, such as proportion of days covered. They also support REMS knowledge checks and patient-support programs. Your program measures what clear materials add.
Prove it on your own patients
Split one patient-support mailing for one brand, such as a start kit or a refill reminder. Half the patients in your support program get today's version, half get the revised one your reviewers approved. Same timing and channels.
Before it starts, you pick the measure (proportion of days covered or on-time refills at 90 days, from your hub or specialty-pharmacy data) and write the rule that decides, such as "expand if the revised group does better and the 95% interval excludes zero." No lift is promised. Your data decides, not ours.
We work from templates only. Your patients' data stays with you.
Medical-information answers people can read
Patients send your medical-information team more questions each year. AI now drafts many standard answers. Each one needs to be clear, true to your sources and reviewed.
HealthLiteracyCopilot drafts from your approved sources, cites them and scores the patient version. A reviewer approves each answer. The record keeps the score, the version and who signed.
Start with a fixed-scope diagnostic. Then run a 90-day pre-MLR pilot on one brand: half its new pieces, drawn at random, are scored before MLR, and the rest go through today's review. You pick the measures before it starts, such as MLR rounds per piece and reviewer comments on readability.
Why HealthLiteracyCopilot
Instead of your team and an agency
"Reviewers argue about wording, and every cycle is opinion."
Standards, not opinion: IHA's N-PLAT, AHRQ's PEMAT and reading grade on every version, with a reason for each change.
See the standards we score withInstead of ChatGPT or Copilot
"AI might change a dose, a date or a disclaimer."
Built for regulated text: a clinical anchor gate, protected terms, and a scorer that never grades its own revisions.
How we differ from general AIInstead of a translation vendor
"Spanish and Section 1557 are where we get caught."
Spanish measured as Spanish, translation risk set by language, and a human translator for any segment that could lose a dose, a number or a "do not".
How we measure SpanishInstead of a readability checker
"Where do we start with 2,000 templates?"
Portfolio Scan ranks the whole library worst first, by the measure each document touches.
See how a library scan worksInstead of focus groups
"Will people actually understand it?"
Test before you send: simulated readers built from your personas, and a teach-back simulator for staff.
See persona testingInstead of shared drives and email
"We have to prove it to NCQA, The Joint Commission or MLR."
The record reviewers ask for: the criteria, the version, the reviewer and the date for every document.
See the review record
In their words
What people using it say
…efficiency, that's a part of it. … But the really important part is that it gets us all on the same page in the assessment piece and removes this variability that may or may not hit the mark from a patient understanding, readability and usability…
Health literacy lead, global biopharmaceutical company …there's an explanation of why the recommendations were made. … And I love this because it's training as it goes.
Health literacy lead, global biopharmaceutical company
From people using HealthLiteracyCopilot, shared anonymously by role and type of organization. Trimmed where marked (…), never reworded.
Built for each role on your team
What each person is measured on, the documents they own and the parts of the platform they'd use most.
- Medical writingWhich document keeps coming back?For heads of medical writing and plain-language summary leadsReview roundsCycle timeLay-summary output Read more
- Regulatory and promotional reviewFind hard-to-read risk text before it reaches MLRFor regulatory affairs, labeling, promotional review and MLR leadsOPDP letters that cite risk textPatient Medication Information (PMI) readinessMLR review roundsAudit trail Read more
- Patient services and adherenceSupport materials patients can follow, dose after doseFor patient services, patient-support program and adherence leadsProportion of days coveredREMS knowledge checksReach in Spanish and other languages Read more
Start with one patient document
Send us one patient document. It comes back in Word with the changes to make and the reason for each one.
Send a blank template, not a copy with a patient's or member's details.
HealthcareGPS is SOC 2 Type II audited and HIPAA compliant. How we protect your documents
Questions
Does this replace MLR review?
No. It prepares materials before MLR review. Your medical, legal, regulatory and safety reviewers decide, and each decision is recorded.
Do protected terms and disclaimers change?
No. Protected terms and approved disclaimers stay word for word, and the meaning check flags any change for your reviewers.
Do you need patient data?
No. Send a blank template or approved public material, never a patient's details.