Services

Federal-grade evidence.
Built from inception.

Four service lines. One through-line: evidence that survives the scrutiny of the reviewers who actually decide — federal payers, CMS innovation model evaluators, and payer medical directors.

SERVICE 01

Evidence Strategy &
RWE Design

Claims, EHR, and geospatial data — designed to meet federal bars from day one.

Real-World Evidence CMS Claims EHR Linkage Geospatial

Most RWE studies are designed for commercial payers — and then hit a wall with CMS. We build evidence packages that speak the language of federal reviewers from the first study design decision. That means quasi-experimental designs that satisfy CMS standards, claims-EHR linkage methodologies that hold up in peer review, and equity sub-group analyses that are never an afterthought.

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Study Design & Protocol
PICO-structured study design with federal reviewer in mind from inception
🔗
Claims-EHR Linkage Analysis
Integration of CMS Chronic Conditions Warehouse, IDR, and EPIC EHR data
⚖️
Equity Sub-Group Analysis
Disaggregated by race, payer status, geography, and dual-eligible status
📋
Evidence Package & Summary
Citable, structured deliverable ready for payer submission or publication
SERVICE 02

AI/ML Audit &
Equity Review

Independent evaluation against the frameworks that federal reviewers actually use.

TRIPOD-AI PROBAST DECIDE-AI DiMe Seal

Most AI evaluation stops at accuracy metrics. We ask harder questions: accurate for whom, validated against what standard, and defensible in front of which reviewer? We apply established frameworks systematically — then add a mandatory equity review that assesses performance across the subpopulations your model will affect most.

TRIPOD-AIPrediction model transparent reporting
PROBASTRisk of bias assessment tool
DECIDE-AIAI decision support reporting guideline
GRADEEvidence quality grading
DiMe SealDigital therapeutics evidence standards
CMS AI PolicyFederal AI governance requirements
SERVICE 03

Health AI
Evidence Review

Three lanes. One question: can your AI prove what it claims?

Pre-Market Validation Procurement Due Diligence Regulatory Readiness

Digital health companies need evidence that moves payers. Payers need independent review before procurement. Both need someone who understands how federal standards actually apply. We serve all three buyer problems across three evaluation lanes.

01
Pre-Market Evidence Validation
Stress-test your evidence package before it reaches payers or CMS. We find the gaps before federal reviewers do.
02
AI Procurement Due Diligence
Independent expert review for health systems and payers buying AI tools — auditing vendor evidence and equity claims.
03
Regulatory Readiness Assessment
Map your product to FDA SaMD, CMS innovation models, and ONC AI governance — with a gap-closing roadmap.
SERVICE 04

Federal Market
Entry Advisory

Inside knowledge of how federal programs actually evaluate products and proposals.

CMS Innovation Models Medicare Coverage Federal Contracting

Getting a digital health product into a CMS innovation model or a Medicare coverage pathway requires knowing exactly what evidence is needed and how federal evaluators think. We've been on the inside — building the analytics for QRS, bundled payments, and oncology care models. We bring that institutional knowledge directly to your market entry strategy.

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Federal Pathway Mapping
Identify the right CMS innovation model, coverage pathway, or contract vehicle for your product
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Evidence Gap Analysis
Side-by-side crosswalk of your current evidence against federal requirements
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Proposal & Submission Support
Analytics narrative and technical writing for federal contract proposals — $50M+ in awarded contracts supported

"We don't translate your evidence for federal buyers. We build it federal-ready from day one."

Calibrate Health Advisors LLC · Virginia

Not sure which service fits?

Every engagement starts with a scoping call. We'll assess your project, your data, and your target pathway — and tell you honestly whether we're the right fit and which service line applies.

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