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Reimbursement

Health Economics and Outcomes Research(HEOR)

In one line

Research discipline that generates economic, clinical, and patient-reported evidence to support payer access, HTA submissions, and value demonstration.

Definition

Health Economics and Outcomes Research (HEOR) is the multidisciplinary field that generates economic models (cost-effectiveness, cost-utility, budget impact), real-world evidence, and patient-reported outcomes data used by payers, HTA bodies, and health systems to assess a technology's value. HEOR deliverables include the Global Value Dossier, AMCP Format submissions to US health plans, and country-specific HTA submissions (NICE, CADTH, IQWiG, HAS).

Why it matters

Strong HEOR is the difference between coverage and non-coverage in single-payer systems and is rising in importance for US commercial payers. Increasingly, HEOR planning starts at preclinical/early clinical to ensure trial endpoints support the value story.

Common pitfalls

•Designing pivotal trials around regulatory endpoints only and finding the dataset can't support the HEOR case.
•Treating HEOR as a post-launch activity instead of an evidence-generation strategy from Phase 1.

Sources

ISPOR — Good Practices · ISPOR
AMCP Format for Formulary Submissions · AMCP
CMS - Coverage · CMS

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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