Disease State Education (DSE) — Definition, Scope, and Guardrails

1. Purpose 

This document establishes a clear, defensible definition of Disease State Education (DSE) and the guardrails required to ensure such content is non‑promotional medical education and outside the scope of legal and regulatory promotional review. 

2. Definition 

Disease State Education (DSE) is non‑promotional, unbranded educational content intended to improve understanding of a medical condition, including epidemiology, pathophysiology, clinical presentation, diagnostic principles, guideline‑based management, and general categories of diagnostic or therapeutic modalities. 

DSE
  • Does not reference, describe, or imply any specific company product, service, platform, algorithm, report, or feature; 
  • Does not make claims—explicit or implicit—regarding performance, effectiveness, safety, accuracy, or clinical benefit of any specific product or service; and 
  • Is not intended to influence the selection, ordering, prescription, or use of any particular product or service. 
When these criteria are met, DSE is considered medical education, not promotion.

3. Intended Audience and Distribution  

DSE content may be made available to internal and external audiences, provided all requirements in this Appendix are met. External visibility alone does not convert DSE into promotional material. 

4. Permitted Content (All Must Apply)  

DSE may include the following, provided content remains unbranded and non‑comparative: 
  • Disease epidemiology, burden, and natural history
  • Pathophysiology and mechanisms of disease
  • Signs, symptoms, and clinical presentation
  • Differential diagnosis
  • General diagnostic or therapeutic modality categories (e.g., ECG, ambulatory monitoring, implantable monitoring, imaging, laboratory testing)
  • High‑level diagnostic principles described qualitatively
  • Guideline‑based management frameworks (e.g., professional society guidelines)
  • Balanced discussion of risks, limitations, and uncertainties across modality categories 

5. Prohibited Content (Automatic Exclusion from DSE) 

Content does not qualify as DSE if it includes any of the following: 
  • Product, service, platform, algorithm, report, feature, or brand references
  • Quantitative or qualitative performance claims (e.g., accuracy, yield, sensitivity, specificity, outcomes, turnaround time)
  • Comparative or directional statements that favor a modality in a manner consistent with company offerings
  • Case studies, vignettes, workflows, or examples resembling real‑world use of a company product or service
  • Operational, commercial, or access‑related information (e.g., ordering, billing, reimbursement, onboarding, report interpretation)
  • Calls to action (explicit or implied), including language such as choose, switch, order, prescribe, consider 

6. Device Category Guardrails 

When device or modality categories are included, all of the following are required: 

  • Category‑level framing only (no product proxies)
  • Symmetric presentation of strengths and limitations across categories
  • No quantification or optimization language
  • No implication of preference, superiority, or clinical advantage 

7. Structural and Governance Requirements 

To maintain DSE classification, the following controls are mandatory: 

  • DSE content must reside in a separate Academy or education section, clearly distinct from product education
  • Content must be owned and approved by Medical Affairs/Clinical leadership
  • The following disclaimer must be included verbatim: 
“This material is disease‑state education for general informational purposes only and does not describe or recommend any specific product or service.” 
  • Any reuse or adaptation of DSE content for commercial or product‑related purposes requires re‑classification and appropriate review 

8. Review and Lane Assignment Rule 

If content meets the definition and all guardrails in this document, it is classified as Disease State Education and follows a medical‑only review pathway.
If any prohibited element is present, the content exits the DSE lane and must follow applicable promotional and MLR review processes. 

9. Audit Test  

For documentation and audit purposes, reviewers must be able to answer “No” to the following:
Could this content reasonably be used to support a claim about one of the company’s products or services, even indirectly?
A “Yes” response disqualifies the content from DSE classification.