Appendix g — 🔗 DIH Healthcare Integration Model

The Core Insight: DIH as a Trial Insurance Provider

The DIH doesn’t disrupt healthcare - it enhances it by functioning like an insurance company that covers clinical trial participation.

How It Actually Works (The Realistic Model)

1. The Patient Journey

Traditional Path:

1. Patient sees doctor
2. Doctor prescribes FDA-approved treatment
3. Insurance covers it (maybe)
4. Patient pays copay

DIH-Enhanced Path:

1. Patient sees doctor
2. Doctor can ALSO recommend relevant trials (like pre-1962)
3. DIH covers trial participation costs
4. Patient pays minimal copay ($20-50)
5. Patient gets experimental treatment AND contributes to research

2. The DIH Insurance Model

What DIH Covers (Like Insurance):

• Trial medication costs
• Required testing and monitoring
• Travel reimbursement (if needed)
• Lost wage compensation
• Complication coverage

Patient Responsibilities:

• Small copay ($20-50 per month)
• Report outcomes via app
• Attend follow-ups
• Share de-identified data

3. Integration Points with Existing System

At the Doctor’s Office:

• DIH portal integrated into EMR systems
• Doctors see trial options alongside standard treatments
• One-click enrollment (like e-prescribing)
• Automatic eligibility checking

At the Pharmacy:

• Trial medications dispensed like regular prescriptions
• Pharmacy becomes trial distribution site
• Standard pickup/delivery options
• Automatic refill reminders

With Existing Insurance:

• DIH supplements, doesn’t replace
• Covers what traditional insurance won’t (experimental treatments)
• Seamless billing coordination
• No coverage gaps

4. The Money Flow (Realistic Version)

graph TD
    A[1% Treaty Funds] --> B[DIH Treasury]
    B --> C[Trial Coverage Pool]
    C --> D[Covers Patient Costs]
    D --> E[Medications]
    D --> F[Testing]
    D --> G[Travel/Time]
    H[Patient Copay $20-50] --> D
    I[Data Generated] --> J[dFDA Database]
    J --> K[Better Treatment Rankings]

5. Why This Works Better Than Direct Payments

Avoids Perverse Incentives:

• No “professional patients” gaming the system
• No coercion of desperate people
• Maintains doctor-patient relationship
• Preserves medical ethics

Reduces Friction:

• Works within existing workflows
• Uses familiar insurance model
• No new systems to learn
• Doctors remain gatekeepers

Ensures Quality:

• Medical oversight maintained
• Safety monitoring preserved
• Professional standards upheld
• Data quality assured

Real-World Example

Sarah has Type 2 Diabetes:

Old System:

• Metformin not working well
• No other options covered
• Pays $500/month for branded drug
• Still has poor control

With DIH Integration:

1. Doctor checks DIH portal during visit
2. Sees 5 relevant trials for new diabetes drugs
3. Recommends Trial #3 based on Sarah’s profile
4. Sarah enrolls with one click
5. DIH covers all costs
6. Sarah pays $30 copay
7. Gets experimental drug that might work better
8. Reports blood sugar via app
9. Data helps next patient

Implementation Requirements

Technical Infrastructure

• EMR integration APIs
• Pharmacy network connections
• Claims processing system
• Patient portal/app
• Data collection platform

Regulatory Framework

• Modified clinical trial regulations
• Insurance coordination rules
• Privacy/HIPAA compliance
• Prescription handling protocols
• Safety monitoring standards

Stakeholder Buy-In

• Doctors: CME credits for trial participation
• Pharmacies: Dispensing fees for trial meds
• Hospitals: Infrastructure payments
• Insurers: Reduced long-term costs from better treatments

The Pre-1962 Model (What We’re Returning To)

Before the 1962 Kefauver-Harris Amendment:

• Doctors could prescribe experimental treatments
• Patients and doctors decided together
• Innovation happened at bedside
• FDA only regulated safety, not efficacy

We’re bringing this back, but with:

• Modern safety monitoring
• Real-time data collection
• Systematic outcome tracking
• Global knowledge sharing
• Insurance coverage for trials

Cost Structure (Realistic Numbers)

Per Patient Per Trial:

• Medication costs: $200-2000/month (covered by DIH)
• Monitoring costs: $100-500/month (covered by DIH)
• Travel/time: $50-200/month (covered by DIH)
• Patient copay: $20-50/month
• Data collection: $10/month (automated)

Total DIH cost per patient: $360-2,710/month Traditional trial cost per patient: $6,800-13,600/month

Efficiency gain: 75-80% cost reduction

Why Doctors Will Love This

1. More treatment options for desperate patients
2. Professional satisfaction from contributing to research
3. CME credits for participation
4. No liability (covered by trial insurance)
5. Simple integration (one click in EMR)
6. Better outcomes from expanded options

Why Patients Will Use This

1. Affordable access to cutting-edge treatments ($20-50 copay)
2. Doctor recommended (trusted source)
3. Insurance-like coverage (familiar model)
4. No financial risk (DIH covers everything)
5. Helping others while helping themselves

The Transition Plan

Phase 1: Pilot Programs (Year 1)

• 10 health systems
• 5 disease areas
• 10,000 patients
• Prove the model works

Phase 2: Regional Rollout (Year 2)

• 100 health systems
• 20 disease areas
• 100,000 patients
• Refine operations

Phase 3: National Scale (Year 3+)

• All willing providers
• All diseases
• Millions of patients
• Full integration

The Bottom Line

The DIH isn’t trying to replace the healthcare system. It’s adding an “experimental treatment insurance layer” that:

• Works within existing infrastructure
• Respects current relationships
• Maintains safety standards
• Reduces costs dramatically
• Accelerates medical progress

It’s not revolution. It’s evolution. And it starts with a simple insurance card that says: “This covers your clinical trial participation.”