Intent.Health Healthcare Regulatory Deep Dive

FDA: Market Access

Regulates medical devices, drugs, and software-as-a-medical-device (SaMD). Without clearance, you cannot legally sell.

Class I: Low Risk (e.g., Bandages). General controls.
Class II: Moderate Risk (e.g., CT Scanners). 510(k) required.
Class III: High Risk (e.g., Pacemakers). PMA required.

HIPAA: Data Access

Governs Protected Health Information (PHI). If your software touches patient data, you are a "Business Associate."

BAA: Mandatory contract between vendor & provider.
Security Rule: Encryption at rest & in transit.
Privacy Rule: Minimum necessary disclosure.

The "Valley of Death"

The Commercialization Gauntlet

1. Concept & Funding

Innovation begins. Angel/Seed funding secured. Initial prototype developed.
Risk: Technical Feasibility.

2. Regulatory Clearance

FDA submission (510k or PMA). Clinical trials for evidence. This creates the "moat" but burns cash.
Risk: Regulatory Rejection.

3. Reimbursement Coding

Securing CPT/DRG codes from CMS. Without a code, providers can't bill for it, so they won't buy it.
Risk: Payment Denial.

4. Market Access

Getting on GPO contracts, passing IDN Value Analysis Committees (VAC), and IT Security reviews.
Risk: Commercial Adoption.

Why This Matters for Sales

In healthcare B2B, you aren't just selling features; you are selling **compliance and reimbursement**. If you cannot speak the language of FDA approval classes or HIPAA security frameworks, you will never get past the gatekeepers.

Intent Insight

High intent for "SOC2 Type II" or "HITRUST" keywords from a Health System usually signals an active vendor displacement cycle.

Sell to the CISO early

Don't wait until the end of the deal.

Map the VAC Process

Know the Value Analysis Committee schedule.

Validate Reimbursement

Ensure your CPT codes are active.