The insider playbook for clinical AI founders, investors, and executives navigating the FDA, EU AI Act, and Health Canada — simultaneously.
And on the other side of it is $40,000 that belongs to you.
Every year, clinical AI companies collectively leave tens of millions of dollars in FDA waivers, EU compliance vouchers, and Health Canada protections unclaimed. Not because the programmes don't exist — but because no one tells founders where to look.
The FDA has a Financial Hardship Waiver that zeroes out the $11,423 annual registration fee. The EU AI Office has €220 million in compliance grants for SMEs navigating the 2026 enforcement deadline. Health Canada will reject your $14,163 filing fee without refund if a single XML file uses the wrong formatting standard.
This Goldmine maps every door. Every protocol. Every deadline. Built by a physician with 20 years of doing this in the real world.
"The regulatory wall that most founders fear is, for those who understand it, a goldmine. The founders who know how to trigger these mechanisms recover $40,000 to $90,000 before their first hospital signs a contract."
— Dr. Kathyann Sandiford, from Chapter 1Asset 1 is the FDA Form 3602N Execution Guide — the exact protocol for securing the FY 2026 Financial Hardship Waiver and eliminating $11,423 from your regulatory budget before December.
It is free because once you see the quality of the protocol, the decision to get the rest of the Vault is obvious. No email required. No paywall. Download it, hand it to your Regulatory Lead, and file before August 1st.
The FDA takes 60 days to issue your Small Business Determination number. The last safe filing date to guarantee December clearance is August 1, 2026. The fee is legally non-refundable once paid.
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The book gives you the strategy. The Vault gives you the tools to execute it tomorrow morning — one per deadline, in the order that matters.
If you are building or scaling a clinical AI company, this Vault is the compliance infrastructure you don't have time to build from scratch — and can't afford to get wrong.
Regulatory risk is now a standard diligence category for clinical AI. This Vault gives your team the framework and the audit checklist — and a resource to distribute to every portfolio company.
Understand the regulatory credentials of the AI vendors you are procuring — and the financial model that makes the investment defensible to your board.
The free guide demonstrates exactly what the Vault delivers. The $197 purchase pays for itself before you finish Asset 2.
Medical doctor and healthcare consultant with more than 20 years of experience in digital health, health informatics, and healthcare leadership across the Caribbean, the United Kingdom, and the United States.
She holds an MBBS from the University of the West Indies and a Master of Health Services Administration from George Washington University, and is ECFMG Certified — the qualification that allows internationally trained physicians to practise in the United States. She is a recipient of the Organization of American States Graduate Scholarship, awarded in recognition of her contributions to healthcare leadership and innovation.
Over two decades she has designed EHR ecosystems, led clinical AI implementations, served as a Data Protection Officer under UK GDPR, and held Principal Investigator roles on World Bank-funded public health research. Her technical expertise spans HL7 v2, FHIR, ISO 42001 AI governance, HIPAA, UK GDPR, ISO 13485, and FDA digital health guidance. She holds AI literacy certifications from Aston University, the NIH AIMAHEAD Programme, and NHS Health Education England.
Every week you spend without this Vault is another week your competitors are filing first. The EU voucher runs out. The FDA waiver window closes. The Health Canada fee clock is already running.
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