Composite Study. Representative matters drawn from our engagements. Details are composites and do not describe any single client.
The Situation
A non-US digital health company with a GDPR-compliant product entering the United States.
Engagement: U.S. market-entry assessment, entity formation, healthcare regulatory counsel, and U.S.-ready commercial contracts.
The Challenge
The company assumed U.S. entry was mostly a corporate formality. Form an entity, open a bank account, start selling. It is not. GDPR-compliant data practices do not automatically satisfy HIPAA. A product classification under EU rules does not map cleanly onto the U.S. regime. And the healthcare fraud-and-abuse laws that apply the moment a company touches U.S. payors and providers were not on anyone’s list.
Enter the wrong way and the cost of unwinding it, across tax, governance and regulatory, dwarfs the cost of doing it right once.
Our Approach
We assessed the business model against U.S. federal and state requirements before the company committed capital, then handled formation: the right structure and the right state, with governance documents and registered-agent arrangements.
Healthcare compliance was built in from the start, with HIPAA reconciled against the existing GDPR posture, product classification assessed under U.S. rules, and Anti-Kickback and state-licensure analysis for the markets actually being entered. Finally we redrafted the commercial agreements to U.S. standards, where risk allocation and indemnity norms differ sharply from European practice.
The Results
The company entered on a structure and compliance foundation built for the market rather than retrofitted to it, with its European data practices reconciled to HIPAA before launch rather than after an incident. There were no surprises after the first contract, because the surprises had been mapped before it.
Key Takeaway
For a non-US health company, U.S. entry is a regulatory project rather than a corporate formality. GDPR is not HIPAA, and the healthcare rules apply from the first sale.
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Strategic Legal Counsel for Healthcare & Health Technology
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