The American dream: what does it take to sell in the US Digital Health market?

Expanding into the U.S. digital health market is an exciting opportunity for European companies. With a market valued at over $300 billion and growing rapidly, the potential is huge. But regulations differ significantly from the EU, meaning companies must adapt to new compliance frameworks before they can succeed.

If your startup is already GDPR compliant, there’s good news: you’re more than halfway there in meeting U.S. regulatory requirements. But HIPAA (Health Insurance Portability and Accountability Act) introduces additional rules that are specific to healthcare data protection.

This guide will walk you through:

✅ The key differences between GDPR and HIPAA

✅ The complexity of each regulation

✅ What it takes to demonstrate compliance

✅ Practical steps to prepare your business for the U.S. market

Let’s dive in!

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HIPAA vs. GDPR: Understanding the key differences

Both HIPAA and GDPR aim to protect sensitive personal data, but they differ in their scope and application.

GDPR: A broad and strict regulation

✅ Covers all personal data of EU citizens, across all industries.

✅ Applies to any business, worldwide, that processes EU citizens' data.

✅ Defines strict legal obligations, but does not provide detailed technical guidelines.

✅ Requires a legal basis for processing personal data (e.g., consent, data processing agreements, contract, legal obligation).

HIPAA: A Healthcare-Specific Regulation

✅ Covers healthcare data (Protected Health Information, or PHI).

✅ Applies to healthcare providers, insurers, and their business associates.

✅ Provides clearer technical and security guidelines for handling PHI (compared to the GDPR).

✅ Requires Business Associate Agreements (BAAs) with vendors who process PHI.

Key Takeaway: If your business is handling any general personal data, GDPR applies. If you’re working with healthcare data in the U.S., HIPAA is essential. Some companies must comply with both.

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Complexity: Which is more challenging?

GDPR: Broad but vague

GDPR applies to every industry, meaning it provides high-level legal rules rather than industry-specific technical standards. Companies often struggle with interpreting requirements, especially when it comes to security measures.

For instance, GDPR mandates “appropriate technical and organizational measures”, but doesn’t specify exactly what those measures should be. Companies must rely on external guidelines (e.g., ISO 27001, NIST) to define their security framework.

HIPAA: Industry-specific but clearer

HIPAA is much more technical and prescriptive. It provides specific security requirements, such as:

🔹 Encryption for data in transit and at rest.

🔹 Access controls and authentication measures.

🔹 Audit logs to track who accesses health data.

Because HIPAA is focused on healthcare, its rules are stricter but easier to follow, as they provide clear technical and administrative measures to implement.

Key Takeaway: GDPR compliance requires interpretation and adaptation, whereas HIPAA compliance is clearer but more rigid in its technical requirements.

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Demonstrating Compliance: GDPR vs. HIPAA

Once you’ve implemented security measures, the next step is proving compliance.

GDPR Compliance: A moving target

Demonstrating GDPR compliance varies by industry. A B2C SaaS platform may have simple requirements, while a B2B health tech company may need certifications, audits, and third-party assessments.

🔹 Common ways to show GDPR compliance:

✅ Having a Data Protection Officer (DPO).

✅ Conducting Data Protection Impact Assessments (DPIAs).

✅ Ensuring contractual safeguards (DPA agreements).

The challenge? Different clients may expect different levels of GDPR readiness. Some hospitals or insurance companies may require external certifications, while smaller clients may only expect a basic privacy policy.

HIPAA compliance: Strict but predictable

On the HIPAA side, only few companies need to implement every requirement. But you must carefully assess which requirements are appropriate (and some them are mandated).

🔹 Common ways to prove HIPAA compliance:

✅ Implementing mandatory security controls (encryption, access logs, risk analysis).

✅ Signing Business Associate Agreements (BAAs) with vendors.

✅ Conducting annual HIPAA risk assessments.

Key Takeaway: GDPR compliance is more flexible but varies by industry, while HIPAA compliance requires strict adherence to well-defined standards. We wrote about the difference about GDPR and HIPAA some time ago in this blog post.

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Steps to prepare for the U.S. Market

If your company is expanding to the U.S., here’s how to prepare:

✅ Step 1: Assess your data processing activities

🔹 Identify if your business processes PHI (Protected Health Information).

🔹 If yes, HIPAA applies, and you must meet its security standards.

✅ Step 2: Secure your data infrastructure

🔹 Ensure data is encrypted at rest and in transit.

🔹 Implement multi-factor authentication (MFA) for access.

🔹 Maintain audit logs to track who accesses PHI.

✅ Step 3: Establish vendor compliance

🔹 If you work with U.S. healthcare clients, they may require HIPAA Business Associate Agreements (BAAs).

🔹 Verify that all third-party vendors comply with HIPAA security standards.

✅ Step 4: Conduct a compliance audit

🔹 If you’re already GDPR-compliant, conduct a HIPAA gap analysis to identify missing requirements.

🔹 Use frameworks like ISO 27001 or NIST to align with both regulations.

Pro Tip: Many EU startups work with HIPAA compliance consultants to navigate the process efficiently.

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Expanding into the U.S. digital health market is a huge opportunity, but compliance is key. While GDPR compliance gives you a strong foundation, you must understand HIPAA’s specific healthcare data protections to succeed.

Final Takeaways:

✅ HIPAA is healthcare-specific; GDPR applies to all personal data.

✅ HIPAA has strict technical requirements; GDPR is more flexible but vague.

✅ HIPAA compliance is predictable; GDPR compliance varies by industry.

✅ B2B healthcare companies must be fully HIPAA-compliant to work with U.S. partners.

By adapting your security policies and infrastructure, your company can successfully expand into the U.S. market while maintaining legal compliance. 🎯

Need help figuring it out? We’re here to help!

Chino.io is the one-stop shop for solving all privacy and security compliance aspects.

As a partner of our clients, we combine regulatory and technical expertise with a modular IT platform that allows digital applications to eliminate compliance risks and save costs and time.

Chino.io makes compliant-by-design innovation happen faster, combining legal know-how and data security technology for innovators.

To learn more, book a call with our experts.

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