HIPAA vs GDPR: What Sets Them Apart?

September 18, 2025

Data privacy isn’t just about checking boxes anymore – it’s about earning trust. For any business handling sensitive personal or health data, especially across borders, the landscape can get complicated fast. Two major regulations – HIPAA (U.S.) and GDPR (EU) – often come up in the same sentence, but they weren’t built with the same blueprint.

One protects patient health records in the U.S. healthcare system. The other? It covers a much broader range of personal data for anyone in the EU, no matter where the company is based. And if you’re dealing with both, you’ll need to play by two very different sets of rules.

Let’s unpack what each law requires, where they overlap, and why understanding both is key to staying out of legal hot water – and building a privacy-first culture.

HIPAA in a Nutshell: What Does It Cover?

HIPAA – short for the Health Insurance Portability and Accountability Act – was passed back in 1996, long before smartphones and cloud storage changed the game. Its main mission? To protect the privacy and security of health information in the U.S.

It applies to “covered entities,” like:

• Healthcare providers (doctors, clinics, hospitals)
• Health insurance companies
• Clearinghouses
• And also to their third-party vendors, known as “business associates”

HIPAA’s main focus is Protected Health Information (PHI). That means any data that can identify a patient and relates to their health – like medical records, treatment notes, lab results, billing info, and so on.

To stay compliant, organizations must:

• Limit access to PHI
• Keep electronic health info secure (e.g., via encryption or login controls)
• Run regular risk assessments
• Educate employees on HIPAA rules
• Report any data breach within 60 days of discovering it

There are two key rules at the heart of HIPAA:

1. The Privacy Rule – governs who can access PHI and when it can be shared
2. The Security Rule – focuses on how electronic PHI is stored, accessed, and transmitted

Organizations that share PHI with vendors (like billing services or cloud storage providers) are required to have Business Associate Agreements (BAAs) in place. These spell out how the vendor will safeguard patient data and what happens if there’s a breach.

What About GDPR?

The General Data Protection Regulation, or GDPR, came into force in 2018 across the European Union – and it turned data protection into a global conversation. Unlike HIPAA, GDPR isn’t specific to healthcare. It applies to any company that handles the personal data of EU residents, no matter where the company is located.

And “personal data” under GDPR casts a wide net. It includes:

• Names
• Email addresses
• IP addresses
• Biometric data
• Health data
• Even photos or GPS coordinates

Some of the most important GDPR requirements include:

• Getting clear, informed consent before collecting personal data
• Giving people the right to access, correct, or delete their data
• Notifying authorities within 72 hours of a data breach
• Appointing a Data Protection Officer (DPO) in some cases
• Keeping data secure through technical and organizational measures

How Are HIPAA and GDPR Different?

Although they both deal with sensitive information, these two laws don’t operate the same way. Here’s how they differ:

1. Who They Apply To

• HIPAA: Only U.S.-based healthcare-related organizations and their vendors
• GDPR: Any company, anywhere in the world, handling EU residents’ data

2. What Counts as Protected Data

• HIPAA: Narrowly focused on PHI – health-related, identifiable information
• GDPR: Much broader – covers any personal data that can identify someone

3. Consent Rules

• HIPAA: Often allows implied consent for things like treatment or billing. For other uses (like marketing), you need written permission.
• GDPR: Consent must be explicit, opt-in, and well-documented for nearly everything.

4. Rights of the Individual

HIPAA gives patients access to their medical records and allows them to request corrections. GDPR goes much further. It gives individuals:

• The right to be forgotten (data erasure)
• The right to data portability (transferring data to another service)
• The right to object to data processing
• The right to restrict certain uses of their data

5. Breach Notification Timelines

• HIPAA: 60 days to notify affected individuals
• GDPR: Just 72 hours to notify both the data protection authority and, in many cases, the individuals affected

6. Penalties for Non-Compliance

• HIPAA: Fines can reach up to $1.5 million per year
• GDPR: Far steeper – up to €20 million or 4% of global annual turnover, whichever is higher

BAAs and DPAs: Two Sides of the Same Coin

If your company works with third-party vendors (and who doesn’t?), you need contracts in place to make sure everyone handles data responsibly.

• HIPAA requires BAAs (Business Associate Agreements) – these outline how PHI will be protected, who’s responsible for what, and how to handle breaches.

• GDPR requires DPAs (Data Processing Agreements) – these are often more detailed and must include how long data will be kept, how it will be used, and what happens when processing ends.

U.S. companies handling both HIPAA and GDPR-regulated data often need to draft layered contracts that satisfy both BAAs and DPA requirements simultaneously.

Managing Both: Tips for Dual Compliance

Handling both HIPAA and GDPR can feel like walking a tightrope – but it’s doable with the right strategy. Here are some steps that help:

• Map your data – Know what you collect, where it lives, and who touches it
• Separate your data – Identify which data falls under HIPAA, GDPR, or both
• Revamp your consent forms – Make sure they align with GDPR standards
• Update breach response plans – Be ready to meet both timelines
• Audit your vendors – Ensure they’re compliant with both frameworks
• Expand employee training – HIPAA training isn’t enough if GDPR applies too.

Final Thoughts: Don’t Pick One – Respect Both

If you’re dealing with PHI and also collecting any personal data from EU residents, you’re in both HIPAA and GDPR territory. Trying to prioritize one over the other isn’t just risky – it could land you in serious legal trouble.

Instead, look at this as an opportunity to build a stronger privacy program overall. Both laws, at their core, are about respecting individuals’ rights and safeguarding their most sensitive data. And that’s not just good compliance – it’s good business.