Data privacy gets complicated quickly when you operate across different countries.
A healthcare company in the United States might already follow HIPAA, the law that protects patients’ health information. But if that same organization has users in Europe, the GDPR may also apply.
For organizations working with international users or digital health services, understanding how GDPR and HIPAA differ is essential for building a privacy strategy that works across both regulatory environments.
In this guide, we compare the two frameworks and explain:
- How GDPR and HIPAA differ
- The types of data each regulation protects
- Where their requirements overlap
- What organizations should consider when navigating both laws
For a deeper explanation of GDPR, see our in-depth guide: Everything you need to know about GDPR.
GDPR and HIPAA explained
What is the GDPR and who does it apply to?
The General Data Protection Regulation (GDPR) is a privacy law introduced by the European Union in 2018. Its goal is to give individuals greater control over their personal data and ensure organizations handle that data responsibly. It places requirements and responsibilities on entities that handle personal data and grants comprehensive rights to users.
Who must comply with the GDPR?
GDPR applies broadly and is not limited to European companies. Organizations must comply if they:
- Are based in the EU
- Offer goods or services (even free ones) to people in the EU
- Monitor the behavior of individuals located in the EU
As a result, a US-based healthcare provider would need to comply with the GDPR if they process the personal data of EU residents.
What is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) is a United States law designed to protect medical information. It was introduced in 1996 and focuses specifically on safeguarding health-related data.
HIPAA was created to protect patient privacy while improving the efficiency of the healthcare system. The law includes several rules that regulate how medical information must be stored, shared, and secured.
Unlike GDPR, HIPAA applies only to specific organizations within the healthcare ecosystem. These include:
- Healthcare providers
- Health insurance companies
- Healthcare clearinghouses
- Business associates that process health data for these entities
Organizations outside healthcare are generally not subject to HIPAA.
GDPR and HIPAA: key differences at a glance
While both regulations protect sensitive information, they operate very differently. GDPR applies broadly across industries, while HIPAA focuses specifically on healthcare.
| Category | GDPR | HIPAA |
|---|---|---|
| Scope | Applies to organizations processing personal data of people in the EU | Applies to healthcare entities and their business associates |
| Data protected | All personal data | Protected health information (PHI) |
| Geographic reach | Global, if EU residents are involved | Primarily applies in the United States |
| Individual rights | Includes rights such as access, correction, deletion, and portability | Focuses mainly on protecting medical records |
| Enforcement authority | EU data protection authorities | US Department of Health and Human Services |
Understanding the data each regulation protects
Personal data under GDPR
GDPR protects personal data, which refers to any information that can identify a person directly or indirectly. Examples include names, email addresses, phone numbers, IP addresses, location data, and identification numbers.
Some types of personal data are considered more sensitive and receive additional protection. These include health information, genetic data, and biometric data. Because this definition is broad, GDPR applies across many industries.
Protected health information under HIPAA
HIPAA protects Protected Health Information, often called PHI. PHI refers to health-related information that can be linked to an identifiable person and is handled by a healthcare provider, insurer, or another covered entity.
Examples include medical records, treatment information, lab results, insurance details, and billing records. Compared with GDPR, HIPAA protects a much narrower category of information.
Penalties and enforcement
GDPR non-compliance consequences
GDPR violations can result in significant penalties. Regulators can issue fines of up to:
- 20 million euros, or
- 4 percent of global annual turnover, whichever is higher
Authorities may also require organizations to change how they process personal data.
HIPAA violation penalties
HIPAA violations are enforced by the US Department of Health and Human Services. Penalties depend on the severity of the violation. Fines can range from:
- $100 per violation for minor cases
- Up to $50,000 per violation for serious violations
The annual maximum penalty for a violation category is typically $1.5 million. In serious cases involving intentional misuse of data, criminal penalties may also apply.
Similarities and common ground
Despite their differences, GDPR and HIPAA share several core principles. Both frameworks emphasize:
Transparency. Organizations should clearly explain how personal data is used.
Security. Sensitive information must be protected using appropriate technical and organizational safeguards.
Accountability. Organizations must demonstrate that they follow privacy rules and protect personal data.
Because of these shared principles, many organizations implement privacy programs that align with both frameworks.
Practical compliance considerations
GDPR compliance for US companies
GDPR may apply if a US organization:
- Offers services to users in Europe
- Operates websites accessible to EU residents
- Tracks user behavior online
Common compliance measures include publishing a clear privacy policy, identifying a legal basis for processing data, collecting consent when required, and responding to user requests such as data access or deletion.
HIPAA compliance for health app developers
Digital health platforms and healthcare apps may be subject to HIPAA when they process health information on behalf of healthcare providers. Typical compliance measures include:
- Encrypting sensitive health data
- Restricting access to authorized staff
- Monitoring access to patient records
- Signing Business Associate Agreements when required
Does HIPAA compliance equal GDPR compliance?
No. Meeting HIPAA requirements doesn’t automatically mean an organization meets GDPR requirements. HIPAA focuses only on healthcare data within the US healthcare system, whereas GDPR regulates many types of personal data and applies globally. Organizations operating internationally may need to comply with both frameworks.
The broader privacy landscape
GDPR and HIPAA are part of a growing global landscape of privacy regulations. Other major privacy laws include:
- California Consumer Privacy Act (CCPA)
- Brazil’s Lei Geral de Proteção de Dados (LGPD)
- Canada’s PIPEDA
- Various US state privacy laws
GDPR vs HIPAA: FAQ
Can a company comply with both GDPR and HIPAA at the same time?
Yes. Organizations operating internationally, especially in healthcare, may need to comply with both sets of regulations if they handle protected health information and personal data of EU residents.
Does GDPR apply to US healthcare providers?
It can. GDPR may apply if a US healthcare provider offers services to people in the EU or processes personal data belonging to EU residents.
Do digital health apps need to comply with HIPAA?
Sometimes. HIPAA applies when an app processes protected health information on behalf of a healthcare provider or another covered entity.
Can anonymized health data fall outside both regulations?
In some cases, yes. If data is fully anonymized and cannot be linked to an identifiable person, it may fall outside both GDPR and HIPAA.
Which regulation should organizations prioritize if both apply?
If both apply, organizations must comply with both frameworks and design privacy practices that meet the requirements of each.
Key takeaway
GDPR and HIPAA both aim to protect sensitive information, but they apply in different contexts. GDPR protects personal data broadly and can apply globally when EU residents are involved. HIPAA focuses specifically on healthcare information within the US healthcare system.
If your organization works with international users or builds digital health products, there’s a good chance you’ll need to consider both legal frameworks. This means being clear about how you collect and use data, keeping your systems secure, and making sure users understand what happens to their information.
If you’re trying to make GDPR compliance simpler for your website or app, iubenda can help. Our solutions help you generate privacy policies, manage consent, and keep track of your compliance setup as your site ans business evolves. Get started with our free website scan.
