GDPR vs HIPAA: Key Compliance Differences Explained

TLDR

• Scope: HIPAA applies to U.S. healthcare data, while the GDPR covers the personal data of individuals within the EU, regardless of the company's location.
• Data Types: HIPAA regulates only Protected Health Information (PHI), while GDPR protects a broader range of personal data, including behavioral and device information.
• Consent: HIPAA requires consent for specific uses, such as marketing, while the GDPR mandates explicit, informed consent for most data processing activities.
• Penalties: HIPAA fines range from $100 to $50,000 per violation, with a maximum of $1.5 million annually, while GDPR fines can reach up to €20 million or 4% of global annual revenue.

Are you confident that your organization is fully compliant with both the HIPAA and GDPR?

The U.S. Department of Health and Human Services (HHS) reported a 264% increase in ransomware attacks, leading to heightened enforcement of HIPAA regulations. Simultaneously, the European Union's Data Protection Commission imposed a $310 million fine on LinkedIn for non-compliance with GDPR's data processing requirements.

These developments underscore the critical importance of understanding and adhering to both the HIPAA and GDPR. Navigating the complexities of these regulations is crucial for organizations that handle sensitive health data, whether operating within the United States, the European Union, or across international borders.

We understand that managing overlapping regulations, such as GDPR and HIPAA, can be overwhelming, especially when you’re responsible for ensuring compliance across multiple digital platforms and global data streams. This article provides a comprehensive comparison of HIPAA and GDPR, highlighting their key differences and similarities. It offers practical guidance to help your organization ensure compliance with both frameworks, safeguard sensitive data, and maintain trust with stakeholders.

What is HIPAA, and Who Must Comply?

HIPAA is a U.S. law that governs the use and protection of health-related data. It applies to any company involved in transmitting or storing protected health information (PHI). If your platform processes medical, insurance, or biometric data, HIPAA’s security and privacy standards apply.

You're likely subject to HIPAA if your stack supports:

• Appointment bookings, claims, or insurance workflows
• Tools used by providers, insurers, or patient engagement systems
• Backend systems that store or transfer health data for other companies

Even if you're not directly in healthcare, if your tools support regulated entities or handle PHI, compliance is essential.
That includes analytics platforms, infrastructure providers, or marketing systems that receive medical event data.

Now, let's turn our focus to GDPR, which governs data protection for individuals in the European Union.

What is GDPR, and Who Must Comply?

The GDPR is the EU’s privacy law, designed to give users control over their personal data. It applies to any business, regardless of location, that collects data from individuals in the European Union. Whether you run conversion tracking, retargeting, or identity resolution, GDPR covers it if EU residents are involved.

Your business must comply with your platform:

• Collects user behavior or device data from EU-based sessions
• Offers products or services that are accessible to users in the EU
• Uses personalization, analytics, or optimization flows involving EU users

This extends to customer data platforms, ad pixels, session replay tools, or identity graphs. It also applies if you're syncing user data across platforms or building remarketing audiences from EU activity. Understanding the scope of GDPR is just the beginning. Let’s now break down the differences between GDPR and HIPAA, so you can get a clearer picture of how these laws compare.

Also read: CCPA vs GDPR: Key Privacy Law Differences Explained.

GDPR and HIPAA Differences: A Detailed Comparison

Understanding the key differences between GDPR and HIPAA is essential if your business handles personal or behavioral data across regulated markets. These two frameworks share a commitment to privacy but diverge significantly in scope, regulated data types, consent expectations, breach notifications, and penalties. If your operations span both the U.S. and EU regions, or if your martech stack includes cross-border data movement, these distinctions directly impact your compliance posture.

Scope and Jurisdiction

HIPAA applies exclusively to organizations operating within the U.S. healthcare ecosystem. If your systems process Protected Health Information (PHI) on behalf of healthcare providers, insurers, or their vendors, HIPAA applies, regardless of your industry. This includes any third-party platform that touches PHI, whether directly or via integration.

GDPR, in contrast, is geography-agnostic but data-subject-focused. It applies to any company that processes the personal data of individualswithin the European Union or the European Economic Area (EEA), regardless of the company's location. This includes:

• Platforms offering goods, services, or content to EU residents (in any language or currency)
• Businesses collecting behavioral data (cookies, IPs, session IDs) from users in the EU
• Martech stacks using audience segmentation, retargeting, or identity stitching involving EU traffic

Key takeaway: HIPAA is industry-specific and applicable only in the U.S.; GDPR is industry-neutral and applies globally if EU data is involved.

Regulated Data Types

HIPAA regulates only PHI, information that relates to a patient’s health status, care delivery, or insurance billing. This includes names, dates of birth, diagnoses, lab results, and payment data when linked to a healthcare service.

GDPR protects all Personally Identifiable Information (PII), which includes:

• Basic identifiers like name, email, and phone number
• Device data such as IP addresses, cookies, GPS, and mobile IDs
• Behavioral and contextual signals like product views, session replays, or shopping patterns
• Special category data like health, race, or biometric information

While both frameworks cover health-related data, GDPR’s scope is far broader, extending protection to all forms of digital personal data, even outside a healthcare context.

Consent Requirements

Under HIPAA, consent is required only in specific scenarios, mainly for non-treatment purposes, such as marketing or research. Many internal data uses (e.g., billing, care coordination) are exempt from needing explicit consent.

GDPR, on the other hand, treats consent as a default requirement. To legally process personal data, your organization must obtain freely given, specific, informed, and unambiguous consent from the individual. Additionally:

• Pre-checked boxes or bundled consent are not valid
• Consent must be revocable at any time
• You must log and store consent records

This difference is critical for advertising platforms, personalization engines, and analytics tools: if you're running retargeting or cross-site tracking, GDPR mandates consent, even if HIPAA does not.

Data Subject Rights

HIPAA gives individuals control over their health data, including:

• Access to their PHI
• Requests for corrections or amendments
• Limits on how their data is shared
• A right to receive a record of disclosures

GDPR goes further and grants users several universal data rights, including:

• Right to access and correct their data
• Right to object to processing (especially profiling and marketing)
• Right to be forgotten (data erasure)
• Right to data portability
• Right to withdraw consent at any time

For companies managing customer identity graphs, cross-device behavior, or long-term engagement data, GDPR’s user rights demand far more robust response workflows than HIPAA alone.

Breach Notification Requirements

Under HIPAA, covered entities are required to notify affected individuals and the U.S. Department of Health and Human Services within 60 days of discovering a breach involving unsecured Protected Health Information (PHI). Notification thresholds vary based on the size of the breach.

GDPR imposes stricter expectations. If a breach could pose a risk to individual rights, you must notify the supervisory authority within 72 hours of becoming aware of it. If the breach is severe, you must also inform users directly, often sooner.

Notable impact for your teams:

• Security incidents must be identified and classified quickly
• Cross-border breaches can require multi-jurisdiction reporting
• Notification systems must be audit-ready and timezone-aware

Penalties and Enforcement: What Happens If You Fail to Comply?

HIPAA penalties depend on the severity of the violation, ranging from $100 to $50,000 per incident, with an annual cap of $1.5 million. The Office for Civil Rights (OCR) oversees enforcement, typically following audits or investigations into breaches.

GDPR imposes significantly higher fines. Non-compliant organizations can face:

• Up to $20 million or 4% of global annual revenue, whichever is greater
• Investigations triggered by user complaints, audits, or breaches
• Regulatory action across multiple EU jurisdictions

If your business uses global data or operates cross-border marketing stacks, the financial exposure under GDPR can be 10 times higher than under HIPAA.

Organizational Roles and Accountability

HIPAA requires the appointment of a Privacy Officer to oversee compliance, training, and incident response. This role is internal and specific to PHI governance.

GDPR requires many companies to appoint a Data Protection Officer (DPO), especially those:

• Processing large volumes of personal data
• Engaging in systematic monitoring
• Handling sensitive categories of data (e.g., health, biometrics)

The DPO must be independent, well-trained in data law, and have direct access to leadership. If your platform processes EU user data at scale, this is a mandatory role, not optional.

Risk Assessments and Documentation Obligations

HIPAA requires regular risk assessments for systems handling PHI. Documentation of access controls, encryption, and incident procedures is essential for audits.

GDPR introduces the Data Protection Impact Assessment (DPIA), mandatory when:

• You engage in high-risk processing
• You use large-scale profiling or automated decision-making
• You introduce new technologies with privacy implications

Your documentation must include the purpose, legal basis, data flows, and third-party sharing, all of which must be maintained in a Record of Processing Activities (ROPA). To help you better understand the full scope of these regulations, we’ve put together a quick comparison chart. This will make it easier to pinpoint where HIPAA and GDPR diverge and intersect.

Also Read: Understanding the General Data Protection Regulation (GDPR).

GDPR vs HIPAA Comparison Table

The table below summarizes the key differences between GDPR and HIPAA compliance across various data types, user rights, penalties, consent rules, and other relevant aspects. If your organization manages global data workflows, this quick reference helps align your operational, marketing, and legal teams.

Compliance Area	HIPAA (U.S. Health Law)	GDPR (EU Privacy Regulation)
Scope	Applies only to U.S. healthcare data and organizations handling PHI (Protected Health Information).	Applies to any company processing the personal data of EU/EEA individuals, regardless of the company's location.
Regulated Data	Strictly PHI, including diagnoses, procedures, medical records, and insurance details when tied to patient identity.	All PII: names, emails, device IDs, cookies, IPs, geolocation, behavioral data, plus sensitive data (e.g., health, biometrics).
Consent Requirements	Required only in certain contexts (e.g., marketing). Routine care, payment, and operations often don’t need consent.	Required for most data processing. Consent must be explicit, informed, freely given, and revocable.
User Rights	Limited to PHI: access, amendment, restrictions on sharing, and accounting of disclosures.	Broad rights: access, correction, erasure, objection, portability, and withdrawal of consent.
Breach Notification	Must notify affected individuals and HHS within 60 days of breach discovery (based on breach severity).	Must notify the supervisory authority within 72 hours of detecting any risk-based breach; users must be informed when impacted.
Penalties	Up to $50,000 per violation; maximum annual penalty of $1.5 million.	Up to €20 million or 4% of global annual revenue—whichever is higher.
Enforcement Authority	U.S. Department of Health and Human Services (HHS), specifically the Office for Civil Rights (OCR).	Data Protection Authorities (DPAs) in each EU country are coordinated by the European Data Protection Board (EDPB).
Required Roles	A Privacy Officer is required for internal PHI governance.	DPO required for high-risk or large-scale processing. Must operate independently with access to leadership.
Risk Assessments	Regular security risk assessments are conducted for PHI systems. Must document controls and review regularly.	DPIAs are mandatory for high-risk processing (e.g., profiling, large-scale user tracking). Documentation must be current.
Cross-Border Applicability	U.S.-only, but may apply to foreign vendors supporting U.S. healthcare providers.	Global. Any company interacting with EU data subjects must comply with the relevant EU data protection regulations.

Now that we’ve broken down the primary differences, let’s explore the shared principles between these two frameworks, which will guide your compliance efforts.

Also watch: Database Compliance Standards

https://www.youtube-nocookie.com/embed/jvc9ND_Za6c?rel=1

Key Similarities Between GDPR and HIPAA Compliance

Both GDPR and HIPAA promote strong data governance. If you're working with sensitive user data, such as health, behavioral, or personal information, these similarities help streamline your approach across markets.

At the core is data minimization. Both laws expect you to collect only the data you truly need. For your teams, this means:

• Avoid capturing full user sessions unless required
• Don’t store personally identifiable data without a defined business purpose
• Ensure tagging plans and data maps are reviewed for necessity

Security measures are also critical under both frameworks. Whether you're dealing with PHI or digital identifiers, your infrastructure must include:

• End-to-end encryption
• Access controls based on user roles
• Secure API integrations with tokenized authentication

Transparency is another shared requirement. You must inform users clearly about:

• What data do you collect?
• Why was it collected?
• Who can access it?
• How long has it been retained?

This applies to cookie banners, privacy policies, consent modals, and onboarding flows.

When breaches happen, timely disclosure is required under both laws. You need:

• A breach detection process
• Predefined incident response workflows
• Templates for regulator and user notification

Both laws also demand assigned responsibility. You should designate:

• A Privacy Officer (HIPAA) or Data Protection Officer (GDPR), depending on applicability
• Internal owners for training, audits, and privacy reviews

By aligning with these standard requirements, your teams can reduce legal exposure and maintain user trust across jurisdictions.

So, how can you manage both GDPR and HIPAA compliance seamlessly? Let’s walk through a few practical steps to help you stay compliant with both regulations.

How to Comply with GDPR and HIPAA Together?

Managing both GDPR and HIPAA can be complex, but a unified, efficient approach is possible. Focus on core compliance pillars that apply across both laws.

1. Classify Your Data Types Clearly

Understanding what data you handle is your starting point. Categorize by:

• Personal Data: Names, emails, device IDs (GDPR)
• Health Data (PHI): Diagnoses, treatments, patient IDs (HIPAA)
• Behavioral Data: Session activity, referral paths, marketing IDs (potentially both)

This helps map what rules apply, where, and how.

Use Ingest IQ for centralized, privacy-first data collection and mapping across your digital properties.

2. Implement Smart Consent Workflows

Consent is mandatory under the GDPR and required in specific HIPAA use cases, such as marketing.

• Use region-aware banners for GDPR users
• Provide a clear opt-in/opt-out for non-essential tracking
• Store consent logs and make revocation easy

Consent should be explicit, informed, and granular.

Deploy region-aware banners and consent pop-ups using Web Tagging, ensuring EU users see GDPR-compliant options. Along with using Tag Manager Reports to audit consent records, and Data Governance to maintain revocation and user preference updates.

3. Control Data at the Server Level

Move tracking, transformation, and enrichment server-side. This improves security and reduces data exposure.

• Strip PII or PHI before routing to third-party tools
• Tokenize sensitive fields in databases
• Limit client-side scripts and cookies when possibleRoute all tracking and enrichment through Ingest IQ and Data Streaming to keep sensitive processing off the client.

4. Assign Clear Privacy Roles

Both laws require accountability. Assign responsibilities to reduce risk.

• HIPAA: Appoint a Privacy and Security Officer
• GDPR: Assign a DPO for high-risk or large-scale processing
• Create cross-functional teams for legal, tech, and marketing alignment

5. Strengthen Governance and Documentation

Keep your compliance systems auditable and up-to-date.

• Maintain access logs, processing records, and vendor agreements
• Document data flows and risk mitigation efforts
• Conduct periodic reviews of all policies and systems

6. Build a Unified Breach Response Plan

Have one framework for breach detection, assessment, and reporting, adjusted for each regulation’s timeline.

• GDPR: Notify within 72 hours
• HIPAA: Notify individuals within 60 days
• Automate alerts and escalation triggers where possible

7. Prioritize Ongoing Training

Your staff must know what’s at stake and how to act.

• Train teams on data access limits, consent handling, and user rights
• Run simulated breach response drills
• Refresh training every 6–12 months

By aligning these controls, you reduce regulatory risk and support compliant growth across markets. One well-structured compliance foundation supports both laws and builds long-term user trust.

Final Thoughts

Managing GDPR and HIPAA begins with understanding their key differences, including scope, consent requirements, breach notification rules, and penalties. While GDPR covers all personal data, HIPAA focuses on U.S. health information. Yet both demand data minimization, user transparency, and strong governance.

You don’t need separate systems. A unified framework, precise data classification, region-aware consent, and secure server-side tracking can support both laws. It reduces compliance risk while maintaining effective marketing and analytics.

If you’re looking for a platform that simplifies this process, Ingest Labs delivers what modern organizations need. It offers a privacy-first data infrastructure that supports GDPR- and HIPAA-aligned server-side tracking, consent management, and tag orchestration, as well as secure event streaming, cross-device identity resolution, real-time tag validation, and privacy QA tools. Whether you manage eCommerce funnels, healthcare journeys, or multi-channel campaigns, Ingest Labs helps you collect, process, and activate data without sacrificing compliance or performance.

Discover how Ingest Labs can help you achieve your compliance and data objectives today. Request a Demo

FAQ

1. Is something GDPR compliant if it is HIPAA compliant?
   No, being HIPAA compliant does not automatically mean it is GDPR compliant. HIPAA focuses on protecting health-related information in the United States. At the same time, GDPR has broader data protection requirements for all personal data of EU residents, including transparency, consent, and user rights.
2. What are the differences between HIPAA and PCI compliance?
   HIPAA applies to healthcare organizations and governs the privacy and security of protected health information (PHI). In contrast, PCI DSS applies to any entity that processes credit card payments and focuses on securing cardholder data. They serve different industries and protect different types of data.
3. What is the difference between GDPR and US privacy laws?
   The GDPR is a comprehensive, unified data protection law that applies across all EU member states, granting individuals extensive rights over their data. In contrast, US privacy laws are sector-specific and state-based, with no single federal standard in place. As a result, GDPR is generally broader and stricter.
4. What are the differences between the GDPR and the Data Protection Act?
   The UK’s Data Protection Act 2018 complements and implements GDPR standards but includes additional UK-specific provisions. While both laws protect personal data, the Data Protection Act adjusts how GDPR is applied domestically in the UK, especially after Brexit.
5. What is the difference between GDPR and confidentiality?
   GDPR is a legal framework that governs how personal data must be collected, processed, and stored, while confidentiality is a principle or agreement to keep certain information private. GDPR includes confidentiality as one of its principles, but extends far beyond it by enforcing user rights, consent, and transparency.