The General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) are both data protection laws that are aimed at safeguarding people’s privacy.
However, they operate in different contexts and jurisdictions, covering distinct types of data. The GDPR applies to the personal data of individuals in the EU, while HIPAA protects the health and healthcare data of U.S. residents when it’s handled by healthcare service providers and related entities.
This GDPR vs HIPAA comparison explores where the two laws overlap, where they differ, and what businesses need to know about effectively managing compliance with these frameworks.
At a glance
- Scope: The GDPR covers all personal data of individuals in the EU, while HIPAA protects only health-related data of U.S. patients handled by healthcare entities and their associates.
- Consent: The GDPR generally requires explicit, opt-in consent for data processing, whereas HIPAA permits certain uses of protected health information (PHI) without prior authorization.
- Data rights: Individuals under the GDPR have broad rights to access, correct, and erase their data. HIPAA grants narrower rights focused mainly on access and amendment of health records.
- Breach response: Both laws mandate breach notifications, but the GDPR requires disclosure to authorities within 72 hours, compared with HIPAA’s 60-day window.
- Compliance overlap: Being compliant with one law doesn’t guarantee compliance with the other, but a unified, consent-led data privacy strategy can help meet both sets of requirements.
Scope comparison: What the GDPR covers vs what HIPAA covers
The GDPR and HIPAA each seek to safeguard personal information, but the extent of their application is quite different. The GDPR aims to protect personal data of individuals in the European Union, while HIPAA applies to the PHI of patients in the United States.
The GDPR and personal data
Personal data is broadly defined under Art. 4 GDPR as any information that relates to or can be used to identify a natural person, either directly or in aggregate through profiling. This could be someone’s name, location data, or even online identifiers.
Consider the example of a fitness tracking app. When a user signs up, they provide their name and email address, and the app then monitors the number of steps they take and routes that they walk each day.
The app will have to comply with the GDPR if people in the EU use it because it involves the collection of names, contact information, and data about users’ location.
HIPAA and PHI
While HIPAA also focuses on data protection, it only applies to certain data relating to individuals’ health or healthcare.
This information is defined by the federal law as individually identifiable health data like a patient’s medical history, laboratory results, billing information, or insurance information. The law does not apply to de-identified health information, which doesn’t identify an individual.
For example, patient portals for accessing medical records in the U.S. must follow HIPAA guidelines and take adequate steps to safeguard the PHI of patients.
Who needs to comply with the GDPR vs HIPAA: jurisdictions explained
It’s not only the type of information collected that matters for HIPAA and GDPR compliance, but also which individuals, businesses, or other entities handle that personal or health data.
In terms of the GDPR, any businesses that handle the personal data of EU residents must comply with the regulation, regardless of whether they’re incorporated or have a presence in the region.
HIPAA, on the other hand, applies only to the data of individuals in the U.S., and the individual’s PHI must be collected by covered entities, defined by the Act as:
- Healthcare providers: Doctors, clinics, dentists, hospitals, pharmacies, therapists, and other healthcare providers.
- Health plans: Health insurance companies, health maintenance organizations, company health plans, and other healthcare companies.
- Healthcare clearinghouses: Billing services, repricing companies, and health information system providers.
Any business associates of these healthcare service providers (e.g., entities that handle PHI on behalf of covered entities) must also comply with HIPAA under a Business Associate Agreement (BAA).
If your business handles physical or mental health data of individuals in both the EU and U.S., you will likely have to comply with both the GDPR and HIPAA. While there is some overlap in the requirements of these laws, complying with one won’t mean you’re automatically compliant with the other.
GDPR vs HIPAA: Key similarities and differences
| Similarities | Differences |
| Aims to protect sensitive data and prevent unauthorized disclosure or misuse. Require organizations to implement technical and organizational safeguards to protect data. Grant individuals rights over their data, such as the right to access and request corrections. Require breach notifications when data is exposed or compromised. Require documentation to demonstrate compliance. | The GDPR protects all personal data of people in the EU, while HIPAA protects patient data of people in the U.S. The GDPR applies globally to any business handling the personal data of people in the EU, whereas HIPAA applies only to U.S. healthcare operations and their associates. HIPAA permits certain uses and disclosures of PHI without consent, while the GDPR requires a legal basis for processing, of which explicit, informed consent is one. |
Granular comparison of GDPR vs HIPAA: compliance obligations, guidelines, and penalties
The GDPR and HIPAA have similar data privacy principles, but they take different approaches to how that protection is achieved. Below we unpack the main obligations, showing how each law governs consent, data processing, breach response, and penalties.
Consent and legal basis for processing
The GDPR requires explicit consent from individuals before data collection and processing, while HIPAA permits certain uses and disclosures of health data without direct authorization.
GDPR
Consent is central to GDPR compliance. Frequently, individuals must actively opt in before any processing of personal data can take place, unless there is another valid and justifiable legal basis per Art. 6 GDPR.
This consent must be freely given, specific, informed, and unambiguous. Even when processing is necessary for medical care, healthcare providers still need a valid legal basis, often explicit consent, to handle sensitive health information.
HIPAA
Under HIPAA, covered entities are permitted to use and share PHI for treatment, payment, and operational purposes without the need for prior patient consent, though robust data security requirements still apply. However, explicit written authorization is required for non-routine disclosures (e.g., sharing data for marketing, research, or third-party use).
Patients may request limits on certain disclosures, like those made to family members or persons involved in the individual’s care, but providers aren’t always obligated to grant them. Because the U.S. does not have a universal healthcare system, it is also more likely that data will need to be shared among more third parties, including insurance and billing entities.
Data minimization and purpose limitation
The GDPR limits how much data can be collected and how long it’s kept, while HIPAA doesn’t explicitly govern the retention of patient records.
GDPR
Art. 5 GDPR requires organizations to collect only the minimum amount of data needed for the specific, clearly defined purpose that was set out when consent was obtained.
This information can’t be reused for unrelated activities or retained indefinitely. Once the purpose has been fulfilled, organizations are expected to either delete or anonymize the data to prevent unnecessary storage or potential misuse.
HIPAA
Data minimization and purpose limitation don’t play a major role in HIPAA compliance. The Act permits covered entities to retain medical records for compliance, continuity of care, and legal purposes.
Retention periods are often set by state law or institutional guidelines. Nonetheless, covered entities should establish a policy on the retention of medical records as a best practice. There may also be additional obligations related to financial record retention for healthcare payments.
Data subject rights
While the GDPR grants individuals extensive data privacy rights, HIPAA offers patients a narrower set of rights focused mainly on access and corrections.
GDPR
As data privacy is the main focus of the GDPR, people located in the EU are given a broad set of rights to ensure they can control how their personal data is collected, used, and stored.
Data subjects have the right to access their data, correct inaccuracies, restrict processing, and request erasure (also known as the right to be forgotten).
Individuals can make data subject access requests (DSARs) to understand what information an organization holds and how they handle that data. They must respond to these requests transparently and within the timeline defined in the Act, which is one month.
HIPAA
Under HIPAA, patients are granted several important rights in relation to their medical information. They may:
- Access their health records
- Request corrections to inaccuracies
- Request a notice of privacy practices
- Request a record of disclosures
- Request a report on when and why PHI was shared for certain purposes
- Revoke consent of the use of PHI for certain purposes, such as marketing
These rights have been provided to create transparency and promote patient trust, but they don’t offer patients full control over medical data.
Data breach rules
Both HIPAA and GDPR requirements include strong data security measures and breach reporting, but the GDPR demands faster disclosure to authorities and affected individuals than HIPAA.
GDPR
Organizations that collect and handle the personal data of individuals within the EU must conduct risk assessments and implement appropriate safeguards to ensure sufficient data protection, including detecting and controlling unauthorized access.
If a data breach occurs, it must be reported to the relevant supervisory authority within 72 hours. If the breach poses a high risk to the rights and freedoms of natural persons, affected individuals must also be notified promptly.
HIPAA
The HIPAA Breach Notification Rule requires covered entities and their business associates to report any unauthorized use or disclosure of protected health information.
Where a data breach does occur, the covered entity or its business associates must notify affected individuals, the U.S. Department of Health and Human Services (HHS), and, in some cases, the media, within 60 days.
Penalties and enforcement
The GDPR has steeper fine thresholds than HIPAA, though both laws impose penalties that are intended to encourage proactive data protection.
GDPR
Supervisory authorities in each EU Member State coordinate investigations to maintain consistent data protection standards and hold organizations accountable for violations.
These regulatory bodies can issue fines of up to EUR 20 million or four percent of a company’s annual global turnover, whichever is higher, against organizations that fail to implement adequate data protection measures. Factors like the severity of the breach and an organization’s documented compliance efforts are considered when calculating fines.
HIPAA
The HHS Office for Civil Rights investigates whether organizations are HIPAA-compliant. Penalties are tiered based on intent and the organization’s approach to data protection, ranging from minor fines to criminal charges for willful neglect.
While fines are generally lower than under the GDPR, they still underscore the need for robust data protection policies and demonstrable compliance efforts when handling sensitive personal data in healthcare contexts.
Does compliance with one help with the other?
Being HIPAA-compliant doesn’t automatically make an organization GDPR-compliant. And the reverse is also true. While both laws share the goal of protecting personal and sensitive health data, their frameworks differ in scope and enforcement.
For example, the GDPR requires organizations to appoint a data protection officer (DPO) in many cases, while HIPAA has no equivalent role. Likewise, the GDPR’s focus on consent, data subject rights, and international data transfers aren’t detailed in HIPAA.
That said, some compliance practices do overlap. Implementing strong security measures, clear breach response procedures, and thorough record-keeping can help organizations achieve compliance with both laws. Still, it’s essential to recognize the key differences between these regulations to achieve full, dual compliance.
Achieve dual GDPR and HIPAA compliance with a comprehensive data privacy solution
The GDPR and HIPAA share the same purpose: protecting people’s privacy and ensuring strong data security. However, they operate in very different contexts. The GDPR governs personal data collection across sectors, while HIPAA focuses on personal health information in the U.S. healthcare system.
Being compliant with one doesn’t ensure compliance with the other, and privacy compliance issues can arise when businesses make this false assumption. But a unified, consent-led strategy can help you meet the requirements of both.
Usercentrics provides tools you can use to automate GDPR compliance and meet HIPAA obligations. By centralizing consent management and supporting global privacy frameworks, the platform helps businesses achieve streamlined, multi-regulation compliance while building trust with users, customers, and patients.
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