GDPR and HIPAA are two of the strictest security and privacy regulations in the world today. If your company serves EU citizens, manages health data, or does both, you need to know how to comply with GDPR and HIPAA. 

Although there are some similarities between the two frameworks, their scope, consent regulations, punishment mechanisms, and enforcement are very different. And confusing the two or assuming one covers the other is one of the most often and expensive errors firms make.

This guide will teach you about each framework’s requirements, how they compare across 10 important characteristics, where they overlap, and which one is appropriate for your company. Now let’s begin.

HIPAA Vs. GDPR: Important Takeaways

• HIPAA applies to US healthcare organizations and their business associates handling Protected Health Information (PHI). 
• GDPR applies to any organization processing personal data of EU residents, regardless of industry or location.
• HIPAA requires breach notification within 60 days. GDPR requires it within 72 hours.
• GDPR gives individuals the Right to Be Forgotten and data portability. HIPAA does not include these rights.
• GDPR penalties can reach €20 million or 4% of global annual turnover. HIPAA penalties reach up to $2,190,294 per violation category per year.
• Some businesses, particularly digital health companies serving both US and EU users, must comply with both frameworks simultaneously.
• HIPAA compliance does not mean you are automatically GDPR compliant. The two require separate programs.

HIPAA vs. GDPR Compliance: A 60-Second Side-by-Side Overview

The main distinction between the two regulatory standards is the kind of information they cover. Before diving into the details, here is a quick comparison of both frameworks.

Dimension	HIPAA	GDPR
Scope	Healthcare providers and their business associates	Any organization processing EU residents’ personal data
Data Type	Protected Health Information (PHI)	All Personally Identifiable Information (PII)
Regulatory Authority	U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR)	Each EU member state has its own Data Protection Authority (DPA).
Jurisdiction	United States Healthcare  ecosystem	European Union and European Economic Area (EEA), Global (if EU and UK data is involved)
Breach Deadline	Up to 60 days	72 hours
Penalties	Up to $1.9 million per violation category per year	Up to €20 million or 4% of global annual turnover

What Is HIPAA Compliance?

The Health Insurance Portability and Accountability Act is known as HIPAA. Enacted in 1996, this US federal statute establishes nationwide guidelines for safeguarding private patient health data. HIPAA compliance indicates that covered organisations and their business partners have established the necessary technical, administrative, and physical security measures to protect PHI.

HIPAA enforcement is the responsibility of the Department of Health and Human Services (HHS) Office for Civil Rights (OCR). Businesses that don’t comply face severe reputational harm, obligatory corrective action plans, and civil and criminal penalties. 

Who Is a Covered Entity Under HIPAA?

HIPAA is applicable to both covered entities and their business partners. Healthcare clearinghouses that handle health information, health insurance companies, employer-sponsored health plans, and healthcare providers like hospitals, clinics, physicians, dentists, and pharmacies are all covered businesses.

Any individual or organization that carries out duties or actions involving the use or disclosure of PHI on behalf of a covered entity is considered a business associate. This includes companies that use PHI for work, such as cloud storage providers, billing services, IT support firms, and legal firms.

What are The Three HIPAA Rules That Define Obligations

All covered entities and business associates are required to adhere to three main rules that regulate HIPAA compliance.

HIPAA Privacy Rule

The HIPAA Privacy Rule sets nationwide guidelines for safeguarding PHI, including medical records. It grants patients control over their medical records, including the ability to review and get a copy. Health plans and healthcare providers are required to adhere to stringent restrictions on the use and disclosure of PHI.

HIPAA Security Rule

Electronic PHI, or ePHI, is the specific subject of the HIPAA Security Rule. Covered entities must implement administrative safeguards, physical protections and technology safeguards to guarantee the confidentiality, integrity, and accessibility of ePHI.

HIPAA Breach Notification Rule

Covered entities are required by the HIPAA Breach Notification Rule to notify impacted persons to the Department of Health and Human Services, and in certain situations, the media if a breach of unprotected PHI happens. After the breach is discovered, notifications must be delivered within 60 days. Business associates must notify the covered entity.

What Is GDPR Compliance?

In 2016, the European Union passed the General Data Protection Regulation (GDPR), a comprehensive data privacy law. It regulates how businesses in the EU and the European Economic Area (EEA) gather, keep, process, and move people’s personal data. GDPR compliance is applicable to all organisations, regardless of their location. GDPR is applicable to you if you manage the personal information of EU citizens.

The European Data Protection Board (EDPB) ensures consistency across EU enforcement, but day-to-day enforcement and investigations are conducted by each country’s national Supervisory Authority (DPA). 

Who Is Required to Follow GDPR Regulations?

Any company that handles the personal data of people living in the EU or EEA is subject to GDPR, regardless of its size or sector. This covers companies that were founded within the EU, non-EU companies who provide goods or services to EU citizens, and non-EU companies that keep an eye on how EU citizens behave.

Data processors are companies that handle personal information on behalf of another company. Data controllers are organisations that choose the methods and goals of processing. GDPR requirements apply to both, but data controllers are more accountable.

What are the Seven GDPR Principles?

The GDPR is based on seven fundamental principles that specify how personal data must be managed.

1. Lawfulness, fairness, and transparency

It demands that people are fully informed about how their data is used and that data processing is done on a legitimate legal basis.

2. Data minimization 

Data minimisation demands that just the information required for the specified purpose be gathered.

3. Purpose limitation

The term “purpose limitation” refers to the requirement that data must be gathered for particular, explicit, and lawful reasons and not processed in a way that is inconsistent with those goals.

4. Storage limitation 

Storage limitation requires that data is kept in a form that identifies individuals no longer than necessary. 

5. Accuracy

Accuracy requires businesses to take appropriate measures to guarantee that personal information is correct and current.

6. Integrity and confidentiality

Integrity and confidentiality necessitate the use of suitable organisational and technical protections to protect personal data from loss, destruction, and unauthorised access.

7. Accountability 

Accountability necessitates that data controllers be accountable for and able to prove adherence to each of the six aforementioned criteria.

Now, let’s discuss these two regulations in detail. 

HIPAA vs GDPR Compliance: Full 10-Dimension Comparison

The table below provides a detailed comparison across ten key dimensions which are Regulated Data, Jurisdiction, Industry Scope, Consent, Breach Notification Deadline, Right to Be Forgotten, Data Portability, Penalties, Oversight Authority, Data Protection Officer. 

Dimension	HIPAA	GDPR
Regulated Data	Specific to healthcare data (Protected Health Information or PHI)	pertains to all personal information (PII) It is more broader than HIPAA.
Jurisdiction	United States Healthcare sector	EU and EEA, plus any organization globally processing EU resident data
Industry Scope	The more specific rules of HIPAA mainly affect healthcare providers and their business partners.	The scope of GDPR is broad and includes all industries.
Consent	Not always required. Healthcare professionals may share PHI (Protected Health Information) under HIPAA without the patient’s permission.	Explicit consent required unless another lawful basis applies
Breach Notification Deadline	60 days from discovery.	You must notify your supervisory authority within 72 hours of learning about a breach.
Right to Be Forgotten	The “Right to be forgotten” grant is not available under HIPAA.	GDPR gives people the exclusive “Right to be Forgotten.
Data Portability	Limited patient access rights	Individuals have the right to receive and transfer their data
Penalties	$145 to $73,011 for each infraction, or up to $2,190,294 annually.	Imprisonment is one of the possible criminal penalties. 4% of the yearly global turnover or up to €20 million, whichever is greater.
Regulatory Authority	U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR).	Supervisory Authorities in each EU member state
Data Protection Officer	Not required under HIPAA	Required for certain organizations processing sensitive data at scale

What are the Key Differences Between HIPAA and GDPR Compliance 

1. Consent Rules Differences

Under HIPAA, covered entities do not always need explicit patient consent to use or disclose PHI. The Privacy Rule permits certain uses and disclosures for treatment, payment, and healthcare operations without requiring patient authorization. Consent is required for other types of disclosures, such as marketing.

GDPR takes a much stricter approach. Organizations must have a valid lawful basis for every processing activity. When explicit consent is the chosen basis, it must be freely given, specific, informed, and unambiguous. Individuals can withdraw consent at any time. For health data, GDPR requires explicit consent unless specific exceptions apply, such as processing necessary for medical diagnosis or the provision of healthcare.

2. Right to Be Forgotten Rule 

GDPR grants individuals the Right to Be Forgotten, also known as the right to erasure. Under Article 17 of the GDPR, individuals can request that an organization delete their personal data in certain circumstances, such as when the data is no longer necessary for the purpose it was collected or when the individual withdraws consent.

HIPAA does not include a comparable right. Patients have the right to access and amend their medical records, but they cannot request complete deletion of their health records held by a covered entity. In fact, healthcare providers are often legally required to retain records for specified periods.

3. Breach Notification Timelines Differences

HIPAA and GDPR have very different breach notification deadlines, and this distinction has significant operational ramifications. HIPAA allows covered businesses to notify impacted parties and report to HHS within 60 days of the date of breach discovery. Annual reporting to HHS is allowed for breaches that impact fewer than 500 individuals.

According to GDPR, companies must report a data breach to the appropriate Supervisory Authority within 72 hours of learning about it. Individuals who are at a high risk owing to the breach must also be informed as soon as possible. Organisations subject to GDPR must have strong incident response strategies in place before a breach happens since the 72-hour window provides very little time for internal investigation.

4. Penalty Tiers Differences

Penalties under GDPR are divided into two categories. 

Less serious violations

Fines of up to €10 million, or 2% of global yearly turnover, may be imposed for less significant infractions including neglecting to keep accurate records or failing to notify the Supervisory Authority of a breach. 

More serious violations

Serious infractions, such disregarding people’s rights or violating fundamental data processing standards, can result in fines of up to €20 million or 4% of global annual turnover, whichever figure is higher.

HIPAA Penalty Tiers

The degree of responsibility determines the tiers of HIPAA sanctions. In situations where the covered entity was not informed, the HHS civil penalty structure starts at $100 per violation and goes up to $50,000 per violation for cases of wilful negligence that remain uncorrected. 

5. Data Scope Differences

Only personally identifiable health information (PHI) generated, received, stored, or transmitted by a covered entity or business associate is protected under HIPAA. This type of data is limited and sector-specific.

Names, email addresses, IP addresses, location data, biometric data, genetic data, and any other information that can be used to directly or indirectly identify an individual are all included in the broad category of Personally Identifiable Information (PII), which is covered by GDPR. Under GDPR, health data is given the highest level of protection and is categorised as a particular category of sensitive data.

The Overlap of HIPAA and GDPR Compliance Requirements

Despite their differences, HIPAA and GDPR share several common requirements that create a meaningful area of overlap.

Both Require Security Safeguards to Protect Data

Both frameworks require organizations to implement security safeguards to protect sensitive data. HIPAA mandates administrative, physical, and technical safeguards for ePHI. GDPR requires appropriate technical and organizational measures to protect personal data, including encryption and pseudonymization where appropriate.

Both Require Breach Notification Implementation

Both require breach notification, though the timelines differ significantly. Both frameworks require organizations to conduct risk assessments. HIPAA mandates a formal risk analysis as a foundational step in its Security Rule. GDPR requires organizations to perform a Data Protection Impact Assessment (DPIA) when processing activities are likely to result in a high risk to individuals.

Both Require Data Minimization Principle

Both frameworks also require data minimization in principle. HIPAA’s minimum necessary standard requires covered entities to make reasonable efforts to use, disclose, and request only the minimum amount of PHI necessary. GDPR’s data minimization principle similarly requires that only the data necessary for the stated purpose is collected and processed.

Both Implement Obligations on Third Parties

Additionally, both place obligations on third parties. HIPAA requires Business Associate Agreements with vendors who access PHI. GDPR requires data processing agreements with processors. Both agreements must define the terms under which protected data can be used and the security obligations each party must meet.

Does Your Business Need HIPAA vs GDPR Compliance or Both?

When GDPR Compliance Applies to Your Business

If you gather, store, or handle the personal data of people who live in the EU or EEA, your company must comply with GDPR. This holds true whether your company is headquartered in Australia, the United States, or another country. The location of your company is not the deciding factor. Instead, it is the location of the people whose data you handle.

GDPR applies to a SaaS company that retains user data from European customers, an e-commerce company that exports to EU countries, and a US-based healthcare service with an international patient portal accessible by EU citizens.

When HIPAA Compliance Applies to Your Business

If you are a covered entity or a business associate operating in the United States, your company must comply with HIPAA regulations. If you are a health plan, a healthcare clearinghouse, or a healthcare provider that electronically communicates health information, you are a covered entity. If you manage PHI for a covered firm, even if you are not employed in the healthcare sector, you are considered a business associate.

When GDPR and HIPAA Compliance Are Applicable at the Same Time

Certain businesses are simultaneously subject to both frameworks. Digital health firms, health applications, and telehealth platforms that cater to users in both the US and the EU are most frequently affected by this circumstance.

For example, a health app that simultaneously gathers health data from US and EU users must comply with GDPR’s standards for the personal data of its EU users and HIPAA’s obligations for the PHI of its US users.

Aligning your procedures with the more stringent of the two regulations in each area is the safest course of action in these dual-compliance circumstances.

Dual Checklist for HIPAA and GDPR Compliance

The essential standards of each framework are covered in the following checklist if your company needs to comply with both.

HIPAA Compliance Checklist

Here is the checklist for HIPAA compliance that you must follow:

• Find out if you are a business associate or covered entity.
• Appoint a Security and Privacy Officer for HIPAA
• Perform a formal risk assessment of all PHI vulnerabilities and threats.
• Establish in place technical, administrative, and physical security measures.
• Complete Business Associate Agreements for each vendor that has access to PHI.
• Create a breach response process that allows for a 60-day notification period.
• All employees should receive HIPAA Privacy and Security Rules training.
• Keep records of all compliance-related activities for a minimum of six years.

GDPR Compliance Checklist

Follow this checklist to make sure your organization follow GDPR compliance guidelines:

• To determine what information you collect, why, and where it goes, map all the flows of personal data.
• Provide a legitimate foundation for each processing action.
• Assign a Data Protection Officer (DPO) if necessary.
• Establish a 72-hour notice and breach detection process.
• Establish procedures that respect people’s rights, such as the right to data portability, erasure, and access.
• Comply with all third-party processors’ data processing agreements.
• For high-risk processing operations, perform a Data Protection Impact Assessment.
• Keep documentation of processing operations as mandated by Article 30.

HIPAA vs GDPR Compliance in the Broader Privacy Landscape

GDPR and HIPAA are not separate laws. Businesses that operate across many jurisdictions must be aware of additional frameworks that may also apply, as the global data privacy landscape has grown dramatically.

US State Privacy Laws

A number of US states have passed strong privacy rules that go beyond HIPAA. Residents of California have rights comparable to those found in GDPR under the California Consumer Privacy Act (CCPA) and its amendment, the California Privacy Rights Act (CPRA). These rights include the right to know what data is collected, the ability to have it deleted, and the right to choose not to have it sold. In contrast to HIPAA, the CCPA is not exclusive to the healthcare sector and is applicable to all industries.

Similar legislation have been passed by Virginia, Colorado, Connecticut, and Texas, among other states. In addition to HIPAA and GDPR, organisations that handle data from citizens of different states may also have to adhere to a number of state-level frameworks.

Outside of the US, PIPEDA in Canada regulates how personal data is gathered, used, and disclosed for commercial purposes. Brazil’s LGPD, which is based on the GDPR, is applicable to any organization that handles the personal data of Brazilian citizens. Organisations handling health data or extensive consumer data will encounter an increasingly complicated patchwork of compliance obligations as privacy regulations continue to grow globally.

Does HIPAA compliance mean you are also GDPR compliant?

No, you are not GDPR compliant just because you are HIPAA compliant. The two frameworks differ in terms of individual rights, breach notification deadlines, permission procedures, and extent. HIPAA only addresses PHI in the context of US healthcare. GDPR applies to all personal data of EU citizens in all sectors of the economy. Businesses that must comply with both must create distinct compliance processes that cater to the particular needs of each.

What is the biggest difference in HIPAA vs GDPR compliance?

Scope is the biggest distinction. Only PHI is protected under HIPAA, which only pertains to the US healthcare sector. Any firm, regardless of industry or type of data, that handles the personal information of EU citizens is subject to GDPR. Furthermore, GDPR offers people data portability and the Right to Be Forgotten, both of which are absent from HIPAA.

Can a US company be fined under GDPR?

Indeed. GDPR is applicable depending on the location of the people whose data is processed, not the organization’s headquarters. GDPR applies to US businesses that handle the personal data of EU citizens, and noncompliance may result in fines from the appropriate Supervisory Authority. The maximum penalty is €20 million or 4% of the world’s yearly revenue, whichever is greater.

What are the consequences for not complying with GDPR versus HIPAA regulations?

HIPAA civil fines have an annual ceiling of $2,190,294 for each category of violation and range from $145 to $73,011. Penalties under GDPR are graduated. Fines for less significant infractions can reach €10 million, or 2% of the world’s yearly turnover. Fines for the most egregious infractions can reach €20 million or 4% of the world’s yearly turnover, whichever is greater. Beyond monetary fines, both regimes also include criminal sanctions and reputational repercussions. 

What is PHI under HIPAA versus personal data under GDPR compliance frameworks?

Health information that identifies a person that is created, received, kept, or communicated by a covered entity or business associate in the course of providing healthcare is referred to as PHI under HIPAA. Any information pertaining to an identified or identifiable person is considered personal data under GDPR, including names, email addresses, IP addresses, location data, and health information. Compared to HIPAA’s PHI, GDPR’s definition is substantially more expansive and encompasses many more data types.

Do digital health apps have to adhere to both GDPR and HIPAA regulations?

The user base determines this. HIPAA is applicable if a digital health app gathers health information from US users who meet the requirements to be covered entity patients. GDPR is applicable concurrently if that same app handles the personal data of EU citizens. In situations where the two frameworks clash, it is best practice to adhere to the most stringent criteria. Many digital health apps that cater to customers worldwide are required to comply with both standards.

Final Thoughts

You now have a comprehensive understanding of the differences between GDPR and HIPAA compliance, where they overlap, and which one pertains to your company. The main lesson is clear: these are two different frameworks with different regulations, deadlines, and sanctions. No company can afford to take the risk of assuming one covers the other.

We understand that juggling several compliance responsibilities can be difficult, particularly when the consequences include fines in the millions of dollars and reputational harm. That is why FortNexShield is here to help. 

We help business associates, healthcare organisations, and firms exposed to the EU develop compliance programs that meet GDPR and HIPAA regulations. Make an appointment for a consultation right now, and allow us to assist you in creating a compliance policy that safeguards your company on both sides of the Atlantic.