The General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) are two important regulations that govern information privacy and security for organizations handling sensitive personal data.
Although the two share similar goals, they have notable differences in scope, requirements, and enforcement. Understanding these distinctions can help organizations design effective security and privacy practices.
In this article, we’ll break down key similarities and differences between HIPAA and the GDPR to clarify their respective focus areas and discuss practical implications for compliance.
GDPR at a glance
The GDPR is an EU regulation introduced in 2018, designed to set the standard for protecting the personal data of individuals in the EU. It also gives data subjects greater control over how their data is collected, processed, and shared.
GDPR compliance is mandatory for any organization that handles EU personal data. It divides in-scope entities into two categories depending on their role in processing:
- Data controllers are organizations that determine how and why personal data is collected and processed
- Data processors are organizations that collect, store, and process data on behalf of controllers
To promote responsible handling of personal information, the GDPR defines seven data protection principles. These provisions guide most of the regulation’s requirements and include concepts like data minimization, purpose limitation, accountability, and accuracy.
The GDPR also outlines eight data subject rights that grant users greater control over how their data is handled, as well as the ability to hold organizations accountable.
The GDPR is enforced by data protection authorities in each Member State, coordinated through the European Data Protection Board (EDPB). Non-compliance can result in corrective action or severe financial penalties, split into two tiers:
{{cta_withimage14="/cta-blocks"}} | GDPR compliance checklist
HIPAA at a glance
HIPAA is a US regulation introduced in 1996. Its goal is to provide federal baseline standards for handling protected health information (PHI). PHI is any individually identifiable information that relates to a person’s past, present, or future health; the provision of care; or payment for care.
Any individual or organization that creates, receives, or maintains PHI as part of its operations must comply with HIPAA. In-scope organizations fall into one of two categories: covered entities and business associates.
To keep up with evolving threat vectors and changes to PHI, HIPAA has received updates over the years in the form of additional rules. The three most notable ones are:
- Privacy Rule: Defines standards for safeguarding PHI and outlines guidelines for permissible uses and disclosures
- Security Rule: Introduces strict requirements for maintaining the integrity, security, and confidentiality of electronic PHI (ePHI)
- Breach Notification Rule: Establishes strict breach reporting guidelines and sets the criteria for what constitutes a breach
HIPAA is enforced by the HHS Office for Civil Rights (OCR), which can audit in-scope organizations following complaints, breaches, or at random. Non-compliance can result in corrective action, substantial financial penalties, or even criminal charges, depending on severity.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Similarities between GDPR and HIPAA
Although the GDPR and HIPAA are different regulations, they overlap in several important areas. For example, both the GDPR and HIPAA:
- Focus on data security and privacy: Both the GDPR and HIPAA outline stringent standards for ensuring the security and privacy of personal information, whether at rest or in transit.
- Outline requirements for monitoring sensitive data: Each regulation mandates processes to detect, document, and prevent unauthorized access to sensitive data.
- Mandate the appointment of internal data protection leadership: The GDPR details appointing a data protection officer (DPO), while HIPAA involves both a privacy officer and a security officer.
- Emphasize regular stakeholder training: Both regulations highlight the importance of training your stakeholders to familiarize them with security and privacy practices.
- Lack formal certification: Neither the GDPR nor HIPAA offer a certificate for achieving compliance. Instead, organizations are expected to demonstrate it through appropriate safeguards, regular internal audits, and thorough self-attestation and documentation.
4 key differences between GDPR and HIPAA
Although the GDPR and HIPAA share similar goals around protecting sensitive information, they differ in critical ways. Here’s a quick table for an at-a-glance view of how GDPR and HIPAA differ in general, after which we’ll take a closer look at the four differences that matter most in practice.
“
A common misconception is that GDPR and HIPAA are product-centric frameworks, when in reality, they are data-centric. Both regulations are fundamentally concerned with how sensitive information—, whether that’s the personal data of data subjects under GDPR or protected health information (PHI) under HIPAA—, is collected, used, shared, and safeguarded. Rather than emphasizing product features alone, they require organizations to take a company-wide view of their data processing activities and interactions to ensure they meet compliance obligations.”
In particular, it’s critical to understand the following four GDPR and HIPAA differences in detail:
- Type of data covered
- Data subject rights
- Legal basis for processing
- Reporting timelines
1. Type of data covered
While both HIPAA and the GDPR handle sensitive data, the specific types of data can vary.
The GDPR casts a much broader net and covers all personal data that can directly or indirectly be traced to individuals in the EU. It also specifies special categories of personal data, which require additional permissions and protections, and include:
- Racial or ethnic origin
- Political opinions
- Union memberships
- Genetic data
- Religious beliefs
- Biometric/health
HIPAA is slightly narrower in scope. Although PHI is also personal data, it’s a more restricted subset consisting of health and related information. However, HIPAA also establishes designated record sets, which are a group of records that contain PHI. If non-identifiable information is part of the same record set as PHI, it must also be protected under HIPAA.
2. Data subject rights
Both HIPAA and the GDPR give specific rights to data subjects. For HIPAA, many of these are outlined in the Privacy Rule and include:
- Right to receive a copy of your PHI
- Right to correct health information
- Right to know how your health information is shared and used
- Right to restrict uses and disclosures of your health information
- Right to an accounting of disclosures
- Right to request confidential communications
Although there is overlap, the GDPR provides data subjects with additional rights, such as:
- Right to erasure (the “right to be forgotten”)
- Right to data portability
- Right to object to processing
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
3. Legal basis for processing
Under the GDPR, organizations must establish a lawful basis before starting a new processing activity. Data subjects must also be informed about data collection before it starts, and they must give explicit consent.
The GDPR outlines six possible lawful bases:
- Consent: The data subjects give clear, voluntary, and informed consent to data processing
- Contractual obligation: Processing is necessary to fulfill a contractual obligation
- Vital interest: Processing is required to protect the data subject’s or another individual’s vital interests
- Legal obligation: Processing is necessary to meet a legal obligation
- Public interest task: Processing is necessary for carrying out a task in public interest or while exercising official authority
- Legitimate interest: Processing is necessary for the legitimate interests of the controller or a third party, except where overridden by the rights and freedoms of the data subject
Conversely, HIPAA permits organizations to use PHI for treatment, payment, and other healthcare operations without obtaining authorization. All other uses of PHI must still be disclosed to the patient and require their explicit approval.
4. Reporting timelines
The reporting timelines and criteria for both regulations differ significantly. Under HIPAA’s Breach Notification Rule, covered entities are required to report breaches affecting 500 or more individuals to the Secretary of Health within 60 days of discovery; smaller breaches can be reported annually. Depending on the number of affected individuals, organizations may also need to send out individual or media notices within the same time frame.
The reporting window under the GDPR is different in that once a breach is discovered, controllers have 72 hours to notify the data protection authority in the state where the breach occurred when the breach is likely to result in a high risk to their rights and freedoms. If a report isn’t made within this time frame, the organization must provide a clear justification.
{{cta_withimage14="/cta-blocks"}} | GDPR compliance checklist
Which regulation should you align with?
The regulation you should pursue depends on your primary industry, the type of data your organization handles, and your competitive landscape. An organization may need to comply with both. For instance, a US-based healthtech organization that handles the personal data of EU residents may be subject to both the GDPR and HIPAA, requiring them to comply with each or risk facing financial penalties on either end.
If you do have to comply with both, you can pursue them in either order. Although HIPAA and the GDPR differ in scope and responsibilities, both regulations focus on personal data processing activities. This overlap provides opportunities to unify compliance efforts in areas such as security controls, shared policies, and data management processes.
Be aware, regulatory differences can create conflicts, particularly when it comes to data handling. The GDPR’s right to erasure requires you to delete a data subject's information on request, while HIPAA requires healthcare providers to retain records for a minimum of six years. Addressing these issues requires detailed documentation and careful policy design.
Even if you’re not in scope for either regulation, pursuing compliance with one or both can serve as demonstrable proof of your organization’s dedication to data security and privacy, boosting your competitive potential.
That said, achieving and maintaining compliance with these extensive regulations can be challenging without a structured approach. You can streamline the process with a dedicated automation solution, such as Vanta, and automate repetitive workflows to reduce manual effort.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
Streamline GDPR and HIPAA compliance with Vanta
Vanta is a leading trust management platform that streamlines compliance, be it for the GDPR or HIPAA, with step-by-step guidance, agentic workflows, continuous monitoring, and unified visibility. It helps operationalize complex requirements with the help of systems built around compliance, risk, and trust management.
Vanta offers granular support for security and compliance teams at any scale with features like:
- Automated evidence collection through more than 400 integrations
- Tracking and closing framework gaps
- Real-time monitoring and risk management for GDPR readiness
- Pre-built, customizable policy templates
- Security training materials
- A unified dashboard for everything GDPR and HIPAA powered by automated evidence collection, document uploads, and instant security reports
You can also get support for 35+ compliance and privacy frameworks or create custom ones with Vanta to align with your unique regulatory landscape.
Book a personalized demo today to consult with one of our product experts.
{{cta_simple19="/cta-blocks"}} | GDPR product page
FAQs
Does HIPAA apply outside the US?
HIPAA is a US law and generally does not apply outside the United States. However, if a non-US organization enters a business associate agreement (BAA) with a covered entity to handle PHI, it becomes contractually subject to HIPAA’s requirements.
Does GDPR apply to US healthcare companies?
If a US healthcare company only treats US residents, the GDPR doesn’t apply. However, US healthcare organizations that also operate within the EU or treat EU residents in the US would have to ensure their protections meet GDPR standards.
Can one compliance program cover both GDPR and HIPAA?
Without careful program design, a single compliance program likely can’t 100% cover both the GDPR and HIPAA because of inherent conflicts. While you can unify some of the processes since both regulations heavily emphasize data privacy and security, there will be some misalignments, such as the difference in breach notification timelines.
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
GDPR and other frameworks
GDPR and HIPAA: Key differences and similarities
Looking to streamline the work for GDPR compliance?
The General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) are two important regulations that govern information privacy and security for organizations handling sensitive personal data.
Although the two share similar goals, they have notable differences in scope, requirements, and enforcement. Understanding these distinctions can help organizations design effective security and privacy practices.
In this article, we’ll break down key similarities and differences between HIPAA and the GDPR to clarify their respective focus areas and discuss practical implications for compliance.
GDPR at a glance
The GDPR is an EU regulation introduced in 2018, designed to set the standard for protecting the personal data of individuals in the EU. It also gives data subjects greater control over how their data is collected, processed, and shared.
GDPR compliance is mandatory for any organization that handles EU personal data. It divides in-scope entities into two categories depending on their role in processing:
- Data controllers are organizations that determine how and why personal data is collected and processed
- Data processors are organizations that collect, store, and process data on behalf of controllers
To promote responsible handling of personal information, the GDPR defines seven data protection principles. These provisions guide most of the regulation’s requirements and include concepts like data minimization, purpose limitation, accountability, and accuracy.
The GDPR also outlines eight data subject rights that grant users greater control over how their data is handled, as well as the ability to hold organizations accountable.
The GDPR is enforced by data protection authorities in each Member State, coordinated through the European Data Protection Board (EDPB). Non-compliance can result in corrective action or severe financial penalties, split into two tiers:
{{cta_withimage14="/cta-blocks"}} | GDPR compliance checklist
HIPAA at a glance
HIPAA is a US regulation introduced in 1996. Its goal is to provide federal baseline standards for handling protected health information (PHI). PHI is any individually identifiable information that relates to a person’s past, present, or future health; the provision of care; or payment for care.
Any individual or organization that creates, receives, or maintains PHI as part of its operations must comply with HIPAA. In-scope organizations fall into one of two categories: covered entities and business associates.
To keep up with evolving threat vectors and changes to PHI, HIPAA has received updates over the years in the form of additional rules. The three most notable ones are:
- Privacy Rule: Defines standards for safeguarding PHI and outlines guidelines for permissible uses and disclosures
- Security Rule: Introduces strict requirements for maintaining the integrity, security, and confidentiality of electronic PHI (ePHI)
- Breach Notification Rule: Establishes strict breach reporting guidelines and sets the criteria for what constitutes a breach
HIPAA is enforced by the HHS Office for Civil Rights (OCR), which can audit in-scope organizations following complaints, breaches, or at random. Non-compliance can result in corrective action, substantial financial penalties, or even criminal charges, depending on severity.
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
Similarities between GDPR and HIPAA
Although the GDPR and HIPAA are different regulations, they overlap in several important areas. For example, both the GDPR and HIPAA:
- Focus on data security and privacy: Both the GDPR and HIPAA outline stringent standards for ensuring the security and privacy of personal information, whether at rest or in transit.
- Outline requirements for monitoring sensitive data: Each regulation mandates processes to detect, document, and prevent unauthorized access to sensitive data.
- Mandate the appointment of internal data protection leadership: The GDPR details appointing a data protection officer (DPO), while HIPAA involves both a privacy officer and a security officer.
- Emphasize regular stakeholder training: Both regulations highlight the importance of training your stakeholders to familiarize them with security and privacy practices.
- Lack formal certification: Neither the GDPR nor HIPAA offer a certificate for achieving compliance. Instead, organizations are expected to demonstrate it through appropriate safeguards, regular internal audits, and thorough self-attestation and documentation.
4 key differences between GDPR and HIPAA
Although the GDPR and HIPAA share similar goals around protecting sensitive information, they differ in critical ways. Here’s a quick table for an at-a-glance view of how GDPR and HIPAA differ in general, after which we’ll take a closer look at the four differences that matter most in practice.
“
A common misconception is that GDPR and HIPAA are product-centric frameworks, when in reality, they are data-centric. Both regulations are fundamentally concerned with how sensitive information—, whether that’s the personal data of data subjects under GDPR or protected health information (PHI) under HIPAA—, is collected, used, shared, and safeguarded. Rather than emphasizing product features alone, they require organizations to take a company-wide view of their data processing activities and interactions to ensure they meet compliance obligations.”
In particular, it’s critical to understand the following four GDPR and HIPAA differences in detail:
- Type of data covered
- Data subject rights
- Legal basis for processing
- Reporting timelines
1. Type of data covered
While both HIPAA and the GDPR handle sensitive data, the specific types of data can vary.
The GDPR casts a much broader net and covers all personal data that can directly or indirectly be traced to individuals in the EU. It also specifies special categories of personal data, which require additional permissions and protections, and include:
- Racial or ethnic origin
- Political opinions
- Union memberships
- Genetic data
- Religious beliefs
- Biometric/health
HIPAA is slightly narrower in scope. Although PHI is also personal data, it’s a more restricted subset consisting of health and related information. However, HIPAA also establishes designated record sets, which are a group of records that contain PHI. If non-identifiable information is part of the same record set as PHI, it must also be protected under HIPAA.
2. Data subject rights
Both HIPAA and the GDPR give specific rights to data subjects. For HIPAA, many of these are outlined in the Privacy Rule and include:
- Right to receive a copy of your PHI
- Right to correct health information
- Right to know how your health information is shared and used
- Right to restrict uses and disclosures of your health information
- Right to an accounting of disclosures
- Right to request confidential communications
Although there is overlap, the GDPR provides data subjects with additional rights, such as:
- Right to erasure (the “right to be forgotten”)
- Right to data portability
- Right to object to processing
{{cta_withimage13="/cta-blocks"}} | HIPAA compliance checklist
3. Legal basis for processing
Under the GDPR, organizations must establish a lawful basis before starting a new processing activity. Data subjects must also be informed about data collection before it starts, and they must give explicit consent.
The GDPR outlines six possible lawful bases:
- Consent: The data subjects give clear, voluntary, and informed consent to data processing
- Contractual obligation: Processing is necessary to fulfill a contractual obligation
- Vital interest: Processing is required to protect the data subject’s or another individual’s vital interests
- Legal obligation: Processing is necessary to meet a legal obligation
- Public interest task: Processing is necessary for carrying out a task in public interest or while exercising official authority
- Legitimate interest: Processing is necessary for the legitimate interests of the controller or a third party, except where overridden by the rights and freedoms of the data subject
Conversely, HIPAA permits organizations to use PHI for treatment, payment, and other healthcare operations without obtaining authorization. All other uses of PHI must still be disclosed to the patient and require their explicit approval.
4. Reporting timelines
The reporting timelines and criteria for both regulations differ significantly. Under HIPAA’s Breach Notification Rule, covered entities are required to report breaches affecting 500 or more individuals to the Secretary of Health within 60 days of discovery; smaller breaches can be reported annually. Depending on the number of affected individuals, organizations may also need to send out individual or media notices within the same time frame.
The reporting window under the GDPR is different in that once a breach is discovered, controllers have 72 hours to notify the data protection authority in the state where the breach occurred when the breach is likely to result in a high risk to their rights and freedoms. If a report isn’t made within this time frame, the organization must provide a clear justification.
{{cta_withimage14="/cta-blocks"}} | GDPR compliance checklist
Which regulation should you align with?
The regulation you should pursue depends on your primary industry, the type of data your organization handles, and your competitive landscape. An organization may need to comply with both. For instance, a US-based healthtech organization that handles the personal data of EU residents may be subject to both the GDPR and HIPAA, requiring them to comply with each or risk facing financial penalties on either end.
If you do have to comply with both, you can pursue them in either order. Although HIPAA and the GDPR differ in scope and responsibilities, both regulations focus on personal data processing activities. This overlap provides opportunities to unify compliance efforts in areas such as security controls, shared policies, and data management processes.
Be aware, regulatory differences can create conflicts, particularly when it comes to data handling. The GDPR’s right to erasure requires you to delete a data subject's information on request, while HIPAA requires healthcare providers to retain records for a minimum of six years. Addressing these issues requires detailed documentation and careful policy design.
Even if you’re not in scope for either regulation, pursuing compliance with one or both can serve as demonstrable proof of your organization’s dedication to data security and privacy, boosting your competitive potential.
That said, achieving and maintaining compliance with these extensive regulations can be challenging without a structured approach. You can streamline the process with a dedicated automation solution, such as Vanta, and automate repetitive workflows to reduce manual effort.
{{cta_simple18="/cta-blocks"}} | HIPAA product page
Streamline GDPR and HIPAA compliance with Vanta
Vanta is a leading trust management platform that streamlines compliance, be it for the GDPR or HIPAA, with step-by-step guidance, agentic workflows, continuous monitoring, and unified visibility. It helps operationalize complex requirements with the help of systems built around compliance, risk, and trust management.
Vanta offers granular support for security and compliance teams at any scale with features like:
- Automated evidence collection through more than 400 integrations
- Tracking and closing framework gaps
- Real-time monitoring and risk management for GDPR readiness
- Pre-built, customizable policy templates
- Security training materials
- A unified dashboard for everything GDPR and HIPAA powered by automated evidence collection, document uploads, and instant security reports
You can also get support for 35+ compliance and privacy frameworks or create custom ones with Vanta to align with your unique regulatory landscape.
Book a personalized demo today to consult with one of our product experts.
{{cta_simple19="/cta-blocks"}} | GDPR product page
FAQs
Does HIPAA apply outside the US?
HIPAA is a US law and generally does not apply outside the United States. However, if a non-US organization enters a business associate agreement (BAA) with a covered entity to handle PHI, it becomes contractually subject to HIPAA’s requirements.
Does GDPR apply to US healthcare companies?
If a US healthcare company only treats US residents, the GDPR doesn’t apply. However, US healthcare organizations that also operate within the EU or treat EU residents in the US would have to ensure their protections meet GDPR standards.
Can one compliance program cover both GDPR and HIPAA?
Without careful program design, a single compliance program likely can’t 100% cover both the GDPR and HIPAA because of inherent conflicts. While you can unify some of the processes since both regulations heavily emphasize data privacy and security, there will be some misalignments, such as the difference in breach notification timelines.
A note from Vanta: Vanta is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
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