The intersection of GDPR and HIPAA

The General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) set the standards for data protection in the European Union and the United States, respectively. Global organizations must understand their intersection to mitigate data breaches, uphold patient privacy rights, and navigate the complexities of international data protection laws effectively.

Additionally, organizations can use HIPAA compliant emails to ensure transparency in data processing practices and enhance data security measures, adhering to GDPR and HIPAA regulations.

GDPR is a broad spectrum of data protection

The General Data Protection Regulation (GDPR), implemented in May 2018, is founded on seven principles that guide how EU citizens’ personal data should be handled, regardless of the organization’s location. 

• Lawfulness: Data processing must be lawful, adhering to the rules and regulations.
• Fairness: Data processing must be conducted in a way that is fair to the data subjects.
• Transparency: Data subjects must be clearly informed about how their data is being processed.

• Data must be collected for specified, explicit, and legitimate purposes and not further processed in a manner incompatible with those purposes.

• Data collected should be adequate, relevant, and limited to what is necessary and the purposes for which they are processed.

• Data must be accurate and, where necessary, kept up to date. Every reasonable step must be taken to ensure that inaccurate data, having regard to the purposes for which they are processed, are erased or rectified without delay.

• Data should be kept in a form that permits the identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed.

• Personal data must be processed with appropriate security, including protection against unauthorized or unlawful processing, accidental loss, destruction, or damage.

• The data controller is responsible for and must be able to demonstrate compliance with all the other principles, like implementing appropriate measures and being able to provide evidence of compliance.

HIPAA focuses on health data privacy

The Health Insurance Portability and Accountability Act (HIPAA), enacted in 1996 in the United States, protects health information. It establishes standards for protecting individually identifiable health information held by covered entities and their business associates. 

HIPAA principles include:

 1. Privacy Rule

HIPAA protects identifiable health information held or transmitted by a covered entity or its business associate in any form or media, whether electronic, paper, or oral. It also specifies the circumstances under which PHI can be used or disclosed without patient authorization, like treatment, payment, and healthcare operations.

Additionally, patients have rights over their health information, including the right to access, amend, and receive an accounting of disclosures of their PHI.

2. Security Rule

HIPAA’s Security Rule mandates that covered entities implement comprehensive risk management practices to identify potential threats against protected health information (PHI). Covered entities must also use administrative, physical, and technical safeguards to secure PHI. These safeguards include access controls, encryption, audit controls, and transmission security to protect the confidentiality, integrity, and availability of sensitive health information.

3. Breach Notification Rule

A breach is defined as an impermissible use or disclosure of PHI that compromises its security or privacy. Covered entities must notify affected individuals, the Secretary of Health and Human Services (HHS), and, in certain cases, the media of breaches of unsecured PHI. Furthermore, notifications must be issued “without reasonable delay” and not later than 60 days after discovering the breach.

4. Enforcement Rule

HIPAA’s Enforcement Rule establishes procedures for investigations, hearings, and civil money penalties for HIPAA violations.

Specifically, it outlines tiered penalties based on the level of negligence, with increasing fines for more severe or willful neglect violations. Penalties can range from $100 to $50,000 per violation, with a maximum annual penalty of $1.5 million for repeated violations.

5. Omnibus Rule

The HIPAA Omnibus Rule introduces requirements that extend certain HIPAA obligations to business associates of covered entities who receive, maintain, or transmit PHI. It incorporates modifications and enhancements mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act to improve privacy and security protections for health information across the healthcare sector. 

Additionally, the rule regulates using PHI for marketing and fundraising, requiring patient authorization to ensure compliance and protect patient privacy rights.

Similarities between GDPR and HIPAA

• Data protection: Both GDPR and HIPAA emphasize the protection of personal data through principles such as data minimization, purpose limitation, and security measures.
• Individual rights: Both regulations grant individuals rights over their data, including access, correction, and, under GDPR, the right to be forgotten.
• Security measures: Both require organizations to use security measures to protect data from breaches and unauthorized access.

What is the difference between GDPR and HIPAA?

• Scope: GDPR covers all personal data, while HIPAA specifically targets PHI.
• Jurisdiction: GDPR applies to any organization processing the data of EU citizens, while HIPAA applies to covered entities and business associates within the U.S. healthcare sector.
• Fines and enforcement: GDPR imposes fines for non-compliance (up to €20 million or 4% of global turnover), whereas HIPAA’s penalties vary based on the level of negligence.

Go deeper: What are the penalties for HIPAA violations?

GDPR and HIPAA for global organizations

The globalization of healthcare services, medical institutions, insurance companies, and tech firms often means handling patient data across different countries. These organizations must navigate both GDPR and HIPAA to comply with data protection standards no matter where the data originates or where the organization operates. 

For example, a U.S.-based telemedicine company serving European patients must adhere to GDPR requirements while also maintaining HIPAA compliance.

Sharing data

While cross-border data transfers are common, the GDPR imposes strict regulations on transferring personal data outside the EU, including requirements for adequate data protection measures. 

While the GDPR acknowledges that “Flows of personal data to and from countries outside the Union and international organizations are necessary for the expansion of international trade and international cooperation,” it enforces strict regulations on transferring personal data outside the EU. 

Specifically, the GDPR states, “A transfer could take place only if, subject to the other provisions of this Regulation, the conditions laid down in the provisions of this Regulation relating to the transfer of personal data to third countries or international organizations are complied with by the controller or processor.”

When U.S.-based entities (governed by HIPAA) share health data with entities in the EU, they must use GDPR-compliant mechanisms, like standard contractual clauses (SCCs) or binding corporate rules (BCRs), to ensure “compliance with the general principles relating to personal data processing, the principles of data protection by design and by default.”

Unified data protection strategy

Global organizations must create a unified data protection strategy with data governance frameworks to address both regulations. For example, organizations can adopt data minimization practices, use encryption methods, and ensure transparent data processing activities to meet GDPR and HIPAA requirements simultaneously.

Enhanced data subject rights

GDPR grants extensive rights to data subjects, including the right to access, rectify, and erase their personal data, while HIPAA provides patients with rights over their health information. Global organizations must honor these rights, ensuring EU citizens can exercise their GDPR rights even when their data is processed by a U.S.-based entity.

Incident response and breach notification

Both GDPR and HIPAA have strict requirements for reporting data breaches. Under GDPR, organizations must notify the relevant supervisory authority within 72 hours of becoming aware of a breach, and potentially the affected individuals. 

HIPAA requires covered entities to notify affected individuals, the Department of Health and Human Services, and in some cases, the media. 

Organizations operating under both frameworks must have an incident response plan that satisfies both requirements with timely notifications.

Risk management and compliance audits

Global organizations should conduct regular audits to identify and mitigate potential vulnerabilities in their data protection practices. Specifically, they should assess their security controls, evaluate third-party vendors, and ensure continuous compliance.

Ultimately, integrating GDPR and HIPAA compliance can help organizations address potential issues before they lead to penalties and reputational damage.

Cultural and ethical considerations

According to Sharon Kamowitz Privacy & Compliance Consulting, “Much has been written about the impact of cultural differences on international business relationships, compliance, and ethics. Similarly, privacy laws across the globe reflect cultural differences.”

More specifically, navigating the intersection of GDPR and HIPAA also involves understanding the cultural and ethical implications of data protection. 

GDPR’s foundation is rooted in the fundamental right to privacy, which is a human right in Europe. More specifically, the GDPR states “This regulation respects all fundamental rights and observes the freedoms and principles recognized in the Charter as enshrined in the Treaties [including] the right to cultural diversity.”

HIPAA, while focused on privacy, emphasizes the security of health information within the healthcare industry. So, global organizations must ethically handle Protected Health Information (PHI) to uphold patient confidentiality, respect individual privacy rights, and comply with regulatory requirements.

Moreover, HIPAA's Privacy Rule mandates providing patients information about their privacy rights and how their health information will be used and disclosed, ensuring transparency and respect for cultural diversity in healthcare practices.

Using HIPAA compliant emails for GDPR regulations

HIPAA compliant emails align with both GDPR and HIPAA regulations, ensuring robust data protection and privacy standards for sensitive health information across international borders. 

Firstly, HIPAA mandates emails containing PHI are encrypted to prevent unauthorized access during transmission and aligns with GDPR's emphasis on data protection through technical measures, meeting both GDPR and HIPAA regulations. Organizations can use a HIPAA compliant emailing platform, like Paubox, which encrypts emails during transit and at rest, mitigating the risk of potential breaches.

Secondly, HIPAA compliant emails support GDPR compliance by promoting transparency and accountability in data processing. Global organizations must use secure email platforms that provide audit controls and access logs to comply with GDPR's accountability principle. Organizations can track and monitor emails, facilitating prompt response to data breaches and ensuring timely notification as required by GDPR's breach notification requirements.

Furthermore, HIPAA compliant email practices enhance organizational efficiency and patient trust. Covered entities can securely communicate with patients, healthcare professionals, and business associates globally without compromising data security or violating privacy regulations to help strengthen organizational reputation and credibility in handling health information.

Read also: Do international companies have to abide by HIPAA?

FAQs

Do HIPAA compliant emails also comply with GDPR?

Yes, HIPAA compliant email practices, especially regarding data encryption and security measures, can align with GDPR’s requirements for protecting personal data.

How can organizations ensure HIPAA and GDPR compliance in their emails?

Organizations can use HIPAA compliant email platforms, like Paubox, which offers encryption, access controls, and audit logs, aligning with both regulations’ data protection standards.

How can providers protect patient privacy under HIPAA and GDPR?

Healthcare providers should educate staff on privacy practices, use HIPAA compliant platforms, like Paubox, to send patient data, and obtain patient consent for data processing.

Go deeper: How to obtain patient consent for email communication