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.
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, fairness, and transparency
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.
Go deeper: What are the penalties for HIPAA violations?
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.
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.”
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.
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.
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.
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.
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.
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?
Yes, HIPAA compliant email practices, especially regarding data encryption and security measures, can align with GDPR’s requirements for protecting personal data.
Organizations can use HIPAA compliant email platforms, like Paubox, which offers encryption, access controls, and audit logs, aligning with both regulations’ data protection standards.
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