GDPR vs. HIPAA: Similarities, Differences, and Tips for Achieving Compliance

What Is GDPR? 

The General Data Protection Regulation (GDPR) is a regulatory framework established by the European Union to protect the personal data and privacy of individuals within the EU. It came into effect on May 25, 2018, and applies to all companies handling the data of EU citizens, regardless of the company’s location. GDPR aims to give control to individuals over their personal data and unify the data protection laws within the EU.

GDPR mandates strict data protection measures, including the lawful basis for processing personal data, obtaining explicit consent, and ensuring data subjects’ rights such as access, rectification, and erasure. Non-compliance can result in substantial fines, up to 4% of a company’s global annual turnover or €20 million, whichever is higher. The regulation also requires the appointment of a Data Protection Officer (DPO) for certain organizations to oversee compliance efforts.

What Is HIPAA? 

The Health Insurance Portability and Accountability Act (HIPAA) is a US federal law to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. Enacted in 1996, HIPAA outlines various provisions to ensure the confidentiality, integrity, and security of Protected Health Information (PHI). It applies to healthcare providers, health plans, and healthcare clearinghouses, collectively referred to as covered entities, as well as their business associates.

HIPAA includes two main rules: the Privacy Rule and the Security Rule. The Privacy Rule sets standards for the protection of PHI in any form, while the Security Rule specifically focuses on electronic PHI. HIPAA also incorporates the Breach Notification Rule, which details the procedures to follow in case of a data breach. Violations can result in significant penalties, ranging from $100 to $50,000 per violation, depending on the extent of negligence.

The Similarities Between GDPR and HIPAA 

1. Controlled Access to Sensitive Data

Both GDPR and HIPAA stipulate stringent access controls to protect sensitive data. These regulations mandate that organizations implement measures to ensure only authorized personnel can access personal data or PHI. This typically involves robust user authentication processes, role-based access controls, and routine audits to monitor and log access patterns. Ensuring controlled access helps mitigate risks associated with data breaches and unauthorized information disclosures.

Beyond access controls, both regulations require that any access to sensitive information is justified by a legitimate need. Organizations must demonstrate that access to personal data or PHI is granted on a need-to-know basis, ensuring that data privacy and security principles are upheld.

2. Methods for Detecting Unauthorized Changes to PHI

Detecting unauthorized changes to sensitive data is a core requirement under both GDPR and HIPAA. Organizations must employ audit controls and monitoring mechanisms to track any modifications to personal data or PHI. These measures help to promptly identify suspicious activities and potential security breaches, enabling organizations to take swift corrective actions and maintain data integrity.

For detection methods, logging every access and alteration to personal data or PHI is essential. Analysis of these logs can reveal patterns indicative of unauthorized changes, thus ensuring compliance with regulatory standards.

3. Require PHI Encryption at Rest and in Transit

Encryption is a fundamental requirement under both GDPR and HIPAA for protecting sensitive data. Specifically, these regulations mandate the encryption of PHI and personal data both at rest and in transit. Encrypting data at rest involves securing stored data, such as databases, using encryption algorithms that render the data unreadable without proper decryption keys. This ensures that even if the physical media is compromised, the data remains protected.

Encrypting data in transit focuses on securing data as it moves across networks. This involves using protocols such as TLS (Transport Layer Security) to protect data from interception during transmission.

4. Require an Appointed DPO

Both GDPR and HIPAA emphasize the importance of having a designated individual responsible for data protection compliance. Under GDPR, certain organizations must appoint a Data Protection Officer (DPO), who oversees compliance efforts, manages data protection strategies, and acts as a point of contact for data protection authorities. The DPO’s role includes monitoring internal compliance, advising on data protection impact assessments, and training staff involved in data processing.

HIPAA does not explicitly mandate a DPO but does require covered entities to designate a HIPAA Security Officer. These officers are responsible for developing and implementing privacy and security policies, conducting risk assessments, and ensuring compliance with HIPAA’s provisions. The parallel requirement for a designated data protection role underscores the importance of accountability and oversight in maintaining data privacy and security.

GDPR vs HIPAA: The Key Differences 

1. Covered Entities 

GDPR applies to any organization, regardless of its size or industry, that processes the personal data of EU citizens. This broad applicability ensures that all entities dealing with personal data adhere to the same stringent data protection standards.

HIPAA is more specific in its scope. It primarily applies to covered entities in the healthcare sector, such as healthcare providers, health plans, and healthcare clearinghouses. Additionally, HIPAA extends to business associates that handle PHI on behalf of covered entities. 

2. Jurisdiction

GDPR applies to organizations within the European Union and those outside the EU that process the personal data of EU citizens. This extraterritorial scope means that any company dealing with EU citizen data, regardless of its location, needs to comply with GDPR. On the other hand, HIPAA is a US-specific regulation that applies only to covered entities and their business associates operating within the United States.

The distinction in jurisdiction has practical implications for multinational organizations. Companies operating in the US, but doing business with entities in the European Union, might need to comply with both regulations simultaneously.

3. Types of Data Protected

GDPR and HIPAA protect different types of data. GDPR applies to any personal data, which includes information relating to an identifiable individual, such as names, addresses, phone numbers, and online identifiers. This rule impacts organizations across various sectors, given its broad definition of personal data. 

HIPAA focuses on Protected Health Information (PHI), which pertains to medical records and health-related information used by healthcare providers, insurers, and clearinghouses. This difference broadens GDPR’s scope to encompass almost any data that can identify a person, impacting sectors beyond healthcare. HIPAA’s narrower focus on health information makes it more targeted but still critical for entities within the healthcare industry. 

4. Regulatory Authority

The regulatory authorities overseeing GDPR and HIPAA enforcement also differ. GDPR is enforced by Data Protection Authorities (DPAs) within each EU member state. These authorities have the power to investigate, audit, and impose fines for non-compliance. Organizations dealing with EU citizens’ data must navigate potential investigations from multiple DPAs across different member states, adding to the complexity of compliance.

HIPAA enforcement is managed by the Office for Civil Rights (OCR) under the US Department of Health and Human Services (HHS). OCR conducts audits, investigates complaints, and enforces penalties for HIPAA violations.

5. Legal Basis for Processing

Under GDPR, organizations must have a valid legal basis for processing personal data, such as consent, performance of a contract, legal obligation, vital interests, public task, or legitimate interests. This framework requires organizations to carefully evaluate and document the legal basis for each processing activity.

HIPAA specifies that PHI can be used or disclosed only for treatment, payment, and healthcare operations (TPO) without requiring patient authorization. Any other use or disclosure typically requires explicit patient consent.

6. Penalties

The penalties for non-compliance differ between GDPR and HIPAA. GDPR’s fines are substantial, with maximum penalties reaching up to 4% of global annual turnover or €20 million, whichever is higher. These fines underscore the EU’s commitment to stringent data protection and serve as a deterrent against non-compliance.

HIPAA penalties are tiered based on the level of negligence, with fines ranging from $100 to $50,000 per violation. The maximum annual penalty can reach $1.5 million. Understanding the potential financial ramifications of non-compliance is crucial for organizations striving to adhere to both GDPR and HIPAA standards.

7. Breach Notification

Under GDPR, organizations must notify the relevant Data Protection Authority within 72 hours of becoming aware of a data breach. Affected individuals must also be informed if the breach is likely to result in high risks to their rights and freedoms.

HIPAA’s Breach Notification Rule mandates that covered entities notify affected individuals without unreasonable delay, and no later than 60 days after discovering a breach. Additionally, breaches affecting more than 500 individuals must be reported to the Department of Health and Human Services (HHS) and the media.

Tips for Ensuring Compliance with Both Regulations 

Appoint a Data Protection Officer (DPO)

Appointing a Data Protection Officer (DPO) is a critical step in ensuring compliance with both GDPR and HIPAA (in the HIPAA regulation, this role is called the HIPAA Security Officer). The DPO is responsible for overseeing the organization’s data protection strategy and implementation. This role is essential for managing compliance, conducting audits, and acting as a liaison between the organization and regulatory authorities.

The DPO must possess an understanding of data protection laws and practices. They should regularly monitor compliance, provide training to staff, and ensure that data protection policies are up-to-date. By appointing a knowledgeable DPO, organizations can better manage their data protection responsibilities and mitigate the risk of non-compliance.

Conduct Risk Assessments

Conducting regular risk assessments is fundamental to maintaining compliance with GDPR and HIPAA. These assessments help identify potential vulnerabilities and threats to personal data and PHI. By understanding the risks, organizations can implement appropriate safeguards to protect sensitive information.

Risk assessments should cover all aspects of data handling, including data collection, storage, transmission, and processing. Organizations must document their findings and take action to address any identified risks. Regularly updating these assessments ensures that the organization’s data protection measures remain effective against evolving threats.

Data Classification and Mapping

Data classification and mapping are essential practices for ensuring compliance with GDPR and HIPAA. Organizations must classify data based on its sensitivity and map where and how it is stored, processed, and transmitted. This process helps identify which data is subject to regulatory requirements and ensures that appropriate protection measures are in place.

Through data classification and mapping, organizations can manage their data and ensure that sensitive information is protected. This practice also supports other compliance activities, such as responding to data subject access requests and conducting impact assessments.

Encryption and Security Measures

Implementing encryption and other security measures is crucial for protecting sensitive data under GDPR and HIPAA. Encryption ensures that data is unreadable to unauthorized individuals, protecting it from breaches and theft. Organizations must use strong encryption standards for data at rest and in transit to meet regulatory requirements.

In addition to encryption, organizations should deploy other security measures such as firewalls, intrusion detection systems, and secure access controls. Regularly updating and patching systems helps protect against vulnerabilities. By prioritizing encryption and security measures, organizations can safeguard sensitive data and maintain compliance.

Employee Training and Awareness

Employee training and awareness are vital components of a successful compliance strategy. Training ensures that staff understand their responsibilities under GDPR and HIPAA and are equipped to handle personal data and PHI appropriately. Regular training sessions help reinforce best practices and keep employees informed about the latest regulatory requirements.

Organizations should develop comprehensive training programs that cover data protection principles, security practices, and incident response protocols. Encouraging a culture of data protection within the organization helps mitigate risks and enhances overall compliance efforts.

GDPR Compliance with Exabeam

Exabeam helps organizations meet both the technological and operational requirements of GDPR including:

• External Threat Reduction: Exabeam works alongside existing security solutions, using machine learning and behavioral analytics to identify unusual activity that may be indicative of an adversary’s attempt to find and access data. Exabeam threat timelines combine events from anomalies and correlation rules to group events by user or device. 
• Internal Threat Reduction: Exabeam works alongside identity and access management solutions to prevent security incidents resulting from the accidental or malicious abuse of allocated permissions. By flagging activity that falls outside the norm for a given user, Exabeam helps to detect potential incidents that could lead to data theft. Ideal log sources mapped to use cases and the MITRE ATT&CK^Ⓡ framework show which tools in the security arsenal can combine to show the clearest picture of events.

Visualization and Dashboards: Exabeam offers clear compliance-based GDPR Dashboards for easy download, export, or emailing regularly in support of GDPR mandates and the needs of the data privacy officer.