GDPR and HIPAA Compliance: Differences & Similarities

The General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) are both regulations that protect personal data in their respective territories, but they have different scopes and requirements. The GDPR is a broader European Union (EU) legislation that applies to any organization handling personally identifiable information of EU or UK citizens and residents. While HIPAA is focused on healthcare organizations and how personal health information is used in the United States. Below is an analysis highlighting the main differences and similarities between GDPR and HIPAA.

Key Differences Between GDPR and HIPAA

The GDPR and HIPAA are both important for data protection regulations, but they have slightly different approaches.

Protected Data

• GDPR protects any data that relates to, or can lead to the identification of a living person that resides in the European Union or the United Kingdom. This applies to both residents and citizens. 
• HIPAA focuses on any information about health status, care, or payment that is created or collected by a HIPAA Covered Entity (or a Business Associate of a Covered Entity), that can be linked to a specific individual.

Scope and Jurisdiction

• GDPR sets compliance standards for all entities that fall within its scope. A US-based care provider would be required to comply with the GDPR if they process the personal data of EU-based users.
• HIPAA sets standards for covered entities (health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically) and their business associates. Health providers based in other countries are required to comply with the GDPR if they process the personal data of US-based users.

Consent Requirements

• GDPR states that explicit consent is mandatory for the processing of personal health data (which falls under sensitive data). However, the data may be processed without consent if it meets one of the conditions of processing in Article 9 of the GDPR and a legal basis applies. Under Article 9, the special categories include racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health, data concerning a person’s sex life or sexual orientation. The processing of this sensitive data is generally prohibited unless one of the following conditions from Article 9(2) applies:
  • Employment and social security obligations (Article 9(2)(b))
  • Vital interests protection (Article 9(2)(c))
  • Legitimate activities of non-profit organizations (Article 9(2)(d))
  • Data made public by the data subject (Article 9(2)(e))
  • Legal claims or judicial acts (Article 9(2)(f))
  • Substantial public interest (Article 9(2)(g))
  • Preventive or occupational medicine, assessment of working capacity (Article 9(2)(h))
  • Public health (Article 9(2)(i))
  • Archiving, scientific or historical research, or statistical purposes (Article 9(2)(j))
• HIPAA allows disclosure of some PHI for treatment, payment, and healthcare operations without explicit patient consent. This includes information related to billing (name, address, date of birth, dates of service and types of services provided), competency evaluations of healthcare professionals, quality assessment of services and customer service activities. Some exceptions are psychotherapy notes, services paid in full out-of-pocket and sensitive types of health information (e.g., substance abuse treatment records, HIV status). 

Individual Rights

• GDPR grants individuals rights such as:
  • Right to be informed about the collection and use of their personal data
  • Right of access to their personal data
  • Right to rectification of inaccurate or incomplete data
  • Right to erasure (also known as the “right to be forgotten”)
  • Right to restrict processing of their data
  • Right to data portability
  • Right to object to processing of their data
  • Rights related to automated decision-making and profiling
• HIPAA provides individuals with rights to access and amend their health information, and to receive an accounting of disclosures. However, HIPAA does not grant the “right to be forgotten”. For a more in-depth view of HIPAA rights can be found on this blog.

Penalties

• GDPR can impose a maximum fine of €20 million or 4% of global annual turnover, whichever is higher. This is enforced by Data Protection Authorities (DPAs) in each EU member state. 
• HIPAA enforces civil and criminal penalties, but generally with lower maximum fines. These fines can be assessed per violation, which means they could potentially be applied for each affected patient. In cases of widespread breaches affecting numerous patients, fines could theoretically reach the maximum annual cap for each tier multiple times.
  • Civil penalties are tiered based on the level of negligence, with an annual cap of $1.5 million applies per identical provision violated:
    • Tier 1 (No Knowledge): $100 to $50,000 per violation, annual maximum of $25,000
    • Tier 2 (Reasonable Cause): $1,000 to $50,000 per violation, annual maximum of $100,000
    • Tier 3 (Willful Neglect, Corrected): $10,000 to $50,000 per violation, annual maximum of $250,000
    • Tier 4 (Willful Neglect, Not Corrected): $50,000 per violation, annual maximum of $1.5 million
  • Criminal penalties are divided into three tiers:
    •  Tier 1: Up to $50,000 fine and 1 year imprisonment
    • Tier 2 (False Pretenses): Up to $100,000 fine and 5 years imprisonment
    • Tier 3 (Personal Gain or Malicious Intent): Up to $250,000 fine and 10 years imprisonment

Data Breach Notification

• GDPR requires that the supervisory authority be notified within 72 hours of becoming aware of a breach, unless the breach is unlikely to result in a risk to individuals’ rights and freedoms. Controllers must notify affected individuals only if the breach is likely to result in a high risk to their rights and freedoms. The notification must include the nature of the breach as well as an approximate number of individuals affected and the records concerned. It should also include the name and contact details of the data protection officer and the measures taken or proposed to address the breach. 
• HIPAA states that covered entities must notify affected individuals of all security breaches within 60 days, regardless of breach size. If more than 500 people are affected, both affected individuals and the Department of Health must be informed as well as a prominent media outlet in the state or jurisdiction. Similarly to HIPAA  standards, notification should include a description of the breach, the types of information involved. It should also include the steps the individual can take to protect themselves, the steps the entity is taking to investigate and mitigate the breach and contact information for further details. 

GDPR and HIPAA Key Difference: Highlights

GDPR and HIPAA: Overlapping Requirements

Despite their differences, GDPR and HIPAA share some common principles:

• Data Security

  • Both regulations require organizations to implement appropriate technical and organizational measures to protect personal data from unauthorized access, use, or disclosure. Likewise, both highlight the importance of employee training on data security and privacy practices. While not explicitly required, certain certifications can demonstrate compliance like ISO 27001, SOC-2 and NIST CSF.

• Data Minimization

  • Through Article 5(1)(c) of the GDPR and HIPAA’s “minimum necessary” rule, both promote the principle of collecting and processing only the data that is necessary for the specified purpose. This aims to enhance data privacy and security while reducing risks associated with data breaches. This data should be regularly reviewed and unnecessary data should be deleted. 

• Accountability

  • Both require organizations to be accountable for their data processing activities and to demonstrate compliance with the regulations. Additionally, the legislation emphasizes the importance of maintaining records of processing activities and companies are required to conduct regular risk analyses to ensure compliance best practices.

• Designated Privacy Officer

  • Both regulations require organizations to appoint a designated individual responsible for overseeing data protection and privacy compliance. In GDPR, this role is called a Data Protection Officer, while HIPAA refers to it as a Privacy Officer.

Complying with Both GDPR and HIPAA

Complying with both GDPR and HIPAA can be challenging, but it is possible. Here are some steps that organizations can take:

1. Appoint a Designated Privacy Officer: Appointing an individual who understands both legislations is crucial in the implementation of the data protection strategy and the auditing of compliance measures. This person acts a liaison between the organization and regulatory authorities. 
2. Data Mapping: Identify the data that the organization processes, including its source, the purpose of processing, and the location of the data. Classifying and mapping the data ensures that the protection measures in place correlate with the level of sensitivity of the data. 
3. Gap Analysis: Compare the requirements of GDPR and HIPAA and identify gaps in the organization’s compliance program. We recommend that companies adopt the stringent practices required by the GDPR as a baseline for all data processing. This helps minimize the gap in compliance between both legislations. 
4. Policy Development: Develop policies and procedures that address the requirements of both GDPR and HIPAA. This includes aligning requirements related to breach notification procedures, data subject rights (access, rectification, erasure) and consent management processes.
5. Training: Train employees on the requirements of both GDPR and HIPAA. Training programs should ensure staff understand their responsibilities regarding data processing and incident report protocols. 
6. Implementation: Implement the necessary technical and organizational measures to protect personal data. This can be done through strong encryption for data at rest and in transit, access controls that limit access to authorized personnel only, install firewalls and intrusion detection systems and ensure systems are patched and updated management. 
7. Monitoring: Continuously monitor the organization’s compliance program to ensure that it is effective. Using compliance software tools to track and manage requirements compliments internal audits efforts. Companies should consider external audits for a more objective assessment.

Conclusion

Achieving and maintaining compliance with GDPR and HIPAA is an ongoing process that demands continuous monitoring, adaptation, and improvement. Regular audits, updated training programs, and the use of compliance software are essential for identifying vulnerabilities, addressing emerging threats, and demonstrating a commitment to data protection best practices. This proactive approach not only safeguards sensitive information but also fosters trust with individuals and enhances the organization’s reputation in an increasingly data-driven world.