The General Data Protection Regulation (GDPR) is a comprehensive data protection regulation in the European Union that focuses on safeguarding personal data of EU residents, covering a wide range of data processing activities and providing individuals with extensive rights, while HIPAA compliance is a specific set of regulations in the United States aimed at protecting sensitive healthcare information (PHI) and ensuring its confidentiality, integrity, and availability within the context of healthcare organizations, with both regulations sharing similarities in terms of data protection objectives but differing in scope, geographical applicability, and the type of data they primarily govern. GDPR and HIPAA are two important data protection frameworks that ensure the confidentiality, integrity, and security of sensitive information within their respective jurisdictions.
What is GDPR?
The GDPR is a data protection regulation enacted by the European Union (EU) in May 2018. Its primary objective is to safeguard the personal data of EU residents and ensure that individuals have control over their data. The regulation applies to all organizations that process the personal data of EU citizens, regardless of where the processing takes place. Personal data, as defined by the GDPR, encompasses any information that can directly or indirectly identify an individual, such as names, addresses, health data, genetic data, and biometric data. Under the GDPR, healthcare professionals and organizations must implement a range of technical and organizational measures to protect patient data from unauthorized access, disclosure, and alteration. They are required to obtain explicit and informed consent from patients before processing their personal data and must have a valid legal basis for such processing. Patients have the right to access their data, request corrections, and even request the erasure of their data under certain circumstances. The GDPR imposes strict reporting requirements on data breaches. In the event of a breach that poses a risk to the rights and freedoms of individuals, healthcare professionals must notify the relevant supervisory authority within 72 hours of becoming aware of the breach. Patients affected by the breach must also be informed without undue delay.
What is HIPAA?
On the other hand, HIPAA is a US federal law that governs the privacy and security of PHI held by covered entities, which include healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates. HIPAA was enacted in 1996, and its primary purpose is to facilitate the portability of health insurance coverage while ensuring the confidentiality and integrity of patient’s health information. HIPAA requires covered entities to implement administrative, physical, and technical safeguards to protect PHI from unauthorized use, access, and disclosure. Covered entities must appoint a designated privacy officer responsible for ensuring compliance with the HIPAA Privacy Rule, which sets the standards for the use and disclosure of PHI. The HIPAA Security Rule mandates the implementation of measures to protect electronic PHI (ePHI) from potential cybersecurity threats.
HIPAA establishes patient rights over their PHI. Patients have the right to access their medical records, request amendments to inaccurate or incomplete information, and obtain an accounting of disclosures made by the covered entity. Covered entities are required to obtain patient authorization before using or disclosing their PHI for purposes other than treatment, payment, or healthcare operations. In the context of data breaches, HIPAA imposes a breach notification requirement on covered entities. If a breach of unsecured PHI occurs, covered entities must notify affected individuals, the Department of Health and Human Services (HHS), and in certain cases, the media. The timing and method of notification depend on the size of the breach and the number of individuals affected.
Difference Between GDPR and HIPAA
While both the GDPR and HIPAA share the common goal of protecting sensitive data, they have a number of differences. The GDPR applies to any organization processing the personal data of EU residents, regardless of its location, whereas HIPAA only applies to covered entities and their business associates within the United States. The scope of data protected by these regulations is different. The GDPR covers a broader range of personal data, while HIPAA law focuses specifically on PHI. The GDPR provides comprehensive protection for personal data within the EU, while HIPAA specifically addresses the privacy and security of PHI within the United States. Understanding and adhering to the requirements of these regulations are necessary so that healthcare organizations could protect patient data, maintain trust, and avoid potential legal and financial repercussions.