Privacy and security of sensitive information, especially in the healthcare industry, have become critical in today’s interconnected world, where personal data is routinely collected and exchanged (Terry, 2012). There are many regulations in place around the world to protect people’s health information and guarantee legal observance. Two essential laws in this field are the GDPR in the European Union and the HIPAA in the US. Both laws strive to safeguard people’s right to privacy and control how health data is handled, but they differ in their applicability, legal foundations, and particular requirements. The aims, essential clauses, and repercussions for healthcare organizations and individuals will all be compared and contrasted in this section between the HIPAA and GDPR health legislation. Stakeholders in the healthcare sector will be better able to navigate the complicated world of privacy and data protection if they are aware of the similarities and variations between these standards.
The scope and applicability of each law are critical distinctions between HIPAA and GDPR (Tovino, 2016). To create national guidelines for the privacy of particular healthcare data, HIPAA was passed in 1996 (Moore & Frye, 2019). HIPAA, which is relevant to affected parties such as health professionals, health plans, and clearinghouses for healthcare, primarily focuses on health information privacy and security within the United States. Their business partners who manage protected health information (PHI) on their behalf are also covered (Moore & Frye, 2019). Contrarily, the GDPR, which governs the safeguarding of individual information, including details about health, has a broader scope and applies to all of the European Union member states (Dove, 2018). Healthcare is included in GDPR, an extensive data privacy regulation that was implemented in 2018 and applies to all sectors of society. No matter where an organization is located, if it handles the personal information of people living within Europe, it must comply with the GDPR. Furthermore, there are differences between HIPAA and GDPR concepts and terminology regarding health data (Tovino, 2016). PHI is defined under HIPAA as health data that may be used to distinguish a particular person and that is transferred or stored by a Covering organization or business associate. (Moore & Frye, 2019). It covers any data concerning a person’s past, present, or potential future health state, including medical records, payment history, and other data. On the other hand, the GDPR explains individual data as anything you know pertaining to a natural person who may be identified or located. Other types of information, including names, addresses, identification numbers, and online identifiers, are also included in addition to health-related data (Regulation, 2018).
The enforcement methods and sanctions for non-compliance between HIPAA and GDPR vary (Tovino, 2016). The Security Rule and the Privacy Rule are the two main rules of HIPAA. While the security regulation focuses on protecting electronic PHI, the Rule of Privacy establishes guidelines for handling PHI (Moore & Frye, 2019). In the US, Office for Civil Rights (OCR) at HHS upholds HIPAA compliance. Depending on the degree of negligence, non-compliance with HIPAA may result in civil monetary fines that range from $100 to $50,000 per violation (Szalados, 2021). In extreme circumstances, criminal penalties that result in incarceration may also be applied. The data protection agencies (DPAs) in each member state of the European Union enforce the GDPR. DPAs have the authority to launch investigations, levy penalties, and enact corrective actions. The maximum fines for violating the GDPR are €20 million or 4% of the yearly global sales (Wolff & Atallah, 2021), whichever is higher. Failure to comply using the GDPR results in substantial penalties. The two organizations are different in terms of international data flows (Gupta et al., 2020). Although HIPAA allows international data transfers, covered companies must enter into business partner agreements with any outside parties handling PHI (Seddon & Currie, 2013). These contracts guarantee that the third parties also follow the rules for security and privacy under HIPAA. According to Tikkinen-Piri et al. (2020), the GDPR limits the dissemination of personal information to countries beyond the EU with insufficient data protection standards. However, transfers may occur according to particular legal frameworks, such as the application of mandatory corporate standards or standard contractual clauses.
Both HIPAA and GDPR strongly emphasize getting people’s consent and giving them control over their health data. Without receiving express consent, Per HIPAA, covered organizations may use and disclose PHI for the administration, payment, and provision of healthcare (Tovino, 2016). However, individuals have the right to view their medical data, request restrictions on the use or disclosure of their PHI, and get notification of privacy practices. Contrarily, the GDPR demands individuals’ explicit agreement before processing their data, including health information (Clarke et al., 2019). Additionally, it gives people several rights, including the opportunity to view their data, correct errors, demand erasure (or “right to be forgotten”), and transfer their facts in a portable format.
Health data security must be maintained, and both regulations provide mechanisms for breach notification. To protect PHI and stop unauthorized access or disclosure, HIPAA mandates that covered entities implement administrative, physical, and technical security measures (Sfikas, 2003). Covered entities are required to alert the impacted parties, the HHS (Health and Human Services) department, and, in some circumstances, in the event of a breach, the media. To preserve personal data, particularly health data, and guard against data breaches, enterprises must also comply with the GDPR (Tikkinen-Piri et al., 2020). A breach must be reported to the proper supervisory authority within 72 hours of becoming aware of it unless it is unlikely to endanger the rights and freedoms of individuals. Finally, for healthcare companies and individuals, HIPAA and GDPR both have substantial effects. Under HIPAA, covered companies and business partners are obligated to follow the regulations to keep PHI private and secure (Moore & Frye, 2019). Failure to comply can have severe fines and penalties, a negative impact on one’s reputation, and even legal repercussions. Similarly, enterprises governed by the GDPR must implement suitable safeguards to secure personal information, including health information, and guarantee compliance with the law (Georgiou & Lambrinoudakis, 2020). Significant fines and penalties may result from non-compliance with the GDPR, which might harm an organization’s reputation and financial stability. Both laws give people more control over their health data, the ability to access and update it, and the confidence that their information is being managed safely.
In conclusion, despite having the same objective of safeguarding personal health information and assuring privacy and security, HIPAA and GDPR differ in several ways. While the GDPR has a broader scope and is applicable to the European Union, HIPAA concentrates on health information privacy and security within the United States. The two regulations also have different definitions, consent criteria, enforcement strategies, and punishments. To maintain compliance and safeguard patients’ privacy rights, healthcare companies operating in both regions must know these parallels and variances. Depending on their location and the data they manage, firms must evaluate their duties under HIPAA and the GDPR and put the necessary policies, procedures, and safeguards in place to protect health data. Healthcare organizations operating in both jurisdictions need to be aware of these variations and ensure they follow all applicable laws. Organizations can protect health data’s privacy and security while offering individuals high-quality healthcare services by comprehending and negotiating the complexities of HIPAA and GDPR.
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