Navigating the Regulatory Landscape of Health Data Hosting: A Comparison of France and the United States with Advice for American Companies

Navigating the Regulatory Landscape of Health Data Hosting: A Comparison of France and the United States with Advice for American Companies

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Before diving into the risks associated with hosting these data, it is important to understand what is meant by “health data”.

What is health data? Health data includes any information relating to a person’s health status, whether physical or mental. This encompasses medical records, test results, diagnoses, treatments, as well as any genetic or biometric information. Under the GDPR, these data are considered particularly sensitive and therefore require enhanced protection.

The risks of inadequate security: If the CNIL believes that you have not sufficiently secured the hosted health data, the consequences can be severe. Data breaches can lead to significant financial penalties, not to mention damage to reputation and loss of trust from patients or users. These sanctions are even more substantial as health data are considered sensitive and therefore require a high level of protection.

How to secure these data? To secure health data, it is essential to implement measures such as data encryption, robust firewalls, intrusion detection and prevention systems, and rigorous access management. Staff training is also crucial to avoid human errors that can lead to data breaches. In addition, it is recommended to conduct regular security audits and comply with standards set by bodies such as ANSSI in France.

HDS Certification and the CNIL: It is important to note that as an entity managing health data, you can never be fully compliant with the Health Data Host (HDS) certification if you host the data internally, without using a certified provider. This certification, although not mandatory, is a mark of trust and security. The CNIL can penalize entities that do not meet the required security standards, even if the data are not hosted on an HDS server. However, the absence of HDS certification in itself is not an offense, as long as appropriate security measures are in place.

Navigating the regulatory landscape of health data hosting: A comparison of France and the United States and advice for American companies

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Hosting health data involves navigating a complex and often disparate regulatory environment, especially when comparing the legal frameworks of France and the United States. This article aims to illuminate the differences between these two systems and provide advice to American companies, particularly regarding the hosting of health data of European nationals.

Regulatory Framework in France: In France, the hosting of health data is regulated by strict standards. Companies must obtain Health Data Host (HDS) accreditation to host health data, thus ensuring compliance with high standards in terms of security and confidentiality. Moreover, the European Union’s General Data Protection Regulation (GDPR) imposes additional rules, particularly regarding consent and individuals’ rights.

Regulatory Framework in the United States: In the United States, the Health Insurance Portability and Accountability Act (HIPAA) is the main regulation regarding the protection of health data. Unlike France, there is no specific accreditation requirement for hosts. Compliance with HIPAA focuses on the privacy and security practices of entities managing these data.

Advice for American Companies: American companies that process health data of European citizens must comply with the GDPR, even if these data are hosted in the United States. This involves obligations in terms of consent, data protection, and transparency in the use of data. Additionally, mechanisms such as standard contractual clauses may be necessary for data transfers outside the EU.

Clarification on HDS Hosting: For an American company with an application hosted in the United States, the obligation to use a Health Data Host (HDS) in France only applies if it physically processes or stores health data on French territory. If the hosting and processing of data are entirely in the United States, then the company is primarily subject to American law (HIPAA) and the GDPR for aspects related to European nationals. It is not required to follow the specific regulations of HDS hosting in France unless it has a physical presence or data processing operations on French soil. However, careful attention to GDPR rules remains essential to ensure the protection of health data of European citizens.

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