France has some of the strictest health data compliance regulations in the world, and the stakes for mishandling it are high. In this article, we’ll break down the French health data compliance requirements and offer practical steps to ensure your business stays compliant by leveraging InCountry’s innovative solution.
Who needs to comply with French health data protection?
All organizations that collect, process, or store the health data of French residents or within France are required to comply with the provisions of the healthcare compliance laws in France. We shall highlight these organizations in this section:
- Healthcare providers
Hospitals, clinics, doctors, and other healthcare professionals that collect, store, or process patients’ health data. They are expected to implement France’s healthcare compliance requirements.
- Health tech companies
Developers of medical software, mobile health apps, or wearable devices that handle health-related data.
- Pharmaceutical and research organizations
Companies and institutions conducting clinical trials, medical research, or pharmaceutical development.
- Insurance companies
Health insurance providers that process personal health information for claims and coverage.
- Data processors
Third-party companies providing IT, cloud, or data analytics services related to health data.
- Employers
Organizations that collect health information for workplace safety, employee benefits, or pandemic-related measures.
- International companies
Businesses outside France that process health data related to French residents must comply if they offer services in France.
These types of organizations are obligated to comply with healthcare data sovereignty laws globally. In the next section, we shall review French healthcare data protection laws.
What French health data privacy laws do you need to know?
French healthcare data privacy laws are derived from already existing French data protection laws. In this section, we shall discuss the health data privacy laws business leaders operating in France need to be familiar with. They are as follows:
- General Data Protection Regulation (GDPR).
- French Data Protection Act (Loi Informatique et Libertés).
- Code de la Santé Publique (Public Health Code).
- Health Data Hosting (HDS) Certification.
General Data Protection Regulation (GDPR)
The GDPR needs no introduction, as it is Europe’s apex data privacy law and a leading privacy law globally. Although it applies to everything regarding data protection in Europe, it has some provisions that apply specifically to the health sector. We shall review them below:
- Definition of health data: It defines health data as any information regarding an individual’s physical or mental health, including medical histories, diagnoses, or genetic data. The purpose of the definition is to outline conditions for managing such data.
- Legal basis for processing: Under the GDPR, processing health data requires explicit consent, except in specific cases such as vital interests, public health tasks, or healthcare provision.
- Data subject rights: The GDPR secures the rights of French residents with their data. Such rights include the rights to access, correct, delete, and portability of their health data.
- Data breach notifications: Health data breaches must be reported to supervisory authorities within 72 hours.
French Data Protection Act (Loi Informatique et Libertés)
The French Data Protection Act (Loi Informatique et Libertés) is an important data protection law in France and complements the EU’s GDPR. For business leaders in the medical sector, understanding the provisions of this policy is necessary because it addresses the sensitive nature of health data and imposes some obligations on organizations to protect such information.
First enacted in 1978 and amended several times over the years, the French Data Protection Act establishes rules for collecting, processing, and storing personal data. It emphasizes heightened protection for sensitive data categories, including health data. We shall discuss some of its provisions below:
- Definition of health data
It defined health data to include medical records, diagnostic results, genetic information, and any data revealing an individual’s health status.
- Processing health data
Data subjects must provide informed and clear consent before such data can be processed, except for a special cause such as public health interest or for a medical emergency.
- Data hosting and security
Health data must be hosted by HDS-certified providers to ensure compliance with security and confidentiality standards. HDS-certified providers are companies that have been certified to host health data in France. Healthcare organizations must implement technical and organizational measures to prevent unauthorized access or breaches.
- Transparency and data subject rights
It directs health organizations to inform patients about data usage, storage, and their rights such as the rights of access, rectification, deletion, and objection to processing one’s data. This policy also specifies how data should be shared or transferred, especially when it involves third parties.
- The CNIL’s role
The Commission Nationale de l’Informatique et des Libertés also known as CNIL, oversees the enforcement of the French Data Protection Act. Health organizations must notify CNIL of high-risk data processing activities and cooperate with audits.
- Penalties for non-compliance
The CNIL can impose fines of up to €20 million or 4% of annual global revenue for severe violations. Other non-financial penalties include reputational risks such as public announcements of health organizations found wanting.
- Code de la Santé Publique (Public Health Code)
The Code de la Santé Publique is an important French legislation that governs the entire healthcare system in France. It outlines the rules applicable to healthcare professionals, healthcare institutions, health products, and more broadly, everything related to public health.
It was initially created in 1953 but has undergone several reforms over the years to adapt to societal changes and public health challenges. The primary goals of this policy are to protect public health, organize the healthcare system, and guarantee patient rights. Business leaders in the medical sector should be familiar with its key principles, as they directly impact the handling of sensitive health information. Its provisions are as follows:
- Medical confidentiality. Healthcare providers are obligated to ensure the confidentiality of patient information. Health data can only be disclosed with explicit patient consent or under legal obligations, such as public health emergencies.
- Secure data hosting. Health data must be stored using HDS-certified providers, ensuring compliance with stringent security standards for hosting and managing sensitive health information.
- Processing of health data. Data may be processed without patient consent only for specific purposes, such as treatment, diagnosis, or public health activities. Organizations must ensure minimal data collection and use the data exclusively for defined purposes.
- Data use in research. Health data used for medical research must be anonymized unless explicit patient consent is obtained. Ethical and legal approvals are required before processing health data for research.
- Enforcement and oversight. The French health authorities and CNIL ensure compliance with the Code’s provisions. Non-compliance can result in sanctions, including fines and restrictions on data processing.
- Health Data Hosting (HDS) certification
The Health Data Hosting (HDS) Certification is a French legal requirement for organizations managing health data, established under the Code de la Santé Publique to ensure robust security and confidentiality standards. It applies to healthcare providers, medical researchers, and businesses processing or storing health data. The key provisions of the HDS certification are as follows:
- Mandatory for hosting health data. Any entity hosting or processing health data in France must use an HDS-certified provider. This includes cloud services, IT platforms, and data centers.
- Security requirements. Certified providers must implement measures such as data encryption, access controls, regular security audits, and robust disaster recovery systems, to improve the security of patients’ health data.
- Scope of certification. It covers data storage, backup, restoration, and accessibility while ensuring compliance with French and EU health data protection laws.
- Compliance with GDPR. It aligns with GDPR provisions and emphasizes lawful processing, data minimization, and security safeguards for sensitive health data.
- Enforcement and oversight. Certification is granted and monitored by French regulatory bodies, ensuring continuous compliance.
Health data residency requirements in France
Data residency requirements by country may differ, which is why it’s crucial to thoroughly review the specific regulations for France. French health data residency rules are closely tied to the data privacy laws we’ve previously discussed. In this section, we’ll break down these requirements, providing clarity and actionable insights to help health-related businesses achieve compliance more easily.
- Mandatory use of HDS-certified hosting. Health data in France must be stored and managed by providers certified under the Hébergeur de Données de Santé (HDS) framework. HDS certification ensures compliance with strict standards for security, confidentiality, and accessibility of health data.
- Data storage within the EU. Under the GDPR and healthcare compliance regulations in France, health data should primarily be stored within the EU or in countries with adequate data protection standards recognized by the European Commission. This ensures alignment with GDPR’s data transfer restrictions and the French emphasis on protecting sensitive data.
- Localized data processing for certain uses. Some healthcare services, such as electronic medical records, are required to process and store data exclusively in France to maintain strict control and oversight.
- Restrictions on cross-border data transfers. Some restrictions are placed on cross-border data transfers of health data outside the EU. A health-related organization will require any of the following before performing cross-border transfer:
- Adequacy decisions for the destination country.
- Standard contractual clauses or binding corporate rules.
- Explicit patient consent for the transfer, along with clear information about potential risks.
- Oversight by CNIL. The Commission Nationale de l’Informatique et des Libertés (CNIL) monitors compliance with residency requirements. Non-compliance can lead to fines, sanctions, or restrictions on data processing activities.
French cross-border health data transfer requirements
The French cross-border health data transfer requirements are derived from the GDPR, the French Data Protection Act (Loi Informatique et Libertés), and the Code de la Santé Publique. These regulations impose strict controls to ensure that sensitive health data is protected when transferred outside France or the European Union (EU). Below are some requirements business leaders in the health industry should keep in mind as they seek to transfer data outside France and Europe:
- Data protection adequacy. Health data can only be transferred to countries recognized by the European Commission as providing an adequate level of data protection such as Switzerland, Japan, or the UK. Transfers to non-adequate countries require additional safeguards.
- Appropriate safeguards. If the destination country lacks an adequacy decision, businesses must implement safeguards such as:
Standard Contractual Clauses (SCCs): Pre-approved legal agreements for secure data transfers.
Binding Corporate Rules (BCRs): Internal data transfer policies approved by a supervisory authority.
Codes of conduct or certifications: Mechanisms demonstrating GDPR compliance.
- Explicit patient consent. Transfers of health data require explicit consent from patients, and they must be informed of the destination country, potential risks involved due to lower data protection standards, and consent must be documented and revocable at any time.
- Transfer for public health or medical necessity. Data transfers can only happen without patient consent when it involves protecting public health, providing medical care, or ensuring continuity of healthcare services.
- Data anonymization or pseudonymization. Where possible, health data should be anonymized to prevent identification of individuals during transfers. Pseudonymization is required if anonymization is not feasible.
- Notification to CNIL. Certain high-risk transfers (e.g., large-scale health data processing) require prior consultation or notification to the Commission Nationale de l’Informatique et des Libertés (CNIL).
- Ongoing compliance monitoring. Businesses must ensure that transferred data remains protected and monitor for any changes in the legal status of the destination country or safeguards.
How to comply with health data compliance laws in France — InCountry’s approach
French healthcare data compliance can feel overwhelming. But we don’t stop there. Our Data Residency-as-a-Service solution is designed to make data sovereignty compliance simple and seamless for your business. Think of it as a cloud-based tool that keeps your sensitive data stored and processed within the legal jurisdiction required while still giving you access from anywhere in the world.
It’s compliance without borders and flexibility without the risk.
Partnering with InCountry isn’t just about ticking the compliance box—it’s about peace of mind, knowing your data is in safe hands.
Reach out already let’s discuss your compliance needs and how we can help your business thrive while staying within the dictates of French healthcare laws.