The rise of teleconsultation companies in France: is a stabilised legal and ethical framework likely in 2025?

Mathieu Gautier
Squair, Paris
mgautier@squairlaw.com

Introduction

Teleconsultation services have transformed healthcare delivery in France, particularly after the Covid-19 pandemic accelerated its adoption. By 2025, France’s telemedicine sector has matured into a structured ecosystem, supported by evolving regulations and ethical guidelines.

Following the entering into force of the European Health Data Space (EHDS) Regulation (EU) 2025/327 in March 2025, French teleconsultation companies face a transformative legal and operational landscape. This Regulation, designed to harmonise health data exchange across the European Union, introduces both opportunities and compliance challenges for France’s rapidly growing telemedicine sector. By 2025, the market for remote healthcare in France is projected to reach $7.5bn, but the EHDS Regulation’s interoperability mandate, data security requirements and cross-border provisions will reshape how these companies operate.^[1]

Teleconsultation: from chaos to brand new regulations

At first, teleconsultation services were regulated by Article L6316-1 of the Public Health Code, defining such services as remote medical practice using information technologies. Since September 2018, Amendment 6 to the Medical Convention, approved by a ministerial order on 1 August 2018, allowed the reimbursement for teleconsultations by the health insurance system, subject to certain conditions (care pathway, video transmission). However, commercial companies employing salaried doctors operated in a legal grey area, with their service offerings not always directly covered by reimbursement provisions.

A major shift occurred with the introduction of the Social Security Financing Bill for 2023 (Projet de loi de financement de la Sécurité sociale or PLFSS 2023), adopted in December 2022. Article 53 established a legal status for teleconsultation companies, requiring:

• a commercial structure: companies must operate under the French Commercial Code and avoid control by pharmaceutical or medical device firms;
• mandatory Accreditation: only companies with official accreditation can bill for teleconsultation services to France’s national health insurance system;
• independence: a prohibition on control by drug or medical device manufacturers, except those needed for teleconsultations; and
• digital compliance: adherence to the General Data Protection Regulation (GDPR) and the Data Protection Act, with annual reports required to be filed with the National Council of the Order of Physicians (Conseil national coordonne l’action de l’Ordre des médecins or CNOM) and the respective ministers.

Most importantly, Article 53 introduced direct access to mandatory health insurance (L’assurance maladie obligatoire or AMO) reimbursement for such services.

The implementation of Article 53 marked a shift towards stricter oversight of teleconsultation companies, reflecting the government’s intention to balance innovation with accountability.

Quite a revolution, which was not over.

Adopted pursuant to PLFSS 2023’s Article 53, the Decree of 29 February 2024 specifies conditions for teleconsultation companies to access AMO reimbursement, focusing on certification, security and ethics:

• the accreditation process: teleconsultation companies must undergo a rigorous evaluation process, including submitting a detailed application demonstrating their compliance with professional and technical standards;
• medical oversight: companies must create independent medical committees to review care quality and ethics;
• activity limits: salaried doctors can dedicate only 20 per cent of their practice to teleconsultations; and
• certification requirements: companies must obtain certification that ensures their compliance with digital health standards, including in regard to interoperability and cybersecurity.

These new rules also make it significantly more difficult for teleconsultation companies to work with private practice physicians.

This Decree underscores the importance of aligning business operations with healthcare objectives, ensuring that teleconsultation practices are patient-centric and ethically sound.

2025: more rules to come?

In addition to the new rules imposed on teleconsultation companies, the government has issued a binding framework regarding the interoperability, security and ethics of teleconsultation information systems (IS).

It is particularly noteworthy that this framework establishes a technical and ethical structure that will determine the eligibility of these companies for the accreditation required to enable reimbursement by the French health insurance system.

The framework annexed to the Decree aims to ensure:

• interoperability: the compatibility of the IS with national healthcare systems (DMP, secure messaging, etc);
• security: the protection of health data (GDPR compliance) and the prevention of cyberattacks; and
• ethics: adherence to good medical practices, transparency towards patients and the prevention of conflicts of interest.

Such topics are likely to evolve in light of recently adopted EU regulations, particularly Regulation (EU) 2025/327 on the European Health Data Space (EHDS).

Indeed, under the EHDS Regulation, teleconsultation platforms may be forced to adopt standardised formats for electronic health records (EHRs), prescriptions and diagnostic reports to ensure cross-border compatibility, including:

• the mandatory integration of the EHDS Regulation’s ‘European EHR exchange format’ to enable seamless data sharing with EU healthcare providers; and
• certification requirements: EHR systems must comply with EU technical specifications on security, logging and machine readability.

The EHDS Regulation also imposes strict rules on health data storage and transfers, as follows:

• pseudonymisation for secondary use: data used for research or policy-making must be anonymised; and
• patient consent management: platforms must implement granular consent mechanisms, allowing users to control data access for primary (care) and secondary (research) purposes.

Not a completely new legal framework for teleconsultation companies, but they may be directly concerned by the EHDS Regulation

An online teleconsultation platform is not inherently classified as an EHR system under the EHDS Regulation. However, if the teleconsultation tool integrates or interacts with EHR systems, it may fall within the scope of the Regulation’s requirements on interoperability, security and data exchange.

Teleconsultation platforms are typically designed to facilitate remote communication between healthcare providers and patients. Most teleconsultation platforms store or process patient health data (eg, consultation notes, prescriptions) in a structured format that aligns with the priority categories set out in the EHDS Regulation.

Companies operating such tools should carefully assess their functionalities to determine whether they fall under the broader regulatory framework for EHR systems, as detailed on the EHDS Regulation.

Conclusion

The French and EU regulatory frameworks in 2025 stabilise the provision of teleconsultation services by prioritising security, ethics and interoperability. Accreditation requirements, medical committees and the EHDS Regulation aim to foster trust among patients and practitioners, while curbing commercial excesses.

These new rules impose on teleconsultation companies responsibilities in address the risks inherent to the EU development of e-health. These companies must, therefore, be particularly vigilant regarding the technical developments that will be implemented in order to comply with these requirements.

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