Introduction

The French healthcare system has been significantly evolving these past few years and, like many countries worldwide, the year 2020 marked a turning point in this evolution.

More precisely, the COVID-19 pandemic and related lockdowns shed light on and exacerbated pre-existing issues such as limited access to care, insufficient preventive measures, overcrowded hospitals and emergency facilities, and inadequate cybersecurity across the ecosystem, etc.

Beyond its undeniable social impact, the COVID-19 crisis however revealed a great capacity for resilience and innovation that contributed to the rise of connected tools and digital therapeutics (“DTx”) to allow healthcare professionals to free themselves from administrative burdens and regain time for care, on the one hand, and on the other hand, patients to benefit from easier, faster and more efficient access to care.

From a legal standpoint, this transformation raised new – or at least reinforced – challenges with regards notably to regulation applicable to medical devices, cybersecurity and health data protection, interoperability and liability.

In response, France has laid the foundations of an ambitious digital health strategy.

Digital Health in France: A Developing Strategic Framework

Since 2019, France has undertaken an accelerated development of its digital health strategy. This political orientation has materialised through successive national roadmaps and be reinforced by key initiatives and plans, including Mon espace santé, the Ségur numérique programmes (a national programme launched in 2021 for the secure sharing of data between users and medical staff), the implementation of the “5P medicine” (personalised, preventive, predictive, participative and evidence-based), and particularly the France 2030 acceleration strategy launched in 2021.

The France 2030 acceleration strategy is an important investment plan launched in 2021 to support reindustrialisation, investment and innovation, including in the healthcare sector. An overall budget of EUR54 billion has been granted.

This National Strategy for the Acceleration of Digital Health (the Stratégie d’accélération - Santé numérique) stems from the France 2030 plan with an allocated budget of EUR7.5 billion to the healthcare sector, including EUR400 million to support medical devices companies in France with a focus on digital health. It is structured around five principal axes:

• training healthcare professionals in digital health;
• supporting technological research and innovation;
• facilitating clinical validation and market access of innovations;
• building a robust entrepreneurial ecosystem; and
• deploying solutions at scale across the national territory.

Its implementation is based on a co-construction approach involving industry stakeholders, healthcare institutions, users and local authorities. To monitor the progress of established projects, roadmaps have been drawn up by the ministerial Delegation for Digital Health (“DNS”). These roadmaps describe the priority projects for the next five years, broken down into areas, priorities and objectives, with time milestones and an entity identified as the main stakeholder per area, responsible for their proper implementation. The 2023-2027 roadmap succeeded the previous one covering the years 2019-2022.

With France 2030, the French government intends to pursue its ambition to position France as a European leader in digital health, while ensuring an ethical, inclusive and care quality-driven digital transition.

The Pillars of France’s Digital Health Transformation

Mon espace santé: a digital public service for storing and sharing medical data

Mon espace santé is a national-scale digital health record system and serves as a cornerstone of the National Strategy for the Acceleration of Digital Health. It enables any French citizen to store, manage and share their health documents (eg, prescriptions, test results and hospital reports). The aim is to enable citizens to be better informed, more active in their healthcare pathway and to better control their health data.

Digital services for healthcare professionals

To support healthcare professionals, the State promotes, alongside industrial stakeholders and health companies and start-ups, a suite of digital services, including the shared medical record, digital identity tools (e-CPS), teleconsultation, tele-expertise, remote monitoring, and others. These solutions aim to enhance care coordination, reduce administrative burden, save time for practitioners, and improve the security of information exchanges.

The 2023–2027 roadmap foresees a growing role for data-driven decision-making tools, enhanced digital training for healthcare staff, and stronger integration across healthcare, social care, and medico-social sectors.

In addition to these practical pillars for the effective implementation of the National Strategy for the Acceleration of Digital Health, the integration of technological challenges is also expected.

Integration of Technological Challenges

Integration of artificial intelligence

Artificial Intelligence (“AI”) is seen as a vector of efficiency and innovation. However, its integration within the French healthcare system is conditioned by ethical and responsible implementation. Therefore, on 12 May 2025 the French Digital Health Agency (Agence du Numérique en Santé - “ANS”), alongside the governmental Digital Health Delegation (“DNS”), launched a public consultation ending on 6 June, 2025 on an Implementation Guide for Ethical AI in Health, defining concrete criteria to ensure that AI systems are respectful of human rights, transparent, and explainable. The Implementation Guide for Ethical AI in Health is in line with evolving European regulation, notably the AI Regulation (AI Act) adopted in 2024. In France, conformity with such ethical frameworks is seen as a prerequisite for fostering trust and adoption among professionals and the public alike.

The expansion of telehealth

Telehealth aims to improve healthcare access and comprises five primary types of acts: teleconsultation, tele-expertise, remote monitoring, tele-assistance, and medical regulation (article R.6316-1 of the French Public Health Code). It is considered as a strategic response to systemic issues, such as healthcare professional shortages in rural or peri-urban zones.

The ANS, responsible for the digital transformation of the healthcare system, promotes telehealth as a tool for reducing healthcare access inequalities, improving chronic patient monitoring and optimising care co-ordination within healthcare facilities.

As such, telehealth continues to be supported through public investment, integration into professional software tools, and promotion of adoption among healthcare professionals. Such promotion is further evidenced by the simplification of reimbursement procedures through the latest Convention Médicale, a contract concluded between the statutory health insurance body and medical trade unions which establishes the regulatory framework for the private practice of medicine.

The Big Data opportunity and its risks

The use of large-scale health data (Big Data) offers new perspectives in public health, including real-time epidemiological monitoring, personalised medicine and care pathway optimisation.

In France, “5P medicine” (personalised, preventive, predictive, participative, and evidence-based) is significantly expanding. It leverages the volume, variety and velocity of data from connected objects, administrative databases, research findings and digital user behaviours.

Despite its potential, Big Data raises significant challenges in terms of data access, quality, cybersecurity, and ethical governance. Further regulatory developments in this area are anticipated (for example secondary use and GDPR compliance).

In addition to the use of the technological breakthroughs outlined above, the French digital health programme faces a number of identified challenges and limitations.

Challenges and Limitations

One of the major challenges highlighted by both public and private stakeholders is digital inclusion, ie, ensuring that the digital transition does not deepen existing inequalities. In this context, the 2023–2027 roadmap provides for specific support to vulnerable populations – elderly persons, people with disabilities, those in precarious situations or individuals unfamiliar with digital tools. For example, thousands of digital mediators have been trained to assist citizens with Mon espace santé. Collaborations with local authorities aim to bring digital services closer to the public.

The second key challenge is data protection and national sovereignty. In the context of a globalisation and standardisation of digital practices, data protection is deemed of paramount importance. The development of a national health identity (“INS”), sovereign data hosting within France and compliance with national cybersecurity frameworks (eg, ANSSI’s security protocols) reflect France’s will to protect health data.

The Acceleration of Artificial Intelligence in Healthcare

The use of AI in the life sciences and healthcare sector has significantly increased over the past few years.

From streamlining research and development processes to enhancing clinical decision-making and reinforcing access to care, AI has without doubt begun to transform the healthcare system in France.

AI now plays a key role in various aspects of healthcare: selecting new drug candidates for clinical trials more quickly, preventing the risks of emerging diseases, accelerating diagnosis by detecting elements or anomalies invisible to the human eye, optimising treatment responses, improving access to healthcare by enabling remote patient monitoring and treatment, etc.

The possibilities unlocked by AI in healthcare are vast – but so are the associated risks. Accelerating the use of AI for patients’ treatments and care automatically raises the following question: what happens in case a patient is harmed? Who should be held liable when a diagnosis is missed due to an AI recommendation-based decision? Is it the healthcare professional who followed the recommendation without question, the hospital that deployed the AI tool or the manufacturer of the AI-enabled medical device?

These questions are pressing in France, where applicable legal framework surrounding liability in life sciences and healthcare is complex, and where a new EU Directive is poised to reshape Products Liability Law in France and other EU members states.

Current Legal Framework Applicable to AI-related Liability in France

Under Article L.1142-1 of the French Public Health Code (“FPHC”), healthcare professionals and institutions are only liable for the harmful consequences of acts of prevention, diagnosis or care in the event of a fault, except where their liability is incurred due to a defect in a healthcare product. 

This notion of fault can be difficult to grasp in practice, and it is likely that the acceleration of the use of AI in medical practice raises new, as yet unresolved questions.

As early as 2023, the National Physicians Body (Conseil national de l’ordre des Médecins) questioned the impact of new technologies in general, and AI in particular, in medical practice on the legal interpretation of fault. This was to better understand the stakes in terms of liability incurred by the healthcare professional who is willing to integrate AI into their daily practice, on the one hand, and the healthcare professional who is reluctant to adopt new technologies on the other. 

In practical terms, while the former could be held liable for placing blind trust in an AI tool, the latter could be found at fault and held liable for failing to use a technology that could have enabled a patient to benefit from earlier diagnosis or more appropriate treatment. The principle of “loss of opportunities” (perte de chance) may then apply in such a scenario, potentially marking a shift in the standard of care for practitioners.

On the industrial side, when a health product causes damage to a patient, liability for defective products Law is the most common applicable regime (although plaintiffs and civil courts seem to have increasingly resorted to the fault-based liability regime for the past few years, particularly where the defectiveness of the products if hard to prove and where negligence is easier to demonstrate).

Current French defective product liability legal framework stems from the transposition of the European Directive 85/374/EEC of 25 July 1985. Under existing rules, producers are liable for the damage caused by a defect in their product, whether or not they have a contractual relationship with the victim.

Under Article 1245-3 of the French Civil Code (“FCC”), a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account including the presentation of the product, the time when the product was put into circulation or the use to which it could reasonably be expected. 

While this regime covers all healthcare and “borderline” products (eg, drugs, medical devices, food supplements and cosmetics) it remains too narrow to apply automatically to any AI system as such.

The Upcoming Reform on Products Liability and Concomitant Abandonment of Harmonised AI-Liability Framework

In light of the new challenges raised by the continuous and increasing evolution of new technologies, the European Commission announced in April 2021 its ambition to “promote a European approach to artificial intelligence” by proposing a new legislation aimed at:

• reducing the risks associated with AI systems; and
• adjusting liability rules in case of risk materialisation and damage occurrence.

While the first of these texts reached the end of the legislative process (Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June, 2024 laying down harmonised rules on artificial intelligence, the “AI Act”), the AI Liability Directive proposal, published on 28 September 2022, was withdrawn in February 2025 due to the absence of a “foreseeable agreement.” The European Commission stated that it would reassess whether to introduce a revised proposal or pursue a different approach. 

In parallel, two months earlier, the new European Products Liability Directive (Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC), which provisions will have to be transposed by member states in their national legislation before 9 December, 2026, entered into force.

The new products liability Directive has been established to revise the applicable products liability framework “in light of developments related to new technologies, including artificial intelligence (AI), new circular economy business models and new global supply chains, which have led to inconsistencies and legal uncertainty, in particular as regards the meaning of the term ’product’.”

The simultaneous entry into force of the New Directive and the (temporary?) abandonment of the AI-liability Directive may not be coincidental. It could indicate that the EU has chosen to apply general liability frameworks to AI-related damages instead of developing a specific regime.

Among the most notable updates from the New Directive are:

• the revised definition of “product” which now explicitly includes “digital manufacturing files, raw materials and software” (Article 4(1) of the New directive);
• the introduction of the idea of post-market changes, such as learning algorithms or updates, to assess defectiveness: “in assessing the defectiveness of a product, all circumstances shall be taken into account, including (…) the effect on the product of any ability to continue to learn or acquire new features after it is placed on the market or put into service” (Directive 2024/2853, Article 7).

This latest addition echoes the definition of AI systems under the AI Act, which describes them in Article 3(1) as “a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment (…).”

This new regime, although not initially designated to apply exclusively to a specific category of products, then opens the door to products liability claims related to damages caused by artificial intelligence in Europe and, correlatively due to upcoming transposition, in France.

Unresolved Legal Questions

While the upcoming reform represents a significant step forward in adapting current legislation to technological advancements and changes in practices, the abandonment of the AI Liability Directive means that each member state will continue to interpret and apply liability rules independently, including in relation to AI-related damages.

In the healthcare sector, this is especially problematic given the issues at stake and the multiplicity of actors that may be involved, directly or indirectly, in a patient’s care: medical device manufacturers, software developers, healthcare institutions and professionals, etc. Determining fault and apportioning liability among them – particularly where damage results from complete algorithmic behaviour – will then remain a legal challenge.

Key issues also seem to remain unresolved such as the question of the burden of proof in causation claims involving autonomous systems, or the adequacy of existing insurance coverage for AI-related risks.

Conclusion

France, like many EU member states, finds itself at a critical juncture, where the fast digitalisation of healthcare requires not only political vision and support but also legal and ethical clarity.

The country has largely improved in digital health innovation and infrastructure but remains vigilant in the face of the challenges of ethics, security, inclusion and governance challenges.

The current strategy is part of a long-term vision to transform the healthcare system, enhance prevention and care, and reduce inequalities. It brings together a wide ecosystem of public and private actors within a framework of innovation serving the common good.

The coming years will be decisive in consolidating achievements, building users’ trust, and establishing digital health as a structural pillar of the French healthcare system.