Healthcare AI 2025

FRANCE Law and Practice Contributed by: Liliana Eskenazi, Julie Ernewein and Pauline Lecrenais, Fréget Glaser et Associés

7. Intellectual Property Issues Regarding Healthcare AI 7.1 Patent Protection Verification of Standard Patent Criteria

of elderly patients with respiratory infections. In this particular case, the CNIL accepted an exception to the principle of patients’ individual information for the development of the algorithm, provided that appro - priate measures were implemented (see decision

DR-2024-184 of 19 July 2024). 6.3 Data Sharing and Access

To be eligible for European or national patent pro - tection, an invention must meet both eligibility and patentability requirements. In France, invention patents are governed by the French Intellectual Property Code (Article L. 611-1 et seq. and R. 611-1 et seq.). These provisions apply to AI-related inventions, which may be protected in par - ticular if they serve a technical purpose (see below), and the inventor is human rather than an AI system. AI systems frequently rely on mathematical methods, which are excluded from patentability because these methods are not regarded as inventions (Article 52 of the European Patent Convention, Article L. 611-10 of the French Intellectual Property Code). However, this exclusion is not absolute: an AI-based invention may be eligible for patent protection if the mathematical method contributes to the technical character of an invention by providing a technical solution to a technical problem, and if the invention meets the standard criteria of patent protection. Recent Guidance from the European Patent Office (EPO) The EPO recently stated that patents may be granted when AI leaves the abstract realm of mathematical algorithms and computational models and is applied to solve a technical problem in a field of technology. In its April 2025 edition of the Guidelines for Examina - tion, the EPO further elaborated on its stance by intro - ducing new guidance on AI (G-II, 3.3.1). The EPO clari - fied that “if a claim of an invention related to artificial intelligence or machine learning is directed either to a method involving the use of technical means (eg, a computer) or to a device, its subject matter has tech - nical character as a whole and is thus not excluded from patentability under Art. 52 (2) or (3)”. Examples of eligible technical contributions made by a mathematical method include using neural networks

Cross-border transfers of health data within the EU are primarily governed by the GDPR and the EHDS, which entered into force on 26 March 2025. The EHDS sets a unified framework for secure, efficient sharing of electronic health data across Member States to sup - port research, innovation, public health, and patient care. Transfers outside the EU are allowed only under strict conditions. In France, data from the SNDS are subject to strict data localisation rules: they must be hosted within EU Member States and cannot be transferred outside the EU except under strict and limited conditions (Article R. 1461-1 of the French Public Health Code). 6.4 De-Identification and Anonymisation The processing of health data (classified as sensitive data) is only permitted in specific cases (Article 9 of the GDPR and Articles 6 and 44 of the French Data Protection Act). However, anonymised data, which are not considered personal data, are not subject to these provisions. The CNIL offers guidance on the appropriate anonymi - sation techniques and on how to assess their effec - tiveness. Care must be taken to ensure that the risk of re- identification using reasonable means is negligible (anonymisation vs pseudonymisation). Failing to do so may result in sanctions: in September 2024, the CNIL fined a company that develops and sells management software to healthcare professionals EUR800,000 for processing pseudonymised health data without obtaining the required authorisation, despite the com - pany’s claim that the data were anonymised.

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