Healthcare AI 2025

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

in medical devices to detect irregular heartbeats or medical diagnosis by an automated system process - ing physiological measurements. The French Patent Office (INPI) has also addressed AI patentability. For example, the INPI upheld a patent on medical image analysis after narrowing its scope (see INPI, 4 July 2024, OPP 22-0035). 7.2 Copyright and Trade Secrets Copyright: Software – Yes, Algorithms – No In France, software – including source code, architec - ture and preparatory design material – is protected under copyright law provided that its originality can be demonstrated (Article L.112-2,13°, of the French Intellectual Property Code). Algorithms are, however, more difficult to protect under copyright law. Trade Secret Protection Versus Mandatory Transparency To avoid public disclosure, healthcare innovations can be protected under trade secrets law, provided that the information in question (i) is not generally known or readily accessible to persons within the relevant business sector (ie, is secret); (ii) has actual or poten - tial commercial value due to its secret nature; and (iii) is subject to reasonable protection measures by its lawful holder to maintain its confidentiality (Article L. 151-1 of the French Commercial Code). The secret nature of such information could, however, be called into question due to transparency obliga - tions imposed at both the European and National lev - els — for instance, the requirement to disclose exten - sive information to obtain CE marking, or the need for healthcare professionals and patients to understand how the AI system works. 7.3 Ownership of AI Outputs The question of usage rights and ownership of outputs generated by AI is complex and generally depends on the contractual arrangements with the technology provider. 7.4 Licensing and Commercialisation Various types of licenses can be used, including pro - prietary licenses and co-licenses – eg, in cases involv - ing partnerships between companies and hospitals

or universities. Co-licensing agreements must clearly outline rights of use, ownership, revenue-sharing and responsibilities regarding further development and commercialisation. For instance, in France the PARTAGES project led by a consortium of around 30 partners – including research laboratories, healthcare institutions and deep tech companies – is one of the winners of the France 2030 call for projects on generative AI. A key consideration in such arrangements is the han - dling of health data. Since health data are classified as sensitive under the GDPR, their use is subject to strict legal requirements. 8. Specific Applications of Healthcare AI 8.1 Clinical Decision Support Standard Obligations for Clinical Decision Support AI in Medical Devices Any AI-based medical device (MDAI) providing clini - cal-decision support must comply with the rules appli - cable to medical devices under the EU MDR/IDVR to obtain CE marking. These devices must also comply with national provisions, notably for the device to be reimbursed by the national health insurance (see 2. Legal Framework for Healthcare AI ). Specific Requirements of Transparency and Human Oversight MDAI will fall under the category of high-risk AI sys - tems if the MDAI is a safety component or if the AI system is itself a medical device, and the MDAI is subject to a third-party conformity assessment by a notified body in accordance with the MDR/IVDR. MDAI must therefore comply with the requirements of transparency and human oversight (see 5.2 Transpar- ency and Explainability and 5.4 Human Oversight ). 8.2 Diagnostic Applications In addition to the responses above, French authori - ties/agencies highlight the importance of transparent and responsible use of AI in healthcare by institutions and professionals.

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