FRANCE Trends and Developments Contributed by: Mathilde Merckx, Xavier Lebrasseur, Juliette Migeon and Diane Courtier, Alchimie Avocats
Introduction The French healthcare system has been sig- nificantly 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 exacerbat- ed pre-existing issues such as limited access to care, insufficient preventive measures, over- crowded hospitals and emergency facilities, and inadequate cybersecurity across the ecosystem, etc. Beyond its undeniable social impact, the COV- ID-19 crisis however revealed a great capacity for resilience and innovation that contributed to the rise of connected tools and digital therapeu- tics (“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 accel- erated development of its digital health strat- egy. This political orientation has materialised through successive national roadmaps and be reinforced by key initiatives and plans, includ- ing 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 mil- lion to support medical devices companies in France with a focus on digital health. It is struc- tured around five principal axes: • training healthcare professionals in digital health; • supporting technological research and inno- vation; • 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-construc- tion approach involving industry stakeholders, healthcare institutions, users and local authori- ties. 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,
47
CHAMBERS.COM
Powered by FlippingBook