The health care activities authorizations reform initiated by the Ordinance of 12 May 2021 has now entered a stage of effective implementation. The objective pursued by this reform was to simplify the procedures before the French regional health authorities (ARS) and provide a better response to evolving patient care needs. Holders of health care activities authorizations were required to file renewal applications for their ongoing authorizations to comply with the amendments introduced by the 2021 reform. In addition, nuclear medicine as well as other activities, which were previously regulated primarily through equipment-based authorizations, have been reclassified as health care activities subject to single authorizations encompassing several pieces of equipment to reinforce quality, safety, and territorial planning requirements.

However, implementation has revealed operational difficulties. Many authorizations for costly nuclear medicine equipment were historically held by health cooperation groups (Groupement de Coopération Sanitaire – "GCS de moyens"), a status specifically regulated under French law. As per the reform, these structures were no longer eligible to hold health care activity authorizations. This created legal uncertainty and forced some operators to consider complex restructurings, especially in public-private cooperation settings.

This difficulty was addressed by a decree of 30 December 2024. The decree has created an exception for nuclear medicine, enabling French GCS de moyens to hold such health care activity authorization. This long-awaited clarification restored legal certainty and enabled existing cooperation models to be preserved, without requiring their systematic transformation into health care establishments subject to a more restrictive legal regime.

More broadly, 2025 marked a phase of regulatory "fine-tuning" of the reform. Two decrees introduced procedural simplifications and clarifications. A decree of 25 February 2025 abolished the obligation for holders of health care activity authorizations other than health care establishments to enter into a multi-year objectives and resources agreement with the ARS. A decree of 27 February 2025 removed the annual cap on the number of application filing periods, leaving more flexibility to ARS. It has also brought clarifications on the regime applicable to changes to existing authorizations.

French ARS have progressively rolled out application slots since 2022 on a regional and activity-by-activity basis for holders to submit their renewal application file. This procedure has created an increased workload for the ARS, which have experienced delays in reviewing renewal application files. This process will continue in 2026 in accordance with the updated calendars adopted by each ARS.