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The first IVD device included for coverage under the renewed RIHN 2.0 framework in France
In France, the “Repository of Innovative Procedures outside the Nomenclature” (RIHN) framework provides early, transitional funding for innovative in vitro diagnostic medical devices, enabling the collection of clinical and economic evidence required for future regular reimbursement through inclusion in the NABM (Nomenclature of Medical Laboratory Procedures) or CCAM (Common Classification of Medical Procedures).
In 2024, the RIHN framework was reformed and split into two components:
- List of Innovative Procedures Outside the Nomenclature (LAHN) (“Stock”) - covering previously listed tests;
- RIHN 2.0 (“Flow”) - for new tests included under the revised framework.
RIHN 2.0 is governed by Article 1 of Decree No. 2024-290 (March 29, 2024), which outlines the conditions for inclusion. Entry into the framework requires a positive evaluation by the French National Authority for Health (HAS), along with a mandatory commitment to conduct a clinical study. Coverage is granted for a maximum of six years, renewable once.
On April 16, 2026, the Ministry of Health, Family, Autonomy, and People with Disabilities announced the first technology approved under RIHN 2.0:
- R001 “Artificial intelligence-assisted digitalized urine cytology (involving the in vitro diagnostic medical device VisioCyt Bladder)”, indicated for monitoring the recurrences of non-muscle-invasive bladder cancer (NMIBC), with the maximum tariff of €253 and a maximum duration of six years of exceptional coverage.
The test was positively evaluated by HAS for inclusion in RIHN 2.0 in June 2025. Its inclusion is documented in the April 2026 update of the LAHN (tab “Flow” for RIHN 2.0).
See the details in French here.
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