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First HAS opinion for coverage under renewed RIHN 2.0 framework released in France
The framework for innovative procedures outside the Nomenclature of Biology and Anatomocytopathology (RIHN) provides early and transitional support for innovative in-vitro diagnostic (IVD) tests, conditional on data collection. Once transitional support is concluded, the French National Authority for Health (HAS) evaluates the accumulated evidence to determine whether the test qualifies for regular reimbursement (i.e., NABM Nomenclature). The renewed framework - RIHN 2.0 - was introduced in 2024, with its application process formalized in November of that year.
On June 5, 2025, HAS published its first opinion on the coverage of an innovative IVD test under renewed RIHN 2.0. The favorable opinion concerns an AI-assisted digitalized urine cytology using VisioCyt Bladder, which is indicated for monitoring the recurrence of non-muscle-invasive bladder cancer. The HAS considered the device's innovative nature and the relevance of the data collection protocol submitted by the applicant.
See the details in French here.
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