Italy is moving closer to establishing its own reimbursement pathway for digital therapies. On May 27, 2026, the Italian Chamber of Deputies (Camera dei Deputati) passed a bill on digital therapies with 234 votes in favor and none against. The bill now goes to the Senate, which represents the second and final parliamentary hurdle.
The bill establishes, for the first time, a legal framework for the reimbursement of digital therapies through the Italian National Health Service (Servizio Sanitario Nazionale, SSN). Digital therapies are defined therein as CE-certified software medical devices in accordance with the EU Medical Device Regulation (MDR) (EU 2017/745).
To oversee this process, the law establishes a new 16-member Comitato nazionale per le terapie digitali (National Committee for Digital Therapies) within the Ministry of Health. It determines which products will undergo official evaluation and reports annually to Parliament. The actual review is conducted through the national Health Technology Assessment program for medical devices, coordinated by the state health agency AGENAS. If a therapy is included in the Livelli Essenziali di Assistenza (LEA)—the Italian equivalent of the statutory catalog of covered services—the costs are covered.
Unlike the German DiGA procedure, the draft does not include a fast-track option. An earlier version explicitly provided for an accelerated pathway (“percorso di valutazione rapida”), which was subsequently removed from the adopted text. Provisional reimbursement based on proof of clinical trials is not provided for. Instead, Italy requires clinical validation in accordance with international evidence standards, with an explicit preference for randomized controlled trials.
It remains to be seen whether study data collected for German DiGA will be recognized for Italian listing. In France, for example, evidence collected abroad must be adapted to the country’s own healthcare system with proper justification. This creates another independent market access pathway for digital therapies within the EU that follows the DiGA model but deliberately prioritizes evidence over speed.
You can find the bill and the status of the legislative process here:
- Chamber of Deputies: Provisions on Digital Therapies (Bill No. 1208)
- DigitalHealthItalia: Digital Therapies in the Essential Levels of Care (LEA): The Chamber of Deputies Approves the Consolidated Text