Defining innovativeness of high-technology medical devices in an Italian region

In the field of medical devices, innovation has been debated to a much less extent when compared with pharmaceutical products. In Italy, the regulation of innovative pharmaceutical products was established in 2017, through a resolution1 issued by the national medicines agency (AIFA) after the adoption of a national law.2 According to this regulation, innovative medicines (reported in a national list3) are made immediately available to patients, even without formal inclusion in the regional hospital therapeutic schedules.

As regards medical devices, a first attempt to issue a regulation on innovative devices has been made at the regional level in the Tuscany region. A multidisciplinary group of healthcare professionals (eight members of the so-called ‘Gruppo Regionale permanente sui dispositivi …

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