Italy

In December 2025, the HTA body of Tuscany Regional Healthcare published seven new rapid HTA reports on medical devices in cardiovascular, neurosurgery, neuromodulation, orthopedics, urology, and surgical fields.

In January 2026, the Budget Law 2026 entered into force in Italy, introducing healthcare-related measures, including provisions for National Health Fund financing, increased budgets for recruiting healthcare personnel, initiatives supporting prevention, research, as well as investments in regional healthcare services and digitalization.

On December 17, 2025, the Ministry of Health published two draft HTA reports developed within the National HTA Program for Medical Devices and launched a public consultation. Reports concern continuous glucose monitoring and the treatment of benign prostatic hyperplasia. Comments can be submitted until January 16, 2026.

On December 10, 2025, the Ministry of Health published the Decree for the update of classification systems for diagnosis and procedure coding, effective in 2027, with updates scheduled at least every two years and the continued use of ICD-10-IM until the transition to ICD-11. Implementation will proceed through a pilot phase in 2025 and a nationwide rollout in 2026, supported by conversion tools from ICD-9-CM to ensure continuity, with ICD-9-CM entirely discontinued as of January 1, 2027.

In November 2025, the HTA body of Tuscany Regional Healthcare published six rapid HTA reports (five new assessments and one reassessment) on medical devices in the cardiovascular, gastroenterology, ophthalmology, dermatology and surgical fields.

On October 14, 2025, it was announced that the decree from the Ministry of Health for the National HTA Program for Medical Devices (PNHTA-DM) 2026–2028 has been submitted to the State–Regions Conference opinion. The Program was developed by the National Agency for Regional Health Services (AGENAS) and approved by the HTA Steering Committee.

On October 14, 2025, the National Agency for Regional Health Services (AGENAS) published the list of technologies prioritized for evaluation within the National HTA Program for Medical Devices in 2025. Technologies from the fields of endocrinology, men’s health, neurology/neurosurgery, and radiotherapy have been identified as priorities and are currently undergoing health technology assessment.

In July 2025, the HTA body of Tuscany Regional Healthcare published nine rapid HTA reports (eight new assessments and one reassessment) of medical devices in the ENT, neurosurgery, ophthalmology, orthopedics, peripheral vascular, and surgical procedures fields.

At the end of July 2025, the Ministry of Health published the first report within the national HTA program for medical devices. The program was established in 2017; however, it became fully functional only in late 2023, and the first assessment was launched in 2024 concerning robotic surgery in general (gastrointestinal) surgery, gynecology, and urology areas.

In May 2025, the HTA body of Tuscany Regional Healthcare published seven rapid HTA reports (six new assessments and one reassessment) of medical devices in the cardiovascular, e-health, intensive care and operating room, neuromodulation, ophthalmology, and orthopedics fields.

In April 2025, the HTA body of Tuscany Regional Healthcare published six rapid HTA reports (five new assessments and one reassessment) of medical devices in the cardiovascular, peripheral vascular, endoscopy, and dermatology fields.

In February 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in cardiovascular, endoscopy, pulmonology, and general surgical fields.