eHealth in Italy

Key figures

59 M

inhabitants

8,67 %

of the GPD health expenditures in 2019

125

ASL (regional health agencies)

The Italian health system is based on the universalist model and ensures an essential level of assistance to all its citizens (LEA)

The National Health System - SSN (Servizio Sanitario Nazionale), is financed by public sources from taxes. It provides health care services to the entire population. The Ministry of Health defines the health policy and the orientations of the SSN. 
Decentralisation plays a major role through the 125 ASL (Azienda Sanitaria Locale). The regions set health policy guidelines and are fully autonomous in the organisation and management of their regional systems. They are obliged to provide a basic range of care free of charge to all citizens, called the essential level of assistance - LEA (Livelli essenziali di assistanceenza).

A progressive development of digital health thanks to the Next Generation Italy plan

Thanks to the European Union 2021 recovery and resilience plan, there have been an acceleration of the digitalisation of the Italian health system. The deployment of e-prescriptions, the digital covid certificate, the development of telemedicine and electronic health records are the major innovations of the last three years. Thanks to the Next Generation Italy plan, 15.6 billion euros are being invested in digitalisation and the development of health innovations within the SSN. 

How to access the Italian digital health market ?

1. Get the authorization to enter the Italian market from the General Directorate for Medical Devices and Pharmaceutical Services

The General Directorate for Medical Devices and Pharmaceutical Services (Direzione generale dei dispositivi medici e del servizio farmaceutico) is part of the Ministry of Health. Once the manufacturer has submitted its application by file to the Directorate and the device already has the CE mark, it can enter the Italian market. This institution is also responsible for the general regulation of pharmaceutical activities in relation to the Italian Medicines Agency - AIFA (Agenzia Italiana del Farmaco). In the case of devices produced by manufacturers established outside the European Union, the medical device must be registered in the database of the Ministry of Health. Specific online forms must be completed to fill in all data related to the functioning of the medical device.
In Italy, medical and non-medical solutions for the health organisations (such as clinical records, personal medical records, etc.) follow the same rules as other medical devices. 

2. Submit a medico-economic assessment to the National Agency for Regional Health Services (AGENAS)

The National Agency for Regional Health Services - Agenzia nazionale per i servizi sanitari regionali (AGENAS) is the body in charge of monitoring and surveillance of a medical device, once it has entered the Italian market. This technical and scientific structure of the National Health Service is responsible for the medico-economic evaluation of medical devices (Health Technology Assessment - HTA). It ensures the quality and efficiency of health care and works with the 20 regions of Italy to promote the uptake of innovations and the quality of health care.

3. Register the digital device in the national classification of medical devices

The national classification system for medical devices, called Classificazione Nazionale dei Dispositivi medici (CND), lists the devices on the Italian market. It is sorted alphabetically and each letter corresponds to a category of medical devices.  For example, telemedicine solutions are now in category z. 

4. Get SSN reimbursement for the digital MD

If the device is allowed to be used as part of the services offered by the SSN, this service may be reimbursed, with possible differences between regions related to the type of service. Reimbursement for the provision of health services is based on Diagnosis Related Groups (DRGs).

Government authorities

In charge of the evaluation and legislation of health products

Ministère de la Santé : en charge des politiques nationales de santé Conseil d’administration général pour les dispositifs médicaux et les services pharmaceutiques : autorité de contrôle des dispositifs médicaux Institut national de santé : Le principal centre de recherche, de contrôle et de conseil technico-scientifique en matière de santé publique Agence nationale pour les services de santé régionaux : assure la collaboration technico-opérationnelle avec les régions et les autorités sanitaires individuelles

Associations

They bring companies together and facilitate their incubation

Italian Tech Alliance: supports the development of digital italian companies and their investors

Hubs and innovation clusters

They bring together and facilitate the incubation of new technologies

SPEEDHUB: gives to companies the opportunity to grow with the digital transformation PoloICT: This hub encourages the development of innovation and increases the competitiveness of companies Indicon : a benefit corporation created to support innovation management in lifescience

Training courses

Universities and their gourps that offer training and support for digital health innovations

SDA Bocconi School of Management : cette université spécialisée en management a un département dédié aux nouvelles technologies Università di Padova: This Italian university also offers a Master in Digital Health Università di Napoli Federico II (UNINA) : This university research pole for public health has been focusing on digital health