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posted 3 years ago
On 4 August 2021, the Italian Conferenza Stato Regioni (a body where State and Regions jointly decide on the guidelines for Italian healthcare) issued a Document of Understanding on home treatment for patients.
The document is of great importance because for the first time in Italy a piece of law defines the key points to be respected for care (including digital health) provided at the patient’s home.
Many types of home care are already being provided. By way of example only:
The Document of Understanding implements a legislative provision contained in the 2021 Budget Law (Law 178/2020) and establishes that home care can only be provided after a health authorization has been issued. In the event that care is paid for by the National Health Service (SSN), a further accreditation procedure will also be required.
More precisely, the Document contains the requirements that will have to be met in order to obtain authorization and accreditation.
The main points contained in the Agreement are the following:
In the next 12 months, the Regions will have to adopt the indications of the State-Regions Conference and issue the regional legislative and/or administrative acts to start the authorization and accreditation processes.
These new rules, which will prove useful also for decentralized trials, introduce the new design of our National Healthcare System as outlined in the PNRR (Italian National Recovery and Resilience Plan), which aims to strengthen the territory and increase the digitalization of healthcare. This will entail an important phase of reorganization and redefinition of services for healthcare facilities, sector operators, pharma and medical device companies, also (and above all) from a digital perspective.
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