Digital medicine, PNRR and home care in Italy: the new State-Regions Agreement

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:

• psychological counseling;
• telemonitoring of vulnerable patients via devices;
• telerehabilitation;
• controlling the administration of drugs via devices;
• electronic planners for self-administration tracking;
• notification systems to remind the patient to follow the therapy and/or enter needed data for the management/monitoring of the course of treatment.

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:

• there is no distinction between public and private entities, thus it will apply both types of healthcare facilities;
• the health authorization covers the moment of home care: therefore, the conventional authorization of the health facility will be supplemented by an authorization for the person delivering the care (e.g. a nurses’ cooperative);
• the subject which financially supports the provision of care does not appear to be decisive: in this sense, where the activity falls within the notion of ‘home care’ (Art. 22 of the Ministerial Decree of 12 January 2017 – LEA) the authorization requirement (and perhaps also the accreditation requirement) must, in any case, be applied. Consider, for example, the so-called digital Patient Support Programs (PSP), in which the provision of home care is usually established by the physician as part of a clinical plan, but is then delivered at the patient’s home by the so-called Provider, with charges borne by the pharmaceutical company. In this case, the provider will have to obtain the authorization and (almost certainly) also accreditation if the clinical plan is established within the framework of a public facility;
• the scope of authorizations and accreditations is widened to include areas that until now were not precisely considered ‘healthcare’ (Annex B);
• Annex B also sets out specific requirements of a technological nature (2.AU), organizational nature (3. AU – with the express provision for a health professional), and of a procedural nature (3.2 AU);
• lastly, Annex C sets out all the requirements for accreditation (which mostly enhance and strengthen the authorization requirements).

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.