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Portolano Cavallo | Telemedicine: The new national guidelines in Italy

This article is part of Portolano Cavallo’s “INFORM@ Life Sciences” Newsletter. Click here to subscribe. |

Healthcare services provided remotely are officially a part of the National Healthcare Service (“NHS”), now that the State-Regions Conference has approved the document entitled “National guidelines for the provision of telemedicine services,” drafted by the Ministry of Health (hereinafter the “Guidelines”). Henceforth, the Guidelines shall serve as the national reference for provision of telemedicine services, with this updated version replacing the previous guidelines of 2014.

Italian regions must implement the Guidelines in their respective regional healthcare services (“RHS”), in some cases by updating previously enacted rules (for example, Piemonte and Lombardia recently adopted specific resolutions to implement some telemedicine services within their respective RHS[1]).

1. Guidelines: Main changes

With respect to the previous guidelines of 2014, the Guidelines provide more detailed operational rules concerning the fee system, prescriptions, booking an appointment with a specialist, etc.

As to the remuneration system, the Guidelines specify that the fee for a telemedicine service shall be equivalent to the fee for the same service when provided in the traditional way within the Basic Level of Assistance (“LEA”), including any cost-sharing.

Specific indications are also provided for the fee system as it regards two specific types of services: televisits and teleconsultation. Unlike a televisit, a teleconsultation appointment does not involve a fee, does not involve patient cost-sharing, and does not require a specific NHS prescription, since it is considered an integral part of the work of a specialist physician or healthcare professional, as is the case for an in-person consultation with a patient.

2. Televisit: When it can be used and how

A televisit is one of the main telemedicine healthcare services that can be provided within the NHS. This is an outpatient activity that a physician may decide to carry out remotely, following careful assessment of the situation, when the conditions set out in the Guidelines, specified below, are met.

Patient with a known pathology who does not need a complete physical examination

The Guidelines state that only an outpatient service that does not require a complete examination of the patient may be provided through a televisit. Indeed, although a televisit is carried out in real time via videoconference, with the exchange of useful information and with the possible attendance of a healthcare professional who is with the patient, it is not possible for a physician to perform via a televisit certain steps necessary for a final diagnosis, such as, for instance, auscultation, percussion, and palpation. Therefore, a televisit can be carried out only on a patient who has previously been diagnosed, and it can never be used as the only tool in the physician-patient relationship.

Further requirements set out by the Guidelines

For the purposes of the televisit provision, it is also necessary for the patient to be in one of the conditions strictly dictated by the Guidelines.

For example, the patient must be in the course of a follow-up pathway from a known pathology or have a known pathology and be in a position in which they need oversight or monitoring, or possibly confirmation or modification of the current therapy (e.g., updating the treatment plan).

3. Implementing services remotely: The digital tools needed

Certain technological tools are required to enable the physician and the patient to communicate safely and effectively and thereby ensure that remote services are provided effectively.

Therefore, there must be a functioning network between physicians and patients in the form of a web portal that physicians access with their own accounts for the management of their patients, as well as digital tools such as computers, tablets, or smartphones. Additionally, a videoconference connection appropriate to the type of visit must exist for each televisit.

Minimum standards for the provision of telemedicine services

It is essential for every transfer of data (in the form of videos, images, files, etc.) to be encrypted and in accordance with privacy and security regulations.

The Guidelines also envisage that (i) the physician shall be supported by a technical coordination center responsible for the management of telemedicine activities that will offer assistance and a help desk for patients and physicians, and that (ii) a training program shall be implemented to train subjects involved (i.e., patients, caregivers, healthcare professionals) in using the technologies employed.

The introduction of a new position – the Healthcare Director/Manager – is also envisaged. The person in this role will safeguard technical healthcare organization and compliance with minimum performance standards for healthcare services provided remotely.

Patient support tools: For effective equity in the provision of telemedicine services

For the proper implementation of telemedicine services, both the patient and the physician must be equipped with adequate tools. In the event that the patient does not have adequate computer tools at home, the Guidelines provide that the patient must be given the opportunity to access Local Health Authority (“LHA”) facilities, or possibly special workstations made available — by agreement — by organizations close to the patient’s home (e.g., pharmacies, physicians’ offices).

4. Patient’s informed consent

The provision of remote healthcare services is subject to the patient’s prior consent to use the service, and the patient’s consent must be duly informed.

Therefore, prior to the start of the televisit, the physician must obtain the consent of the patient (or of an authorized family member). During that process, the patient should be asked to confirm the availability of the technological tools necessary for proper execution of the televisit.

The Guidelines also specify a baseline for the content of the information to be delivered to the patient. At a minimum, the information must specify, among other things, the advantages of remote healthcare service for the patient, any risks, and the purpose of the service. The patient must also be informed of aspects relating to the protection of personal data, such as, for instance, which subjects will have access to the health data and the data controller pursuant to the GDPR.

5. New opportunities connected with the development of telemedicine services

The Guidelines open up new opportunities for possible cooperation between private businesses and healthcare facilities, since it is unlikely that healthcare facilities will be able to meet all the technical and organizational conditions required by the Guidelines to provide telemedicine services.

However — and this may be considered one of the critical points of this document — the Guidelines do not specify in detail the requirements that such third-party operators need to meet for the purpose of offering services to healthcare facilities and via those facilities to patients within the NHS. We refer, in particular, to both the absence of detailed information on data management (collection, transfer, and archiving) and the failure to provide specific quality standards for IT infrastructure, as well as the lack of certification requirements for compliance with these standards.

The absence of indications in this regard may result in a situation of uneven quality of services between regions or even between individual healthcare facilities in the same region. Further and more detailed regulations would therefore be desirable in order to define quality standards for these facilities throughout the country, especially if third-party operators are to be selected through public tenders or open selection procedures.

This appears especially important, considering that, to strengthen telemedicine services in this COVID-19 emergency period, Law no. 178/2020 (Budget Law 2021) provides for an allocation of certain funds for the purchase by public and private (accredited) healthcare facilities of IT devices that will allow remote reporting, consultation between specialists and remote home care (Article 1, par. 444).

Authors:

  • Erica Benigni, Associate, PORTOLANO
  • Elisa Stefanini, Counsel, PORTOLANO

Compliments of Portolano Cavallo – a member of the EACCNY.