How Covid changed telemedicine in Italy: Current status and next steps

In Italy, the Covid-19 pandemic rapidly accelerated implementation of telemedicine, which then was named one of the top priorities in the National Recovery and Resilience Plan. Mission No. 6 of that plan (Health) earmarks EUR 1 billion for the development of telemedicine to provide healthcare locally.

As an extension of that, the legislature has intensified its efforts in this area, most recently with the Decree of the Ministry of Health of September 21, 2022, published in the Gazzetta Ufficiale on November 2 under the headline “Guidelines for telemedicine services—functional requirements and levels of service.”

Below is a brief recap of the main events that shaped the current status.

The pandemic and ministerial guidance

Year 2020 served as a testing ground for measuring the resilience of Italy’s National Healthcare System (Servizio Sanitario Nazionale, or “SSN”), as it was responsible for continuing to provide service during the pandemic. It did so in part by employing digital tools both to treat patients remotely and to facilitate the interaction and exchange of information among healthcare professionals.

Istituto Superiore di Sanità interim guidelines

In April and October 2020, the Istituto Superiore di Sanità issued interim guidelines^[1] intended to support and facilitate the use of telemedicine to interact with and treat those with the virus and to provide ongoing treatment, especially for minors, fragile parties, and those with chronic illnesses.

These guidelines were purposefully limited to the pandemic, though they also had a general effect on access to telemedicine services provided by the individual Italian regions, with an eye to more widespread usage of these tools (for example, see the Lombardia region joint decision of August 5, 2020 to begin providing remote doctor appointments^[2]). During the pandemic, the provision of telemedicine services still felt fragmented and inconsistent, depending as it did on the abilities of the individual regions to regulate access to services in compliance with national guidelines and the willingness of healthcare facilities in those regions to implement methods for providing remote healthcare services in the real world.

National guidelines for providing telemedicine services

On December 17, 2020, the State-Regions Conference approved a document drawn up by the Ministry of Health containing national guidelines for providing telemedicine services (“National Guidelines”) that updated the previous 2014 guidelines to establish consistent rules for provision of telemedicine services as part of a general reorganization of the SSN in response to issues and needs that arose during the Covid-19 pandemic.

On November 18, 2021, the National Guidelines were followed up with specific ministerial guidelines for telerehabilitation services provided by healthcare professionals. These guidelines, which were approved by the State-Regions Conference, cover all remote services designed to rehabilitate, restore, improve, or otherwise maintain the psychological and physical functioning of people with disabilities and/or disorders.

In addition to identifying the types of telemedicine services to be provided and the terms for providing them, the National Guidelines are designed to associate telemedicine with essential levels of assistance (LEA) and to apply to it rules in effect on pricing and patient copays (known in Italy as “tickets”). Furthermore, the document provided early standards for:

1. informed patient consent for telemedicine services;
2. the responsibilities of the professionals involved;
3. technological and functional threshold requirements for providing services.

Localized health care reform and the role of telemedicine

Compatibly with that approach, the new model for organizing localized health care outlined as part of the reforms in the National Recovery and Resilience Plan (“PNRR”) casts telemedicine in a central role.

Models and standards for the development of localized health care via the SSN

Decree of the Ministry of Health No. 77 of May 23, 2022 approved a document titled “Models and standards for the development of localized health care via the National Health Service” designed to strengthen localized treatment and care services by providing them to users at the closest possible point, including potentially at home (known as primary assistance). The decree identified common structural and organizational standards for providing healthcare services locally, beginning with the areas known as healthcare districts.^[3] These are defined areas equipped with certain minimum facilities (such as Community Homes and Community Hospitals) where associated healthcare professionals practice according to the standards and requirements detailed in the decree itself.

“Organizational guidelines containing the digital model for activating home health assistance”

This model focuses on home health care and implementation of telemedicine services to be provided at the patient’s home by extant and/or newly created facilities, while meeting the minimum requirements and service standards previously established in the National Guidelines, as well as—specifically for home health services—the Ministry of Health Decree of April 29, 2022 that approved “Organizational guidelines containing the digital model for activating home health assistance.” The guidelines cover provision of various telemedicine services in home settings, including methods for providing access and for patient intake; they also cover the roles and responsibilities of those involved.

Telemedicine services are further regulated by the recently issued “Guidelines for telemedicine services” approved with Decree of the Ministry of Health of September 21, 2022, which list functional threshold requirements (such as minimum levels of service), technological requirements (such as indications regarding development of regional telemedicine infrastructures and their interaction with each other), and the digital skills and training users and professionals need to access/administer various telemedicine services.

Effective implementation of telemedicine services at the local level is up to the individual autonomous regions and provinces. By January 2023, they must have general terms in place for arranging localized health care in compliance with the guidelines set forth by the government via the actions mentioned above.^[4]

National telemedicine platform and the Electronic Health Record

As noted above, the PNRR allocated approximately EUR 1 billion for telemedicine to be used for the regions’ implementation of the services and for financing the national telemedicine platform. For the latter there will be a call for tenders handled by Agenas. As part of Mission No. 6 (Health), substantial resources have also been allocated for modernizing technological and digital hospital resources.

National telemedicine platform

The national telemedicine platform, scheduled to be ready for testing and startup by November 2023, will serve as the central infrastructure ensuring consistency across the telemedicine services provided locally. Contrary to what has happened until now, it will do so by approving and monitoring telemedicine solutions implemented by the autonomous regions and provinces via their own systems, including any preexisting systems, as long as they can interface with each other.

Specifically, according to Agenas guidelines, the national platform shall include:

• qualifying services, a group of organizational best practices designed to foster adoption of telemedicine systems at the local level (including systems for collecting and monitoring data produced at the local level; systems for identifying medical devices that can be integrated with the platform; systems for profiling various parties involved and establishing their roles and the various authorization levels needed to access and view data);
• minimum services, specifically listed basic services (remote appointments, teleconsultation, telemonitoring, and teleassistance) for which the national platform will make available to regions and healthcare structures a series of application components, that when integrated into local technological systems, allow those services to be disbursed.

Regarding development at the regional level of application components to support provision of telemedicine services in conjunction with national infrastructure, on September 30, 2022, the Ministry of Health issued a decree approving the operating plan and Agenas guidelines for selecting and evaluating proposals submitted by the regions. Puglia and Lombardia have been chosen as “frontline” regions and therefore have been assigned to provide procedures for arriving at telemedicine solutions that meet the Agenas guidelines, potentially by relying upon their own central purchasing bodies; the applications developed by them then will be made available to the other Italian regions.

Finally, the national telemedicine platform must be designed to integrate fully with national computer systems, such as the Public Digital Identity System (SPID) and Electronic Identity Card (CIE), the National Registry of Healthcare Recipients (Anagrafe Nazionale Assistiti, or ANA), PagoPA, and the National Health Insurance Card System, as well as the Electronic Health Record (“FSE”).

Guidelines for activating the Electronic Health Record (FSE)

Plans for full implementation of the FSE are underway. The most recent move in this area was adoption of FSE implementation guidelines published on July 11 of last year. The guidelines were broken down into four principal directives: (i) provide consistent and uniform digital healthcare services; (ii) make the contents consistent in terms of data and codes; (iii) strengthen the architecture to improve the interface between various regional FSE systems; (iv) strengthen governance of FSE activation. Based on these guidelines, the autonomous regions and provinces now must issue ad hoc plans for updating their existing systems with the end goal of making the FSE the sole and exclusive point of access to online SSN services.

Finally, interaction between regional FSE systems and the telemedicine platform will be key. Recently, Agenas published a document on “points of contact” between the two. This demonstrates how under the telemedicine services umbrella, the regional digital infrastructures—operating on the national telemedicine platform—will transmit data collected via the FSE.

Conclusions

The regulatory framework that is developing is incredibly encouraging. While the national legislature is acting to set requirements and minimum standards for the provision of telemedicine services, the autonomous regions and provinces are working to organize access to services in their areas (for example, with regard to pricing and reimbursement).

Creation of a national platform for telemedicine and the related regional applications should make it possible to overcome the fragmentation that still plagues localized telemedicine services, making it possible for all users, regardless of geographical location, to benefit from these services in accordance with national standards.

Finally, full implementation of the FSE in the various regions under the requirements established by the July 11 guidelines will ensure that data collected while providing remote services is properly filed as part of an integrated service that is easy for both patients and professionals to access and consult.

PNRR resources and the role of the regions in effectively implementing telemedicine in Italy, beginning with acquiring the necessary technological tools and training users and professionals, will be of key importance. In first steps, in May 2022, the Ministry of Health and the individual autonomous regions and provinces of Italy entered into institutional development contracts (CIS), binding agreements that require local bodies to implement PNRR measures in accordance with operating plans attached to those individual agreements that lay out in detail the methods and timelines for various actions, from creation of new facilities to modernization of technological and digital resources.

In July 2022, Invitalia, the National Agency for Inward Investment and Economic Development, designated to provide economic, technical, and financial support to administrations and to serve as their central purchasing body, announced three calls for tenders amounting to more than EUR 3 billion for the creation of localized healthcare facilities in line with the guidelines for reform of localized health care (for example, community homes and hospitals that will also provide telemedicine services) and for any other infrastructure work needed on existing hospitals and facilities.

[1] Interim guidelines for telemedicine services during the Covid-19 health emergency dated April 13, 2020 and October 10, 2020; click here for specific pediatric information.
[2] Ruling of the Regional Government of Lombardia No. XI/3528 of August 5, 2020.
[3] Organization/functional outlines for local health centers serving a population estimated at approximately 100,000.
[4] Among the leading Italian regions is Lazio, which approved its “General document for planning localized health care” with regional government resolution No. 643 of July 26, 2022.