The new standards for territorial care and telemedicine services in accordance with Ministerial Decree 77/2022

The Italian version of this article has been published on June 29, 2022 on AgendaDigitale.eu.

On June 22, 2022, the decree of the Ministry of Health No. 77 on “Models and standards for the development of territorial care in the National Health Service” (the “Document”) was published in the Official Gazette.

This publication is part of the reforms envisaged by the National Recovery and Resilience Plan (“NRRP”), mission six, component one, titled “Proximity networks, telemedicine facilities for territorial health care.”

The new model of organization for territorial care puts the citizen at the center and focuses on the health needs of the user, regardless of living situation and geographical area. It also follows a logic of integration of health services, social services, and health-social services.

At the same time, this new arrangement requires and guarantees the provision of care services through telemedicine, in all its forms.^[1] Remote delivery of healthcare services is increasingly common and plays a central role in planning new modes of citizen care and treatment.

Of course, the role of the Regions will be crucial to effective implementation, as these services fall within the scope of ”health protection,” the subject of legislation under Section 117 of the Constitution. Consequently, the Regions and the Autonomous Provinces of Trento and Bolzano should effectively ground the models and standards provided in the regulations in force to date in compliance with the principles established therein.

1. The new territorial arrangement

The Document outlines a new and innovative model of organization for territorial care. It aims to provide effective responses to the increasing need to build a care network that stands as an alternative to hospital facilities. It also reshapes performance and services to be as close as possible to the user, to the point of reaching the user at home.

The goal is to ensure uniform levels of primary care throughout the country by identifying common structural, technological, and organizational standards. The newly outlined system also aims to reduce inequalities through a service delivery model that allows current critical issues to be overcome. In particular, it can offset the lack of uniform delivery of Essential Levels of Care (“LEAs”) and limited development of the territorial network, including with reference to people’s need for care over time.

The pivot of the new model is the Health District, which is an organizational-functional arrangement of the Local Health Authority (ASL), covering a population of about 100,000 people, within which the following will occur:

• • develop outreach facilities, such as Community Homes,^[2] as a reference point for responding to the needs of the target population;
  • strengthen home care so that the home can become the preferred location for care;
  • integrate health care, social care. and social-health care, as well as developing multi-professional teams that offer 360-degree care, with particular attention to mental health and conditions of greater fragility;
  • implement systematic logic for initiative medicine^[3] and patient care by categorizing the population by intensity of needs, using predictive algorithms that allow differentiated intervention strategies, thanks to the growing availability of digital data;
  • implement digital service models for home care—taking full advantage of telemedicine and telemonitoring tools—and integrate the professional networks operating in the territory and at the hospital.

2. Delivery of telemedicine services

Planning territorial care within the Health Districts will result in minimum standards being met throughout the territory, such as full implementation of the now-emerging Community Homes and Community Hospitals, which will also deliver services via telemedicine.

To this end, physicians and other health professionals who are part of multi-professional teams^[4] will have to be adequately trained in the use of such technologies. It is expressly provided that a Family or Community Nurse^[5] must “systematically” use digital, telemedicine, and telehealth tools.

Consistent with the reform’s goals of increasing accessibility and reducing inequality in access to care, as well as ensuring an approach that is as equal as possible across the territory, it is stipulated that systems providing telemedicine services—operating at any corporate, regional, interregional, and/or national level—must do the following:

• interoperate with the various national (ANA, NSIS, TS, PAGOPA, SPID, and so on) and regional (ESF, CUP, and so on) systems supporting health care, ensuring compliance with interoperability standards for data;
• support the coordination of organizational processes and structures, including overcoming technological fragmentation;
• support the activation of telemedicine services for individual patients, based on the directions of the Health Project^[6];
• standardize the interfaces and architectures for the use of telemedicine services, both for the user and the professional, with a view to streamlining, usability, and reduction of clinical risk, while also ensuring integration with regional/national profiling systems (e.g., the SPID);
• make available throughout the entire territory uniformly structured services with high levels of security developed with a modular approach and ensuring compliance with current national guidelines.

Moreover, the Document touches upon the role of healthcare professionals in accessing the use of telemedicine services by the patient. It supplements what was provided earlier in the national indications for the provision of telemedicine services approved at the State-Regions Conference on December 17, 2020.

On this point, the Document makes explicit that physicians and other healthcare professionals bear professional responsibility for telehealth activities in the form of (i) identifying the most suitable tools for the provision of remote services to the individual patient according to the principles of proportionality, appropriateness, effectiveness, and safety; and (ii) assessing the suitability of the individual patient to receive the service at home, including by verifying the patient’s ability to use the necessary technological tools, which must become part of the patient’s history (e.g., whether the patient is able to use a smartphone, tablet, or PC or can learn to use them, possibly with the help of family members).

Regarding the minimum requirements and service standards necessary for the provision of telemedicine services, the Document expressly refers to the provisions of the national directions of December 17, 2020.

3. Telemedicine increasingly at the center of health care

The new organizational model for territorial care that is taking shape in part thanks to this project envisages an increasing focus on the citizen and, parallel to that, the increasingly widespread use of digital and telemedicine tools. Thanks to the impetus from the NRRP, the actual implementation of these innovations appears to be getting closer and more feasible.

The Document is to be read in conjunction with the recent “Organizational Guidelines Containing the Digital Model for the Implementation of Home Care,” approved by Decree of the Ministry of Health on April 29, and published in the Official Gazette on May 24, 2022. This was adopted as part of the sixth mission of the NRRP, which places great emphasis on the use of telemedicine in the specific context of home care.

As already noted, the effective implementation of these services will not be possible without the regions playing an active role. They will have to put into practice what the national legislature envisages in compliance with the established principles and objectives.

[1] For a definition of individual telemedicine services, see the “National Directions for the Delivery of Telemedicine Services,” approved at the State-Regions Conference on December 17, 2020.

[2] A Community Home is defined as a close and easy-to-reach physical place where citizens can access health and social-health care.

[3] Initiative medicine is defined as a model of care based on proactive care for the individual, from prevention and health education through morbidity.

[4] In addition to general practitioners and pediatricians, this includes nurses, pharmacists, psychologists, and social workers, as well as other prevention and rehabilitation professionals.

[5] Defined as the professional figure of reference for the purposes of nursing care within the community of reference.

[6] The Health Project is the planning, management, and verification tool for territorial care envisaged by the Document.