Telemedicine: the path towards organic regulation continues
The use of information technologies in the health sector has been using numerous applications for some time now, ranging from the transmission of documents in digital format - think of the Civil Protection ordinance of last March 19 on the dematerialization of medical prescriptions - the adoption of independent living solutions, such as sensors and remote monitoring systems for patients, or, again, the IT management of workflows in the care units.
The examples could be many others, but the aspect on which we would like to focus today is telemedicine, with particular reference to television, on which the Conference of Regions and Autonomous Provinces has recently issued a document which aims, as an objective, the adoption of an organic discipline (Doc. n. 20/167 / CR06d / C7 of 10 September 2020, "Provision of remote outpatient specialist services - Simplification of access to care - Televisita").
Telem edicina and televisita: what are we talking about?
Before examining the guidelines, however, it seems appropriate to clarify what we are talking about. First of all, according to the definition of the WHO, by telemedicine we mean "the provision of care and assistance services, in situations where distance is a critical factor, by any health worker through the use of information technologies and communication for the exchange of information useful for the diagnosis, treatment and prevention of diseases and trauma, for research and evaluation and for the continuous training of health personnel, in the interest of the health of the individual and the community "(WHO Organization. A health telematics policy in support of WHO's Health-For-All strategy for global health development: report of the WHO group consultation on health telematics, 11–16 December, Geneva. WHO press, 1997).As can be seen, it is a very broad definition, suitable for encompassing numerous practices and activities. These include, in fact, television, ie the remote interaction between doctor and patient - with the possible support of a caregiver - which can lead to the prescription of drugs or treatments.
The involvement of the patient distinguishes the televist from teleconsultation and telecooperation, which, on the other hand, concern only doctors and health workers.
Therefore, understanding the basic notions of the subject, it seems useful to see some concrete applications. According to the aforementioned document of the Conference of Regions and Autonomous Provinces, telemedicine has so far been used in Italy in the cardiology field, in particular for the transmission and monitoring of information sent by implantable devices (pacemakers and defibrillators). Furthermore, the vital parameters detected on ambulances were transmitted to hospitals to anticipate patient monitoring, or, to cope with emergencies, teleconsultation was used with the transmission of images. These, therefore, are just a few possibilities offered by telemedicine, but many others could be hypothesized, especially in this period of emergency linked to COVID-19.
Legal value of guidelines and regulatory landscape
As already mentioned, the guidelines constitute a first step for the adoption of an organic discipline in the field of television, but they do not, in themselves, have a binding effect.In fact, the Conference of Regions e Autonomous Provinces was established in Pomezia on 15 and 16 January 1981 as a political coordination body between the Presidents of the Councils of the Regions and the Autonomous Provinces. It, therefore, expresses the point of view of the subjects who come together.
Moreover, the legal landscape on which the guidelines intervene is characterized by particular fragmentation. It seems useful to mention some of the most recent to account for the episodic nature of the legislative interventions on the subject.
Thus, for example, the National Chronicity Plan (sanctioned pursuant to Article 4 of Legislative Decree 28.8.1987, n. 281, on 15 September 2016 - Rep. atti160 / CSR) , affirming that Telemedicine and Teleservice make it possible to favor the home management of the person, proposed experimentation with models of assistance such as home teleassistance, specialist teleconsultation and medical telemonitoring.
Art. 21, paragraph 4, of the D.P.C.M. of 12 January 2017, then, specified that in the context of integrated care pathways and territorial district assistance, interventions that allowed the people assisted to stay at home should be given priority.
Again, the Three-year Plan for Information Technology in the Public Administration of 31.05.2017 assigned a central role for the development of Italian public information technology in health matters - among other things - to the Telemedicine Project.
The guidelines
After having seen what value the guidelines assume and the context in which they are issued, we can move on to the actual examination of their content.Firstly, the conditions for activating remote outpatient services were defined. The televised, always provided that the patient's physical examination (traditionally consisting of inspection, palpation, percussion and auscultation) is not required, can proceed if:
the patient is included in a follow-up path from a known disease or in a PDTA (diagnostic therapeutic assistance path) formalized by the competent AUSL, or at a regional level; the patient needs monitoring, confirmation, adjustment, or change of the therapy in progress (e.g. renewal of the therapeutic plan or modification of the same); the patient needs anamnestic evaluation for the prescription of diagnostic tests, or staging of a known or suspected pathology; or if the doctor needs an explanation of the results of diagnostic or staging tests carried out, which may be followed by the prescription of any further investigations, or therapy; any other scenario where the doctor evaluates the possibility of providing the visit in "televised" mode. As regards the tariff system, it was suggested - among other things - the opportunity to apply the same tariffs already in force for the provision of equivalent services in the "traditional" mode.
Again, as a prerequisite for television, the informed adhesion of the patient, personally or through a guardian, also in order to be able to set up a remote communication system that respects the technical specifications and current regulations on privacy and security.
health responsibility for acts performed on television, then, the full responsibility of health professionals was affirmed, as well as the corresponding activities in presence.
The technological infrastructure
Particularly interesting, then, are the provisions dedicated to the technological infrastructure necessary to support the television activity.The Regions and the Autonomous Provinces, in fact, have deemed it necessary, in addition to obvious elements basic (for example, a connection always available, a web portal accessible via notebook, tablet or smartphone by healthcare professionals and patients, etc.) also that healthcare professionals have differentiated systems to communicate with the patient (SMS, email with texts encrypted, video communication) and the presence of a technical coordination center that manages the activities of the service, assisting and routing the video calls of users.
Lastly, to cope with the digital divide that mainly affects certain segments of the population, it is envisaged that where the patient has difficulty in finding the IT tools for television at home, the possibility of accessing local ASL structures or dedicated stations, made available by bodies close to home, must be guaranteed of the same or pharmacies.
