Telemedicine: Italy’s Lombardia and Piemonte regions give the green light to televisits
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Since this summer, two additional regions have agreed to allow and recognize televisits at the Regional Health System (“RHS”)’s expenses. Lombardia and Piemonte have even issued specific resolutions so that public healthcare establishments and accredited private bodies can remotely provide health care that previously was provided through traditional appointments.

These resolutions come in the wake of measures adopted at all levels of government to deal with the spread of COVID-19, using digital tools to reduce movement as much as possible and maintain social distancing. These include recent regulations on electronic prescriptions and electronic health records (Fascicolo sanitario elettronico). In this context, regions implemented telemedicine services within the RHS, paving the way for new methods for providing health care, starting from televisits.

Televisits: Definitions and main requirements

Telemedicine in general and televisits, a type of telemedicine, are not regulated by law on a national level. On the basis of the “National Guidelines for Telemedicine” from February 20, 2014 (“National Guidelines”), a televisit is defined as a healthcare act in which a doctor remotely interacts with a patient, and it can lead to the prescription of drugs and therapies.

In line with this document and essentially using the same definition for a televisit, many Regions have issued specific resolutions to establish the conditions under which televisits can be provided by public and accredited private healthcare establishments at the expense of the RHS, making them similar to traditional doctor’s appointments.

Below we analyze the resolutions adopted by Lombardia and Piemonte (respectively resolution No. 3528 of August 5, 2020 and resolution No. 6-1613 of July 3, 2020, and collectively the “Regional Resolutions”) and highlight the key aspects that help to establish how these services shall be provided.

When a televisit can replace a traditional appointment

A televisit can replace a traditional appointment with a doctor in person. However, the Regional Resolutions limit them to cases that involve ongoing care of patients who need ambulatory services and do not need to be examined.

In particular, based on the Regional Resolutions, ambulatory services can be provided via televisit under the following conditions: (i) the patient is receiving follow-up therapy for a known pathology; (ii) the patient is under diagnostic workup and therapeutic care formalized in the healthcare establishment, or at the regional level; (iii) the patient needs monitoring, confirming, adjusting, or changes to ongoing therapy (e.g., renewal or modification of the therapeutic plan); (iv) the patient needs an anamnestic evaluation for the prescription of diagnostic tests, or to establish staging of a known or suspected pathology; (v) the patient needs an explanation from the doctor about the results of diagnostic or staging tests that have been performed, which can be followed by prescription of participation in an in-depth study or a therapy.

Video connection

Pursuant to the Regional Resolutions, a televisit must be carried out through a video connection with the patient. More specifically, the connection shall be in real time and shall allow the doctor to see the patient and interact with him or her, relying on the support of a caregiver or a healthcare professional when necessary.

This specification clarifies some confusing issues that arose from reading the National Guidelines, where it seemed that the interaction did not necessarily have to take place in real time. (The guidelines indicate that “the connection can take place in real or delayed time.”) Therefore, for the purposes of the Regional Resolutions, telephone or written interaction (albeit online and in real time) would not be sufficient, and instead doctor and patient must see each other and be able to interact directly. To this end, there is also the possibility of a caregiver lending support when the patient has special needs.

Information for the patient

Moreover, the Regional Resolutions require that each patient agree to a televisit in advance, after having been adequately informed about the aspects that characterize the service and also having been provided with an online contact for seeking documents/information from the specialist. Patients shall also be provided with the possibility of accessing a remote communications system. This shall all be carried out in compliance with the current regulations on data protection and security.

More specifically, the Regional Resolutions state that the patient must be informed of the following:

  • what the service consists of, what its objective is, what the potential benefits and possible risks are;
  • how the information will be managed and maintained and who will have access to personal and clinical data;
  • which facilities and professionals will be involved;
  • what the tasks and responsibilities of each structure will be;
  • the identifying details of the data controller(s) and of at least one data processor, if identified, with methods for accessing an updated list of data processors indicated;
  • how to contact the data controller or data processor;
  • what rights the patient holds in relation to his/her data.

Authorization to provide televisits

Also clarified is the fact that the national and regional regulatory framework that regulates the authorization, accreditation, and contractual requirements related to traditional provision of traditional ambulatory services by accredited and contractually established private providers also applies with regard to ambulatory services provided via televisit by the same. In other words, no further authorization is required for private healthcare establishments to provide televisits in the context of the RHS, as long as they are already authorized, accredited, and contractually established to provide the equivalent services in person. Furthermore, ambulatory services provided via telemedicine, pending any national regulations, shall be subject to the same rates and the same remuneration system for the provision of services in a traditional way, including any fees—patient co-pays and additional fees—charged to citizens.

Technological requirements

From the patient’s point of view, the only requirement for document/information-related interaction with the specialist and access to a remote communication system based on the specifications required by the services is access to a digital connection. However, according to the Regional Resolutions, requirements for providers are more complex.

Indeed, each provider shall have digital infrastructure at its disposal that guarantees appropriate communications and interaction between doctors and patients in compliance with the regulations on the protection of personal data and cybersecurity (e.g., any voice, video, images, or files shall be encrypted during transmission) and to this end specific procedures and requirements must be in place. This is a relevant aspect to consider, including in light of the fact that data concerning health conditions are processed in the context of televisits.

Furthermore, at the end of a televisit, a report must be drawn up that, in addition to the usual information, indicates the quality of the connection and confirms its suitability for performance of the service; if the telemedicine tool has not allowed the essential content of the service to be provided unchanged, public and private healthcare establishments are required to perform the ambulatory services in question in a traditional manner without charging any additional costs to the RHS and/or the patient.

It will be interesting to see whether there will be many cases in which technological difficulties prevent adequate provision of the service and whether these difficulties, which basically will result in duplication of the services provided (first remotely and then in person), will create more difficulties and inefficiencies in providing services to patients.

What about televisits in the private system?

The provisions established by the Regional Resolutions apply to structures that operate within the RHS. Therefore, televisits provided in the private system, by clinics and healthcare professionals operating privately outside of the RHS, are not currently regulated.

Of course, indications included in these (and other) regional resolutions help by providing some criteria for the evaluation of modalities through which televisits can be provided, but without being automatically binding. Certainly, the decision about whether to replace a personal examination with a televisit is ultimately left to the doctor, who will have to assess it on a case-by-case basis under his or her own responsibility.

Next steps

Although the current health situation provided the impulse to implement televisits within the RHS, the Regional Resolutions themselves make clear that the plan is to keep this tool in place even after the emergency has ended. Telemedicine, and in particular televisits, make healthcare services more accessible throughout the area, thus creating more equitable access to services and ensuring continuity of care.

Specifically, both Regional Resolutions refer to additional telemedicine services that are to be developed and regulated. The resolution issued by Piemonte explores the possibility for Public Healthcare Providers of the RHS to (i) experiment with providing televisit services in other care settings not mentioned in the resolution; and (ii) implement technological and digital solutions that may be essential to guaranteeing regular oversight and monitoring of patients by the RHS (for example: telereporting, telemonitoring, and telerehabilitation).

Proposal on televisits from the Health Commission and the Conference of Regions

Finally, the content of these Regional Resolutions largely reflects the document drafted by the Health Commission and the Conference of Regions to regulate the provision of specialized ambulatory services included in essential services through telemedicine, and specifically televisits.

This document, dated July 27, 2020, was met with opposition from the National Federation of Doctors (FNOMCeO), which asked that approval of the procedure be suspended to make time for an assessment of its compatibility with the Doctors Code of Conduct (art. 78 of which states that “the doctor, using online systems, cannot replace a medical examination, which takes the form of a direct relationship with the patient, with an exclusively virtual relationship.”)

Despite this slowdown, great strides have been made in the process of moving toward clearer regulation for televisits, and much more will need to be done to keep pace with innovative technology that can enhance the health and wellbeing of patients.

Articolo inserito in: Life Sciences, COVID-19
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