Telemedicine in Italy: Healthcare authorization profiles in the modern medico-legal reading

Article type: Article Commentary

Authors: Bolcato, Vittorio^{a; †;} | Basile, Giuseppe^{b; c; †} | Bianco Prevot, Luca^b | Fassina, Giovanni^{d; e} | Rapuano, Silvia^f | Brizioli, Enrico^f | Tronconi, Livio P.^{f; g}

Affiliations: [a] Astolfi Associati Legal Firm, Milan, Italy | [b] Trauma Unit and Emergency Department, IRCCS Galeazzi Orthopaedics Institute, Milan, Italy | [c] Legal Medicine Unit, Clinical Institute San Siro, Milan, Italy | [d] Department of Public Health, Experimental and Forensic Medicine, Unit of Forensic Sciences, University of Pavia, Pavia, Italy | [e] Unit of Legal Medicine, IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia, Italy | [f] GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy | [g] Department of Human Sciences, European University of Rome, Rome, Italy

Correspondence: [*] Address for correspondence: Vittorio Bolcato, MD, Astolfi Associati Legal Firm, Via Larga 8, Milan, Italy. E-mail: [email protected]. ORCID: https://orcid.org/0000-0002-3419-3002

Note: [†] These authors contributed equally to this work.

Abstract: BACKGROUND:The ruling n. 38485, 20 June 2019, of the Italian Supreme Court, III criminal section, addressed by the perspective of the law the very sensitive and new issue of telemedicine. OBJECTIVE:This commentary deals with the issue of authorization of telemedicine activities by the health authority, starting from the Italian Court of Criminal Cassation, III section, decision n. 38485/2019. The case law explored the authorization of a health point, which carries out telemedicine services. METHODS:Starting from the perspective discussed by Italian health regulations, the paper examines how the health act could be defined, with the possibilities offered by telecommunications, and how it now relates legally to the physical place where it takes place. RESULTS:Even if telemedicine opens the way to virtual spaces of health practice, the Ministry of Health Italian Guidelines pose functional and logistical issues to guarantee users’ safety and health care system accountability. Then, functional requirements for health legitimate practice, and their continuous monitoring, together with the responsibilities of the service centers, health professionals and health facilities, are discussed. CONCLUSION:The questioning of States’ health law, in a broad health system such as that of the Europe, characterized by autonomous health regulations, is extremely important for cross-border health policy with telemedicine, as overall regulatory compliance in health care is the ground criterion for risk prevention and patient safety, to be properly verified.

Keywords: Telemedicine, risk management, authorization, health services, remote follow-up, health law, medico-legal

DOI: 10.3233/JRS-240004

Journal: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-10, 2024