Medical Legal Aspects of Telemedicine in Italy: Application Fields, Professional Liability and Focus on Care Services During the COVID-19 Health Emergency

Abstract

Telemedicine services can be classified into the macro-categories of specialist Telemedicine, Tele-health and Tele-assistance. From a regulatory perspective, in Italy, the first provision dedicated to the implementation of Telemedicine services is represented by the Agreement between the Government and the Regions on the document bearing “Telemedicine—National guidelines,” approved by the General Assembly of the Superior Health Council in the session of 10th July 2012 and by the State Regions Conference in the session of 20th February 2014. Scientifically, several studies in the literature state that information and communication technologies have great potential to reduce the costs of health care services in terms of planning and making appropriate decisions that provide timely tools to patients. Another clear benefit is the equity of access to health care. The evolution of telemedicine poses a series of legal problems ranging from the profiles on the subject of authorization and accreditation to those concerning the protection of patient confidentiality, the definition and solution of which, in the absence of specific regulatory provisions, is mainly left to the assessment of compatibility of the practices adopted so far, with the general regulatory framework. In terms of professional liability, it is necessary to first clarify that the telemedicine service is comparable to any diagnostic-therapeutic health service considering that the telemedicine service does not replace the traditional health service, but integrates the latter to improve its effectiveness, efficiency and appropriateness.

Telemedicine in the Time of the COVID-19 Pandemic: Results from the First Survey among Italian Pediatric Diabetes Centers

“…In Italy, though, these guidelines provide the regulatory framework, and the new basic healthcare levels (what the National Health System reimburse) were approved in 2017 [ 12 ], comprising of telemedicine as an “alternative and augmentative communication tools and software.” However, the present survey showed that telemedicine in pediatric diabetes is still used in a semi-voluntary way, due to the lack of adequate and uniform platforms, legally accurate traceability of most telemedicine tools, and non-recognition of the work and “televisits” in budgetary terms.…”

The effect of the COVID-19 pandemic on telemedicine in pediatric diabetes centers in Italy: Results from a longitudinal survey

“…Whether or not there is a public health emergency, regulatory health systems should recognize the potential of telehealth and remember that any care performed outside a clinic at home is always beneficial [2] , [23] , [24] , [25] , [26] , [27] . We hope that the focus on telehealth over the last year continues after the pandemic and that its use can be considered a vital part of diabetes physician’s “virtual bag” [2] .…”

Will telemedicine survive after COVID-19?

“…Legal and regulatory obstacles were still present, such as the procurement process that companies had to follow to have their technology approved by the regulatory provincial entities. 9 Challenges remained, such as concerns in medical liability, 10 and proof of the value of telemedicine on a wider scale was still limited. Lastly, ethical obstacles such as privacy and confidentiality, as well as cybersecurity issues, technological barriers (eg, bandwidth/WiFi, hardware), and data availability to external actors also hindered the spread of telemedecine.…”