December 10, 2019

Case-law clarifications concerning telemedicine

On June 20, 2019, the Court of Cassation issued a relevant ruling on telemedicine. Indeed, it clarified which activities, in the context of telemedicine, shall be qualified as typical health services and, therefore, are subject to the prior authorization of the competent Italian Region under Article 193 of Royal Decree No. 1265 of July 27, 1934 (hereinafter, “TULPS”).

In this case, a company was concerned by a criminal investigation since, for the purpose of carrying out a telemedicine service, instructed a nurse to collect patients’ data (to be electronically sent) in premises that had not been previously authorized by the competent Region.

The Court of Cassation considered the activity carried out by the Company at these premises without the authorization required by Article 193 TULPS to be legitimate for the following reasons.

Indeed, the mentioned authorization is only necessary in cases where medical services are carried out. In this case, according to the Court, no health service had been provided since the Company performed – through a nurse – a mere collection and transmission of patients’ data. This activity was considered to be devoid of medical value since the nurse used non-invasive self-diagnosis devices that may be used by the patients on their own.

On the contrary, the effective healthcare service consisted in the activity of data processing and diagnosis, which was carried out by the medical staff of the clinic where the Company transmitted the data.

In conclusion, it may be inferred that in the case of telemedicine (i.e. where the health service is provided to the patient by a doctor who is located in a different place, through the use of innovative technologies):

  • only the person who actually performs the health service shall obtain the prior authorization from the Region under Article 193 TULPS;
  • the person who processes health data and carries out diagnostic activities shall obtain the prior authorization from the Region under Article 193 TULPS; and
  • the person who merely collects and transmits data using non-invasive self-diagnostic tools, by providing a mere logistical and practical support for patients, does not provide any healthcare service and, therefore, he/she is not required to obtain any prior authorization under Article 193 TULPS.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
Search by...
Follow us on
Follow us on