A telemedicine platform may or may not be considered a medical device, depending on functionality and intended use. The issue has been raised several times over the past two years and has become more pressing in Italy since the publication of the State-Regions Agreement on National Indications for Telemedicine (Accordo Stato Regioni sulle Indicazioni Nazionali per la telemedicina - 17 December 2020). In fact, the Agreement states that the system for the provision of remote services must have certain basic characteristics, including the "Certification of the hardware and/or software, as a medical device, suitable for the type of service to be provided through telemedicine" (paragraph "Elementi e standard accessori", page 12). Therefore, from a straightforward reading of the Agreement it would appear that a telemedicine platform is always a medical device.
Doubts and certainties
We have repeatedly expressed, during conferences and debates, our reservations with regard to such a blunt statement: in fact, the qualification of a software as a medical device depends not only on the medical purpose of the software, but also on the 'functionality' of the software itself, more precisely on the presence or absence of data processing. In particular, if the software processes, analyses, creates or modifies medical information, it can/should be qualified as a medical device (obviously when it also has a medical purpose); if, on the other hand, it only performs a data storage activity, it cannot be qualified as such (see MDCG 2019-11 for more details). It is therefore not necessarily the case that a telemedicine platform is always a medical device: it depends on what it 'does'.
Judgment 452/2022 of the Lombardy Regional Administrative Court
Of the same opinion is the recent judgement of the Lombardy Regional Administrative Court in Milan, section IV. 23 February 2022 number 452, which certainly deserves an in-depth analysis, also due to the importance of the subject matter at this historical moment. Here is the case.
A healthcare company issued a call for tenders for the assignment of a home telemonitoring service for patients suffering from chronic obstructive pulmonary disease and medium/severe chronic heart failure. The subject of the contract was the provision of the home health telemonitoring service for patients suffering from the above-mentioned pathologies to be carried out through the use of equipment suitable for acquiring the patient's parameters as well as the provision of services related to the storage, evaluation and management of patients and parameters, with the components (external or integrated) necessary for transmission management. More precisely these were 'pulse oximeters', i.e. saturation meters, detecting SpO2 by means of a reusable sensor, with the option of installing the app on patients' smartphones, and 'electrocardiography equipment', detecting single-channel electrocardiographic signals.
Application rejected
The tender was awarded to company A but competitor B challenged the awarding decision raising (among other things) the lack of CE certification as a medical device of the telematic platform (as regards pulse oximeter and electrocardiographs it was common ground that medical device marking was required). The suspension petition before both the Regional Administrative Court and the Council of State was rejected, and the matter was decided before the Lombardy Regional Administrative Court, which ruled that the qualification of the platform as a medical device was not necessary.
The reasons
The judges of the Lombardy Regional Administrative Court, analysing its functionality, stated the following: "(...) from the description of the objective and functional characteristics of the above-mentioned platform - storage and management of patient data, monitoring data and data relating to therapy and clinical decisions (art. 61 of the Specifications, p. 30) - it is not apparent that any medical activity in the strict sense of the term, i.e. diagnosis, prevention, control, therapy or mitigation of a disease, is to be carried out by means of the platform, which is instead intended to perform tasks that are accessory and supportive of the telemedicine activity, the latter being carried out only by means of the devices intended for the acquisition of the patient's clinical parameters (i.e. the oximeters and electrocardiographs).
It is therefore a telematic system having a function of mere aggregation and management of data, through which no diagnostic or therapeutic activities can be carried out, but only data can be reported, monitored and processed exclusively by means of the medical devices operating on the patient at home'.
No data processing for medical purposes
According to the judges, in essence, the platform acted as a collector of the information acquired and processed through the equipment (oximeters and electrocardiographs) provided to patients, as well as a database capable of sorting and classifying the health data without any processing of the same for medical purposes (diagnosis, treatment, etc.). With regard to the non-requirement of the CE marking as a medical device, the judges state: "To confirm the conclusions reached above, reference may be made to the case-law of the Court of Justice of the European Union, according to which 'Article 1(2)(a) of Directive 93/42, (…) provides that a software constitutes a medical device for the purposes of that directive when it satisfies two cumulative conditions which any such device must satisfy, relating respectively to the purpose pursued and the action produced'.
The National Telemedicine Platform does not require CE marking
The ruling is very recent, so we do not know whether or not it will be challenged before the Council of State. However, even the annex to the recent call for tenders for the public-private partnership regarding the National Telemedicine Platform (“Indicazioni metodologiche per la per la perimetrazione delle proposte di PPP per la piattaforma nazionale di telemedicina”) does not seem to require the CE marking of the platform. Beware, however, of the functionalities that are intended to be provided.
In the section entitled 'Teleassistance', innovative core and microservices are envisaged. With regard to the "Artificial Intelligence System (smart suggestion AI)" it is stated as follows: "Even the minimum teleassistance service has the possibility of accessing a vast wealth of information that resides both in the local archives of regional instances and, in aggregated and anonymised form, within the National Telemedicine Repository. It is therefore possible to develop analytics that, by applying AI algorithms, can develop certain forms of intelligent suggestions (i.e. smart suggestions) to support healthcare professionals in identifying how to provide care effectively when they are engaged in a care process”. Now, there is no doubt that a software tool capable of making 'smart suggestions' is a medical device. And therefore must be marked according to the new EU Reg. 2017/45.