July 6, 2022

Telemedicine: When is software a medical device? The Court responds

This article has been published on May 23, 2022 on Agenda Digitale, within our Legal Health section (Italian)

On February 23, 2012, the Regional Administrative Court of Lombardy—seat of Milan—issued a ruling on the qualification as a medical device of a software platform used to provide healthcare services remotely.

The Regional Administrative Court, in line with the (limited) available jurisprudence and the guidelines provided by the EU Medical Devices Coordination Group, held that a platform that does not perform data analysis or processing for medical purposes—but merely stores and classifies data—does not qualify as a medical device.

These statements, while not unexpected, have significant impact on numerous initiatives that public administrations are launching to encourage private operators to implement telemedicine infrastructure. The most recent initiative was launched at the end of March by the National Agency for Regional Health Services (Agenas) to explore the possibility of setting up a public/private partnership for the design, implementation, and provision of IT services facilitating access to the National Telemedicine Platform. The goal would be to better integrate local service providers into the platform, improving telemedicine services on a national scale.

The regulatory framework in this area is constantly evolving, as evidenced by the draft decree of the Ministry of Health (sent to the State-Regions Conference at the end of April) envisaged by the PNRR and containing organizational guidelines for the “Digital Model for the implementation of home assistance.” Therefore, the development of jurisprudence that establishes ground rules for the regulation of telemedicine is certainly a positive step that will provide certainty for businesses.

The case before the court

The ruling in question was issued in the context of a tender from a public healthcare company seeking bids for the supply of home telemedicine services for people with COPD (chronic obstructive pulmonary disease) and CHF (congestive heart failure). The company needed both leased electronic medical equipment for determining patient parameters (pulse oximeters and electrocardiogram machines) and services related to the storage and management of patient data, monitoring data, and data related to therapy and clinical decisions.

For the equipment, the tender specifications expressly noted that medical devices needed CE certification and needed to be registered with the CND (National Classification of Medical Devices) and the relevant RDM (General Medical Device Directory), but no requirement to that effect was dictated with reference to the software platform for data storage and management.

After company Alpha was awarded the contract, company Beta filed an appeal challenging the legitimacy of the outcome on the grounds that (inter alia) the computer platform offered by the winning bidder had not obtained CE marking. This was based on the assumption that the definition of a medical device contained in Article 2(1) of Regulation (EU) 2017/745 (and formerly in Article 1(2) of Directive 93/42/EEC, applicable to the case at hand) also includes any software intended by the manufacturer to be used for one of the medical purposes set out therein, including the diagnosis, monitoring, prevention, prognosis, and mitigation of human disease.

The ruling looks at requirements that a piece of software must meet in order to fall within the scope of the relevant legislation, namely Regulation (EU) 2017/745 (“MDR”) and, previously, Directive 93/42/EEC.

The decision of the court

Ruling on the appeal, the Regional Administrative Court examined the specific functional features of the platform supplied, though it noted that the special tender regulations indicated that the software was to act as a mere collector of the data acquired by means of the electronic medical equipment.

Indeed, once the health data are collected they are transmitted to the platform, which merely classifies and files them, creating a database that can be consulted in the context of telemedicine services. The software is not intended to perform any medical activity in the strict sense (diagnosis, monitoring, control, and the like), unlike the equipment, which acquires patient data.

Therefore, the platform performs no data analysis and has no processing function for medical purposes. Mere storage and classification of the data cannot be considered as such, and those functions must be present to consider software as having a specific medical purpose and, consequently, to classify the software as a medical device.

The Regional Administrative Court cited case-law of the Court of Justice of the European Union, which states that “software is a medical device when it is specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of medical device” and “that is not the case with a software program which, although intended to be used in a medical context, nevertheless has the sole purpose of storing and transmitting data.” Though the software in these circumstances is used in a medical context, it is not a medical device.

Accordingly, the Regional Administrative Court rejected (among others) these grounds for appeal on the basis of its analysis of the function of the computerized platform, finding that the platform cannot be classified as a medical device and consequently shouldn’t bear the relevant CE marking.

Analysis and processing of data for medical purposes as a determining criterion

The ruling of the Regional Administrative Court is in line with the development of the law and jurisprudence on the subject of the distinction between “mere” software and platforms and those that can be classified as medical devices.

Indications to this effect can be found in the very definition of medical device under the MDR (Art. 2, no. 1 and Recital no. 19) as well as in the guidelines of the Medical Device Coordination Group published in October 2019. The latter expressly exclude from the scope of the MDR all those computer systems intended only to transfer, store, convert, format, or file data, without any processing for a specific medical purpose.

In conclusion, it is clear that the qualification of a software platform as a medical device cannot be separated from an in-depth investigation of its mode of operation and use; the mere fact that the software is used to perform medical activities is not sufficient.

Finally, it should be noted that even in the absence of a specific medical purpose, software may still fall within the scope of the MDR if it constitutes an accessory to a medical device, insofar as it is intended to be used “with one or more medical devices, in order, in particular, to enable those devices to be used in accordance with their intended purpose, or to specifically and directly assist the medical functionality of the devices in relation to their intended purpose” (Article 2(2) of the MDR).

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