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Medical apps: healthcare medical devices

The use of technology in the healthcare sector is spreading more and more, especially now that the COVID health emergency has imposed distance, and has limited physical presence only to the cases of actual urgency. Medical apps, software and programs range from self-monitoring, such as calories counters and pedometers, to online health assistance.

If once medical software were a prerogative of the sole professionals, today citizens can also enjoy new health technologies as patients (think of the need to digitalise visits, prescriptions, follow-ups and therapies).

News in health care

This is something new for health assistance; it is believed that this will allow to provide remote clinical assistance in the future, with interventions on the patients that are more targeted, and directly at home. In fact, it will be possible to perform personalised analyses, provide specific diagnoses, and allow doctors to have a real and constant remote control in the clinical treatment of patients.

In order to ensure a correct dissemination of these technologies, efficiency, and privacy for users, it is essential that such Apps receive the correct legal framework. Only Apps with a medical purpose, appropriately stated by the manufacturer, are to be considered as medical devices (hereafter MDs).

The correct legal framework depends not only on the intended use, but also on the user (either patient or professional), and on the use of the collected data; for instance, Apps collecting the data regarding the diet can be either medical devices if they can contribute to diabetes monitoring, or generic Apps for wellness, if they only count calories. In this sense, in order to facilitate the legal framework of these products, the new European Regulation on Medical Devices, Reg. EU 745/2017, whose full implementation was postponed until May 2021, contains a classification rule dedicated to software and medical apps.

Apps as medical devices

In case such Apps are medical devices to all effects, they will be subject to the strict discipline of the Regulation, providing for that software intended to provide information for diagnostic or therapeutic purposes, or even intended for physiologic process monitoring belong to class IIa, consequently requiring the intervention of a Notified Body to obtain the CE marking.

Medical apps manufacturers shall comply with the obligations of the Regulation, including the presence of information on the design and validation of the software, traceability and post-marketing surveillance, as well as specific measures to protect patients’ clinical data in compliance with Reg. UE 679/2016 (General Data Protection Regulation – GDPR).

Medical apps have all requirements to represent a useful tool in the management and monitoring of patients, as well as in the speeding up of diagnosis and targeted treatments. When appropriately managed, they are a great resource for both public health and technological and scientific progress of our country, not only in the current contingency but also at end of the pandemic emergency.

Written by: Sofia Tabacco

Foto by Foundry from Pixabay