Why Compassana is not a medical device

To begin with, it is important to distinguish between therapeutic products, medicinal products and medical devices.

Therapeutic products are used in the detection, prevention and treatment of diseases, injuries and disabilities.

Their quality, effectiveness and safety are governed by Swiss federal law in the Therapeutic Products Act. The law makes a distinction between medicinal products and medical devices:

• Medicinal products are primarily medications, in that they have a medicinal effect on human beings.
• By contrast, medical devices are defined as products whose primary medical effect is not achieved by means of a medicinal product. This means that instruments, materials and software can be classified as medical devices.

Article 3 (1) of the Swiss Medical Devices Ordinance specifies three criteria for this:

1. They are intended by their manufacturer to be used for human beings.
2. They achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means.
3. The medical device serves to fulfil a specific medical purpose, for example, the “diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease”.

Why is Compassana not a medical device?
With the Compassana Health Platform and the Compassana app at its core, Compassana is a digitally enabled health care ecosystem.

The Compassana Platform delivers the technical infrastructure to enable partners within the Compassana ecosystem to work with each other in a secure and integrated manner. This technology does not serve any medical purpose and patients do not even have direct access to it. Therefore, the Compassana Platform does not constitute a medical device.

The Compassana app can be used, for example, to save medical information, book appointments and transmit messages securely. Additional services can also be used and integrated with the aid of the Compassana app – even ones that are medical devices themselves, for instance, those you use to record your blood pressure or temperature at home and make the readings accessible to your trusted health care specialists via telemedicine for the purpose of making a diagnosis.

This, however, does not make Compassana a medical device, because the app itself does not achieve a medical effect – either in or on the human body.

The app itself does not use any algorithms that have a medical justification and does not feature any sensors or actuators with the intention of producing a medical effect. Furthermore, the Compassana app does not feature any functions that have a diagnostic or therapeutic effect, i.e. that are intended to fulfil a medical purpose. This is why we do not offer the Compassana app for medical purposes.

For more detailed information on medicinal products (medications) and medical devices, visit the Federal Office of Public Health (FOPH) website.