Connected medical devices
An overview
Last updated
An overview
Last updated
First we start by listing examples of connected devices: what are they used for?
Connected devices are used for many applications:
And different price tags
As examples:
a smart bed in an hospital can include 10 to 15 sensors
there exists opensource insuline pumps (https://openaps.org)
On top of those individual medical equipment, there are expensive ultrasound or imaging devices such as CAT/MRI/PET scanners, biochemistry analyzers, etc.
During the interviews, we reviewed the monitoring provided by large vendors. In particular, we investigated how they managed cyber risks and incidents, and we discussed with their solution engineers about remote updates.
Biosency is producing a connected PPG sensor system using smart data is a monitoring and prevention solution dedicated to respiratory insufficiency.
Biosency is a French startup, but is looking to develop its sales overseas. As such being able to ensure compliance with FDA and Health Canada regulations is of critical importance.
An important activity is related to quality insurance (ISO 13485). To get the CE marking (class 2A), the company had to comply with several standards (ISO 80601-2-6, IEC 60601, ETSI EN 300 328 V2.1.1) but nothing related directly to cybersecurity.
The innovative system to reduce sleep apnea disorders is composed of 3 components:
a cardio-respiratory recorder,
a kinesthetic stimulator
and a real-time processing application, integrating an “on-off” control method to trigger the kinesthetic stimulation as a function of respiratory event detection of a given patient.
which have been patented. Some results have been published in nature:
Yet, the innovation doesn't take into account a systems approach that includes security and privacy.
