> For the complete documentation index, see [llms.txt](https://mediam.gitbook.io/mediam/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://mediam.gitbook.io/mediam/specification/use-cases/connected-medical-devices.md).

# Connected medical devices

An overview

First we start by listing examples of connected devices: what are they used for?

## Categories

Connected devices are used for many applications:

![Types of connected medical devices - Source : BSI eCare](https://3178453543-files.gitbook.io/~/files/v0/b/gitbook-legacy-files/o/assets%2F-MRtPf74KcFoj7U-KiQV%2F-MSCpluaGtX2_lN3rI6q%2F-MSCxctsMU8QQYaEzfri%2Fimage.png?alt=media\&token=4422ca93-f197-4537-b574-66c0998a9905)

And different price tags

![Price of connected medical devices - Source : BSI eCare](https://3178453543-files.gitbook.io/~/files/v0/b/gitbook-legacy-files/o/assets%2F-MRtPf74KcFoj7U-KiQV%2F-MSCpluaGtX2_lN3rI6q%2F-MSCxyHivVnm0XuF7NdX%2Fimage.png?alt=media\&token=8e2d43f9-9f47-48f8-8161-a7afe3a5fc14)

As examples: 

* a smart bed in an hospital can include 10 to 15 sensors 
* there exists opensource insuline pumps ([https://openaps.org](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. 

## Example of a large vendor

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. 

![Focal Point software, ](https://3178453543-files.gitbook.io/~/files/v0/b/gitbook-legacy-files/o/assets%2F-MRtPf74KcFoj7U-KiQV%2F-Mabwsazjd_61jQMYTCz%2F-MabxmZUxd5JBRJ04RAN%2Fimage.png?alt=media\&token=ece69990-80bd-4f9d-9808-a20615a3c5cc)

## Designing new devices

### Startup example

[Biosency ](https://biosency.com/)is producing a connected PPG sensor system using smart data is a monitoring and prevention solution dedicated to respiratory insufficiency.

![Boraband and its data analysis](https://3178453543-files.gitbook.io/~/files/v0/b/gitbook-legacy-files/o/assets%2F-MRtPf74KcFoj7U-KiQV%2F-MSD-RbL-lH3zJgAxyCr%2F-MSD-x6wvEOE-cwqmIl_%2Fimage.png?alt=media\&token=d16dc1ef-876b-498b-8bf7-37a0dd7ab6fc)

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.

### Research example 

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](https://www.nature.com/articles/s41598-018-21430-w): 

![An innovative system against sleep apnea](https://lh3.googleusercontent.com/pysBakh9ILECqj8dgF7ogJJTUDPuDQzZPetDOi4CmBgC-2Qfxtc6MTJxdVjQTHiXLRcBxssVn346wLLr9evAFMPQSFchzXkTenHXI_Z7dkLBvk8Hiie_EvF5Nma2tQtyrnfvdg8)

Yet, the innovation doesn't take into account a systems approach that includes security and privacy.