**9. Security of mobile health**

Although mobile health represents a strong potential for innovation, it will have little future without a trusted environment. Its use requires a secure framework to guarantee the quality of care. The development of applications and connected health objects in an unregulated international framework presents several risks and raises ethical questions. These risks mainly concern:


As a result, the establishment of a set of quality criteria for mobile health has proved necessary at the present time.

The French High Authority for Health has published a reference framework of good practices for manufacturers and assessors of connected applications or objects. The quality criteria adopted are divided into 5 areas (Haute Autorité de santé. Good practice guidelines on applications and connected objects (Mobile Health or mHealth) [66].


This standard was designed to ensure that an application or connected object is technically capable of delivering reliable and quality health information, protecting personal data and is easy to use.

In the US, the FDA has differentiated between medical and wellness applications, as well as between diagnostic and monitoring applications. It has applied regulatory oversight to the various internal or external sensors of the Smartphone as well as applications used to diagnose or monitor the health status of patients to ensure their safety [67]. To this effect, these different devices must provide evidence and undergo clinical trials that prove their reliability and safety [68]. Several mobile applications have received FDA approval. Examples include the KardiaMobile (AliveCor, Inc.) which provides electrocardiograms, the "Mobile MIM" diagnostic radiology application, the "BlueStar" for the management of type 2 diabetes… [69].
