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In recent years the surge of AI technology has allowed for a variety of healthcare applications to be developed. These applications are a great way to empower and motivate users to track their own health, and are a valuable addition to an overall healthy lifestyle. 

There are however some things to keep in mind when downloading an application which helps you monitor your health. Overall, it’s important to understand that there are 2 different types of apps: 

  • Health and wellness apps
  • mHealth apps that work as a medical device

Knowing which type of app you’re downloading is important, as there are some vital differences between these categories. This article will guide you through the characteristics of both wellness apps and mHealth, so that you can make informed decisions when choosing an app to track your own health.

What do wellness apps do?

Health and wellness apps can provide useful information to their users and allow them to track their health. Some popular examples of these sorts of apps are health apps that track your fitness activity, your diet, sleep cycle, stress, pregnancy or menstrual period.

There is a broad variety with a lot of options to choose from when it comes to wellness apps. It’s important to know that there isn’t a high level of regulation in this field. This means that the accuracy and scientific validation of these apps may be hard to confirm.

How does mHealth stand out from other apps that track your health?

Mobile health apps (mHealth) deliver healthcare through smart devices such as smartphones. This means that applications which are considered mHealth are used to convey healthcare information, and to assist with the detection, diagnosis and treatment of diseases. As it’s important that these kinds of apps are accurate and safe to use, they are heavily regulated to ensure their quality and precision.

Because of their scalability and broad range, mHealth applications can be used to facilitate the remote monitoring of conditions for a big population. This brings along a lot of advantages, as people can be more empowered to check their own health with qualitative, reliable, and user-friendly resources, which may ultimately lead to earlier detection and better management of conditions. This in turn can lead to improved outcomes overall. Especially with a growing and ageing population, mHealth provides a great opportunity to serve the broad public remotely, and to allocate hospital resources to those who really need it.

When do we speak of a medical device?

When an instrument, or in this case a software, is used for a medical purpose, then it is classified as a medical device. In order to be classified as a medical device, a product must undergo an assessment to make sure that it lives up to the requirements of safety and performance as intended. 

Medical devices can be divided into classes, depending on how invasive they are, which part of the body they affect, how long they should be used and how the device works. Typically mHealth apps fall into class I or IIa.

Where does FibriCheck fit on this spectrum?

Keeping track of your health is important, and using apps to do so can be beneficial and empowering. However, it is important to know that the app which you are using is qualitative, safe, and provides you with accurate information.

You can know whether you’re downloading a health and wellness app or an mHealth application by looking for a quality mark or by checking a public database. An mHealth application will always be CE or FDA cleared, which guarantees regulatory approval and oversight.

FibriCheck is a reliable heart health partner, as it is CE-certified as a medical device class IIa (CE1639). This means that by measuring your heart rhythm and heart rate with FibriCheck, you can be sure that you’re using a product which lives up to the high standards of quality, safety, accuracy, and data protection. FibriCheck has also been cleared by the FDA and is entered in the ARTG 336797, which further demonstrates the high quality standards that FibriCheck lives up to.

We received our CE-certification by undergoing a thorough examination of our product, algorithm, and clinical performance. In order to maintain this certification, we uphold the quality of our product to the highest standards and undergo regular audits. 


Want to know more about our certificates, security, and the way we handle data? Visit our trust center for a full overview.

Download the FibriCheck app

Check your heart rhythm today and avoid the dangers of undiagnosed heart rhythm disorders like atrial fibrillation.


Created on October 12th, 2023 at 08:05 am

Last updated on February 2nd, 2024 at 12:03 pm

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