Blood pressure apps are useful tools for people who want to regularly monitor their blood pressure. They can help capture, store, and evaluate the measurements. Additionally, they can provide tips and advice for a healthy lifestyle. The European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) recommend self-measurements and the benefits of using apps in their guidelines.
Tips
But how do you find the right blood pressure app for yourself? Here are some criteria to consider:
- Quality and Security: The app should come from a reputable source and ensure high data protection. The measurements should not be shared with third parties without consent or used for advertising purposes. The app should also be regularly updated and improved.
BloodPressureDB stands for quality and security since 2011. It is one of the few apps that even carries the seal of approval from the German Hypertension League. - Compatibility and Usability: The app should be compatible with your smartphone or tablet and offer simple and intuitive operation. It should also provide the option to synchronize measurements with an external blood pressure monitor or enter them manually. BloodPressureDB is available for Android devices, Apple (iOS) devices, and as a browser-compatible web app. This ensures maximum compatibility. In addition to manual entry, Bluetooth measuring devices from many manufacturers are supported.
- Features and Content: A blood pressure app should do more than just display measurements. It should include graphical representations of blood pressure trends, a reminder function for measurements, and an export function for the data. The app should also provide information and tips on blood pressure, hypertension, and prevention. BloodPressureDB offers not only this but much more: e.g., the recording of medications as well as their storage and intake reminders.
- Reviews and Experiences: Is the app positively rated and recommended by other users? You should read the comments and reviews to get an impression of the app's quality and reliability. BloodPressureDB has been downloaded millions of times and has correspondingly many customer reviews. Additionally, professional groups such as pharmacists and doctors also like to recommend the BloodPressureDB app.
BloodPressureDB stands for quality and security since 2011. It is one of the few apps that even carries the seal of approval from the German Hypertension League.Does an app need approval as a medical device?
Unfortunately, the approval criteria for medical devices have changed, so this question can no longer be simply answered with a yes. BloodPressureDB was approved as a medical device under Class I according to MDD. However, with the introduction of the Medical Device Regulation (MDR), the classification of software has changed. There is now a new requirement, the notoriously known Rule 11 in professional circles:
Software intended to provide information that is used to make decisions for diagnostic or therapeutic purposes belongs to Class IIa [or higher].
This means that an app that is not a medical device is allowed to provide data to the doctor. However, an app classified as a Class I medical device under MDR is not allowed to do so. This is absurd, but it is the law. We have also discussed this with our regulatory authority. They are aware of the issue but feel compelled to proceed this way until a new legislative change occurs. The old approval as a medical device did not include this restriction. In the future, BloodPressureDB will therefore be offered without medical device approval for the purpose of data recording. A transfer of data from the app directly to the treating physician is not subject to approval requirements. Therefore, we can continue to offer this in the future.
According to current regulations, an app does not necessarily have to be a medical device. However, if it wants to be one, it must meet at least the requirements of Class IIa. A Class I app under MDR is also possible, but then the data cannot be used for therapy.
Conclusion
A blood pressure app can be a useful addition to blood pressure monitoring, but it does not replace a doctor's visit or medical treatment.
By Horst Klier. This article is medically reviewed. Last updated by Sabine Croci (06/2024).
Information on the website and within the app cannot replace a consultation with a doctor, but can certainly complement it.
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