Overall App Summary:
In summary, Hello Heart is an outstanding mobile application for patients who are interested in monitoring and tracking their blood pressure. However, it falls short on its claim for helping people manage their high blood pressure, as it fails to present high-quality evidence to backup their claims. The app has a very good user interface, is intuitive to use, and has features and functionalities that make it an attractive option among the many that exist in the app store. One key functionality, that’s missing, is the ability to electronically share the BP diary/report with the healthcare provider. Furthermore, the price point of $59.99 is extremely high, given that there are a number of blood pressure “journal/ log/ diary” apps available that are free. Without a prospective clinical trial establishing the true health/ clinical benefit of the Hello Heart app for patients with high blood pressure, the high price point may not be justified.
App’s Intended Use:
The Hello Heart app is intended to be used for those (consumers or patients) interested in monitoring/ tracking, as well as, managing blood pressure. Per the company’s website, the mobile app is a “first mobile therapeutic clinically-tested app to help you manage high blood pressure and related heart risks.”
Who’s this app most useful for?
This app is most useful for patients with borderline or high blood pressure. It may also be helpful for those healthy people that have a family history of high blood pressure and are interested in monitoring and tracking blood pressure on a routine basis.
How should people use it?
Patients with borderline or high blood pressure (or those with obesity who are at risk for developing high blood pressure) may use this app on a regular basis to track and manage their blood pressure. Setting up reminders may help them remember to measure their blood pressure daily. The app also provides some basic information and education around blood pressure levels using American Heart Association guidelines and also offers some “insights” into lifestyle modifications.
Why should anyone use this app? Is it clinically relevant?
The Hello Heart app is relevant for those with borderline or high blood pressure, as it allows for a relatively easy way to track their blood pressure over time. The other aspects of the app (key functionalities) may also encourage and drive lifestyle changes that may positively impact their blood pressure levels (reduction of BP to optimal level). One key feature that’s lacking is the ability to share the BP diary/ report with your healthcare provider.
Is there any evidence that the app actually works?
The company states on its website that it has conducted an observational analysis of its user base, which shows a significant reduction in blood pressure after initiation of use; but that is a very weak study design and the analysis is not published in a peer-reviewed journal. To our knowledge, there is lack of unbiased, high-quality evidence that supports clinical effectiveness.
Regulatory compliance implications?
The Hello Heart mobile app is not a traditional medical device (blood pressure cuff), but probably falls under the definition of a mobile medical device based on the mobile medical application (MMA) guidance (see abbreviated criteria below). In our opinion, the Hello Heart app meets the regulatory definition of a “device,” but poses minimal risk to patients and consumers, and thus, the FDA will most likely exercise enforcement discretions and will not expect the company to submit premarket review applications or to register and list their apps with the FDA.
What is the most important/ desirable feature of the app?
Easy data entry; blood pressure measurement and blood pressure medication reminders; blood pressure report with insights; and the ability to connect to the electronic health record (however, this is quite limited).
If there’s a paid version, is it worth the upgrade?
The app is quite expensive ($59.99) for blood pressure tracking/ monitoring. Even if the app was quite successful in driving reduction in blood pressure, it would be hard to imagine patients paying out of pocket that much money to download the app. If there is sustainable reduction in blood pressure among patients with uncontrolled HTN, it may be a cost-effective option for patients, caregivers, payers, and healthcare providers especially if reimbursed.
Security and Privacy
Password: Required for login; support for TouchID on iOS
Encryption: Encryption support reported on website