FibriCheck - Check your heart, prevent strokes

Version: 1.6.0 | Cost: In App Purchases

Level 4 - Regulated
Country: BE
Category: Angina, Stroke/Transient Ischaemic Attack, Caring for Elderly, Abnormal Heart Rhythms (Arrhythmias), Atrial Fibrillation, Heart Rate
Released: 25/08/2016
Updated: 15/05/2020
Version: 1.6.0
Size: 15mb
Developer: Qompium
Reviewed On: 25/06/2020
This App achieved an ORCHA score of 85%.

It was assessed as a Level 4 App. These Apps can be focused on general health or specific conditions and contain advanced and complex features that are subject to formal regulation. Where they collect data we assess their data use policies and compliance with relevant standards. Because they are health focused we also assess their compliance in the Clinical Assurance as well as the User Experience domains.

This App does collect data and it is therefore assessed and scored based on its performance in all the sections of our review.

Data Privacy
22.6/30
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Clinical Assurance
45/50
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User Experience
17.1/20
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Developer description
FibriCheck detects arrhythmias via your smartphone. Keep an eye on your heart’s health with our medical app. As opposed to your heart rate which varies constantly, your heart rhythm should stay regular throughout the day. With this medically certified application you can timely detect heart rhythm disorders and prevent possible complications (e.g. a stroke). A measurement only takes 1 minute, after which you will get immediate and actionable results. The CE-certification and FDA clearance guarantee results of a medical quality standard. The results are easily shareable with your GP or cardiologist if needed. The technology that is used by FibriCheck is of the same level as an ECG (electrocardiogram). In other words, your smartphone turns into a full-fledged medical device ___ Did you know that one in four develops cardiac arrhythmias over their lifetime? The most common of these disorders is atrial fibrillation, a condition responsible for 20% of all strokes. Getting diagnosed in time is therefore of vital importance. Risk factors for the development of cardiac arrhythmias include: high blood pressure, diabetes, other heart diseases, a history of heart attacks or strokes. Symptoms like palpitations or shortness of breath can also be warning signs of an underlying rhythm disorder. ___ FibriCheck is a class aII CE-certified medical device and a 510(k) FDA approved application. Qompium: is a CE-certified medical device company in conformity with the Essential Requirements of Medical Device Directive 93/42/EEC and is certified according to ISO13485
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We have identified that this App provides the following key features

General Information
The App provides general information or guidance
Alerts And Notifications
The App provides alerts and notifications relevant to its area of focus
Health Tracking
The App allows users to record relevant health information either manually or automatically using connected Apps or devices
Data Sharing
The App allows users to share information in the App with others or other Apps/Systems
Remote Clinical Monitoring
The App allows the remote monitoring of certain health data by health and care professionals
Health Tracking
The App allows users to record relevant health information either manually or automatically using connected Apps or devices
Wellbeing Tracking
The App allows users to record relevant wellbeing information either manually or automatically using connected Apps or devices
Carer Support
The App provides features that help those caring for others
Data Sharing
The App allows users to share information in the App with others or other Apps/Systems
Automated Guidance
The App uses the data it has to provide automated advice and guidance about a user's health
WHAT DO WE LOOK FOR?

This review area looks at what information an App collects from users, what it does with that information and how secure is its handling of that data. For some Apps this is only a minor issue as they don’t gather much information. Other Apps can gather lots of very personal and sensitive information and for these it is important to know how they go about handling this.

Data Collection

The data collected about users is/ isn't capable of identifying that it relates to them.

The type of data that it collects is classified as sensitive data.

(Identifiable and Sensitive) - Because of the type of data that this App collects it is particularly important that the App takes the security and privacy of that data seriously and only enables others to see or share this information if the user has expressly consented to this.

Data Use

The App does state that it won't share user data in any way with other people without the user's consent.

The App does allow users to share information in the App with other Apps, systems, organisations or users.

Data Security

The App does encrypt the information it collects to make it safe from other people as it is transferred from the App.

The App does encrypt the information it collects to make it safe from other people as it is retained by the the developer.

WHAT DO WE LOOK FOR?

This review area looks at what evidence there is that there is a suitably qualified professional or organisation behind the App or that it has been endorsed, accredited or underwritten by such an individual or organisation. It also assesses what evidence there is around user testing and what evidence there is that supports the effectiveness of the App in terms of claimed health benefits. The higher the Level of the App and the more sophisticated its functions, the more crucial this becomes.

Professional Assurance

It was clear from our review that a suitably qualified professional or organisation was involved in the Apps development.

It wasn't clear from our review how regularly the advice and guidance given by the App was reviewed and updated by relevant professionals.

Testing

It was clear from our review that the App had been involved in any clinical trials or similar testing to demonstrate its 'real world' effectiveness.

This app is a medical device and has a CE mark.

WHAT DO WE LOOK FOR?

This Review Area looks at how an App has been designed to support the overall user experience. This includes its availability on both primary platforms, how customisable the App is, how well it caters for end users with different capabilities and needs – such as visual or other impairments – how content is managed, how well supported the App is and what it costs. This area also looks at overall User Review scores from both platforms.

Testing

It wasclear from our review that the App had been through end user testing as part of its design and development.

Customisation

The App does provide customisable features.

End user capacity

The App does provide support for users with poor sight.

The App does provide support for users with hearing difficulties.

Support

The App doesn't appear to have a clear approach to dealing with user issues.

Cost

The App isn't entirely free to use.

We evaluate more apps than anyone, so that you can be aware of the good and bad.

Any score below 65% would indicate that an App has some issues that users should investigate further prior to using this App.

Scores below 45% indicate that an App has considerable issues or challenges and in its current form is potentially unhelpful or unsafe.

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