The current version of this application has not yet been reviewed.

Preventicus Heartbeats.

Version: 1.6.3 | Cost: In App Purchases

Level 4 - Regulated
Country: Germany
Category: Stroke/Transient Ischaemic Attack, Atrial Fibrillation
Released: 22/06/2016
Updated: 25/05/2018
Version: 1.6.3
Size: 128mb
Developer: Preventicus GmbH
Reviewed On: 23/07/2018
This App achieved an Orcha score of 82%

It was assessed as a Level 4 App. These Apps can be focussed 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 focussed 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 Security
19.8/30
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Clinical Assurance
45/50
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User Experience
16.8/20
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Developer description
Take regular recordings of your heart rhythm.This can identify undetected cardiac rhythm disorders—primarily atrial fibrillation—and thereby help prevent strokes. According to the American Heart Association, stroke is the second most common cause of death worldwide.On the other hand, clinical studies have proven that nine out of ten strokes are preventable.The main risk factors include undetected cardiac rhythm disorders, primarily atrial fibrillation. Preventicus Heartbeats not only analyzes your pulse, but specifically your vital heart rhythm—simply and at any time using your smartphone camera without any accessory devices.The app is clinically validated and designed to detect irregular heartbeats(e.g.ectopic beats)and check for the presence of any absolute arrhythmia suspicious of atrial fibrillation.The app works with an accuracy nearly equivalent to that of an ECG tracing—as clinical studies have confirmed. Measuring your heart rhythm regularly helps in prevention.Just as important as regular blood pressure measurements, Preventicus Heartbeats should therefore be your constant companion in situations occurring in life where heart rhythm disorders occur with a greater frequency and, if left undetected, can have fatal consequences in the face of risk factors like : • High blood pressure • Diabetes • Age > 55 years in combination with risk factors • Heart palpitations • Previous arrhythmia(or atrial fibrillation) • Previous heart attack • Previous stroke • Menopause Preventicus Heartbeats lets you visualize your heart rhythm by recording it on a PDF report.That makes your heart rhythm analysis reproducible at any time for viewing by you or your doctor. You can also book optional Telecare Services to support you and your doctor.Working at a Telecare Center, medical technicians specialized in the cardiac rhythm analysis of pulse - related data offer you : • A direct medical - technical evaluation of your recorded heartbeat data to rule out possible measurement errors and to verify rhythm disorders • Detailed notes on potential rhythmic abnormalities to give to your doctor • A summarizing Telecare Report, e.g.to pass on to your doctor Extra functions Free test version : ? • One - minute quick test with heart rhythm analysis : abnormal or not?? PAID FULL VERSION(in - app purchase) : ? • Five - minute test with heart rhythm analysis : normal(green), suspicious(yellow)or absolute arrhythmia suspicious of atrial fibrillation(red)? • Enhanced recording time features an excellent accuracy of approx.95 % ? • One - minute quick test possible any time too? • Heart rhythm data can be displayed on a PDF report, reproducible at any time for viewing by user and / or doctors • All data can be archived • Optionally bookable Telecare Services provided by third - party suppliers Preventicus Heartbeats is a clinically validated medical device that is in conformity with the Essential Requirements of Medical Device Directive 93/42/EEC EEC or its respective national transpositions. The quality management system in place at Preventicus GmbH is certified according to ISO 13485 : 2012. This standard provides the framework and specifies the international requirements for quality management systems, particularly those governing manufacturers of medical devices. ??Terms of Use : http : //www.preventicus.com/en/terms-of-use.html Data Security Policy : http : //www.preventicus.com/en/privacy-policy-app.html
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We have identified that this App provides the following key features:

Alerts And Notifications
The App provides alerts and notifications relevant to its area of focus
Data Sharing
The App allows you 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
Automated Guidance
The App uses the data it has to provide automated advice and guidance about your health
Wellbeing Tracking
The App allows you to record relevant wellbeing information either manually or automatically using connected Apps or devices
WHAT DO WE LOOK FOR?

This review area looks at what information an App collects from you, 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 you is capable of identifying that it relates to you

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 you have expressly consented to this.

Data Use

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

The App does allow you 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.

Regulation

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 was clear 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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