Kardia

Version: 5.8.0 | Cost: In App Purchases

Level 4 - Regulated
Country: US
Category: Abnormal Heart Rhythms (Arrhythmias), Atrial Fibrillation, Electrocardiogram (ECG)
Released: 06/01/2013
Updated: 04/03/2020
Version: 5.8.0
Size: 264mb
Developer: AliveCor, Inc.
Reviewed On: 28/04/2020
This App achieved an ORCHA score of 88%.

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
25.6/30
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Clinical Assurance
45/50
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User Experience
17.5/20
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Developer description
Kardia works with the FDA-cleared KardiaMobile, KardiaMobile 6L, or KardiaBand EKG devices—-the most clinically-validated mobile EKG solution available to consumers. Just touch the sensors on your Kardia EKG device for 30 seconds to capture a medical-grade EKG anytime, anywhere - no probes or wires necessary. Get an immediate result from Kardia's Instant Analysis of Normal, Possible Atrial Fibrillation, Bradycardia, Tachycardia, or Unclassified rhythms. For additional analysis, you can choose to send the recording to your physician or to one of our partners for a paid Clinician Review by a cardiologist (in the US, the UK, Ireland, and Australia only). The Kardia system is recommended by leading cardiologists and used by people around the world for accurate electrocardiogram (ECG or EKG) recordings. Track your heart health data with the medical accuracy your doctor can trust. Kardia integrates with Apple Health to create a combined view of your health metrics. NOTE: Requires KardiaMobile or KardiaBand hardware to record an EKG ---------------------------------- U.S. users of KardiaMobile AliveCor will send your first EKG to a U.S. board-certified cardiologist for analysis (a $19 value within the app). Due to federal regulations, this analysis must be completed before you are able to view your first EKG, take additional EKGs, and access Instant Analysis results provided by AliveCor algorithms. The analysis can take up to 24 hours, but typically less, and will include a report detailing the findings. If you are using KardiaMobile 6L, this review is not required.
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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
Social Support Networks
The App has its own or provides access to social networks 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
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
Auto Health Tracking
The App allows you 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
Automated Guidance
The App uses the data it has to provide automated advice and guidance about a user's health
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 does 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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