Submission Form for Health Apps

Version 0.4 Mar 12, 2013
(c) JMIR Publications Inc. 2012-2013, http://www.jmir.org
Unauthorized use of this form or any part of this form without written permission is strictly prohibited.

With filling in this form you are giving JMIR Publications Inc. and its partners the permission to publish and disseminate this information, in full or in excerpts, on a perpetual and royalty free basis. This includes publication in a database format, making this information available in machine readable form, and publishing this information as part of an app review ("peer-review"). We reserve the right to reject apps for listing in the database or for peer-review. Additional costs for peer-review or listing in third-party databases (e.g. appsRX) may apply.

App reviews:
Manufacturers/developers or third party entities can apply for a peer-review of the app (use the checkbox at the end of the form). Reviewers are medical and mHealth experts from the JMIR peer-reviewer database (possibly complemented by consumers/patient experts) who will receive a small honorarium to prepare a narrative review of the app, which will be published in a Pubmed-indexed publication of JMIR Publications Inc. (e.g. Journal of Medical Internet Research) and which forms the basis of certification/accreditation for partners such as appsRX.
With filling in this form you permit JMIR peer-reviewers to use quotes from this form as a basis for their review (if you wish the app to be reviewed). We reserve the right to shorten quotes from this form or make minor editorial changes to spelling and wording. If developers/manufacturers request a peer-review, they will receive the review for comment/response (which will be published alongside the review) or they can make software changes to address the reviewers comments, which may lead to an update of the review before it is published.

Definitions:
Apps: can be mobile apps, or interactive stand-alone websites, or desktop apps
Creator/manufacturer: the entity ultimately responsible for the content
Developer: the entity who coded the app, may be identical with the creator/manufacturer, but may also be a contractor of the creator/manufacturer.

    About me

    Who filled in the form and why?
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    About the app

    Basic information about the app
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    Details about the app

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    Security and Privacy

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    FDA approval

    If a mobile app is intended for use in performing a medical device function it is a medical device. The intended use of a mobile application determines whether it meets the definition of a “device.” As stated in 21 CFR 801.4,5 intended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives. When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.
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    Development and Testing Process, and Evidence-Base

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    JMIR Peer-review / AppsRX Listing Application

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