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.
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About me
Who filled in the form and why?
Your name *
What is your name?
Your email address *
What is your email address?
Your role *
List any other persons who helped filling in this questionnaire and describe their input
List name, role, and email address, and describe the level of their involvement. If you are a student, please describe if you contacted the creator/manufacturer of the app and to what degree the manufacturer supplied material
About the app
Basic information about the app
Name of the app *
What is the name of the app?
Version *
Current version(s). The same program for different operating systems may have different version numbers, in this case please write the operating system in brackets e.g. (iOS)
Last update of current version specified above *
Date(s) of update of the current version(s). The same program for different operating systems may have different version numbers, in this case please write the operating system in brackets e.g. (iOS)
Update/revision cycles *
How often are major updates/revisions made? Future planned release dates? Major new features planned, and their timeline?
Platforms *
Required
Countries *
The app is intended to be used in the following countries (or enter "global" if the content is non-country specific)
URL(s) where the app can be downloaded/obtained *
e.g. link to iTunes store, Android market, Blackberry App World listing or (if web-based only) website URL
Promo codes/Tester access instructions *
If the app is not free of charge or not (yet) available for the public, please describe how testers/reviewers can obtain access. E.g. enter itunes promo codes (at least 4) or similar. Make sure to provide these for each platform.
URL(s) of creator/manufacturer owned websites/webservices *
Websites or webservices controlled by the creator/manufacturer which are related to the app, e.g. if the app stores information on one or more webservers. One URL per line (explanation in brackets)
URL(s) of marketing material, user manual, general information, articles about the app *
URL(s) of screenshots *
Please enter URLs pointing to screenshots (jpg or png preferred) of the app.
I am the creator/copyright holder of the screenshots above and give permission for reproduction in articles published by and on sites associated with JMIR Publications Inc. and its partners *
Third-party URLs *
Third-party applications/modules or "cloud" applications (e.g. Microsoft Healthvault) which are used by the app but not controlled by the owner/developer (explanation in brackets)
Hardware components *
Are any additional hardware components required for the app (provide details, including where to obtain them)
Total retail price (approx US$) *
Of the app and any required additional software and hardware
Name of the creator/manufacturer (company/organization name) *
Entity (company, person, organisation, institution) primarily responsible for making the content of the resource. Name of the information provider. A “mobile medical app manufacturer” may include anyone who  initiates specifications, designs, labels, or creates a software  system or application in whole or from multiple software  components. This term does not include entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions, such as owners and operators of “android market”, “iTunes store”, and “BlackBerry App World.”. It is important to understand that software developers that are  only responsible for performing design and development  activities to transform the author’s specifications into a mobile medical app would not constitute manufacturers, and instead the author would be considered the manufacturer.
Type of creator entity
Type of entity (company, person, organisation, institution) primarily responsible for making the content of the resource. Name of the information provider.
Clear selection
Main Contact *
Name of the main contact to answer questions about the app, e.g. developer or CEO
Main Contact Email *
Email address of the main contact to answer questions about the app, e.g. developer or CEO
Main Contact Role *
e.g. developer or CEO
Name of contributors  (company/organization name) *
Entity/entities (company, person, organisation, institution) who contributed to the app, e.g. developers (add a description of the role in bracket)
Link to About section *
URL linking to an about section specifying creator and contributors (or describe the menupoint where this can be found)
User Support *
How is user support provided, how can users give feedback? List support contacts, Feedback Form URLs, support policies, turnaround times etc
Details about the app
What is/are the main target audience(s) of the app? *
Required
Indications and Target Audience  e.g. by specialty or diagnosis, in more detail, including medical indications *
To whom should the app be "prescribed" (if consumer app) or which kind of health professionals should use it.  If these are quotes from a website or marketing material, please use quotation marks and cite the URL in brackets.
What is/are the main purpose(s) of the app? *
Please list what the app tries to achieve and describe the intended use (use a numbered list). Any peer-review and further evaluation will be evaluated against the stated purpose of the app. If these are quotes from a website or marketing material, please use quotation marks and cite the URL in brackets.
Similar apps / competitors
List the names of some other apps (if any) which have a similar purpose/functionality (in brackets you may specify where they differ)
What is/are the main purpose(s) of the app? Classification *
Required
Key features and functionality of the app? *
 Describe in detail the key features and functionality of the app, provide example workflows and use cases (a narrative of scenarios on how the app is supposed to work and help the user). Any peer-review and further evaluation will test these stated functionalities and features.  If these are quotes from a website or marketing material, please use quotation marks and cite the URL in brackets.
Who is/are the authors of the information provided in the app? What are their credentials (degrees, affiliations)? *
E.g. names, degrees and email addresses of the medical advisors. These individuals must personally vouch for the credibility of the app
Authors/Credentials Disclosure *
Where in the app are these disclosed/mentioned/listed? (e.g URL or menu point)
Financial Disclosure: Funding sources *
Please declare sources of funding. This is required for all apps, including those with no external sources of funds, and apps funded by government agencies, pharmaceutical companies or other commercial entities. • All funding must be declared: government agency, private companies, donations, etc. • Owners/creators/developers also have to declare all conflicts of interest.
Financial Disclosure in App *
Where in the app are these disclosed/mentioned/listed? (e.g URL or menu point)
Conflicts of interest *
Owners/creators/developers should declare all conflicts of interest. For example, if an app gives advice about a medical condition and the app creator is identical with or sponsored by a pharmaceutical or device company which also sells drugs or equipment for condition, then this should be disclosed. Such relationships are not per se unethical, but failure to disclose such relationships is.
Conflicts of interest Disclosure in App *
Where in the app are these disclosed/mentioned/listed? (e.g URL or menu point)
Contraindications *
Who should not use the app
Contraindications Disclosure *
Where in the app are these disclosed/mentioned/listed? (e.g URL or menu point)
Known limitations *
Known limitations of the app
Potential harm, side-effects, risks *
Disclose known cases of patients having been harmed, side-effects, risks for using the app
Security and Privacy
Privacy Policy *
Describe mechanisms to protect the privacy of users (copy & paste privacy policy)
Privacy Policy Location
URL or menu point where privacy policy can be found
Privacy Settings
Does the app provide sensible interfaces and default settings for the privacy controls? What are these default settings?
Privacy Access Logs
URL or menupoint where the app provides access logs so consumers can see who their information has been shared with?
Security *
Describe how the app collects, stores or transmits any personal information, including, but not limited to, usernames and passwords. Describe mechanisms to ensure the security of the app e.g. using HTTPS protocol, authentication procedures, password resetting procedures, password storage (salted hash?) etc.
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.
FDA approval *
Does the app require FDA approval (or approval of other national regulatory agencies). Note: This depends on the intended purpose of the app - see "intended purpose / classification" question above.
FDA approval - Details *
Please provide details, e.g. why the app does not require FDA approval, or links to applications/approval documents
Development and Testing Process, and Evidence-Base
Describe the level of formative evaluation / user centered design approaches during development *
E.g. technical evaluation, surveys, individual interviews, focus groups, formal usability tests
Formative Evaluation - Key publications *
Cite key Medline-indexed publications with any usability studies, focus group studies, or other types of formative evaluation
What is the evidence-level of the app? *
This does NOT include formative studies such as usability studies, but refers to health-related outcomes. In the appsRX model, a app must be at a minimum been peer-reviewed in order to be prescribable, and the peer-review report must be published in a Medline-indexed journal. JMIR offers peer-review of apps (check the checkbox below to indicate if you want this).
Required
What are the primary and secondary outcomes the studies (EL2-EL4) are looking at? *
Trial registration *
RCTs only: Provide a Trial Registration number and link to trial registry entry (e.g. clinicaltrials.gov). One line per trial (if multiple trials)
Theory or evidence behind the app/intervention/content *
What prior key evidence or content sources is the app based on? Cite publications and explain how the existing evidence was incorporated into the app. If these claims, statements and references were made on the creators website or marketing material, please use quotation marks and cite the URL in brackets.
Theory/Evidence base - Key publications *
Cite key Medline-indexed publications (numbered list with links to pubmed.gov abstracts)
Peer-review - Key publications *
Cite key Medline-indexed publications containing a peer-review of the app, if any (or enter "none").
Reviews in trade journals, blogs
Cite (e.g. by URL or bibliographic information) any independent reviews of the app in trade journals or on blogs (e.g. imedicalapps, mobihealthnews)
Outcome evaluation Observational - Key publications *
Cite key Medline-indexed publications containing non-randomized outcomes data of users
Outcome evaluation Randomized - Key publications *
Cite key Medline-indexed publications containing randomized trial-based outcomes data of users
Outcome evaluation - Key findings *
What are the key findings of outcome studies (e.g. copy&paste abstract)
Notes
Additional information about the app which did not fit into any other question
JMIR Peer-review / AppsRX Listing Application
I hereby apply for ..
General feedback
E.g. comments/questions about this form
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