App Content Guidelines & Survey
Please read through the guidelines below and provide feedback using the brief survey at the end.
App Content (C) Guidelines
Content guidelines will assess whether the information provided in the application is current and accurate.
Guideline C1 Credible Information Sources
The app is based on one or more credible information sources including, but not limited to: protocols, published guidelines, evidence-based practice and peer-reviewed journals. Appendix 2 provides a selected number of accepted condition specific guidelines.
Requirements for Guideline C1
- 01 The app should specify the source of content with documentation. Is it based on content from a recognized source (e.g., guidelines from a public or private entity) with, and documentation (e.g., link to journal article, medical textbook citation) about the information source and copyright compliance is provided. The source should point to current and accepted protocols and guidelines.
- 02 If the app is based on content other than from a recognized source, documentation about how and when the content was formulated is provided, including information regarding its relevancy and reliability.
- 03 If a previous version of an app or its content becomes medically dangerous due to updated current medical guidelines, the app publisher has a documented process and annual review period or mechanism to update or retract the outdated content version and notify users.
Guideline C2 Current Information
The app’s content reflects up-to-date information.
Requirements for Guideline C2
- 01 Documentation about the source of the app’s content and explanation as to why it is deemed to be up-to-date is provided.
- 02 The date(s)/source(s) of the app’s content is provided through an “About” section (tab, button or equivalent).
- 03 The app publisher has a method or protocol for determining if an app’s content requires updating to remain up-to-date. The app publisher will provide an annual review schedule to ensure that content contained in the app is up to date.
- 04 The app publisher has a method or protocol for updating the app’s content when new or changing information warrants. Updates should include a description of and documentation for each change.
- 05 Any significant deviations in an app’s content from the original source (e.g., excerpts, abbreviated versions) are indicated and explained.
Guideline C3 Information Accuracy
The app’s description and content are truthful, fair, and not misleading.
Requirements for Guideline C3
- 01 documentation is provided to substantiate any claims made in the description and/or content.
- 02 Disclosures are provided, as needed, to prevent deception. Such disclosures shall be presented in a clear and conspicuous manner.
- 03 Disclosures are provided, as needed, if the app requires an additional fee(s) (e.g., subscription fee) in order to fully access the app, its associated functionality, and/or content.
Guideline C4 Accuracy of Results
An app that contains tools that perform user or patient management functions, including but not limited to, mathematical formulae, calculations, data tracking, reminders, timers, measurements, or other such functions, does so with consistent accuracy and reliability to the degree specified in the app.
Requirements for Guideline C4
- 01 When operated, the app produces consistent and accurate results that are independently verifiable.
- 02 The app publisher will provide the accuracy and reliability of any calculations in product documentation. Product documentation will also include appropriate sources that support the validity of calculations, measures and other functions
Guideline C5 Advertising Within the App
An app that contains advertisements clearly identifies the advertising and complies with all applicable regulatory requirements, particularly advertisements that involve or relate to products or services that are clinical or related to health.
Requirements for Guideline C5
- 01 Information in any app that constitutes advertising is denoted by the message “This is an advertisement” or equivalent legibly displayed next to the advertisement or clearly super-imposed on the actual ad or advertorial.
- 02 Information in any app that constitutes advertising will always comply with all applicable regulatory requirements related to the marketing of any product or service, including, but not limited to those of the FDA, FTC, FCC, and any laws, rules, regulations and policies of other regulatory entities in all jurisdictions that app’s owner makes its product available.
- 03 App publisher takes commercially reasonable efforts to clearly and prominently indicate (e.g., in the “About” section) that any advertisement, which may be perceived as health care or medical advice or treatment, is being displayed for the sole purpose of advertising and should not be construed as a substitute for medical or clinical advice.
Guideline C6 Documentation of Evidence
The level of evidence and quality of evidence for an app should be transparent and visible to users and health professionals.
Requirements for Guideline C6
* C6.01 The app’s public description should clearly state which type of research has been performed to validate its content. These can include the following levels of research:
I. Systematic review or meta-analysis of randomized control trials
II. Randomized control trial/s (number of trials if more than one)
III. Quasi-experimental study
IV. Case-control or cohort studies
V. Systematic reviews of descriptive and qualitative studies
VI. Single descriptive or qualitative study
VII. Expert medical or academic opinion
- 02 If level of research performed on the opinion is based on expert or academic opinion (VII) or no study, the app’s public description should clearly state, “The effectiveness of the app has not been studied”.
- 03 If a study was performed, documentation should clearly state who performed such study (C7.01) and whether the study was performed by an independent entity. Furthermore, the app’s documentation should state if the study has been published in a peer-reviewed journal, and if so, include the date and the title for both the journal and article. App’s documentation should also state any ownership that the study authors (C7.01) have in the solution company, its partners or investors, either currently or at the time the study was performed.
- 04 If a study was performed, documentation should state the exposure environment (e.g. hospital, home, community health center, etc.). It should also state the demographics, socioeconomic status, IT literacy, rural/urban, and type/stage of illness of study participants. The relevance of these characteristics to app’s goals should be explained.
Guideline C7 Transparency of Evidence
The basis of evidence in literature for the app and the app’s design should be transparent and visible to users and health professionals.
Requirements for Guideline C7
- 01 App documentation should state whether the app is based upon the results of a study/studies published in peer-reviewed journals. This can include studies of non-digital health interventions that have inspired solution designs. If based on peer-reviewed publications, documentation should state that the app is “informed by the independent study of a separate intervention in a peer-reviewed journal” and include the date and the title for both the journal and article. This statement is in addition to, not replacement, of the preceding statement of which type of research has been specifically performed on the app.
Given that literature reviews are significantly less costly than performing studies,
- 02 Documentation should state whether such study authors (C7.01) have had any cooperation with the app publisher, and whether the study authors provide any active input on the app. App documentation should also state any financial relationships that are planned, exist or have existed between such study authors (C8.01) and the app publisher, its partners or investors.
- 03 If an app is based on peer-reviewed literature, the documentation should state what type of user research was performed to adapt the literature and solution to the needs of the target user. This could include, but is not limited to design research, human centered design, formative research, user centered design, and co-creation with users. This type of qualitative research can complement and translate quantitative research, but it should not be presented as a replacement for quantitative research.
Guideline C8 Publishing Outcomes Data
The types of results achieved by the app or study of the app should be transparent and visible to users and health professionals.
Requirements for Guideline C8
- 01 Documentation should clearly state what metric or indicator is used in studies and claimed to be accomplished by the application. This can include the following type of indicators:
I. Health outcomes
II. Biological outcomes
III. Health behavior outcomes
IV. Online analytics or online behavior outcomes
If the cited indicator is only an online outcome (IV), documentation should clearly state that results do not include “tangible outcomes in health behavior or health outcomes”.
- 02 The public source of the metric definition should be cited in the app’s documentation. This could include a health association, peer-reviewed journal, health standards body.
Guideline C9 Transparency of Data
The context of the app and data should be clear to users and health professionals.
Requirements for Guideline C9
- 01 The app’s public description should accurately state in plain language what type of individual health data is collected by the app, who it is shared with, and what it used for. This description should specify whether this data is sold to app publisher’s partners
- 02 App documentation should specify in which types of environments it is designed to operate for all relevant users (e.g. hospital, home, community health center, etc.). This description should explain how the app has been designed to operate in this environment with the minimum burden.
For further information and guidance, refer to “How to Make Effective Disclosures in Digital Advertising,” Federal Trade Commission. (https://www.ftc.gov/sites/default/files/attachments/press-releases/ftc-staff-revises-online-advertising-disclosure-guidelines/130312dotcomdisclosures.pdf)
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