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230 - Hello, I am developing a free iPad application that provides healthcare education presentations for HCPs only. This app will be available for download from Apple's app store. What kind of user gating am I required to have for this app? Is a disclaimer + check box certification of the HCP status enough? Furthermore, I have heard about new sections being implemented in the PAAB code that are related to this - possibly referred to as "access control". Do you have any information concerning these guidelines? Thank you!
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No, a disclaimer and a checkbox are not sufficient. Assuming that the content on the app exceeds that which is permissible within the consumer advertising regulations, you'll need a well-controlled entry system (i.e. some sort of gate which poses an effective barrier of entry for non-HCPs) . For apps, this is often done through a password entry mechanism which is encountered once the user tries to open the app (after having downloaded it on his/her device). In such cases, it is critical to ensure that the combined content prior to successful password entry (e.g. app name, keywords that generate the app name as a search result, content on app store description, user generated comments...) do not exceed the consumer regulations. Another option is to place the app download in a gated part of the pharma manufacturer's website (such that consumer regulations do not need to be considered in creating any post-gate app descriptions). In this scenario, we've seen and approved barriers requiring some sort of hardware (such as USB sticks) distributed in a controlled manner by the manufacturer, a password distributed in a controlled manner by the manufacturer, the HCP's license number (cross-validated for verification), or a URL sent to the HCP through a targeted email.
