Reviewer Checklists and Other Guidance

This is a compilation of past Take 5 trainings presented before full board meetings. If you have any suggestions for future take 5 training , please email the IRB QA and Education Team.

July, 2017-Mobile Medical App Worksheet

This month, we want to share with you a new worksheet (DOCX) that study teams would need to complete if using a mobile medical app.

How this is going to affect me as a reviewer?

If the study you are reviewing is using a mobile app, you should be aware of FDA and Emory requirements if applicable.

  • FDA: mobile apps (software programs that run on smartphones and other mobile communication devices) are considered "mobile medical apps" if they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (FDA website).

    • If the mobile app is considered a "mobile medical app", the FDA may require an IDE submission. This will occur only if the app is intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device. For example, an app that controls a ventilator or an app that has an attachment that allows the read of glucose strips. Both apps would be considered accessory to a regulated medical device and they should be submitted to the FDA. Check the FDA website for more examples.

    • In other cases, the FDA intends to exercise enforcement discretion if the mobile medical app poses minimal risk to patients and consumers. For example, an app who help patients to self-manage their disease or condition. Please check the FDA website for a detailed list.

  • Emory requirements if using IIHI or ePHI use: If the study is capturing individually identifiable health information (IIHI), ePHI or sensitive information via the app, the security group at Emory IT (OIT) is in charge to review the use. If you notice that the app in question is storing this type of information, look for an email, comment, or any other information indicating that OIT already reviewed this use. If you cannot find it, contact your study facilitator or study analyst.