2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. MOBILE MEDICAL APPS FDA guidance Developed by: U-MIC University of Michigan IRB Collaborative

4. Mobile medical apps 3 Developed by: U-MIC FDA guidance on mobile medical apps February 2015 federal guidance does not establish legally enforceable responsibilities reflects FDA’s current thinking/recommendations regarding mobile medical apps mobile medical apps FDA applies regulatory oversight to mobile apps that represent medical devices could pose a risk to a patient’s safety should the mobile app malfunction

5. Mobile medical apps 4 Developed by: U-MIC FDA definitions mobile platform commercial, off-the-shelf computing platform with or without wireless connectivity handheld smart phones tablet computers other portable computers mobile app a software application that can be run on a mobile platform or a web-based software application that is tailored to a mobile platform but is executed on a server

6. Mobile medical apps 5 Developed by: U-MIC FDA definitions mobile medical app meets the Food, Drug, and Cosmetic (FD&C) Act’s definition of a device is intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device Mobile app’s intended use determines whether app meets definition of a device may be shown by labeling claims advertising materials oral/written statements by manufacturers or their representatives Mobile app is considered a device when its intended use is the diagnosis of a disease or condition, or the cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body

7. Mobile medical apps 6 Developed by: U-MIC FDA definitions regulated medical device meets the FD&C Act’s definition of a device has been cleared or approved by the FDA review of a premarket submission or otherwise classified by the FDA

8. Mobile medical apps 7 Developed by: U-MIC mobile medical apps subject to regulatory oversight extension of one or more medical devices via connection (physically or wirelessly) to a device for purposes of controlling the device for use in active patient monitoring or analysis of medical device data transform mobile platform into a regulated medical device by use of attachments display screens sensors by including functionalities similar to those of currently regulated medical devices become a regulated medical device by performing patient-specific analysis providing patient-specific diagnosis or treatment recommendations similar to or perform the same function as types of software devices that FDA has already cleared or approved

9. Mobile medical apps 8 Developed by: U-MIC mobile apps not considered mobile medical apps not subject to FDA regulation intended to provide access to electronic copies (e.g., electronic or audio books) of medical textbooks or other reference materials with generic text search capabilities intended for health care providers to use as educational tools for medical training or to reinforce past training intended for general patient education facilitate patient access to commonly used reference information automate general office operations in a health care setting not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease generic aids or general-purpose products magnifying glasses audio recording devices

10. Mobile medical apps 9 Developed by: U-MIC enforcement discretion low-risk mobile apps medical app may meet definition of a medical device FDA may choose not to enforce requirements Such apps include those that help patients self-manage their conditions no specific treatment or treatment suggestions provide patients with simple tools organize and track health information provide access to information related to conditions/treatments help patients document, show, or communicate potential medical conditions automate simple tasks for health care providers enable patients or providers to interact with Personal Health Record Electronic Health Record transfer, store, convert format, and display medical device data in its original format from a medical device

11. Mobile medical apps 10 Developed by: U-MIC enforcement discretion FDA will not regulate example: mobile apps that coach patients with conditions such as cardiovascular disease hypertension diabetes obesity prompt patients to employ strategies for maintaining a healthy weight getting optimal nutrition exercise/fitness managing salt intake adherence to medication regimen

12. Mobile medical apps 11 Developed by: U-MIC enforcement discretion FDA will not regulate example: mobile apps that help patients with conditions such as post-traumatic stress disorder depression anxiety disorders obsessive-compulsive disorder maintain coping skills “skill of the day” behavioral technique audio messages patients may access when in increased distress

13. Mobile medical apps 12 Developed by: U-MIC eResearch section 7-2.2 Special Considerations

14. Mobile medical apps 13 Developed by: U-MIC mobile medical apps

15. THANK YOU. Brian Seabolt IRBMED 14 Developed by: U-MIC